Page last updated: 2024-11-06

aripiprazole

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Description

Aripiprazole: A piperazine and quinolone derivative that is used primarily as an antipsychotic agent. It is a partial agonist of SEROTONIN RECEPTOR, 5-HT1A and DOPAMINE D2 RECEPTORS, where it also functions as a post-synaptic antagonist, and an antagonist of SEROTONIN RECEPTOR, 5-HT2A. It is used for the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER, and as an adjunct therapy for the treatment of depression. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

aripiprazole : An N-arylpiperazine that is piperazine substituted by a 4-[(2-oxo-1,2,3,4-tetrahydroquinolin-7-yl)oxy]butyl group at position 1 and by a 2,3-dichlorophenyl group at position 4. It is an antipsychotic drug used for the treatment of Schizophrenia, and other mood disorders. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID60795
CHEMBL ID1112
CHEBI ID31236
SCHEMBL ID8255
SCHEMBL ID5335696
SCHEMBL ID12961254
MeSH IDM000602020

Synonyms (162)

Synonym
AC-1554
CHEMBL1112 ,
aripiprex
nsc-759266
abilify mycite
AKOS005558247
HY-14546
HMS3393I18
AB00639935-09
7-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}-1,2,3,4-tetrahydroquinolin-2-one
gtpl34
aristada (aripiprazole lauroxil)
abilify
abilify od
2(1h)-quinolinone, 7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydro-
7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril
aripiprazole [usan]
7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydrocarbostyril
aripiprazole depot
opc 14597
7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydro-2(1h)-quinolinone
hsdb 7320
abilitat
7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butyloxy)-3,4-dihydro-2(1h)-quinolinone
abilify discmelt
bms-337039
opc-14597
opc-31
discmelt
opc 31
aripiprazole
129722-12-9
MLS001424078
24-29-3
smr000466383
MLS000759517
cpd000466383
NCGC00159510-02
DB01238
NCGC00159510-03
aripiprazole (jan/usp/inn)
D01164
abilify (tn)
aripiprazolum
aripiprazol
MLS001165779
CHEBI:31236 ,
7-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}-3,4-dihydroquinolin-2(1h)-one
MLS001195621
HMS2051I18
HMS2093F22
HMS2089M20
bdbm50130293
7-[4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy]-3,4-dihydro-1h-quinolin-2-one
L001339
FT-0662279
FT-0662278
STK625160
A19454
abilify maintena
aripiprazole [usan:inn:ban]
nsc 759266
unii-82vfr53i78
82vfr53i78 ,
abilify maintena kit
abilify digital
dtxcid1026083
tox21_111728
cas-129722-12-9
dtxsid3046083 ,
BCP9000317
pharmakon1600-01505851
nsc759266
7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1h)-quinolinone
HMS2230M18
CCG-100891
FT-0600352
NCGC00159510-04
AB07660
CS-0766
S1975
2(1h)-quinolinone, 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-
HMS3373D04
aripiprazole [mart.]
aripiprazole [who-dd]
aripiprazole [ema epar]
aripiprazole [vandf]
aripiprazole [mi]
aripiprazole [inn]
aripiprazole [usp-rs]
aripiprazole [ep monograph]
abilify mycite kit
aripiprazole [usp monograph]
aripiprazole [jan]
aripiprazole [hsdb]
aripiprazole [orange book]
DL-178
NC00141
AM20090766
BBL029082
SCHEMBL8255
tox21_111728_1
NCGC00159510-05
KS-1030 ,
7-{4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy}-3,4-dihydrocarbostyril
7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]3,4-dihydro-2(1h)-quinolinone
7-(4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy)-3,4-dihydrocarbostyril
7-{4-[-4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy}-3,4-dihydrocarbostyril
7-[4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butoxy]-3,4-dihydro-2(1h)-quinolinone
7-{4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy}-3, 4-dihydrocarbostyril
SCHEMBL5335696
MLS006011892
7-{4-[4-(2,3-dichloro-phenyl)-piperazin-1-yl]-butoxy}-3,4-dihydro-1h-quinolin-2-one
7-(4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy)-3,4-dihydroquinolin-2(1h)-one
pripiprazole
arpizol
SCHEMBL12961254
7-(4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butoxy)-3,4-dihydroquinolin-2(1h)-one
7-[4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy]-3,4-dihydro-quinolin-2(1h)-one
AB00639935_11
AB00639935_10
J-005707
SR-01000759353-4
SR-01000759353-6
sr-01000759353
HMS3657K13
aripiprazole 1.0 mg/ml in acetonitrile
SBI-0206870.P001
HMS3715J07
7-{4-[4-(2,3-dichloro-phenyl)-piperazin-1-yl]-butoxy}-3,4-dihydro-1h-quinol in-2-one
1026778-41-5
SW197521-3
BCP04902
Q411188
aripiprazole; 7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydrocarbostyril
mfcd00892072
SY053146
Z1521553846
aripiprazole (abilify)
asprito
BRD-K70358946-001-06-6
EN300-119521
7-[4-[4-[2,3-bis(chloranyl)phenyl]piperazin-1-yl]butoxy]-3,4-dihydro-1h-quinolin-2-one
9sc ,
HMS3884E18
HMS3744A13
129722-12-9 (free base)
BA164218
aripiprazole- bio-x
aripiprazole-d8(butyl-d8)
ps25 - aripiprazole/dehydroaripiprazole
ariprazoleimpurity
aripiprazole (mart.)
aripiprazole (ep monograph)
7-(4-(4-(2,3-bis(chloranyl)phenyl)piperazin-1-yl)butoxy)-3,4-dihydro-1h-quinolin-2-one
aripiprazole (usp-rs)
7-(4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butoxy)-1,2,3,4-tetrahydroquinolin-2-one
aripiprazole orally disintegrating
n05ax12
2(1h)-quinolinone, 7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydro- list acronyms
aripiprazole (usp monograph)
aripiprazole, 1mg/ml in acetonitrile

Research Excerpts

Overview

Aripiprazole (OPC-14597) is a novel atypical antipsychotic drug that is reported to be a high-affinity D(2)-dopamine receptor partial agonist. It is prescribed for many psychiatric diseases such as schizophrenia and mania in bipolar disorder.

ExcerptReferenceRelevance
"Aripiprazole (OPC-14597) is a novel atypical antipsychotic drug that is reported to be a high-affinity D(2)-dopamine receptor partial agonist."( Aripiprazole, a novel atypical antipsychotic drug with a unique and robust pharmacology.
Arrington, E; Chiodo, LA; Liu, LX; Mailman, R; Renock, S; Roth, BL; Shapiro, DA; Sibley, DR, 2003
)
2.48
"Aripiprazole is an atypical FDA-approved anti-psychotic drug with potential against AD."( Therapeutic Effects of Aripiprazole in the 5xFAD Alzheimer's Disease Mouse Model.
Choi, JY; Jeong, YJ; Ko, YG; Lee, HJ; Oh, SJ; Park, HJ; Son, Y, 2021
)
1.65
"Aripiprazole is an antipsychotic drug used to treat schizophrenia and bipolar disorder. "( The antipsychotic aripiprazole induces peripheral antinociceptive effects through PI3Kγ/NO/cGMP/K
Aguiar, DC; de Almeida, DL; Duarte, IDG; Ferreira, RCM; Moreira, FA; Romero, TRL, 2022
)
2.5
"Aripiprazole was found to be an effective first-line antidepressant in LLD. "( Aripiprazole as First-Line Therapy for Late-Life Depression: A Case Note Review.
Sonal, A; Srivastava, S,
)
3.02
"Aripiprazole is a second-generation antipsychotic, efficacious in patients with schizophrenia during acute episodes. "( Place of the partial dopamine receptor agonist aripiprazole in the management of schizophrenia in adults: a Delphi consensus study.
Alamome, I; Azorin, JM; Drapier, D; El Hage, W; Fakra, É; Jardri, R; Llorca, PM; Mouchabac, S; Nuss, P; Rabbani, M; Simon, N; Vacheron, MN, 2022
)
2.42
"Aripiprazole is an antipsychotic with a partial agonism of dopamine D"( Aripiprazole for the treatment of schizophrenia: Recommendations of a panel of Spanish experts on its use in clinical practice.
Alamo, C; Almenta Gallego, D; Arques-Egea, S; Fraguas, D; Gómez-Revuelta, M; Hernández Huerta, D; Núñez Arias, D; Oda Plasencia-García, B; Parro Torres, C; Romero-Guillena, SL; Ros Cucurul, E; Sánchez-Lafuente, CG, 2023
)
3.8
"Aripiprazole is an atypical antipsychotic drug, which is prescribed for many psychiatric diseases such as schizophrenia and mania in bipolar disorder. "( Block of Voltage-Gated Sodium Channels by Aripiprazole in a State-Dependent Manner.
Fauler, M; Föhr, KJ; Jungwirth, B; Messerer, DAC; Rapp, M; Zimmer, T, 2022
)
2.43
"Aripiprazole seems to be an effective and well-tolerated antipsychotic drug in the treatment of CS accompanying autism."( Aripiprazole Used to Treat Capgras Syndrome in an Adolescent Diagnosed With Autism.
Baykal, S; Mutlu, C,
)
3.02
"Aripiprazole (APZ) is an atypical antipsychotic that can safeguard mice against autism-like behavior induced by valproic acid (VPA)."( Maternal treatment with aripiprazole prevents the development of a valproic acid-induced autism-like phenotype in juvenile male mice.
de Andrade, GM; de Barros Viana, GS; de Oliveira Ferreira, E; Lima, FAV; Neves, KRT; Pessoa Gomes, JM, 2023
)
1.94
"Aripiprazole is a medication used to treat psychotic symptoms in schizophrenia or bipolar I disorder (BP-I) that can be taken orally or injected into the muscle. "( A Randomized, Open-Label, Multiple-Dose, Parallel-Arm, Pivotal Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole 2-Month Long-Acting Injectable in Adults With Schizophrenia or Bipolar I Disorder.
Harlin, M; Jan, M; Jin, N; Larsen, F; Madera-McDonough, J; Such, P; Watkin, S; Yildirim, M, 2023
)
2.56
"Aripiprazole (ARI) is an atypical antipsychotic that improves some cognitive functions."( Aripiprazole combined with nerve growth factor improves cognitive function in mice with schizophrenia model.
Bai, M; Chen, H; Kang, L; Li, Q; Li, S; Lin, Y; Lu, C; Tang, Z; Xiong, P; Zhang, H, 2023
)
3.07
"Aripiprazole is an antipsychotic medicine used to treat a variety of mental disorders, including irritability linked with autism disorder in children. "( Application of a nucleophilic substitution reaction for spectrofluorimetric determination of aripiprazole in pharmaceutical dosage form and plasma matrix; greenness assessment.
Abdullah, O; Alaqel, SL; Alharbi, A; Almalki, AH; Almrasy, AA; Althobaiti, YS; Alturki, MS; Ramzy, S, 2023
)
2.57
"Aripiprazole is an atypical antipsychotic medication, and its use in treating borderline personality disorder (BPD) is debatable because it is not FDA-approved for treating BPD. "( Efficacy and Safety of Aripiprazole in Borderline Personality Disorder: A Systematic Review.
Benites-Zapata, VA; Campos-Rodriguez, SK; Fernández, MF; Ortiz-Saavedra, B; Pino-Zavaleta, DA; Valdivieso-Jiménez, G, 2023
)
2.66
"Aripiprazole is a better choice to avoid relevant short-term weight gain."( An open-label randomised comparison of aripiprazole, olanzapine and risperidone for the acute treatment of first-episode schizophrenia: Eight-week outcomes.
Cai, S; Cheng, Z; Correll, CU; Deng, H; Han, X; Lu, Z; Wang, C; Xiang, Y; Yang, F; Yang, L; Yu, X; Yuan, Y; Zhao, J, 2019
)
1.5
"Aripiprazole, which is a quinolinone derivative, has been widely used to treat schizophrenia, major depressive disorder, and bipolar disorder."( Optimization of Processing Parameters of Nanoemulsion Containing Aripiprazole Using Response Surface Methodology.
Ahmad, S; Ashari, SE; Salim, N; Samiun, WS, 2020
)
2.24
"Aripiprazole is a quinolinone derivative. "( Electrophilic Aromatic Synthesis of Radioiodinated Aripiprazole: Experimental and DFT Investigations.
Anouar, EH; Farag, ZR; Geesi, MH; Moustapha, ME, 2020
)
2.25
"Aripiprazole is an atypical antipsychotic commonly used in the treatment of childhood disorders, such as bipolar disorder, psychosis, and irritability associated with autism spectrum disorder. "( Low-dose Aripiprazole Induced Enuresis Continuum in a Child.
Karatoprak, S; Uzun, N,
)
1.99
"Aripiprazole lauroxil (AL) is a long-acting injectable antipsychotic approved for treatment of schizophrenia in adults. "( Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study.
Du, Y; Hard, M; Marandi, M; von Moltke, L; Walling, DP; Wehr, A; Weiden, PJ, 2020
)
2.21
"Aripiprazole is a third generation antipsychotic approved by the US Food and Drug Administration (FDA) for the treatment of schizophrenia. "( A safety evaluation of aripiprazole in the treatment of schizophrenia.
Preda, A; Shapiro, BB, 2020
)
2.31
"Aripiprazole is a generally well-tolerated third-generation antipsychotic with low rates of motor side effects and metabolic adverse effects that occur commonly with several alternative antipsychotics. "( A safety evaluation of aripiprazole in the treatment of schizophrenia.
Preda, A; Shapiro, BB, 2020
)
2.31
"Aripiprazole lauroxil (AL) is a long-acting atypical antipsychotic approved for the treatment of schizophrenia in adults. "( Aripiprazole Lauroxil Dosing Regimens: Understanding Dosage Strengths and Injection Intervals.
Du, Y; Faldu, S; Rege, B; Sommi, RW; Wehr, A; Weiden, PJ, 2022
)
3.61
"Aripiprazole is known to be a prolactin-sparing antipsychotic; however, data regarding its effects on prolactin and estrogens in postmenopausal women are lacking."( Prolactin and Estrogen Levels in Postmenopausal Women Receiving Aripiprazole Augmentation Treatment for Depression.
Hartz, SM; Lenze, EJ; Ma, C; Mulsant, BH; Nicol, GE; Patrick, C; Rahman, T; Reynolds, CF; Yingling, M,
)
1.09
"Aripiprazole is an atypical antipsychotic commonly used in the treatment of psychiatric disorders, such as schizophrenia, bipolar disorder, and irritability associated with autism spectrum disorder. "( Low-Dose Aripiprazole-Induced Nocturnal Enuresis in a 9-Year-Old Boy: A Case Report and the Possible Underlying Mechanism.
Özdemir, YE; Tanir, Y,
)
1.99
"Aripiprazole is a third-generation atypical antipsychotic drug that acts as a stabilizer of the dopaminergic and serotonergic system. "( Resolution of enuresis with aripiprazole in children with psychiatric disorders: two case reports.
Capizzi, M; Gliubizzi, C; Guccione, F; Mangano, S; Marino, A; Nardello, R, 2021
)
2.36
"Aripiprazole is an atypical antipsychotic drug that is metabolized by cytochrome P450 (CYP) 2D6 and CYP3A4, which mainly form its active metabolite dehydro-aripiprazole. "( Influence of CYP2D6 Phenotypes on the Pharmacokinetics of Aripiprazole and Dehydro-Aripiprazole Using a Physiologically Based Pharmacokinetic Approach.
Abad-Santos, F; Hempel, G; Kneller, LA; Koller, D; Zubiaur, P, 2021
)
2.31
"Aripiprazole monotherapy is a recommended option for the treatment of mania in BD."( Gamma oscillations predict treatment response to aripiprazole in bipolar disorder.
Arıkan, MK; Günver, G; İlhan, R; Metin, B; Öksüz, Ö, 2021
)
1.6
"Aripiprazole lauroxil is an extended-release prodrug of aripiprazole for intramuscular injection, approved for schizophrenia treatment. "( Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia.
Citrome, L; Hard, ML; Mills, RJ; Sadler, BM; Turncliff, RZ, 2017
)
3.34
"Aripiprazole is a newer atypical antipsychotic that displays a unique pharmacological profile, including partial D2 agonism and functionally selective properties. "( Aripiprazole, A Drug that Displays Partial Agonism and Functional Selectivity.
Holahan, MR; Tuplin, EW, 2017
)
3.34
"Aripiprazole is an atypical antipsychotic agent commonly used in the management of schizophrenia. "( Aripiprazole-induced hypersensitivity pneumonitis.
Gunasekaran, K; Jennings, J; Lone, N; Murthi, S, 2017
)
3.34
"Aripiprazole lauroxil (AL) is a long-acting injectable medication approved for the treatment of schizophrenia. "( Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model.
Hard, ML; Mills, RJ; Sadler, BM; von Moltke, L; Wehr, AY; Weiden, PJ, 2017
)
2.15
"Aripiprazole is an atypical antipsychotic with dopaminergic and serotonergic effects. "( Aripiprazole-Related Diurnal Enuresis in Children: 2 Cases (Aripiprazole-Related Enuresis).
Gunes, S,
)
3.02
"Aripiprazole lauroxil (AL) is a long-acting injectable atypical antipsychotic that was evaluated for the treatment of schizophrenia in a randomized, placebo-controlled, Phase 3 study. "( Effect of aripiprazole lauroxil in patients with acute schizophrenia as assessed by the Positive and Negative Syndrome Scale-supportive analyses from a Phase 3 study.
Citrome, L; Cutler, AJ; Du, Y; Nasrallah, HA; Risinger, R; Silverman, BL; Zummo, J, 2018
)
2.33
"Aripiprazole is a second generation antipsychotic widely prescribed for the treatment of psychiatric diseases. "( Aripiprazole-induced Asymptomatic Hypertension: A Case Report.
Ayhan, MG; Eren, İ; Kürkcü, A; Özbek, S; Seven, H, 2017
)
3.34
"Aripiprazole lauroxil (AL) is a long-acting injectable atypical antipsychotic recently approved for treatment of schizophrenia on the basis of a large-scale trial of two doses of AL versus placebo. "( Aripiprazole Lauroxil Compared with Paliperidone Palmitate in Patients with Schizophrenia: An Indirect Treatment Comparison.
Cameron, C; Desai, DN; Drake, C; Hutton, B; Kotb, A; Weiden, PJ; Zummo, J,
)
3.02
"Aripiprazole is an atypical antipsychotic which used for the treatment of schizophrenia and bipolar disorder."( Aripiprazole prevents renal ischemia/reperfusion injury in rats, probably through nitric oxide involvement.
Gholampour, H; Moezi, L; Shafaroodi, H, 2017
)
2.62
"Aripiprazole lauroxil (AL) is an FDA-approved treatment for schizophrenia. "( A Phase-1 Study Comparing Pharmacokinetic and Safety Profiles of Three Different Dose Intervals of Aripiprazole Lauroxil.
Hard, M; Risinger, R; Weiden, PJ, 2017
)
2.11
"Aripiprazole is a dopamine D2 receptor partial agonist that exhibits partial agonistic activity against serotonin-1A (5-HT1A) receptors and full antagonistic activity against 5-HT2A receptors."( [Efficacy of low-Dose Aripiprazole to Treat Clozapine-Associated Tardive Dystonia in a Patient with Schizophrenia].
Huh, L; Lee, BJ, 2017
)
1.49
"Aripiprazole is a dopamine D2- and serotonin 5-hydroxytryptamine (5-HT)"( Aripiprazole in treatment of Gilles de la Tourette syndrome - New therapeutic option.
Janik, P; Szejko, N,
)
3.02
"Aripiprazole lauroxil (AL) is a long-acting injectable atypical antipsychotic recently approved for the treatment of schizophrenia."( Efficacy and safety of aripiprazole lauroxil once-monthly versus aripiprazole once-monthly long-acting injectable formulations in patients with acute symptoms of schizophrenia: an indirect comparison of two double-blind placebo-controlled studies.
Cameron, C; Desai, D; Drake, C; Hutton, B; Kotb, A; Weiden, PJ; Zummo, J, 2018
)
2.23
"Aripiprazole is a new drug for the treatment of adults with schizophrenia. "( Aripiprazole-induced transient myopia: A rare entity.
Alam, MS; Chiranjeevi, P; Praveen Kumar, KV, 2018
)
3.37
"Aripiprazole is a second-generation antipsychotics, acting as a partial dopamine D2 receptor agonist. "( Switching antipsychotic treatment to aripiprazole in psychotic patients with neuroleptic-induced tardive dyskinesia: a 24-week follow-up study.
Chan, CH; Chan, HY; Chen, YC, 2018
)
2.2
"Aripiprazole is an effective and safe augmentation for treatment resistance."( Advances in Pharmacotherapy of Late-Life Depression.
Beyer, JL; Johnson, KG, 2018
)
1.2
"Aripiprazole is an atypical antipsychotic drug approved worldwide for treatment of acute and long term schizophrenia in adults. "( Aripiprazole Nanocrystal Impregnated Buccoadhesive Films for Schizophrenia.
Al-Dhubiab, BE, 2017
)
3.34
"Aripiprazole is a third-generation atypical antipsychotic medication, which is widely used for various psychiatric disorders across the lifespan. "( Aripiprazole-Induced Neutropenia: Case Report and Literature Review.
Chaudhary, AM; Felin, T; Naveed, S, 2018
)
3.37
"Aripiprazole is an atypical antipsychotic with a long half-life. "( Prolonged QRS Widening After Aripiprazole Overdose.
Dewey, K; Mazer-Amirshahi, M; Porter, R, 2019
)
2.25
"Aripiprazole is a second generation antipsychotic medication that has been a useful addition to the treatment of severe mental illness due to its low metabolic and sedation risk profile. "( Aripiprazole and pregnancy: A retrospective, multicentre study.
Frayne, J; Galbally, M; Snellen, M; Watson, SJ, 2018
)
3.37
"Aripiprazole is an atypical antipsychotic drug with a polypharmacological mechanism of action and a favorable tolerability profile. "( Aripiprazole-induced atrial fibrillation in a patient with concomitant risk factors.
Anastasia, A; D'Urso, G; de Bartolomeis, A; Patti, S; Toscano, E, 2018
)
3.37
"Aripiprazole lauroxil is an LAI that offers multiple dosing options but requires oral treatment overlap during initiation for the first 21 consecutive days."( Aripiprazole Lauroxil NanoCrystal
Clark, C; Davis, E; Ehret, MJ; Luttrell, SE,
)
2.3
"Aripiprazole is an atypical antipsychotic drug that is commonly used in children and adolescents."( Aripiprazole-Induced Hoarseness: A Case Report.
Çam Ray, P; Işik, Ü,
)
3.02
"Aripiprazole is an interesting psychoactive compound acting as a dopamine D2 partial agonist, serotonin 5-HT(1A) partial agonist and serotonin 5-HT(2A) antagonist. "( Aripiprazole-induced persistent hiccup: a case report and review of the literature.
Amore, M; Belvederi Murri, M; Cervetti, A; Monacelli, F; Piccinini, G; Pompili, M; Serafini, G; Visimberga, S, 2019
)
3.4
"Aripiprazole is an atypical antipsychotic with partial agonism at dopamine and serotonin receptors. "( Aripiprazole Toxicity With a Biphasic Course of Somnolence.
Gupta, D; OʼHara, C, 2019
)
3.4
"Aripiprazole is a new drug applied in schizophrenia treatment. "( [Application of HPLC-UV method for aripiprazole determination in serum].
Florek, E; Gomółka, E; Piekoszewski, W; Synowiec, A; Zieba, A; Zyss, T, 2012
)
2.1
"Aripiprazole is an antipsychotic drug with a variant but not absent adverse effect profile."( Aripiprazole versus other atypical antipsychotics for schizophrenia.
El-Sayeh, HG; Hunger, H; Khanna, P; Komossa, K; Leucht, S; Rummel-Kluge, C; Schwarz, S, 2013
)
2.55
"Aripiprazole LAI (ALAI) is a lyophilized powder that needs to be reconstituted with sterile water to form an injectable suspension without affecting the original molecule."( Long-acting injectable aripiprazole: how might it fit in our tool box?
Aggarwal, A; Gopalakrishna, G; Lauriello, J, 2013
)
1.42
"Aripiprazole is an atypical antipsychotic drug which belongs to the benzisoxazole derivatives. "( Aripiprazole.
Ardiana, F; Indrayanto, G; Lestari, ML, 2013
)
3.28
"Aripiprazole is a second-generation antipsychotic that is increasingly being prescribed to children and adolescents. "( Repeated aripiprazole treatment causes dopamine D2 receptor up-regulation and dopamine supersensitivity in young rats.
Charntikov, S; Crawford, CA; Der-Ghazarian, T; Lee, RJ; McDougall, SA; Varela, FA, 2014
)
2.26
"Aripiprazole is an effective treatment for mania in a population that includes adults, children and adolescents, although its use leads to gastrointestinal disturbances and movement disorders. "( Aripiprazole alone or in combination for acute mania.
Brown, R; Geddes, J; Taylor, MJ, 2013
)
3.28
"Aripiprazole is a drug with partial agonist activity at the level of dopamine receptors D2, which may be effective for antipsychotic- induced hyperprolactinemia."( Treatment of antipsychotic-induced hyperprolactinemia: an update on the role of the dopaminergic receptors D2 partial agonist aripiprazole.
Cavuto, M; De Berardis, D; Di Giannantonio, M; Fornaro, M; Girinelli, G; Iasevoli, F; Marini, S; Martinotti, G; Mazza, M; Perna, G; Piersanti, M; Serroni, N; Valchera, A, 2014
)
1.33
"Aripiprazole is an antipsychotic drug with an important adverse effect profile."( Aripiprazole versus other atypical antipsychotics for schizophrenia.
El-Sayeh, HG; Khanna, P; Komossa, K; Leucht, S; Ma, H; Rummel-Kluge, C; Suo, T; Xia, J, 2014
)
2.57
"Aripiprazole (Abilify(®)) is an atypical antipsychotic that is widely used in the treatment of psychiatric conditions. "( Aripiprazole: a review of its use in the treatment of manic episodes in adolescents with bipolar I disorder.
McKeage, K, 2014
)
3.29
"Aripiprazole is a partial agonist at dopamine (D2) and serotonin (5-HT1a) receptors and 5-HT2 antagonist. "( Aripiprazole effects on self-administration and pharmacodynamics of intravenous cocaine and cigarette smoking in humans.
Campbell, C; Lofwall, MR; Nuzzo, PA; Walsh, SL, 2014
)
3.29
"Aripiprazole (ARI) is an atypical antipsychotic drug, which has also been shown to have a beneficial effect on cognitive function."( Evaluation of antidepressant and memory-improving efficacy of aripiprazole and fluoxetine in alcohol-preferring rats.
Burda-Malarz, K; Czubak, A; Jędrzejewski, L; Kus, K; Nowakowska, E; Ratajczak, P; Sadowski, C, 2014
)
1.36
"Aripiprazole (ABILIFY(®)) is an atypical antipsychotic drug that is proposed to act via partial agonism of dopamine D2 receptors. "( Aripiprazole (ABILIFY MAINTENA®): a review of its use as maintenance treatment for adult patients with schizophrenia.
Perry, CM; Shirley, M, 2014
)
3.29
"Aripiprazole (ARI) is a second-generation antipsychotic acting as a dopamine-serotonin system stabilizer and partial agonist at D2 receptors. "( A safety evaluation of aripiprazole for treating schizophrenia during pregnancy and puerperium.
Gentile, S, 2014
)
2.16
"Aripiprazole is an antipsychotic that acts as a partial agonist at dopamine D2 receptors, with a favorable pharmacological profile. "( The antipsychotic aripiprazole selectively prevents the stimulant and rewarding effects of morphine in mice.
Aguiar, DC; Almeida-Santos, AF; Duarte, ID; Ferreira, RC; Gobira, PH; Moreira, FA; Romero, TR; Souza, DP, 2014
)
2.18
"Aripiprazole lauroxil is a linker lipid ester of aripiprazole for extended-release intramuscular (IM) injection. "( Relative bioavailability and safety of aripiprazole lauroxil, a novel once-monthly, long-acting injectable atypical antipsychotic, following deltoid and gluteal administration in adult subjects with schizophrenia.
Du, Y; Ehrich, EW; Hard, M; Risinger, R; Turncliff, R, 2014
)
2.11
"Aripiprazole is an antipsychotic drug that shows a partial agonistic activity at D2 receptors."( Severe exacerbation of psychosis after sudden withdrawal of chlorpromazine in the treatment of methamphetamine-associated psychosis with aripiprazole and chlorpromazine: 2 case reports.
Devi Thakoor, JP; Hao, W; Wang, G; Wang, X,
)
1.06
"Aripiprazole is a second-generation antipsychotic drug with partial dopamine agonistic activity. "( Aripiprazole induced non-cardiogenic pulmonary edema: a case report.
Cakıcı, M; Celik, M; Cetin, M; Polat, M; Suner, A, 2014
)
3.29
"Aripiprazole is an atypical antipsychotic with proven efficacy in schizophrenia and bipolar I disorder, with a pharmacological profile distinct from other available antipsychotics and a side-effect profile that is different from other agents in the class; these characteristics make it a possible alternative in patients requiring a change in antipsychotic treatment due to lack of efficacy or persistent side-effects."( Switching antipsychotic medication to aripiprazole: position paper by a panel of Italian psychiatrists.
Brugnoli, R; De Filippis, S; Di Sciascio, G; Fagiolini, A; Maina, G, 2015
)
1.41
"Aripiprazole is an atypical antipsychotic that acts as a partial agonist at dopamine D2 receptors. "( Aripiprazole-Induced Hypoprolactinemia in an Adult Male with First-Episode Psychosis.
Jarvis, GE; Margolese, HC; Propst, AJ, 2016
)
3.32
"Aripiprazole is a novel atypical antipsychotic."( The Effects of Sub-Chronic Treatment with Aripiprazole on Pentylenetetrazole- and Electroshock-Induced Seizures in Mice: The Role of Nitric Oxide.
Hosseini, M; Moezi, L; Niknahad, H; Oveisi, S; Shafaroodi, H, 2015
)
1.4
"Aripiprazole is an antipsychotic drug which acts through dopamine and serotonin receptors. "( The effect of acute aripiprazole treatment on chemically and electrically induced seizures in mice: The role of nitric oxide.
Hosseini, M; Moezi, L; Niknahad, H; Oveisi, S; Shafaroodi, H, 2015
)
2.18
"Aripiprazole is a wide-used antipsychotic drug with therapeutic effects on both positive and negative symptoms of schizophrenia, and reduced side-effects. "( Unique Effects of Acute Aripiprazole Treatment on the Dopamine D2 Receptor Downstream cAMP-PKA and Akt-GSK3β Signalling Pathways in Rats.
Chen, J; Deng, C; Huang, XF; Lian, J; Pan, B, 2015
)
2.17
"Aripiprazole is a low-risk antipsychotic regarding cardiac safety in healthy patients. "( The cardiac safety of aripiprazole treatment in patients at high risk for torsade: a systematic review with a meta-analytic approach.
Graff, C; Kanters, JK; Meyer, J; Nielsen, J; Polcwiartek, C; Sneider, B; Taylor, D, 2015
)
2.17
"Aripiprazole is an antipsychotic that acts as a partial agonist at dopamine D2 receptors. "( Effects of aripiprazole on caffeine-induced hyperlocomotion and neural activation in the striatum.
Aguiar, DC; Batista, LA; Moreira, FA; Silveira, VT; Viana, TG, 2016
)
2.27
"Aripiprazole is an antipsychotic that acts by multiple mechanisms, including partial agonism at dopamine D2 and serotonin 5-HT1A receptors. "( The antipsychotic aripiprazole induces antinociceptive effects: Possible role of peripheral dopamine D2 and serotonin 5-HT1A receptors.
Aguiar, DC; Almeida-Santos, AF; Duarte, ID; Ferreira, RC; Moreira, FA; Romero, TR, 2015
)
2.19
"Aripiprazole is a third-generation antipsychotic with a dopamine receptor-binding profile distinct from other second-generation antipsychotics."( Aripiprazole.
Prommer, E, 2017
)
2.62
"Aripiprazole is a partial D2 receptor agonist, whereas DRT includes full D2 receptor agonist."( Pathological Gambling Associated With Aripiprazole or Dopamine Replacement Therapy: Do Patients Share the Same Features? A Review.
Challet-Bouju, G; Derkinderen, P; Etcheverrigaray, F; Gaboriau, L; Grall-Bronnec, M; Jolliet, P; Leboucher, J; Perrouin, F; Sauvaget, A; Victorri-Vigneau, C, 2016
)
1.43
"Aripiprazole is a D2 receptor partial agonist hypothesised to enhance PFC dopamine functioning, possibly improving working memory."( An investigation into aripiprazole's partial D₂ agonist effects within the dorsolateral prefrontal cortex during working memory in healthy volunteers.
Deakin, JF; Dursun, S; Elliott, R; McKie, S; Murphy, A, 2016
)
1.47
"Aripiprazole is a partial dopamine agonist with low sedation, relatively favourable metabolic profile and a tendency to lower, rather than raise, prolactin. "( Aripiprazole long-acting injection: promising but more evidence needed.
Culhane, C; Hope, J; Keks, NA, 2016
)
3.32
"Aripiprazole is a first or second line treatment frequently used because it has reduced side effects such as weight gain, sleepiness, dyslipidemia, insulin resistance, hyperprolactinemia and extrapyramidal symptoms."( [Aripiprazole, gambling disorder and compulsive sexuality].
Dafreville, C; Mété, D; Paitel, V; Wind, P, 2016
)
2.07
"Aripiprazole is an antipsychotic associated with reduced side effects compared to other antipsychotics. "( [Aripiprazole, gambling disorder and compulsive sexuality].
Dafreville, C; Mété, D; Paitel, V; Wind, P, 2016
)
2.79
"Aripiprazole is a third generation antipsychotic drug that possesses a unique pharmacodynamic profile, which in conjunction with recently published scientific data on the drugs' influence on antidepressant, anxiolytic and cognitive functions, suggests a highly positive future potential for restorative cognitive treatment and ongoing healthy function."( Cognitive Impairment in Schizophrenia, Neurotransmitters and the New Atypical Antipsychotic Aripiprazole.
Getova, DP; Topolov, MK, 2016
)
1.38
"Aripiprazole is an atypical antipsychotic approved for the treatment of irritability and aggression in children and adolescents aged 6-17 years with autism spectrum disorder."( Aripiprazole for the treatment of irritability and aggression in children and adolescents affected by autism spectrum disorders.
Pavone, P; Rizzo, R, 2016
)
3.32
"Aripiprazole is a D2-like receptor (D2R) partial agonist with a favourable clinical profile. "( Chronic administration of aripiprazole activates GSK3β-dependent signalling pathways, and up-regulates GABAA receptor expression and CREB1 activity in rats.
Deng, C; Huang, XF; Pan, B, 2016
)
2.18
"Aripiprazole is a partial dopamine agonist with only minor neurological and psychiatric adverse effects, making it a potential first-line drug for the treatment of psychiatric disorders. "( Neurological, Metabolic, and Psychiatric Adverse Events in Children and Adolescents Treated With Aripiprazole.
Bruhn, CH; Fink-Jensen, A; Jakobsen, KD; Nielsen, J; Pagsberg, AK, 2016
)
2.09
"Aripiprazole augmentation is an efficacious strategy in older depressed adults who fail to remit with two or more adequate antidepressant trials, including a course of venlafaxine."( Impact of Prior Treatment on Remission of Late-Life Depression with Venlafaxine and Subsequent Aripiprazole or Placebo Augmentation.
Blumberger, DM; Hsu, JH; Karp, JF; Lavretsky, H; Lenze, EJ; Mulsant, BH; Reynolds, CF; Roose, SP, 2016
)
2.1
"Aripiprazole is a unique atypical antipsychotic with partial agonist activity on the dopamine-2 (D2) receptor. "( Risk of Extrapyramidal Adverse Events With Aripiprazole.
Carleton, BC; Etminan, M; Procyshyn, RM; Samii, A, 2016
)
2.14
"Aripiprazole once-monthly is a second generation antipsychotic recently developed."( Aripiprazole once-monthly as treatment for psychosis in Turner syndrome: literature review and case report.
Carlone, C; Nicolò, G; Pompili, E; Silvestrini, C,
)
2.3
"Aripiprazole is an antipsychotic that acts as a partial agonist at dopamine D2 receptors. "( Movement Disorders Induced by the "Atypical" Antipsychotic Aripiprazole.
Chouinard, S; Huot, P; Selfani, K; Soland, VL, 2017
)
2.14
"Aripiprazole (ARP) is a popular antipsychotic drug that has demonstrated ameliorative effects on hyperprolactinemia. "( Partial regimen replacement with aripiprazole reduces serum prolactin in patients with a long history of schizophrenia: A case series.
Abe, H; Funahashi, H; Ishida, Y; Naono, H; Naono-Nagatomo, K; Takeda, R; Uchimura, D, 2017
)
2.18
"Aripiprazole is a partial agonist for the dopamine D2, serotonin 5-HT1A receptors, and an antagonist for 5HT2A receptors."( [Acute Dystonia due to Aripiprazole Use in Two Children with Autism Spectrum Disorder in the First Five Years of Life].
Kabukçu Başay, B; Küçükköse, M, 2017
)
1.49
"Aripiprazole, which acts as a dopamine/5-HT system stabilizer, approaches the optimal characteristics sought in medication to be considered for testing in the treatment of alcohol dependence."( Aripiprazole in the treatment of patients with alcohol dependence: a double-blind, comparison trial vs. naltrexone.
Di Giannantonio, M; Di Nicola, M; Janiri, L; Martinotti, G, 2009
)
2.52
"Aripiprazole is a second-generation antipsychotic that seems to have a favorable side-effect profile."( The safety of the electroconvulsive therapy-aripiprazole combination: four case reports.
Karakatsanis, NA; Karapoulios, E; Kouzoupis, AV; Masdrakis, VG; Oulis, P; Soldatos, CR; Zervas, IM, 2008
)
1.33
"Aripiprazole is a fairly new atypical antipsychotic substance. "( Large variability of aripiprazole and dehydroaripiprazole serum concentrations in adolescent patients with schizophrenia.
Bachmann, CJ; Heinzel-Gutenbrunner, M; Hiemke, C; Remschmidt, H; Rieger-Gies, A; Theisen, FM, 2008
)
2.11
"Aripiprazole is a first next-generation atypical antipsychotic drug with dopamine system stabilizing, serotonin (5-hydroxytryptamine, 5-HT) 5-HT1A receptor partial agonistic, and 5-HT2A receptor antagonistic properties. "( Aripiprazole inhibits marble-burying behavior via 5-hydroxytryptamine (5-HT)1A receptor-independent mechanisms.
Abe, M; Egashira, N; Fujiwara, M; Iwasaki, K; Matsushita, M; Mishima, K; Nishimura, R; Oishi, R; Okuno, R, 2008
)
3.23
"Aripiprazole is a relatively new antipsychotic drug, said to be the prototype of a new third generation of antipsychotics; the so-called dopamine-serotonin system stabilisers. "( Aripiprazole versus typical antipsychotic drugs for schizophrenia.
Bhattacharjee, J; El-Sayeh, HG, 2008
)
3.23
"Aripiprazole is a new antipsychotic agent that has proven safe and efficacious in controlled clinical trials. "( Combination of aripiprazole and other psychopharmacological treatments in resistant and multi-resistant patients.
Barbero, JD; Benito, N; Cobo Gómez, JV; Coronas, R; Domenech, C; Fuste, G; García-Parés, G; Gómez, JV, 2008
)
2.14
"Aripiprazole is a novel atypical antipsychotic drug with neuroprotective properties. "( Aripiprazole and its human metabolite OPC14857 reduce, through a presynaptic mechanism, glutamate release in rat prefrontal cortex: possible relevance to neuroprotective interventions in schizophrenia.
Wang, SJ; Yang, TT, 2008
)
3.23
"Aripiprazole is a dopamine partial agonist approved for use in adults for short- and long-term treatment of schizophrenia and bipolar disorder. "( A multiple-center, randomized, double-blind, placebo-controlled study of oral aripiprazole for treatment of adolescents with schizophrenia.
Carson, WH; Findling, RL; Forbes, RA; Ivanova, S; Iwamoto, T; Jin, N; Marcus, R; McQuade, RD; Nyilas, M; Robb, A, 2008
)
2.02
"Aripiprazole is an efficacious and well-tolerated add-on treatment for sertraline-resistant BPD patients."( Efficacy and tolerability of aripiprazole augmentation in sertraline-resistant patients with borderline personality disorder.
Bellino, S; Bogetto, F; Paradiso, E, 2008
)
1.36
"Aripiprazole is a new dopaminergic agent and has been reported to be clinically useful as an antipsychotic drug with reduced extrapyramidal motor side effects."( Aripiprazole-induced rabbit syndrome: a case report.
Caykoylu, A; Deniz, O; Ekinci, O; Kuloglu, M, 2010
)
2.52
"Aripiprazole is a second-generation antipsychotic that is increasingly prescribed in a variety of psychiatric disorders. "( Predictors of aripiprazole treatment continuation in hospitalized patients.
Ammerman, DK; Coley, KC; Fabian, TJ; Ganguli, R; Kim, E; Kim, MS; Saul, MI; Scipio, TM; Whitehead, R, 2008
)
2.15
"Aripiprazole is an effective antipsychotic in the long-term treatment of both positive and negative symptoms. "( Long-term efficacy and safety of aripiprazole in patients with schizophrenia, schizophreniform disorder, or schizoaffective disorder: 26-week prospective study.
Cho, SJ; Jang, JH; Kang, DH; Kim, YK; Kwon, JS; Yoo, SY, 2009
)
2.08
"Aripiprazole is a new generation antipsychotic drug with a partial agonist effect on dopamine D2 and D3 receptors. "( Aripiprazole in combination with other antipsychotic drugs may worsen psychosis.
Adan-Manes, J; Garcia-Parajua, P, 2009
)
3.24
"Aripiprazole is an atypical antipsychotic drug primarily characterized by partial agonist activity at dopamine(DA) D2 receptors and serotonin-1A (5-hydroxytryptamine, 5-HT1A) receptors and minimal side effects.Based on its pharmacological profile, including stabilization of mesocorticolimbic DA activity (a pathway implicated in drug addiction), we investigated the effects of aripiprazole on relapse to morphine seeking in rats. "( Aripiprazole blocks reinstatement but not expression of morphine conditioned place preference in rats.
Li, SX; Liu, LJ; Lu, L; Wu, P; Zou, Y, 2009
)
3.24
"Aripiprazole acts as a partial agonist at dopamine D2 and D3 and serotonin 1A receptors and as an antagonist at serotonin 2A receptors (HTR2A). "( HTR2A A-1438G/T102C polymorphisms predict negative symptoms performance upon aripiprazole treatment in schizophrenic patients.
Chen, CH; Chen, SF; Shen, YC, 2009
)
2.02
"Aripiprazole (ABILIFY) is an effective antipsychotic used in a dose range from 10 to 30 mg, administered once daily. "( Psychosocial functioning in patients with schizophrenia treated with aripiprazole - an office-based real-world setting. Results from the German post-marketing surveillance study.
Bergmann, F; Ebrecht, M; Kungel, M; Modell, S; Nass, A; Spevakné-Göröcs, T; Urban, R; Werner, C; Zacher, A, 2009
)
2.03
"Aripiprazole is a potent (high-affinity) partial agonist at D2 and 5-HT1A receptors and a potent antagonist at 5-HT2A receptor and is associated with less weight gain than olanzapine."( Aripiprazole added to overweight and obese olanzapine-treated schizophrenia patients.
Borba, CP; Boxill, R; Cather, C; Copeland, PM; Evins, AE; Fan, X; Freudenreich, O; Goff, DC; Henderson, DC; Sharma, B, 2009
)
2.52
"Aripiprazole is a novel antipsychotic medication characterized by partial agonism at the D2 and 5-HT1A receptors and by antagonism at the 5-HT2A receptor. "( Aripiprazole in L-dopa-induced dyskinesias: a one-year open-label pilot study.
Bernardi, S; Edito, F; Meco, G; Purcaro, C; Stirpe, P; Valente, M; Vanacore, N, 2009
)
3.24
"Aripiprazole (ARI) is an atypical antipsychotic approved by the Food and Drug Administration for use in major depressive disorder as an adjunct to antidepressants. "( Electrophysiological studies in the rat brain on the basis for aripiprazole augmentation of antidepressants in major depressive disorder.
Blier, P; Chernoloz, O; El Mansari, M, 2009
)
2.04
"Aripiprazole is an atypical antipsychotic that has been shown to be more effective than placebo and at least as effective as haloperidol and risperidone in the treatment of schizophrenia and schizoaffective disorder. "( Aripiprazole: dose-response relationship in schizophrenia and schizoaffective disorder.
Mace, S; Taylor, D, 2009
)
3.24
"Aripiprazole (Abilify) is an atypical antipsychotic drug characterized by partial agonist activity at dopamine (DA) D(2)/D(3) receptors and a low side-effect profile. "( Repeated aripiprazole administration attenuates cocaine seeking in a rat model of relapse.
Do, PH; Feltenstein, MW; See, RE, 2009
)
2.21
"Aripiprazole is an atypical antipsychotic with a pharmacological profile, different from other atypical antipsychotics. "( [Aripiprazole induced Parkinsonism: A case report].
Germain, C; Pasquier de Franclieu, S; Petitjean, F, 2009
)
2.71
"Aripiprazole is an atypical antipsychotic that is a partial agonist at the D2 and 5HT1a receptors and an antagonist at 5HT2a receptors. "( Movement disorders associated with aripiprazole use: a case series.
Agarwal, P; Griffith, A; Hall, DA; Seeberger, LC; Segro, V, 2009
)
2.07
"Aripiprazole appears to be a safe and tolerable treatment in children and adolescents with TD that appears to reduce tics; it should be further investigated as a treatment option in controlled trials."( Aripiprazole in children and adolescents with Tourette's disorder: an open-label safety and tolerability study.
Coffey, BJ; Goldman, R; Hirsch, S; Jummani, R; Lyon, GJ; Samar, S; Spirgel, A, 2009
)
3.24
"Aripiprazole acts as a potential dopamine partial agonist and the dopamine blockade in the basal ganglia might be one of the causes of urinary incontinence and enuresis."( Use of aripiprazole in clozapine induced enuresis: report of two cases.
Kim, CE; Lee, MJ, 2010
)
1.54
"Aripiprazole is an atypical antipsychotic that has been found to improve positive and negative symptoms of schizophrenia with a favorable adverse-effect profile."( Aripiprazole in schizophrenia and schizoaffective disorder: A review.
Stip, E; Tourjman, V, 2010
)
2.52
"Aripiprazole is a 3(rd) generation atypical antipsychotic U.S."( Aripiprazole: a drug with a novel mechanism of action and possible efficacy for alcohol dependence.
Anton, RF; Vergne, DE, 2010
)
2.52
"Aripiprazole is a relatively new therapeutic option due to its partial D2 agonism."( Favourable results in treatment-resistant schizophrenic patients under combination of aripiprazole with clozapine.
Asenbaum, S; Barnas, C; Fischer, P; Mossaheb, N; Spindelegger, C, 2010
)
1.31
"Aripiprazole is an atypical antipsychotic indicated for the treatment of adult patients with schizophrenia. "( Trial of aripiprazole in the treatment of first-episode schizophrenia.
Hahn, SW; Ham, BJ; Kang, RH; Lee, HY; Lee, MS; Paik, JW, 2010
)
2.22
"Aripiprazole is an effective and well-tolerated antipsychotic agent in patients with first-episode schizophrenia. "( Trial of aripiprazole in the treatment of first-episode schizophrenia.
Hahn, SW; Ham, BJ; Kang, RH; Lee, HY; Lee, MS; Paik, JW, 2010
)
2.22
"Aripiprazole is an atypical or newer generation antipsychotic with a unique mechanism of action impacting dopaminergic and serotonergic neurotransmission."( Aripiprazole in autism spectrum disorders and fragile X syndrome.
Erickson, CA; McDougle, CJ; Posey, DJ; Stigler, KA, 2010
)
2.52
"Aripiprazole is a unique antipsychotic that seems to act as a partial agonist at dopamine D2-receptors, contrasting with other drugs in this class, which are silent antagonists. "( Anti-aversive effects of the atypical antipsychotic, aripiprazole, in animal models of anxiety.
Biojone, C; Casarotto, PC; Guimarães, FS; Moreira, FA; Resstel, LB; Zangrossi, H, 2011
)
2.06
"Aripiprazole is a dopamine D2/D3 receptor partial agonist that is currently used as an antipsychotic drug in clinical settings."( Repetitive administration of aripiprazole enhances locomotor response to methamphetamine in mice.
Chen, CH; Cheng, MC; Hsu, SH, 2011
)
1.38
"Aripiprazole is a dopamine D(2) receptor partial agonist undergoing evaluation as a pharmacotherapy for stimulant-use disorders. "( Discriminative stimulus, subject-rated and cardiovascular effects of cocaine alone and in combination with aripiprazole in humans.
Glaser, PE; Hays, LR; Lile, JA; Rush, CR; Stoops, WW, 2011
)
2.03
"Aripiprazole is a novel, third-generation antipsychotic with comparable efficacy to SGAs, but a more favorable side effect profile."( Aripiprazole as a viable alternative for treating delusions of parasitosis.
Bhutani, T; Busse, KL; Koo, JY; Ladizinski, B, 2010
)
2.52
"Aripiprazole is an atypical antipsychotic that acts as a partial D2 dopamine and a serotonin 5-HT₁(A) agonist and a serotonin 5-HT₂(A) antagonist."( Attenuation of reinforcing and psychomotor stimulant effects of amphetamine by aripiprazole.
Bäckström, P; Etelälahti, TJ; Hyytiä, P, 2011
)
1.32
"Aripiprazole is an atypical neuroleptic with a unique mechanism of action. "( Efficacy of high-dose aripiprazole for treatment-resistant schizoaffective disorder: a case report.
Gumus, S; Kamberyan, K; Saatcioglu, O; Yanik, M, 2010
)
2.12
"Aripiprazole is a partial agonist at dopamine D(2) and D(3) and serotonin 5-HT(1A) receptors, and is an antagonist at 5-HT(2A) receptors."( Aripiprazole as adjunctive therapy for patients with major depressive disorder: overview and implications of clinical trial data.
Forbes, A; Pae, CU; Patkar, AA, 2011
)
2.53
"aripiprazole has proven to be an effective medication for the acute treatment of manic and mixed episodes, as well as for the prophylactic-maintenance phase of bipolar disorder in patients recovering from a manic/mixed episode. "( Aripiprazole for the treatment of bipolar disorder: a review of current evidence.
Casamassima, F; Fagiolini, A; Forgione, RN; Marra, FS; Nitti, M, 2011
)
3.25
"Aripiprazole is an atypical antipsychotic approved for the treatment of irritability associated with autistic disorder in pediatric patients aged 6-17 years. "( Aripiprazole: in the treatment of irritability associated with autistic disorder in pediatric patients.
Curran, MP, 2011
)
3.25
"Aripiprazole, which is a partial dopamine D2 receptor agonist, may have an impact on cognitive dysfunction in patients with schizophrenia."( Effect of adjunctive treatment with aripiprazole to atypical antipsychotics on cognitive function in schizophrenia patients.
Kaneda, A; Kaneko, S; Sugawara, N; Tomita, T; Yasui-Furukori, N, 2012
)
1.38
"Aripiprazole appears to be an alternative for children and adolescents who are vulnerable to these side effects and are having trouble coping with them."( [Aripiprazole use in children and adolescent psychiatric patients].
Bentué-Ferrer, D; Chevreuil, C; Guillemot, P; Lemonnier, E; Polard, E,
)
1.76
"Aripiprazole is a drug belonging to the group of atypical antipsychotics. "( Aripiprazole induced transient myopia: a case report and review of literature.
Biswas, J; Gandhi, RA; George, RJ; Nair, AG, 2012
)
3.26
"Aripiprazole is an antipsychotic agent to treat schizophrenia, which acts through dopamine D(2) partial agonism, serotonin 5-HT(1A) partial agonism and 5-HT(2A) antagonism. "( Neurobehavioral and genotoxic parameters of antipsychotic agent aripiprazole in mice.
Camacho, LR; Celso, F; Da Rosa, KM; Da Silva, TG; Dos Santos, Bde J; Freitas, TM; Monteiro, JD; Pereira, P; Picada, JN; Pontes, VM; Vieira, LR, 2011
)
2.05
"Aripiprazole is an eff ective and well-tolerated treatment for ADHD and CD symptoms; however, additional studies (specifically, placebo-controlled and double-blind studies) are needed to better defi ne the clinical use of aripiprazole in children and adolescents with ADHD-CD."( Aripiprazole in children and adolescents with conduct disorder: a single-center, open-label study.
Akyol Ardic, U; Ardıc, UA; Ercan, E; Ercan, ES; Uysal, T, 2012
)
3.26
"Aripiprazole is a new, atypical antipsychotic with a unique mechanism of action, which may have positive effects on cognitive functions."( Influence of aripiprazole on the antidepressant, anxiolytic and cognitive functions of rats.
Burda, K; Czubak, A; Kus, K; Nowakowska, E; Ratajczak, P; Zin, J, 2011
)
1.46
"Aripiprazole is an atypical antipsychotic with a pharmacological and clinical profile distinct from other atypical antipsychotics."( Aripiprazole in patients with bipolar mania and beyond: an update of practical guidance.
Abbar, M; Ågren, H; Altamura, AC; Bellivier, F; Fountoulakis, KN; Goodwin, GM; Grunze, H; Holsboer-Trachsler, E; Licht, RW; Pitchot, W; Schlaepfer, TE; Vieta, E, 2011
)
3.25
"Aripiprazole is a neuroleptic to consider in the treatment of delusional parasitosis."( [Delusional parasitosis associated with dialysis treated with aripiprazole].
Choi, KM; Duarte, C; Li, CL,
)
1.09
"Aripiprazole (Abilify®) is an atypical antipsychotic indicated for the treatment of mania associated with bipolar I disorder. "( Aripiprazole: a review of its use in the management of mania in adults with bipolar I disorder.
Dhillon, S, 2012
)
3.26
"Aripiprazole is a new generation antipsychotic drug that shows a partial agonistic activity at D(2) and 5-HT(1A) receptors. "( Severe psychotic exacerbation during combined treatment with aripiprazole/haloperidol after prior treatment with risperidone.
Grohmann, R; Holl, AK; Letmaier, M; Painold, A; Vergin, H, 2012
)
2.06
"Aripiprazole is an important antipsychotic drug. "( Determination of aripiprazole in rat plasma and brain using ultra-performance liquid chromatography/electrospray ionization tandem mass spectrometry.
Bartlett, MG; Liang, F; Terry, AV, 2012
)
2.16
"Oral aripiprazole (Abilify®) is an atypical antipsychotic agent that is approved worldwide for use in adult patients with schizophrenia. "( Aripiprazole: a review of its use in the management of schizophrenia in adults.
Croxtall, JD, 2012
)
2.34
"Aripiprazole is an atypical antipsychotic with unique pharmacological properties, used for a variety of indications, including psychotic and mood disorders in youth. "( Aripiprazole in pediatric psychosis and bipolar disorder: a clinical review.
Doey, T, 2012
)
3.26
"Aripiprazole is a dopamine D/D3 and serotonin 5-HT1A receptor partial agonist which is approved for treatment of schizophrenia. "( [Pharmacology of antipsychotics at human dopamine D2 and D3 receptors].
Kikuchi, T; Tadori, Y, 2012
)
1.82
"Aripiprazole is a partial dopamine D2-receptor antagonist that blocks dopamine at higher dopamine concentrations and augments/releases prefrontal cortex dopamine at lower concentrations."( Impulse control loss rapidly reversed by aripiprazole in a patient with concomitant bipolar disease type I and posttraumatic frontal lobe lesions.
Khemiri, L; Moreira, T; Runeson, L, 2011
)
1.36
"Aripiprazole is an atypical neuroleptic with agonistic and antagonistic dopaminergic and serotonergic effects. "( Aripiprazole for the treatment of Tourette syndrome: a case series of 100 patients.
Bokemeyer, S; Kleimann, A; Müller-Vahl, KR; Wenzel, C, 2012
)
3.26
"Aripiprazole is an effective first-line treatment for acute bipolar mania with a favorable safety/tolerability profile."( A UK panel consensus on the initiation of aripiprazole for the treatment of bipolar mania.
Bobmanuel, S; Davies, W; Dratcu, L; Farmer, A; George, M; Rana, T; Singh, M; Turner, M, 2012
)
2.09
"Aripiprazole is an atypical antipsychotic approved for pediatric use in schizophrenia, bipolar I disorder, and autistic disorder."( The effects of aripiprazole on electrocardiography in children with pervasive developmental disorders.
Caldwell, RL; Erickson, CA; Ho, JG; McDougle, CJ; Orsagh-Yentis, DK; Posey, DJ; Stigler, KA, 2012
)
1.45
"Aripiprazole is an atypical antipsychotic drug approved for the treatment of psychiatric disorders such as schizophrenia, bipolar disorder, major depressive disorder and autism. "( Neurite outgrowth mediated by the heat shock protein Hsp90α: a novel target for the antipsychotic drug aripiprazole.
Hashimoto, K; Ishima, T; Iyo, M, 2012
)
2.04
"Aripiprazole (ARI) is an antipsychotic drug that is metabolized to dehydroaripiprazole (DARI) by CYP2D6. "( High-performance liquid chromatography method using ultraviolet detection for the quantification of aripiprazole and dehydroaripiprazole in psychiatric patients.
de Andrés, F; de la Rubia, A; Dorado, P; González, AP; González, I; Llerena, A; Naranjo, ME; Peñas-Lledó, EM, 2012
)
2.04
"Aripiprazole is an atypical antipsychotic used for schizophrenia, manic and mixed episodes associated with bipolar I disorder and as adjunctive therapy for major depressive disorder. "( Aripiprazole, alcohol and substance abuse: a review.
Brunetti, M; Dezi, S; Di Tizio, L; Grandinetti, P; Martinotti, G; Pozzi, G, 2012
)
3.26
"Aripiprazole is an antipsychotic that acts as a partial agonist at dopamine receptors. "( Effects of aripiprazole, an atypical antipsychotic, on the motor alterations induced by acute ethanol administration in mice.
Aguiar, DC; Almeida-Santos, AF; Moreira, FA; Viana, TG, 2013
)
2.22
"Aripiprazole is an atypical antipsychotic medication that is a partial dopamine D(2) and serotonin 5-hydroxytryptamine (1A) receptor agonist and 5-hydroxytryptamine (2A) receptor antagonist. "( Aripiprazole-induced seizure in a 3-year-old child: a case report and literature review.
Joseph, SA; Sweis, RT; Thabet, FI,
)
3.02
"Aripiprazole is a D2 and D3 receptor partial agonist that is unlike other second generation antipsychotics. "( The neurocognitive effects of aripiprazole compared with risperidone in the treatment of schizophrenia.
Okamoto, Y; Sato, G; Yamashita, H; Yamawaki, S; Yoshimura, S, 2012
)
2.11
"Aripiprazole is a newer atypical antipsychotic drug with partial agonist activity at dopamine receptors and antagonist activity at 5-HT(2A) receptors, with a low side-effect profile."( Aripiprazole in the treatment of Alzheimer's disease.
De Deyn, PP; Drenth, AF; Kremer, BP; Oude Voshaar, RC; Van Dam, D, 2013
)
2.55
"Aripiprazole is a second-generation antipsychotic that may be selected for patients with prolonged QTc intervals and at risk for TdP. "( Torsades de pointes after administration of low-dose aripiprazole.
Leung, JG; Nelson, S, 2013
)
2.08
"Aripiprazole is an investigational agent for treating schizophrenia that has a novel pharmacologic profile. "( Efficacy and safety of aripiprazole and haloperidol versus placebo in patients with schizophrenia and schizoaffective disorder.
Ali, MW; Carson, WH; Ingenito, GG; Kane, JM; McQuade, RD; Saha, AR; Zimbroff, DL, 2002
)
2.07
"Aripiprazole is a quinolinone derivative and the first of a new class of atypical antipsychotics. "( Aripiprazole.
Goa, KL; McGavin, JK, 2002
)
3.2
"Aripiprazole is a new atypical antipsychotic with a unique receptor binding profile that combines partial agonist activity at D2 and 5HT1A receptors with potent antagonism at 5HT2A receptors."( Aripiprazole: a review of its pharmacology and clinical use.
Taylor, DM,
)
2.3
"Aripiprazole is a dopamine partial agonist and a serotonin-2A antagonist; it is dosed 10-30 mg/d, with no initial titration necessary. "( Aripiprazole: a new atypical antipsychotic drug.
Bowles, TM; Levin, GM, 2003
)
3.2
"Aripiprazole is a novel antipsychotic with a unique mechanism of action. "( Aripiprazole in the treatment of schizophrenia: safety and tolerability in short-term, placebo-controlled trials.
Ali, M; Iwamoto, T; Kaplita, S; Marcus, R; Marder, SR; McQuade, RD; Safferman, AZ; Saha, A; Stock, E, 2003
)
3.2
"Aripiprazole is a dopamine D2 receptor partial agonist with partial agonist activity at serotonin 5HT1A receptors and antagonist activity at 5HT2A receptors. "( Aripiprazole, an antipsychotic with a novel mechanism of action, and risperidone vs placebo in patients with schizophrenia and schizoaffective disorder.
Ali, M; Carson, WH; Ingenito, G; Kujawa, MJ; Marder, SR; Potkin, SG; Saha, AR; Stock, E; Stringfellow, J, 2003
)
3.2
"Aripiprazole is a novel atypical antipsychotic for the treatment of schizophrenia. "( Efficacy and safety of aripiprazole vs. haloperidol for long-term maintenance treatment following acute relapse of schizophrenia.
Ali, M; Archibald, D; Carson, WH; Ingenito, G; Kasper, S; Lerman, MN; Marcus, R; McQuade, RD; Pigott, T; Saha, A, 2003
)
2.07
"Aripiprazole is a novel antipsychotic for the management of schizophrenia. "( Aripiprazole for the prevention of relapse in stabilized patients with chronic schizophrenia: a placebo-controlled 26-week study.
Carson, WH; Ingenito, GG; Pigott, TA; Saha, AR; Stock, EG; Torbeyns, AF, 2003
)
3.2
"Aripiprazole (OPC-14597) is a novel atypical antipsychotic drug with a low incidence of side effects. "( Aripiprazole (OPC-14597) fully substitutes for the 5-HT1A receptor agonist LY293284 in the drug discrimination assay in rats.
Marona-Lewicka, D; Nichols, DE, 2004
)
3.21
"Aripiprazole is a third-generation antipsychotic agent indicated for use in the treatment of schizophrenia."( Aripiprazole.
Winans, E, 2003
)
2.48
"Aripiprazole is an antipsychotic drug with high affinity for D(2)- and D(3)-receptors and the dopamine autoreceptor."( Focus on aripiprazole.
Green, B, 2004
)
1.46
"Aripiprazole is a novel antipsychotic with a unique mechanism of action, which differs from currently marketed typical and atypical antipsychotics. "( The novel antipsychotic aripiprazole is a partial agonist at short and long isoforms of D2 receptors linked to the regulation of adenylyl cyclase activity and prolactin release.
Aihara, K; Burris, KD; Horie, M; Kikuchi, T; Miwa, T; Shimada, J; Tottori, K; Yocca, FD, 2004
)
2.07
"Aripiprazole is a valuable new therapeutic option in the management of patients with schizophrenia."( Aripiprazole: a review of its use in schizophrenia and schizoaffective disorder.
Perry, CM; Swainston Harrison, T, 2004
)
2.49
"Aripiprazole is an atypical antipsychotic agent with an intrinsic dopamineagonist activity of 30 %. "( [Aripiprazole: a new atypical antipsychotic drug].
Davids, E; Fischer, B; Gastpar, M, 2004
)
2.68
"Aripiprazole is a new atypical antipsychotic with a mode of action that is distinct from currently available antipsychotic drugs. "( Aripiprazole: a new atypical antipsychotic with a different pharmacological mechanism.
Lambert, M; Naber, D, 2004
)
3.21
"Aripiprazole (Abilify) is an atypical antipsychotic drug that has been recently introduced for clinical use in the treatment of schizophrenia. "( Aripiprazole: a novel atypical antipsychotic drug with a uniquely robust pharmacology.
Davies, MA; Roth, BL; Sheffler, DJ, 2004
)
3.21
"Aripiprazole is a newly available atypical antipsychotic for the treatment of schizophrenia."( Aripiprazole in schizophrenia: consensus guidelines.
Burns, T; Dursun, S; Fahy, T; Frangou, S; Gray, R; Haddad, PM; Hunter, R; Taylor, DM; Travis, MJ; Young, AH, 2005
)
2.49
"Aripiprazole is a new psychotropic agent that possesses a unique pharmacologic profile. "( Atypical experience: a case series of pediatric aripiprazole exposures.
Klein-Schwartz, W; Lofton, AL, 2005
)
2.03
"Aripiprazole is a recently released antipsychotic medication which differs from other atypical antipsychotic agents by its partial agonist activity at postsynaptic D2 receptors. "( Aripiprazole: pharmacology, efficacy, safety and tolerability.
Kinghorn, WA; McEvoy, JP, 2005
)
3.21
"Aripiprazole is an atypical antipsychotic that is approved for the treatment of mania and that has a novel mechanism of action, acting as a dopamine-2 receptor partial agonist, thereby increasing dopamine release in some parts of the brain and decreasing dopa-mine release in other brain regions."( Switching outpatients with bipolar or schizoaffective disorders and substance abuse from their current antipsychotic to aripiprazole.
Beard, L; Brown, ES; Garza, M; Jeffress, J; Liggin, JD, 2005
)
1.26
"Aripiprazole is an atypical antipsychotic that has partial agonist activity at D2 receptors."( Aripiprazole attenuates the discriminative-stimulus and subject-rated effects of D-amphetamine in humans.
Glaser, PE; Hays, LR; Lile, JA; Rush, CR; Stoops, WW; Vansickel, AR, 2005
)
2.49
"Aripiprazole is an agent for treating schizophrenia. "( Aripiprazole in psychosis associated with Parkinson's disease.
López-Meza, E; Ramirez-Bermudez, J; Ruiz-Chow, A, 2005
)
3.21
"Aripiprazole is a new chemical entity with a unique pharmacological profile. "( Aripiprazole.
Fleischhacker, WW, 2005
)
3.21
"Aripiprazole is an effective augmentation strategy for improving therapeutic response in patients with treatment-resistant major depressive disorder when administered in combination with standard antidepressant therapy. "( Aripiprazole augmentation of antidepressants for the treatment of partially responding and nonresponding patients with major depressive disorder.
Nemeroff, CB; Simon, JS, 2005
)
3.21
"Aripiprazole is an effective treatment for hostility in patients with schizophrenia or schizoaffective disorder."( Efficacy of aripiprazole against hostility in schizophrenia and schizoaffective disorder: data from 5 double-blind studies.
Carson, WH; Citrome, L; Czobor, P; Hardy, S; Kostic, D; Marcus, R; McQuade, RD; Volavka, J, 2005
)
2.15
"Aripiprazole is a unique atypical antipsychotic drug with an excellent side-effect profile presumed, in part, to be due to lack of typical D(2) dopamine receptor antagonist properties. "( Aripiprazole has functionally selective actions at dopamine D2 receptor-mediated signaling pathways.
Mailman, RB; Urban, JD; Vargas, GA; von Zastrow, M, 2007
)
3.23
"Aripiprazole is a dopamine partial agonist and a serotonin(2A) antagonist with a favorable adverse effect profile."( Acute dystonia with low-dosage aripiprazole in Tourette's disorder.
Fountoulakis, KN; Iacovides, A; Kantartzis, S; Kaprinis, GS; Panagiotidis, P; Siamouli, M, 2006
)
1.34
"Aripiprazole is a relatively new atypical antipsychotic agent that has been successfully employed in therapy for schizophrenia and schizoaffective disorders. "( Aripiprazole in the treatment of patients with borderline personality disorder: a double-blind, placebo-controlled study.
Anvar, J; Bachler, E; Buschmann, W; Egger, C; Fartacek, R; Kaplan, P; Kettler, C; Loew, TH; Muehlbacher, M; Nickel, C; Nickel, MK; Pedrosa Gil, F; Rother, N; Rother, WK, 2006
)
3.22
"Aripiprazole appears to be a safe and effective agent in the treatment of patients with borderline personality disorder."( Aripiprazole in the treatment of patients with borderline personality disorder: a double-blind, placebo-controlled study.
Anvar, J; Bachler, E; Buschmann, W; Egger, C; Fartacek, R; Kaplan, P; Kettler, C; Loew, TH; Muehlbacher, M; Nickel, C; Nickel, MK; Pedrosa Gil, F; Rother, N; Rother, WK, 2006
)
3.22
"Aripiprazole (Abilify) is an atypical antipsychotic drug primarily characterized by partial agonist activity at dopamine (DA) D2 receptors and low side effects. "( Aripiprazole blocks reinstatement of cocaine seeking in an animal model of relapse.
Altar, CA; Feltenstein, MW; See, RE, 2007
)
3.23
"Aripiprazole is a newer atypical antipsychotic agent used for effective treatment of schizophrenia. "( Aripiprazole-induced syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Bachu, K; Gasparyan, A; Godkar, D; Niranjan, S; Sircar, P; Yakoby, M,
)
3.02
"Aripiprazole is an oral atypical antipsychotic drug used in the treatment of schizophrenia and potentially other behavior disorders. "( Aripiprazole exposures reported to Texas poison control centers during 2002-2004.
Forrester, MB, 2006
)
3.22
"Aripiprazole is an atypical antipsychotic that is reported to be effective in the treatment of schizophrenia."( Aripiprazole for schizophrenia. Systematic review.
Adams, CE; El-Sayeh, HG; Morganti, C, 2006
)
3.22
"Aripiprazole is a novel antipsychotic quinolone derivative that has been approved for the treatment of schizophrenia in adults."( Aripiprazole use in individuals with intellectual disability and psychotic or behavioural disorders: a case series.
Alla, L; Sabaratnam, M; Shastri, M, 2006
)
2.5
"Aripiprazole is a novel antipsychotic drug, which displays partial agonist activity at the dopamine D(2) receptor. "( Aripiprazole and its human metabolite are partial agonists at the human dopamine D2 receptor, but the rodent metabolite displays antagonist properties.
Clarke, K; Davies, CH; Forbes, IT; Gribble, A; Hill, M; Jones, DN; Newson, M; Reavill, C; Rourke, C; Scott, C; Westaway, J; Wood, MD, 2006
)
3.22
"Aripiprazole is a new atypical antipsychotic drug with a partial agonist activity at dopamine 2 and serotonin 1A receptors. "( Pharmacokinetic variability of aripiprazole and the active metabolite dehydroaripiprazole in psychiatric patients.
Lunde, H; Lunder, N; Molden, E; Refsum, H, 2006
)
2.06
"Aripiprazole is a recently released antipsychotic medication that differs from other atypical antipsychotic agents by its mode of action as a dopamine D2 partial agonist."( Role of aripiprazole in treating mood disorders.
García-Amador, M; Goikolea, JM; Pacchiarotti, I; Sanchez, RF; Valentí, M; Vieta, E, 2006
)
1.49
"Aripiprazole is a recently introduced antipsychotic with a unique pharmacological profile, a dopamine partial agonist. "( Unique pharmacological profile of aripiprazole as the phasic component buster.
Hamamura, T; Harada, T, 2007
)
2.06
"Aripiprazole is an atypical antipsychotic drug with high in vitro affinity for 5-HT(1A), 5-HT(2A) and dopamine (DA) D2 receptors. "( In vivo actions of aripiprazole on serotonergic and dopaminergic systems in rodent brain.
Artigas, F; Bortolozzi, A; Celada, P; Díaz-Mataix, L; Toth, M, 2007
)
2.11
"Aripiprazole appears to be an effective and relatively safe agent in the long-term treatment of patients with BPD."( Aripiprazole in treatment of borderline patients, part II: an 18-month follow-up.
Loew, TH; Nickel, MK; Pedrosa Gil, F, 2007
)
3.23
"Aripiprazole is a dopamine (DA) D(2) receptor partial agonist, approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia. "( Effect of aripiprazole, a partial dopamine D2 receptor agonist, on increased rate of methamphetamine self-administration in rats with prolonged session duration.
Koob, GF; Pulvirenti, L; Wang, Z; Wee, S; Woolverton, WL, 2007
)
2.18
"Aripiprazole is a psychotropic agent with a novel pharmacologic profile. "( Aripiprazole: pharmacology and evidence in bipolar disorder.
Konarski, JZ; McIntyre, RS; Miranda, A; Soczynska, JK; Woldeyohannes, HO, 2007
)
3.23
"Aripiprazole is an effective atypical antipsychotic for the treatment of schizophrenia, demonstrating better effectiveness than SOC agents used in this study in patients for whom a switch in antipsychotic medication was warranted."( A multicentre, randomized, naturalistic, open-label study between aripiprazole and standard of care in the management of community-treated schizophrenic patients Schizophrenia Trial of Aripiprazole: (STAR) study.
Banki, CM; Beuzen, JN; Hanssens, L; Herman, E; Kerwin, R; L'Italien, G; Lublin, H; McQuade, RD; Millet, B; Pans, M, 2007
)
2.02
"Aripiprazole is a novel antipsychotic drug for the treatment of schizophrenia and schizoaffective disorders. "( Detection and quantification of aripiprazole and its metabolite, dehydroaripiprazole, by gas chromatography-mass spectrometry in blood samples of psychiatric patients.
Chiu, HJ; Hu, TM; Huang, HC; Lan, TH; Liu, CH; Tseng, YL; Wu, YC, 2007
)
2.07
"Aripiprazole acts as a partial agonist of D2 receptors as well as a partial agonist of 5HT1A and an antagonist of 5HT2A. "( [Clinical impact of aripiprazole in patients suffering from schizophrenia].
Drapier, D; Fadier-Salicé, G; Levoyer, D; Millet, B,
)
1.9
"Aripiprazole is a novel antipsychotic with a mechanism of action different from those of traditional first- and second-generation antipsychotics. "( Agitation associated with aripiprazole initiation.
Lafollette, J; Lea, JW; Stoner, SC, 2007
)
2.08
"Aripiprazole is a novel second-generation antipsychotic approved for the treatment of bipolar disorder in adults but there is no systematic data available in pediatric bipolar disorder."( An open-label trial of aripiprazole monotherapy in children and adolescents with bipolar disorder.
Aleardi, M; Biederman, J; Doyle, R; Hammerness, P; Joshi, G; Kotarski, M; Mick, E; Spencer, T; Wozniak, J, 2007
)
2.09
"Aripiprazole is an atypical antipsychotic drug which is metabolized by the polymorphic enzyme cytochrome P450 2D6 (CYP2D6). "( Impact of the CYP2D6 genotype on steady-state serum concentrations of aripiprazole and dehydroaripiprazole.
Hendset, M; Hermann, M; Lunde, H; Molden, E; Refsum, H, 2007
)
2.02
"Aripiprazole is an atypical antipsychotic that acts as a partial agonist at the dopamine D(2) receptor. "( Aripiprazole, an atypical antipsychotic, prevents the motor hyperactivity induced by psychotomimetics and psychostimulants in mice.
Guimarães, FS; Leite, JV; Moreira, FA, 2008
)
3.23
"Aripiprazole is a novel atypical antipsychotic that is approved in the US for use in adolescents with schizophrenia. "( Aripiprazole: in adolescents with schizophrenia.
Keating, GM; Sanford, M, 2007
)
3.23
"Aripiprazole (OPC-14597) is an antipsychotic with a unique pharmacology as a dopamine D2 receptor partial agonist, which has been demonstrated to reduce symptoms of schizophrenia. "( Effects of aripiprazole/OPC-14597 on motor activity, pharmacological models of psychosis, and brain activity in rats.
Freichel, C; Künnecke, B; Maco, M; Moreau, JL; Nordquist, RE; Riemer, C; Risterucci, C; Spooren, W; von Kienlin, M, 2008
)
2.18
"Aripiprazole is a relatively new antipsychotic drug, said to be the prototype of a new third generation of antipsychotics; the so-called dopamine-serotonin system stabilisers. "( Aripiprazole versus typicals for schizophrenia.
Bhattacharjee, J; El-Sayeh, HG, 2008
)
3.23
"Aripiprazole is an atypical antipsychotic with partial agonist activity at D(2) receptors, which could reduce the reinforcing effects of alcohol. "( Effects of aripiprazole on subjective and physiological responses to alcohol.
Arias, AJ; Chan, G; Covault, J; Douglas, K; Kranzler, HR; Oncken, C; Pierucci-Lagha, A, 2008
)
2.18
"Aripiprazole is an atypical anti-psychotic associated with a reduction in prolactin level in anti-psychotic-induced hyperprolactinemia."( Change in sexual dysfunction with aripiprazole: a switching or add-on study.
Aitchison, KJ; McAllister, V; Mir, A; O'Keane, V; Shivakumar, K; Williamson, RJ, 2008
)
1.35
"Aripiprazole is an atypical antipsychotic compound that is approved by the U.S."( Aripiprazole therapy in 20 older adults with bipolar disorder: a 12-week, open-label trial.
Blow, FC; Cassidy, KA; Coconcea, N; Hays, RW; Ignacio, RV; Meyer, WJ; Sajatovic, M, 2008
)
2.51
"Aripiprazole is an effective and safe adjunctive therapy as demonstrated in this short-term study for patients who are nonresponsive to standard ADT."( The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: a second multicenter, randomized, double-blind, placebo-controlled study.
Berman, RM; Carson, WH; Fava, M; Hennicken, D; Marcus, RN; McQuade, RD; Simon, JS; Thase, ME; Trivedi, MH, 2008
)
1.36
"Aripiprazole also acts as a dopamine D2 partial receptor agonist, and has a possible action at adrenergic receptors."( Aripiprazole in the treatment of depressive and anxiety disorders: a review of current evidence.
Masand, PS; Pae, CU; Patkar, AA; Serretti, A, 2008
)
2.51
"Aripiprazole is a novel atypical antipsychotic, which is a high-affinity dopamine D(2) receptor partial agonist."( Inhibitory effects of aripiprazole on interferon-gamma-induced microglial activation via intracellular Ca2+ regulation in vitro.
Hashioka, S; Horikawa, H; Iwaki, T; Kanba, S; Kato, T; Mizoguchi, Y; Monji, A; Seki, Y; Suzuki, SO, 2008
)
1.38
"Aripiprazole is an effective medication for treating patients with schizophrenia and bipolar disorder , and as an adjunct in patients with major depressive disorder and an inadequate response to antidepressant treatment, that is generally safe and well tolerated. "( Proposed strategies for successful clinical management with aripiprazole.
Mago, R, 2008
)
2.03
"Aripiprazole is a dopamine partial agonist antipsychotic drug that has just been approved in Europe for its use in the treatment of acute mania and for the prevention of manic episodes in bipolar disorder. "( [Advances in the treatment of mania: aripiprazole].
Franco, C; Vieta, E,
)
1.85
"Aripiprazole (OPC 14597) is an antipsychotic drug that has high affinity for dopamine D2 and D3 receptors and the dopamine autoreceptor. "( Dopamine D2 and D3 receptor occupancy in normal humans treated with the antipsychotic drug aripiprazole (OPC 14597): a study using positron emission tomography and [11C]raclopride.
Biziere, K; Bramer, S; Dannals, RF; Dogan, AS; Gründer, G; Ravert, H; Stephane, M; Suri, A; Wong, DF; Yokoi, F, 2002
)
1.98

Effects

Aripiprazole has a promising efficacy and favourable tolerability profile that suggests it has a significant role to play in the management of schizophrenia. The drug has a low propensity to cause clinically significant bodyweight gain, hyperprolactinaemia or corrected QT interval prolongation in patients with schizophrenia.

Aripiprazole has a low propensity to cause clinically significant bodyweight gain, hyperprolactinaemia or corrected QT interval prolongation in patients with schizophrenia or schizoaffective disorder. The drug has demonstrated superiority to placebo in clinical studies of the treatment of both schizophrenia and acute bipolar mania.

ExcerptReferenceRelevance
"Aripiprazole has a high affinity for the D2 receptor, but may have a lesser reduction of psychotic symptoms compared to other antipsychotics."( Aripiprazole: examining the clinical implications of D2 affinity.
Anam, A; Gekhman, D; Lynch, S; Mosharraf, N; Soukas, C, 2023
)
3.07
"Aripiprazole; however, has a potential risk of inducing severe rebound psychosis in patients who have already developed dopamine supersensitivity."( The effectiveness of very slow switching to aripiprazole in schizophrenia patients with dopamine supersensitivity psychosis: a case series from an open study.
Fujita, Y; Honma, M; Iyo, M; Kanahara, N; Komatsu, N; Noda, S; Saiga, T; Sasaki, T; Simoyama, T; Suzuki, H; Tadokoro, S; Takase, M; Yamanaka, H; Yanahashi, S, 2020
)
1.54
"Aripiprazole has a low risk for causing extrapyramidal syndrome and can remit neuroleptic-induced tardive dyskinesia (TD). "( Suppression of antipsychotic-induced tardive dyskinesia with aripiprazole in an elderly patient with bipolar I disorder.
Chan, HY; Tan, HK; Wu, WY, 2014
)
2.09
"Aripiprazole, which has a unique pharmacological mechanism of action distinct from other atypical antipsychotics and an excellent safety profile, may be effective in the treatment of some schizophrenic patients with stupor, which sometimes carries a risk of physical debilitation and requires special attention due to the risk of adverse drug reactions."( Prolonged catatonic stupor successfully treated with aripiprazole in an adolescent male with schizophrenia: a case report.
Kirino, E, 2010
)
1.33
"Aripiprazole has a favorable efficacy/safety profile in ESS and appeared to be superior to haloperidol on a number of efficacy and safety outcomes."( Aripiprazole versus haloperidol treatment in early-stage schizophrenia.
Girgis, RR; Lieberman, JA; Merrill, DB; Pikalov, A; Vorel, SR; Whitehead, R; You, M, 2011
)
2.53
"Aripiprazole has a lower risk of raised prolactin and prolongation of the QTc interval."( Aripiprazole versus placebo for schizophrenia.
Belgamwar, RB; El-Sayeh, HG, 2011
)
2.53
"Aripiprazole has a low risk of extrapyramidal symptoms. "( Improvement of tardive dyskinesia and dystonia associated with aripiprazole following a switch to quetiapine: case report and review of the literature.
Endo, T; Fukui, N; Ono, S; Shindo, M; Someya, T; Sugai, T; Suzuki, Y, 2012
)
2.06
"Aripiprazole has a more benign side effect profile (weight gain, blood sugar level, lipid profile) as compared to olanzapine in the short-term treatment of schizophrenia."( Aripiprazole versus olanzapine in the treatment of schizophrenia: a clinical study from India.
Jindal, KC; Munjal, V; Singh, GP, 2013
)
2.55
"Aripiprazole (APZ) has a unique pharmacological profile, as a partial agonist at the dopamine D2 and serotonin 5HT1A receptors and an antagonist at the serotonin 5HT2A receptor; this drug has few side effects (such as extrapyramidal syndrome, hyperprolactinemia, weight gain, metabolic disorders, and sedation) which are typical problems with other antipsychotic drugs. "( Efficacy and safety of aripiprazole in child and adolescent patients.
Kirino, E, 2012
)
2.13
"Aripiprazole has a unique mechanism of action as a dopamine D2 partial agonist, serotonin 5-HT(1A) partial agonist and serotonin 5-HT(2A) antagonist."( Aripiprazole: a partial dopamine D2 receptor agonist antipsychotic.
Keck, PE; McElroy, SL, 2003
)
2.48
"Aripiprazole has a low propensity to cause clinically significant bodyweight gain, hyperprolactinaemia or corrected QT interval prolongation in patients with schizophrenia or schizoaffective disorder."( Aripiprazole: a review of its use in schizophrenia and schizoaffective disorder.
Perry, CM; Swainston Harrison, T, 2004
)
2.49
"Aripiprazole has a unique pharmacologic profile that includes partial agonism at several G-protein coupled receptors (GPCRs) [especially dopamine (D2) and 5-HT1A] and antagonistic action at others (especially 5-HT2A)."( Aripiprazole: a novel atypical antipsychotic drug with a uniquely robust pharmacology.
Davies, MA; Roth, BL; Sheffler, DJ, 2004
)
2.49
"Aripiprazole has a promising efficacy and favourable tolerability profile that suggests it has a significant role to play in the management of schizophrenia."( Partial dopamine agonists in schizophrenia.
Launer, M, 2005
)
1.05
"Aripiprazole has a favorable safety and tolerability profile, with minimal propensity for clinically significant weight gain and metabolic disruption."( Aripiprazole: pharmacology and evidence in bipolar disorder.
Konarski, JZ; McIntyre, RS; Miranda, A; Soczynska, JK; Woldeyohannes, HO, 2007
)
2.5
"Aripiprazole has a unique pharmacological profile that includes partial agonism at D(2) receptors, antagonism at 5-HT(2) receptors, and partial agonism at 5-HT(1A) receptors. "( Differential effects of aripiprazole on D(2), 5-HT(2), and 5-HT(1A) receptor occupancy in patients with schizophrenia: a triple tracer PET study.
Graff, A; Kapur, S; Mamo, D; Mizrahi, R; Romeyer, F; Shammi, CM, 2007
)
2.09
"Aripiprazole has highest affinity for h5-HT(2B)-, hD(2L)-, and hD(3)-dopamine receptors, but also has significant affinity (5-30 nM) for several other 5-HT receptors (5-HT(1A), 5-HT(2A), 5-HT(7)), as well as alpha(1A)-adrenergic and hH(1)-histamine receptors."( Aripiprazole, a novel atypical antipsychotic drug with a unique and robust pharmacology.
Arrington, E; Chiodo, LA; Liu, LX; Mailman, R; Renock, S; Roth, BL; Shapiro, DA; Sibley, DR, 2003
)
2.48
"Aripiprazole has extremely high binding affinity for the dopamine D2 receptor, which is the receptor thought to be responsible for the antipsychotic effect, although Aripiprazole is not the most potent of the second generation antipsychotics."( Aripiprazole: examining the clinical implications of D2 affinity.
Anam, A; Gekhman, D; Lynch, S; Mosharraf, N; Soukas, C, 2023
)
3.07
"Aripiprazole has been proven to reduce anxiety, depression, anger, hostility, clinical severity, and obsessive-compulsive behavior, insecurity, melancholy, anxiety, aggressiveness/hostility, phobic anxiety, paranoid thinking, psychoticism, and somatization."( Efficacy and Safety of Aripiprazole in Borderline Personality Disorder: A Systematic Review.
Benites-Zapata, VA; Campos-Rodriguez, SK; Fernández, MF; Ortiz-Saavedra, B; Pino-Zavaleta, DA; Valdivieso-Jiménez, G, 2023
)
1.94
"Aripiprazole has been implicated in pathological gambling and other impulse control behaviours, likely due to partial dopamine agonist activity (there have been no reports with brexpiprazole and cariprazine)."( Comparative Tolerability of Dopamine D2/3 Receptor Partial Agonists for Schizophrenia.
Copolov, D; Hope, J; Keks, N; McLennan, H; Meadows, G; Schwartz, D, 2020
)
1.28
"Aripiprazole; however, has a potential risk of inducing severe rebound psychosis in patients who have already developed dopamine supersensitivity."( The effectiveness of very slow switching to aripiprazole in schizophrenia patients with dopamine supersensitivity psychosis: a case series from an open study.
Fujita, Y; Honma, M; Iyo, M; Kanahara, N; Komatsu, N; Noda, S; Saiga, T; Sasaki, T; Simoyama, T; Suzuki, H; Tadokoro, S; Takase, M; Yamanaka, H; Yanahashi, S, 2020
)
1.54
"Aripiprazole has one of the fewest side-effects among the second-generation antipsychotics."( Aripiprazole reduces liver cell division.
Bulc Rozman, K; Kramar, B; Milisav, I; Pirc Marolt, T; Šuput, D, 2020
)
2.72
"Aripiprazole (APZ) has poor physicochemical properties and bitter taste. "( Salt Engineering of Aripiprazole with Polycarboxylic Acids to Improve Physicochemical Properties.
Afrooz, H; Barakh Ali, SF; Dharani, S; Khan, MA; Mohamed, EM; Nutan, MTH; Rahman, Z, 2021
)
2.39
"Aripiprazole has become one of the most commonly prescribed psychotropics, making a more comprehensive understanding of its reproductive safety profile a priority. "( Reproductive safety of aripiprazole: data from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics.
Caplin, PS; Chitayat, D; Church, TR; Cohen, LS; Freeman, MP; Góez-Mogollón, L; Hernández-Díaz, S; McElheny, SA; Viguera, AC; Young, AV, 2021
)
2.37
"Aripiprazole has been linked to cases of problem gambling (PBG), but evidence supporting this association remains preliminary. "( Problem Gambling Associated with Aripiprazole: A Nested Case-Control Study in a First-Episode Psychosis Program.
Carmichael, PH; Corbeil, O; Corbeil, S; Demers, MF; Dorval, M; Giroux, I; Jacques, C; Roy, MA, 2021
)
2.35
"Aripiprazole has been reported to preserve hippocampal volume and to reduce inflammation."( Association of Aripiprazole With Reduced Hippocampal Atrophy During Maintenance Treatment of First-Episode Schizophrenia.
Ardekani, BA; Bello, I; Cather, C; Diminich, ED; Fan, X; Freudenreich, O; Goff, DC; Hart, KL; Holt, D; Li, C; Marx, J; Qi, W; Tang, Y; Wang, J; Worthington, M; Wu, R; Zeng, B; Zhao, J,
)
1.21
"Aripiprazole has not been reported to have an association with interstitial lung disease."( Aripiprazole-induced hypersensitivity pneumonitis.
Gunasekaran, K; Jennings, J; Lone, N; Murthi, S, 2017
)
2.62
"Aripiprazole has been considered as a dopamine stabilizer and was the first atypical antipsychotic agent approved by the US Food and Drug Administration as an adjunctive to the treatment of unipolar MDD."( Killing two birds with one stone: the potential role of aripiprazole for patients with comorbid major depressive disorder and nicotine dependence via altering brain activity in the anterior cingulate cortex.
Chang, CC; Chang, HA; Chen, TY; Chu, CS; Tzeng, NS, 2014
)
1.37
"Aripiprazole has a low risk for causing extrapyramidal syndrome and can remit neuroleptic-induced tardive dyskinesia (TD). "( Suppression of antipsychotic-induced tardive dyskinesia with aripiprazole in an elderly patient with bipolar I disorder.
Chan, HY; Tan, HK; Wu, WY, 2014
)
2.09
"Aripiprazole (ARP) has been shown to be effective in the treatment of bipolar disorder (BD). "( A meta-analysis of efficacy and safety of aripiprazole in adult and pediatric bipolar disorder in randomized controlled trials and observational studies.
Baglivo, V; Balestrieri, M; Brambilla, P; Gregoraci, G; Isola, M; Meduri, M, 2016
)
2.14
"Aripiprazole has unique DLPFC actions attributed to its prefrontal D2 agonist action. "( An investigation into aripiprazole's partial D₂ agonist effects within the dorsolateral prefrontal cortex during working memory in healthy volunteers.
Deakin, JF; Dursun, S; Elliott, R; McKie, S; Murphy, A, 2016
)
2.19
"Aripiprazole also has 5-HT1A partial agonist and 5-HT2A antagonist properties that may promote sexual activity."( [Aripiprazole, gambling disorder and compulsive sexuality].
Dafreville, C; Mété, D; Paitel, V; Wind, P, 2016
)
2.07
"Aripiprazole has been associated with a low prevalence of metabolic side effects as compared to other second generation antipsychotic (SGA) medications mostly in patients with long standing illness. "( Therapeutic effectiveness and tolerability of aripiprazole as initial choice of treatment in first episode psychosis in an early intervention service: A one-year outcome study.
Abadi, S; Joober, R; Lepage, M; Malla, A; Mustafa, S; Rho, A, 2016
)
2.14
"Aripiprazole has the most consistent evidence of symptom improvement; however, this improvement is small."( Behavioral Disorders in Dementia: Appropriate Nondrug Interventions and Antipsychotic Use.
Cocker, KE; Reese, TR; Thiel, DJ, 2016
)
1.16
"Aripiprazole has been reported to ameliorate behavioral abnormalities in polyI:C-induced mice."( Aripiprazole inhibits polyI:C-induced microglial activation possibly via TRPM7.
Hayakawa, K; Horikawa, H; Inamine, S; Kanba, S; Kato, TA; Kyuragi, S; Mizoguchi, Y; Monji, A; Ohgidani, M; Sagata, N; Sato-Kasai, M; Seki, Y; Shimokawa, N, 2016
)
2.6
"Aripiprazole has been used in the treatment of tardive syndrome, with some reports of a good response."( A Review of Differences in Clinical Characteristics between Tardive Syndrome Induced or Improved by Aripiprazole Treatment.
Chen, YW; Tseng, PT, 2016
)
1.37
"Aripiprazole has been reported to exert variable effects on cognitive function in patients with schizophrenia. "( Blood Biomarkers Predict the Cognitive Effects of Aripiprazole in Patients with Acute Schizophrenia.
Atake, K; Beppu, H; Hori, H; Igata, R; Katsuki, A; Konishi, Y; Tominaga, H; Yoshimura, R, 2017
)
2.15
"As aripiprazole has been available in the USA for bipolar mania since 2004, clinical experience-sharing from clinical and research use of this agent can assist with initiation and administration in practice. "( Practical guidance for prescribing with aripiprazole in bipolar disorder.
Fagiolini, A, 2008
)
1.23
"Aripiprazole has the unique pharmacology of being a partial dopamine agonist serving to stabilize brain dopamine systems in both frontal cortical and subcortical areas."( Aripiprazole effects on alcohol consumption and subjective reports in a clinical laboratory paradigm--possible influence of self-control.
Anton, R; Myrick, H; Randall, P; Voronin, K, 2008
)
2.51
"Aripiprazole has recently received approval for the treatment of moderate to severe manic episodes in bipolar I disorder and prevention of new manic episodes in aripiprazole-responsive patients. "( A UK consensus on the administration of aripiprazole for the treatment of mania.
Aitchison, KJ; Bienroth, M; Cookson, J; Goodwin, GM; Gray, R; Haddad, PM; Moore, B; Ratna, L; Sullivan, G; Taylor, D; Taylor, M, 2009
)
2.06
"Aripiprazole has been used effectively to treat schizophrenia in the clinic; however, its mechanisms of action are not clear. "( Aripiprazole differentially affects mesolimbic and nigrostriatal dopaminergic transmission: implications for long-term drug efficacy and low extrapyramidal side-effects.
Deng, C; Han, M; Huang, XF, 2009
)
3.24
"Aripiprazole has demonstrated a relatively favorable side effect profile compared to other commonly prescribed antipsychotics, including a low propensity for treatment-limiting extrapyramidal symptoms, hyperprolactinemia, and body weight gain."( Receptor reserve-dependent properties of antipsychotics at human dopamine D2 receptors.
Forbes, RA; Kikuchi, T; McQuade, RD; Tadori, Y, 2009
)
1.07
"Aripiprazole has high affinity for dopamine D2 and D3 receptors (DRD2 and DRD3)."( Effects of the DRD3 Ser9Gly polymorphism on aripiprazole efficacy in schizophrenic patients as modified by clinical factors.
Chen, CH; Chen, SF; Shen, YC, 2009
)
1.34
"Aripiprazole has also received approval for the treatment of bipolar disorder as adjunctive therapy or monotherapy (manic or mixed episodes) as well as an augmentation therapy of major depressive disorder (MDD) by the US FDA."( A review of the safety and tolerability of aripiprazole.
Pae, CU, 2009
)
1.34
"Aripiprazole has unique properties that differ from other atypical antipsychotics and fill up the missing gaps, as it is associated with minimal metabolic complications and extrapyramidal side effects that are more commonly seen in other atypical agents."( The use of aripiprazole in early onset schizophrenia: safety and efficacy.
Hamidin, A; Normala, I, 2009
)
1.46
"Aripiprazole, which has a unique pharmacological mechanism of action distinct from other atypical antipsychotics and an excellent safety profile, may be effective in the treatment of some schizophrenic patients with stupor, which sometimes carries a risk of physical debilitation and requires special attention due to the risk of adverse drug reactions."( Prolonged catatonic stupor successfully treated with aripiprazole in an adolescent male with schizophrenia: a case report.
Kirino, E, 2010
)
1.33
"Aripiprazole has a favorable efficacy/safety profile in ESS and appeared to be superior to haloperidol on a number of efficacy and safety outcomes."( Aripiprazole versus haloperidol treatment in early-stage schizophrenia.
Girgis, RR; Lieberman, JA; Merrill, DB; Pikalov, A; Vorel, SR; Whitehead, R; You, M, 2011
)
2.53
"aripiprazole has proven to be an effective medication for the acute treatment of manic and mixed episodes, as well as for the prophylactic-maintenance phase of bipolar disorder in patients recovering from a manic/mixed episode. "( Aripiprazole for the treatment of bipolar disorder: a review of current evidence.
Casamassima, F; Fagiolini, A; Forgione, RN; Marra, FS; Nitti, M, 2011
)
3.25
"Aripiprazole has been associated with fewer adverse effects compared with other atypicals; however, little is known about its tolerability profile in the TS population."( Tolerability profile of aripiprazole in patients with Tourette syndrome.
Cavanna, AE; Eddy, CM; Luoni, C; Rickards, H; Selvini, C; Termine, C, 2012
)
1.41
"Aripiprazole has a lower risk of raised prolactin and prolongation of the QTc interval."( Aripiprazole versus placebo for schizophrenia.
Belgamwar, RB; El-Sayeh, HG, 2011
)
2.53
"Aripiprazole has a low risk of extrapyramidal symptoms. "( Improvement of tardive dyskinesia and dystonia associated with aripiprazole following a switch to quetiapine: case report and review of the literature.
Endo, T; Fukui, N; Ono, S; Shindo, M; Someya, T; Sugai, T; Suzuki, Y, 2012
)
2.06
"Aripiprazole has a more benign side effect profile (weight gain, blood sugar level, lipid profile) as compared to olanzapine in the short-term treatment of schizophrenia."( Aripiprazole versus olanzapine in the treatment of schizophrenia: a clinical study from India.
Jindal, KC; Munjal, V; Singh, GP, 2013
)
2.55
"Aripiprazole (APZ) has a unique pharmacological profile, as a partial agonist at the dopamine D2 and serotonin 5HT1A receptors and an antagonist at the serotonin 5HT2A receptor; this drug has few side effects (such as extrapyramidal syndrome, hyperprolactinemia, weight gain, metabolic disorders, and sedation) which are typical problems with other antipsychotic drugs. "( Efficacy and safety of aripiprazole in child and adolescent patients.
Kirino, E, 2012
)
2.13
"Aripiprazole has been reported to be effective in small case series with short follow-up periods."( Effectiveness of aripiprazole in the treatment of adult Tourette patients up to 56 months.
Kawohl, W; Neuner, I; Nordt, C; Schneider, F, 2012
)
1.44
"Aripiprazole has demonstrated efficacy in the management of behavioral disturbances and has improved some of impaired cognitive functions."( [Efficacy of aripiprazole on cognitive and behavioral changes in a young woman with systemic lupus erythematosus].
Attademo, L; Moretti, P; Quartesan, R, 2012
)
1.47
"Aripiprazole has a unique mechanism of action as a dopamine D2 partial agonist, serotonin 5-HT(1A) partial agonist and serotonin 5-HT(2A) antagonist."( Aripiprazole: a partial dopamine D2 receptor agonist antipsychotic.
Keck, PE; McElroy, SL, 2003
)
2.48
"Aripiprazole has been shown to be a partial agonist at the D(2) family of dopamine (DA) receptors in biochemical and pharmacological studies."( The novel antipsychotic aripiprazole is a partial agonist at short and long isoforms of D2 receptors linked to the regulation of adenylyl cyclase activity and prolactin release.
Aihara, K; Burris, KD; Horie, M; Kikuchi, T; Miwa, T; Shimada, J; Tottori, K; Yocca, FD, 2004
)
1.35
"Aripiprazole has extensive extravascular distribution and more than 99% of"( Aripiprazole: a review of its use in schizophrenia and schizoaffective disorder.
Perry, CM; Swainston Harrison, T, 2004
)
2.49
"Aripiprazole has a low propensity to cause clinically significant bodyweight gain, hyperprolactinaemia or corrected QT interval prolongation in patients with schizophrenia or schizoaffective disorder."( Aripiprazole: a review of its use in schizophrenia and schizoaffective disorder.
Perry, CM; Swainston Harrison, T, 2004
)
2.49
"Aripiprazole has a unique pharmacologic profile that includes partial agonism at several G-protein coupled receptors (GPCRs) [especially dopamine (D2) and 5-HT1A] and antagonistic action at others (especially 5-HT2A)."( Aripiprazole: a novel atypical antipsychotic drug with a uniquely robust pharmacology.
Davies, MA; Roth, BL; Sheffler, DJ, 2004
)
2.49
"Aripiprazole has a promising efficacy and favourable tolerability profile that suggests it has a significant role to play in the management of schizophrenia."( Partial dopamine agonists in schizophrenia.
Launer, M, 2005
)
1.05
"Aripiprazole has demonstrated superiority to placebo in clinical studies of the treatment of both schizophrenia and acute bipolar mania."( Aripiprazole: an overview of a novel antipsychotic.
Folnegović-Smalc, V; Kozumplik, O; Mimica, N; Uzun, S, 2005
)
2.49
"Aripiprazole, however, has not yet been tested for this disorder, and the goal of this study was to determine whether aripiprazole is effective in the treatment of several domains of symptoms of borderline personality disorder."( Aripiprazole in the treatment of patients with borderline personality disorder: a double-blind, placebo-controlled study.
Anvar, J; Bachler, E; Buschmann, W; Egger, C; Fartacek, R; Kaplan, P; Kettler, C; Loew, TH; Muehlbacher, M; Nickel, C; Nickel, MK; Pedrosa Gil, F; Rother, N; Rother, WK, 2006
)
2.5
"Aripiprazole has been licensed despite the fact that few reliable data on this drug are publicly available. "( Aripiprazole for schizophrenia. Systematic review.
Adams, CE; El-Sayeh, HG; Morganti, C, 2006
)
3.22
"Aripiprazole has been extensively studied pre-clinically, both in vitro and in vivo, and these results have been correlated with clinical findings."( Aripiprazole and its human metabolite are partial agonists at the human dopamine D2 receptor, but the rodent metabolite displays antagonist properties.
Clarke, K; Davies, CH; Forbes, IT; Gribble, A; Hill, M; Jones, DN; Newson, M; Reavill, C; Rourke, C; Scott, C; Westaway, J; Wood, MD, 2006
)
2.5
"Aripiprazole has demonstrated efficacy in treatment of bipolar mania, as well as in the maintenance treatment of bipolar disorder. "( Adjunctive aripiprazole in bipolar I depression.
Sokolski, KN, 2007
)
2.17
"Aripiprazole has a favorable safety and tolerability profile, with minimal propensity for clinically significant weight gain and metabolic disruption."( Aripiprazole: pharmacology and evidence in bipolar disorder.
Konarski, JZ; McIntyre, RS; Miranda, A; Soczynska, JK; Woldeyohannes, HO, 2007
)
2.5
"Aripiprazole has made a significant contribution to the treatment of schizophrenia and related disorders with an improved safety and tolerability profile, which has been attributed to its unique pharmacological profile. "( Aripiprazole acts as a selective dopamine D2 receptor partial agonist.
Reavill, C; Wood, M, 2007
)
3.23
"Aripiprazole has higher affinity to dopamine D(2) receptors than haloperidol, which is the likely cause of this observation."( Adjunctive treatment with a dopamine partial agonist, aripiprazole, for antipsychotic-induced hyperprolactinemia: a placebo-controlled trial.
Conley, RR; Jung, DU; Kelly, DL; Liu, KH; Seo, YS; Shim, JC; Shin, JG; Shon, JH, 2007
)
1.31
"Aripiprazole has a unique pharmacological profile that includes partial agonism at D(2) receptors, antagonism at 5-HT(2) receptors, and partial agonism at 5-HT(1A) receptors. "( Differential effects of aripiprazole on D(2), 5-HT(2), and 5-HT(1A) receptor occupancy in patients with schizophrenia: a triple tracer PET study.
Graff, A; Kapur, S; Mamo, D; Mizrahi, R; Romeyer, F; Shammi, CM, 2007
)
2.09

Actions

Aripiprazole has a lower risk of raised prolactin and prolongation of the QTc interval. It does not cause significant EPSE, hyperprolactinaemia, excessive weight gain or cardiac rhythm disturbance.

ExcerptReferenceRelevance
"Aripiprazole does not cause an excessive blockade of DRD2 and is less likely to upregulate DRD2 by aripiprazole's dopamine partial agonistic profile."( The effectiveness of very slow switching to aripiprazole in schizophrenia patients with dopamine supersensitivity psychosis: a case series from an open study.
Fujita, Y; Honma, M; Iyo, M; Kanahara, N; Komatsu, N; Noda, S; Saiga, T; Sasaki, T; Simoyama, T; Suzuki, H; Tadokoro, S; Takase, M; Yamanaka, H; Yanahashi, S, 2020
)
1.54
"Aripiprazole can cause side effects including headache, insomnia, agitation, nervousness, lightheadedness, dizziness, somnolence, akathisia, and weight gain."( Aripiprazole-Induced Neutropenia: Case Report and Literature Review.
Chaudhary, AM; Felin, T; Naveed, S, 2018
)
2.64
"Aripiprazole may cause EPS at clinical dosages by augmenting cholinergic effects via AChE inhibition, in addition to its suppressive effect on dopaminergic neurons."( Inhibition of Recombinant Human Acetylcholinesterase Activity by Antipsychotics.
Arie, C; Fujii, A; Harada, N; Matsuo, K; Obara, K; Tanaka, Y; Yamaki, F; Yoshio, T, 2019
)
1.96
"Aripiprazole had a lower incidence of extrapyramidal reactions than haloperidol (P<0.05), but the overall incidence of side effects of aripiprazole was not lower than traditional drugs for treatment of TD."( [Efficacy and safety of aripiprazole in the treatment of childhood tic disorders: a Meta analysis].
Chen, L; Chen, QB; Fang, Q; Yang, F, 2015
)
1.45
"Aripiprazole can cause irreversible tardive dystonia in some individuals, and additional intervention is sometimes needed. "( Remission of irreversible aripiprazole-induced tardive dystonia with clozapine: a case report.
Ahn, J; Joe, S; Lim, J; Park, C; Park, J, 2015
)
2.16
"Aripiprazole failed to produce a significant effect on overall nicotine withdrawal symptoms after awakening and after lunch."( Long-term treatment with aripiprazole on the waking and postprandial urges to smoke in Chinese heavy smokers.
Bao, YP; Beveridge, TJ; Di, XL; Li, SX; Liu, Y; Lu, L; Sun, HQ; Yang, FD, 2010
)
1.39
"Aripiprazole proved to inhibit the •O(2)(-) generation through the cascade of protein kinase C (PKC) activation, intracellular Ca(2+) regulation and NADPH oxidase activation via cytosolic p47(phox) translocation to the plasma/phagosomal membranes."( Aripiprazole inhibits superoxide generation from phorbol-myristate-acetate (PMA)-stimulated microglia in vitro: implication for antioxidative psychotropic actions via microglia.
Han, YH; Hashioka, S; Hirata, E; Horikawa, H; Inoguchi, T; Kanba, S; Kasai, M; Kato, TA; Maeda, Y; Mizoguchi, Y; Monji, A; Seki, Y; Sonoda, N; Utsumi, H; Yasukawa, K, 2011
)
2.53
"Aripiprazole appears to cause less weight gain than many other antipsychotics."( Changes in weight and other metabolic indicators in persons with schizophrenia following a switch to aripiprazole.
Basu, R; Brar, JS; Chang, CC; Ganguli, R; Garbut, R, 2011
)
1.31
"Aripiprazole has a lower risk of raised prolactin and prolongation of the QTc interval."( Aripiprazole versus placebo for schizophrenia.
Belgamwar, RB; El-Sayeh, HG, 2011
)
2.53
"Aripiprazole seems not to cause significant EPSE, hyperprolactinaemia, excessive weight gain or cardiac rhythm disturbance."( Aripiprazole: a review of its pharmacology and clinical use.
Taylor, DM,
)
2.3
"Aripiprazole does not cause significant prolactin elevation and is associated with a low rate of clinically significant weight gain compared with other atypical antipsychotics."( Aripiprazole, a novel atypical antipsychotic drug.
Argo, TR; Carnahan, RM; Perry, PJ, 2004
)
2.49
"Aripiprazole did however cause more insomnia than perphenazine (n=300, 1 RCT, RR 2.23 CI 1.57 to 3.18, NNH 4 CI 3 to 9) and less need for antiparkinson drugs than 10-20mg/day haloperidol (n=1854, 4 RCTs, RR 0.45 CI 0.33 to 0.60, NNT 4 CI 3 to 5)."( Aripiprazole for schizophrenia.
El-Sayeh, HG; Morganti, C, 2004
)
2.49
"Aripiprazole did not inhibit physostigmine- or norepinephrine-induced lethality in rats."( Mechanism of action of aripiprazole predicts clinical efficacy and a favourable side-effect profile.
Altar, CA; Burris, KD; Hirose, T; Kikuchi, T; Kitagawa, H; Miwa, T; Nabeshima, T; Uwahodo, Y; Yamada, S, 2004
)
1.36
"Aripiprazole displays properties of an agonist and antagonist in animal models of dopaminergic hypoactivity and hyperactivity, respectively."( Aripiprazole, a novel antipsychotic, is a high-affinity partial agonist at human dopamine D2 receptors.
Burris, KD; Kikuchi, T; Molinoff, PB; Molski, TF; Ryan, E; Tottori, K; Xu, C; Yocca, FD, 2002
)
2.48

Treatment

Aripiprazole can be a treatment option for temper outbursts in people with PWS. Treatment decreased activation of the middle frontal, superior frontal and occipital gyrus (ToL), medial temporal and inferior frontal gyrus, putamen and cuneus (WoF) and decreased volume of kidney necrosis.

ExcerptReferenceRelevance
"Aripiprazole can be a treatment option for temper outbursts in people with PWS. "( Aripiprazole treatment for temper outbursts in Prader-Willi syndrome.
Bleich, S; Deest, M; Deest-Gaubatz, S; Eberlein, CK; Frieling, H; Groh, A; Jakob, MM; Seifert, J; Toto, S; Wieting, J, 2022
)
3.61
"Aripiprazole treatment decreased activation of the middle frontal, superior frontal and occipital gyrus (ToL) and medial temporal and inferior frontal gyrus, putamen and cuneus (WoF), while activation increased after risperidone."( Effects of aripiprazole versus risperidone on brain activation during planning and social-emotional evaluation in schizophrenia: A single-blind randomized exploratory study.
Aleman, A; Knegtering, H; Liemburg, EJ; van Es, F, 2017
)
1.57
"Aripiprazole treatment also decreased the volume of kidney necrosis."( Aripiprazole prevents renal ischemia/reperfusion injury in rats, probably through nitric oxide involvement.
Gholampour, H; Moezi, L; Shafaroodi, H, 2017
)
2.62
"Aripiprazole treatment was associated with significant BMI-Z increase, higher in children than in adolescents."( Weight-Change Trajectories of Pediatric Outpatients Treated with Risperidone or Aripiprazole in a Naturalistic Setting.
Bernardini, R; Biganzoli, E; Bravaccio, C; Capuano, A; Carnovale, C; Clementi, E; Marano, G; Molteni, M; Nobile, M; Pisano, S; Pozzi, M; Radice, S; Rafaniello, C; Rizzo, R; Rossi, F, 2019
)
1.46
"In aripiprazole-treated PC12 cells, we previously showed that the mitochondrial membrane potential (Δψm) was rather increased in spite of lowered cytochrome c oxidase activity. "( Aripiprazole increases NADPH level in PC12 cells: the role of NADPH oxidase.
Hamada, Y; Itoh, M; Kaneko, YS; Kodani, Y; Kondo, K; Nagasaki, H; Nagatsu, T; Nakashima, A; Ota, A; Ota, M; Takayanagi, T, 2014
)
2.47
"Aripiprazole-treated AN subjects were more likely than PAE subjects to report somnolence (11.9% vs."( Aripiprazole treatment of irritability associated with autistic disorder and the relationship between prior antipsychotic exposure, adverse events, and weight change.
Forbes, RA; Mankoski, R; Manos, G; Marcus, R; Marler, S; McQuade, R; Stockton, G, 2013
)
2.55
"Aripiprazole-treated participants had better negative symptom outcomes but experienced more akathisia."( A Randomized Comparison of Aripiprazole and Risperidone for the Acute Treatment of First-Episode Schizophrenia and Related Disorders: 3-Month Outcomes.
Addington, J; Bennett, N; Braga, RJ; Correll, CU; Gallego, JA; Greenberg, J; Hassoun, Y; John, M; Kane, JM; Kellner, CH; Lencz, T; Lopez, L; Malhotra, AK; Naraine, M; Petrides, G; Robinson, DG; Sevy, SM; Tohen, M; Zhang, JP, 2015
)
1.44
"Aripiprazole-treated patients also had significantly more akathisia (p=0.03) and agitation (p=0.02) than risperidone-treated patients."( Aripiprazole and Risperidone for Treatment of Methamphetamine-Associated Psychosis in Chinese Patients.
Chawarski, MC; Chen, H; Hao, W; Schottenfeld, RS; Wang, G; Xu, Z; Zhang, S; Zhang, Y, 2016
)
2.6
"Aripiprazole treatment produced a decrease of BP (9.3 mm Hg on systolic and 6.2 mm Hg on diastolic pressure) and an increase in HR (12.1 beats per minute) and QTc interval (9.1 milliseconds)."( Evaluation of the Relationship Between Pharmacokinetics and the Safety of Aripiprazole and Its Cardiovascular Effects in Healthy Volunteers.
Abad-Santos, F; Belmonte, C; Cabaleiro, T; Ochoa, D; Román, M; Sánchez-Rojas, SD; Talegón, M, 2016
)
1.39
"Aripiprazole showed less treatment emerged weight gain."( A Comparative Study of Short Term Efficacy of Aripiprazole and Risperidone in Schizophrenia.
Kumar C, N; Kumar P B, S; Kumar P T, S; Pandey, RS; Thirthalli, J, 2017
)
1.43
"Aripiprazole treatment was generally well tolerated, with criteria for tolerability met for all doses tested."( Tolerability and pharmacokinetics of aripiprazole in children and adolescents with psychiatric disorders: an open-label, dose-escalation study.
Boulton, DW; Carson, WH; Findling, RL; Forbes, RA; Kauffman, RE; Mallikaarjun, S; Nyilas, M; Pikalov, A; Sallee, FR; Shoaf, SE, 2008
)
1.34
"Aripiprazole treatment had no effect on cue-induced Meth craving, or on daily baseline craving assessed over the course of medication treatment, although aripiprazole treatment was associated with increased craving independent of Meth dosing."( Evaluation of subjective effects of aripiprazole and methamphetamine in methamphetamine-dependent volunteers.
Abad, A; Anderson, A; Condos, R; De La Garza, R; Elkashef, A; Halkitis, PN; Li, SH; Mahoney, JJ; Mojisak, J; Newton, TF; Palamar, J; Reid, MS, 2008
)
1.34
"In aripiprazole-treated patients, symptomatic remission rates were consistent at Weeks 8, 16, and 26; sustained remission rates at Week 8 were retained at Weeks 16 and 26."( Criteria for defining symptomatic and sustained remission in bipolar I disorder: a post-hoc analysis of a 26-week aripiprazole study (study CN138-010).
Carlson, BX; Eudicone, J; Marcus, RN; Masand, PS; McQuade, RD; Pikalov, A; Vester-Blokland, E, 2008
)
1.07
"Aripiprazole treatment for 12 months (P = 0.027) and stopping clozapine or olanzapine treatment (P = 0.038) predicted weight loss (> or =3 kg)."( A 12-month follow-up study of treating overweight schizophrenic patients with aripiprazole.
Bruggeman, R; Postema, R; Schilthuis, M; Schorr, SG; Slooff, CJ; Taxis, K; Van Oven, W, 2008
)
1.3
"Aripiprazole-treated patients also showed significant decreases versus placebo in 26 of the 30 PANSS items (all p<0.05)."( The efficacy of aripiprazole in the treatment of multiple symptom domains in patients with acute schizophrenia: a pooled analysis of data from the pivotal trials.
Assunção-Talbott, S; Crandall, DT; Eudicone, JM; Kane, JM; Pikalov, A; Whitehead, R, 2008
)
1.41
"Aripiprazole- and lithium-treated patients remained on blinded treatment for 9 additional weeks."( Aripiprazole monotherapy in the treatment of acute bipolar I mania: a randomized, double-blind, placebo- and lithium-controlled study.
Carson, WH; Cutler, AJ; Keck, PE; Marcus, RN; McQuade, RD; Orsulak, PJ; Sanchez, R; Torbeyns, A, 2009
)
2.52
"Aripiprazole-treated patients had smaller increases in glucose and lipids, but no difference was observed between treatments in the proportion of patients experiencing categorical shifts in these measures."( Olanzapine versus aripiprazole for the treatment of agitation in acutely ill patients with schizophrenia.
Chen, L; Kinon, BJ; Kollack-Walker, S; Sniadecki, J; Stauffer, VL, 2008
)
1.4
"Aripiprazole treatment resulted in improvement from baseline on all efficacy outcome measures, including Positive and Negative Syndrome Scale total, positive, negative, and general subscale, and CGI-Severity scores."( A 12-week, naturalistic switch study of the efficacy and tolerability of aripiprazole in stable outpatients with schizophrenia or schizoaffective disorder.
Chung, S; Jeon, YW; Jeong, B; Jun, TY; Jung, HY; Kim, CE; Kim, CY; Kim, DH; Kwon, JS; Lee, JN; Lee, MS, 2009
)
1.31
"Aripiprazole-treated patients also showed BMI (median reduction 0.8 kg/m(2)) and waist circumference reduction (median reduction 2.0 cm) vs."( Effects of adjunctive treatment with aripiprazole on body weight and clinical efficacy in schizophrenia patients treated with clozapine: a randomized, double-blind, placebo-controlled trial.
Dewaele, P; Fleischhacker, WW; Heikkinen, ME; Hennicken, D; Kerselaers, W; Landsberg, W; Loze, JY; McQuade, RD; Olié, JP, 2010
)
1.35
"Aripiprazole-treated subjects, compared with placebo-treated subjects, also had significantly less heavy drinking during the 14-day medication period."( The effect of aripiprazole on cue-induced brain activation and drinking parameters in alcoholics.
Anton, RF; Henderson, S; Li, X; Myrick, H; Randall, PK; Voronin, K, 2010
)
1.44
"Aripiprazole pre-treatment resulted in bidirectional effects on amphetamine self-administration."( Attenuation of reinforcing and psychomotor stimulant effects of amphetamine by aripiprazole.
Bäckström, P; Etelälahti, TJ; Hyytiä, P, 2011
)
1.32
"Aripiprazole treatment at 3 mg/day improved tardive oromandibular dystonia without worsening Parkinsonism."( Efficacy of aripiprazole in sulpiride-induced tardive oromandibular dystonia.
Ikawa, M; Imai, N, 2011
)
1.47
"Aripiprazole treatment generally did not increase bodyweight to a clinically relevant extent; however, more patients receiving aripiprazole monotherapy than placebo had clinically significant bodyweight gain during 100 weeks' treatment."( Aripiprazole: a review of its use in the management of mania in adults with bipolar I disorder.
Dhillon, S, 2012
)
2.54
"Aripiprazole treatment resulted in no significant difference from placebo in change in mean body weight from baseline (-0.4 vs."( A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole for the treatment of acute manic or mixed episodes in Asian patients with bipolar I disorder (the AMAZE study).
Ishigooka, J; Kanba, S; Kawasaki, H; Kinoshita, T; Kuroki, T; Sakamoto, K, 2014
)
1.36
"Aripiprazole treatment led to significantly more akathisia incidence in the AD group, compared with the SCZ group."( Comparing tolerability profile of quetiapine, risperidone, aripiprazole and ziprasidone in schizophrenia and affective disorders: a meta-analysis.
Moteshafi, H; Stip, E, 2012
)
1.34
"Aripiprazole treatment was well tolerated in both short- and long-term studies, showing a low liability for EPS and hyperprolactinemia, a lack of QTc prolongation, and minimal weight gain or sedation."( Dopamine partial agonists: a new class of antipsychotic.
Lieberman, JA, 2004
)
1.04
"Aripiprazole-treated patients showed significantly greater improvements from baseline in BPRS Psychosis and BPRS Core subscale scores at end point compared with placebo."( Aripiprazole for the treatment of psychosis in patients with Alzheimer's disease: a randomized, placebo-controlled study.
Breder, C; Carson, WH; De Deyn, P; Iwamoto, T; Jeste, DV; Kostic, D; Swanink, R, 2005
)
2.49
"Aripiprazole-treated patients demonstrated significantly greater improvement from baseline to endpoint in mean YMRS total scores compared with placebo-treated patients as early as Day 4 and sustained through Week 3."( Aripiprazole in the treatment of acute manic or mixed episodes in patients with bipolar I disorder: a 3-week placebo-controlled study.
Abou-Gharbia, N; Carson, W; Impellizzeri, C; Iwamoto, T; Kaplita, S; Marcus, R; McQuade, R; Rollin, L; Sachs, G; Sanchez, R; Stock, E, 2006
)
2.5
"Aripiprazole-treated patients had significantly fewer relapses (25%) than placebo patients (43%; p = .013)."( A randomized, double-blind, placebo-controlled 26-week trial of aripiprazole in recently manic patients with bipolar I disorder.
Calabrese, JR; Carlson, BX; Carson, WH; Keck, PE; Marcus, RN; McQuade, RD; Rollin, LM; Sanchez, R, 2006
)
1.29
"Aripiprazole treatment (n=268) resulted in significantly better effectiveness than SOC treatment (n=254; P<0.001; Week 26 LOCF) as evidenced by the IAQ total score beginning at Week 4 (the first assessment point) and sustained through Week 26. "( A multicentre, randomized, naturalistic, open-label study between aripiprazole and standard of care in the management of community-treated schizophrenic patients Schizophrenia Trial of Aripiprazole: (STAR) study.
Banki, CM; Beuzen, JN; Hanssens, L; Herman, E; Kerwin, R; L'Italien, G; Lublin, H; McQuade, RD; Millet, B; Pans, M, 2007
)
2.02
"Aripiprazole treatment was associated with clinically and statistically significant improvement in mean Young Mania Rating Scale scores (-18.0+/-6.9, P<.0001)."( An open-label trial of aripiprazole monotherapy in children and adolescents with bipolar disorder.
Aleardi, M; Biederman, J; Doyle, R; Hammerness, P; Joshi, G; Kotarski, M; Mick, E; Spencer, T; Wozniak, J, 2007
)
1.37
"One aripiprazole-treated patient discontinued due to an AE (akathisia)."( Aripiprazole monotherapy in patients with rapid-cycling bipolar I disorder: an analysis from a long-term, double-blind, placebo-controlled study.
Carlson, BX; Eudicone, JM; Marcus, RN; McQuade, RD; Momah, C; Muzina, DJ; Pikalov, A; Sanchez, R, 2008
)
2.27
"Aripiprazole-treated patients had more favorable changes in lipids, glucose, and body weight versus SoC. "( Predicted risk of diabetes and coronary heart disease in patients with schizophrenia: aripiprazole versus standard of care.
Blonde, L; Gutterman, EM; Hanssens, L; Kan, HJ; Kim, MS; L'Italien, GJ; McQuade, RD, 2008
)
2.01
"Aripiprazole-treated patients had more favorable changes in metabolic parameters compared with SoC, leading to a reduced risk of diabetes and CHD, based on validated models."( Predicted risk of diabetes and coronary heart disease in patients with schizophrenia: aripiprazole versus standard of care.
Blonde, L; Gutterman, EM; Hanssens, L; Kan, HJ; Kim, MS; L'Italien, GJ; McQuade, RD, 2008
)
2.01
"Treatment with aripiprazole suppressed the growth of head and neck cancer cells in a concentration-dependent manner, as evidenced by the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide assay."( Aripiprazole sensitizes head and neck cancer cells to ionizing radiation by enhancing the production of reactive oxygen species.
Jeong, HJ; Jung, CW; Kim, HJ; Kim, JY; Moon, Y; Park, B; Park, MJ, 2022
)
2.5
"Treatment with aripiprazole was only effective at preventing the reinstatement of ethanol-induced CPP when paired with the ethanol-associated environment, but not when administered in the home-cage."( Role of the treatment environment in the effects of aripiprazole on ethanol-induced behavioral sensitization and conditioned place preference in female mice.
Baldaia, MA; Barros-Santos, T; Berro, LF; Borges, ALN; Cata-Preta, EG; de Santana Santos, ACG; Frussa-Filho, R; Hollais, AW; Libarino-Santos, M; Marinho, EAV; Nunes Brandão, NR; Oliveira-Lima, AJ; Santos-Baldaia, R, 2020
)
1.15
"Co-treatment with aripiprazole and an ineffective dose of escitalopram also abolished the behavioral deficits in the studied tests."( Impact of repeated co-treatment with escitalopram and aripiprazole on the schizophrenia-like behaviors and BDNF mRNA expression in the adult Sprague-Dawley rats exposed to glutathione deficit during early postnatal development of the brain.
Kamińska, K; Lech, MA; Leśkiewicz, M; Lorenc-Koci, E; Rogóż, Z, 2021
)
1.19
"Treatment with aripiprazole was associated with a significantly longer time to exacerbation of psychotic symptoms/impending relapse compared with placebo (hazard ratio, 0.46 [95% CI = 0.24-0.88]; p = .016)."( Oral Aripiprazole as Maintenance Treatment in Adolescent Schizophrenia: Results From a 52-Week, Randomized, Placebo-Controlled Withdrawal Study.
Baker, RA; Carson, W; Correll, CU; Kohegyi, E; McQuade, R; Nyilas, M; Salzman, PM; Sanchez, R; Zhao, C, 2017
)
1.31
"Treatment with aripiprazole once-monthly, at any dose, did not result in any clinically meaningful changes from baseline in extrapyramidal symptom scales, clinical laboratory tests, vital signs, or electrocardiogram parameters."( Pharmacokinetics, tolerability and safety of aripiprazole once-monthly in adult schizophrenia: an open-label, parallel-arm, multiple-dose study.
Bricmont, P; Carson, W; Fleischhacker, WW; Forbes, RA; Kane, JM; Mallikaarjun, S; McQuade, R; Sanchez, R, 2013
)
0.99
"Treatment with aripiprazole resulted in significant improvement in the PANSS and Clinical Global Impression scores over time."( The advantage of using 3-week data to predict response to aripiprazole at week 6 in first-episode psychosis.
Cho, DH; Chung, YC; Hahn, SW; Jeong, B; Kim, JH; Kim, SW; Koo, MS; Lee, SH; Lee, SJ; Lee, YH; Park, JI; Rho, SH, 2014
)
0.99
"Pretreatment of aripiprazole and minocycline suppressed apoptosis of oligodendrocytes in the co-culture model with interferon-γ (IFN-γ)-activated microglia, while haloperidol, a traditional antipsychotic drug, did not."( Pretreatment of aripiprazole and minocycline, but not haloperidol, suppresses oligodendrocyte damage from interferon-γ-stimulated microglia in co-culture model.
Horikawa, H; Kanba, S; Kato, TA; Mizoguchi, Y; Monji, A; Sato-Kasai, M; Seki, Y; Yoshiga, D, 2013
)
1.07
"Treatment with aripiprazole was associated with no changes of mean QTc, even if a small increase of QTd, (40.6+6.5 ms vs 46.3+7.2 ms, p<0.01) was observed."( ECG parameters in children and adolescents treated with aripiprazole and risperidone.
Calabrò, MP; D'Amico, G; Gagliano, A; Germanò, E; Guerriero, L; Ingrassia, M; Italiano, D; Lamberti, M; Privitera, C; Siracusano, R; Spina, E, 2014
)
0.99
"Treatment with aripiprazole lauroxil resulted in decreases in agitation and hostility in patients with schizophrenia and this antihostility effect appears to be independent of a general antipsychotic effect."( Effect of aripiprazole lauroxil on agitation and hostility in patients with schizophrenia.
Bose, A; Citrome, L; Claxton, A; Du, Y; Ehrich, EW; Risinger, R; Silverman, BL; Stankovic, S; Zummo, J, 2016
)
1.18
"Treatment with aripiprazole resulted in a reduction in the frequency, duration, and severity of episodes of alternating hemiplegia, along with other therapeutic benefits."( Treatment of alternating hemiplegia of childhood with aripiprazole.
Haffejee, S; Santosh, PJ, 2009
)
0.94
"Treatment with aripiprazole at 10 microM increased the levels of BDNF by 85%, compared with control levels (p<0.01), whereas haloperidol had no effect."( Differential effects of aripiprazole and haloperidol on BDNF-mediated signal changes in SH-SY5Y cells.
Cho, HY; Choi, SM; Ha, EK; Kim, YH; Lee, JG; Park, SW; Seo, MK, 2009
)
1
"Treatment with aripiprazole, olanzapine, quetiapine, or risperidone for 12 weeks."( Cardiometabolic risk of second-generation antipsychotic medications during first-time use in children and adolescents.
Correll, CU; Kane, JM; Malhotra, AK; Manu, P; Napolitano, B; Olshanskiy, V, 2009
)
0.71
"Pretreatment of aripiprazole (40 mg/kg) had a tendency to suppress MK-801 (1.0 mg/kg)-induced pMEK/MEK (Ser218/222) activation."( Effects of aripiprazole on MK-801-induced prepulse inhibition deficits and mitogen-activated protein kinase signal transduction pathway.
Hashimoto, K; Ishii, D; Iyo, M; Kanahara, N; Kohno, M; Matsuda, S; Matsuzawa, D; Nakazawa, K; Ohtsuka, H; Shimizu, E; Sutoh, C, 2010
)
1.08
"Pretreatment with aripiprazole protected dopaminergic neurons in a concentration-dependent manner."( Protective effect of aripiprazole against glutamate cytotoxicity in dopaminergic neurons of rat mesencephalic cultures.
Akaike, A; Izumi, Y; Kume, T; Matsuo, T; Sawada, H; Takada-Takatori, Y, 2010
)
1
"Treatment with aripiprazole came at the total costs per remission of 30,970 Baht while treatment with placebo came at the total costs per remission of 28,409 Baht. "( The cost-effectiveness of aripiprazole as adjunctive therapy in major depressive disorder: Thai economic model.
Leelahanaj, T, 2010
)
1.01
"Treatment with aripiprazole dominates over olanzapine in both schizophrenia and bipolar disorder. "( Metabolic effects and cost-effectiveness of aripiprazole versus olanzapine in schizophrenia and bipolar disorder.
Eriksson, J; Kasteng, F; Lindgren, P; Sennfält, K, 2011
)
0.98
"Treatment with aripiprazole for 8 weeks significantly increased plasma BDNF levels. "( Aripiprazole altered plasma levels of brain-derived neurotrophic factor and catecholamine metabolites in first-episode untreated Japanese schizophrenia patients.
Atake, K; Hayashi, K; Hori, H; Ikenouchi-Sugita, A; Katsuki, A; Nakamura, J; Tomita, M; Umene-Nakano, W; Yoshimura, R, 2012
)
2.17
"Treatment with aripiprazole is associated with significant reduction of the Positive and Negative Symptom Scale (PANSS) scores in youth with schizophrenia, and reductions in items in the negative symptom scores at higher doses (30 mg/day). "( Aripiprazole in pediatric psychosis and bipolar disorder: a clinical review.
Doey, T, 2012
)
2.17
"Treatment with aripiprazole was well tolerated."( Aripiprazole in the treatment of pediatric bipolar disorder: a systematic chart review.
Aleardi, M; Biederman, J; Falzone, R; McDonnell, MA; Mick, E; Spencer, T; Wozniak, J, 2005
)
2.11
"Pretreatment with aripiprazole shifted the dose-response function of methamphetamine to the right in both LgA and ShA rats."( Effect of aripiprazole, a partial dopamine D2 receptor agonist, on increased rate of methamphetamine self-administration in rats with prolonged session duration.
Koob, GF; Pulvirenti, L; Wang, Z; Wee, S; Woolverton, WL, 2007
)
1.07
"Pre-treatment with aripiprazole was generally well tolerated, with tiredness being the most commonly reported adverse event."( Effects of aripiprazole on subjective and physiological responses to alcohol.
Arias, AJ; Chan, G; Covault, J; Douglas, K; Kranzler, HR; Oncken, C; Pierucci-Lagha, A, 2008
)
1.05

Toxicity

Aripiprazole is a generally well-tolerated third-generation antipsychotic with low rates of motor side effects and metabolic adverse effects that occur common. The deltoid muscle is a safe alternative injection site in patients with schizophrenia.

ExcerptReferenceRelevance
"Aripiprazole, effective against positive and negative symptoms, is a safe and well-tolerated potential treatment for schizophrenia and schizoaffective disorder."( Efficacy and safety of aripiprazole and haloperidol versus placebo in patients with schizophrenia and schizoaffective disorder.
Ali, MW; Carson, WH; Ingenito, GG; Kane, JM; McQuade, RD; Saha, AR; Zimbroff, DL, 2002
)
2.07
" This includes general adverse events, a low incidence of reported weight gain and a low liability for inducing movement disorders."( Aripiprazole: profile on efficacy and safety.
Goodnick, PJ; Jerry, JM, 2002
)
1.76
" Safety assessments included adverse event (AE) reports, EPS scales, ECGs, weight, and prolactin, glucose and cholesterol levels."( Aripiprazole in the treatment of schizophrenia: safety and tolerability in short-term, placebo-controlled trials.
Ali, M; Iwamoto, T; Kaplita, S; Marcus, R; Marder, SR; McQuade, RD; Safferman, AZ; Saha, A; Stock, E, 2003
)
1.76
" Discontinuations due to adverse events did not differ significantly between the aripiprazole and placebo groups."( A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania.
Ali, M; Ingenito, G; Keck, PE; Liebeskind, A; Marcus, R; Saha, A; Tourkodimitris, S, 2003
)
0.78
"Aripiprazole had significantly greater efficacy than placebo for the treatment of bipolar disorder patients in acute manic or mixed episodes and was safe and well tolerated in this randomized controlled trial."( A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania.
Ali, M; Ingenito, G; Keck, PE; Liebeskind, A; Marcus, R; Saha, A; Tourkodimitris, S, 2003
)
1.99
" Time to discontinuation due to adverse events or lack of efficacy was significantly greater with aripiprazole than with haloperidol (p=0."( Efficacy and safety of aripiprazole vs. haloperidol for long-term maintenance treatment following acute relapse of schizophrenia.
Ali, M; Archibald, D; Carson, WH; Ingenito, G; Kasper, S; Lerman, MN; Marcus, R; McQuade, RD; Pigott, T; Saha, A, 2003
)
0.85
" Adverse events were generally mild to moderate, were transient in nature, and commonly occurred within the first 3 days of dosing."( Pharmacokinetics, tolerability, and safety of aripiprazole following multiple oral dosing in normal healthy volunteers.
Bramer, SL; Mallikaarjun, S; Salazar, DE, 2004
)
0.58
"Five new antipsychotic drugs introduced in the United States in the last decade offer physicians the ability to treat patients with schizophrenia and bipolar mania without the adverse effects of the first-generation antipsychotics."( The promise of atypical antipsychotics: fewer side effects mean enhanced compliance and improved functioning.
Citrome, L; Volavka, J, 2004
)
0.32
" However, there are still significant adverse effects and toxicities with this class of medications."( Toxicology and overdose of atypical antipsychotic medications in children: does newer necessarily mean safer?
Dubois, D, 2005
)
0.33
"Continued research to evaluate adverse effects and tolerability of atypical antipsychotics compared with first-generation antipsychotics and each other is reviewed."( Toxicology and overdose of atypical antipsychotic medications in children: does newer necessarily mean safer?
Dubois, D, 2005
)
0.33
"While new atypical antipsychotic medications may have a safer therapeutic and overdose profile than first-generation antipsychotic medications, many adverse and toxic effects still need to be considered in therapeutic monitoring and overdose management."( Toxicology and overdose of atypical antipsychotic medications in children: does newer necessarily mean safer?
Dubois, D, 2005
)
0.33
" Several clinical trials have not shown efficacy, and there have been concerns about adverse events."( Efficacy and adverse effects of atypical antipsychotics for dementia: meta-analysis of randomized, placebo-controlled trials.
Dagerman, K; Insel, PS; Schneider, LS, 2006
)
0.33
" Clinical and trials characteristics, outcomes, and adverse events were extracted."( Efficacy and adverse effects of atypical antipsychotics for dementia: meta-analysis of randomized, placebo-controlled trials.
Dagerman, K; Insel, PS; Schneider, LS, 2006
)
0.33
" Adverse events were mainly somnolence and urinary tract infection or incontinence across drugs, and extrapyramidal symptoms or abnormal gait with risperidone or olanzapine."( Efficacy and adverse effects of atypical antipsychotics for dementia: meta-analysis of randomized, placebo-controlled trials.
Dagerman, K; Insel, PS; Schneider, LS, 2006
)
0.33
" Dropouts and adverse events further limit effectiveness."( Efficacy and adverse effects of atypical antipsychotics for dementia: meta-analysis of randomized, placebo-controlled trials.
Dagerman, K; Insel, PS; Schneider, LS, 2006
)
0.33
" Extrapyramidal symptoms (EPS), weight gain, serum prolactin level, QTc interval, and self-reported adverse events were assessed as measures of safety and tolerability."( Efficacy and safety of aripiprazole in the acute treatment of schizophrenia in Chinese patients with risperidone as an active control: a randomized trial.
Chan, HY; Chiang, SC; Hwang, TJ; Hwu, HG; Lin, SK; Lin, WW; Su, TP, 2007
)
0.65
" No patient discontinued the study because of treatment-emergent adverse events."( Efficacy and safety of intramuscular aripiprazole in patients with acute agitation: a randomized, double-blind, placebo-controlled trial.
Auby, P; Marcus, RN; McQuade, RD; Oren, DA; Sack, DA; Tran-Johnson, TK, 2007
)
0.61
" Extrapyramidal symptom-related adverse events were lower for aripiprazole (1."( Efficacy and safety of oral aripiprazole compared with haloperidol in patients transitioning from acute treatment with intramuscular formulations.
Allen, MH; Crandall, DT; Currier, GW; Daniel, DG; Manos, G; McQuade, R; Oren, D; Pikalov, AA; Zimbroff, DL, 2007
)
0.87
"Acutely agitated patients with schizophrenia or schizoaffective disorder treated with aripiprazole IM or haloperidol IM demonstrated similar effective and safe transition to their respective oral formulations."( Efficacy and safety of oral aripiprazole compared with haloperidol in patients transitioning from acute treatment with intramuscular formulations.
Allen, MH; Crandall, DT; Currier, GW; Daniel, DG; Manos, G; McQuade, R; Oren, D; Pikalov, AA; Zimbroff, DL, 2007
)
0.86
" Adverse events (AEs) that occurred in > or = 10% of patients with adjunctive placebo or adjunctive aripiprazole were akathisia (4."( The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: a multicenter, randomized, double-blind, placebo-controlled study.
Berman, RM; Carson, WH; Corey-Lisle, PK; Khan, A; Marcus, RN; McQuade, RD; Swanink, R, 2007
)
0.85
" The treatment-emergent adverse events reported in >or=5% of patients aged 18-40 years receiving aripiprazole were similar to those reported for the overall population."( Efficacy and safety of aripiprazole in subpopulations with acute manic or mixed episodes of bipolar I disorder.
Carlson, B; Eudicone, J; McQuade, R; Pikalov, A; Suppes, T, 2008
)
0.87
" Treatment-emergent adverse events occurring during the pivotal trials revealed statistically significant NNH versus placebo (or placebo equivalent) for aripiprazole for headache (NNH = 20, 95% CI = 11 to 170) and nausea (NNH = 17, 95% CI = 11 to 38), for ziprasidone in the treatment of headache (NNH = 15, 95% CI = 8 to 703), and for olanzapine in treatment-emergent hypotension (NNH = 50, 95% CI = 30 to 154)."( Comparison of intramuscular ziprasidone, olanzapine, or aripiprazole for agitation: a quantitative review of efficacy and safety.
Citrome, L, 2007
)
0.78
" Adverse effects and their impact on treatment course were also evaluated."( Aripiprazole: effectiveness and safety under naturalistic conditions.
Amoretti, A; Di Lorenzo, R; Fiorini, F; Forghieri, M; Genedani, S; Rigatelli, M, 2007
)
1.78
"7%) and treatment-related adverse events (82."( A randomized, multicenter, double-blind, placebo-controlled study of the efficacy and safety of aripiprazole for the treatment of alcohol dependence.
Anton, RF; Breder, C; Carson, WH; Han, J; Kranzler, H; Marcus, RN, 2008
)
0.56
" Adverse events occurring in 10% of patients or more with adjunctive placebo or aripiprazole were akathisia (4."( The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: a second multicenter, randomized, double-blind, placebo-controlled study.
Berman, RM; Carson, WH; Fava, M; Hennicken, D; Marcus, RN; McQuade, RD; Simon, JS; Thase, ME; Trivedi, MH, 2008
)
0.87
" Aripiprazole is a second-generation antipsychotic that seems to have a favorable side-effect profile."( The safety of the electroconvulsive therapy-aripiprazole combination: four case reports.
Karakatsanis, NA; Karapoulios, E; Kouzoupis, AV; Masdrakis, VG; Oulis, P; Soldatos, CR; Zervas, IM, 2008
)
1.52
" Combined application of clozapine and aripiprazole is in accordance with a neurobiological rationale and appears to be a safe and well tolerated."( Adjunctive aripiprazole decreased metabolic side effects of clozapine treatment.
Libiger, J; Masopust, J; Tůma, I, 2008
)
1.01
"Aripiprazole (15 mg/day) is safe and tolerable when combined with cocaine; however, the usefulness of aripiprazole as a treatment for cocaine-use disorders remains to be determined."( The safety, tolerability, and subject-rated effects of acute intranasal cocaine administration during aripiprazole maintenance II: increased aripipirazole dose and maintenance period.
Hays, LR; Lile, JA; Rush, CR; Stoops, WW, 2008
)
2
"Dopamine receptor antagonists are commonly used to counter the adverse effects of opioids such as hallucinations, delusions and emesis."( Suppression of dopamine-related side effects of morphine by aripiprazole, a dopamine system stabilizer.
Amano, T; Asato, M; Hashimoto, K; Ikegami, D; Kuzumaki, N; Matsushima, Y; Nakamura, A; Narita, M; Niikura, K; Shiokawa, M; Suzuki, T; Takagi, S; Takei, D; Tsurukawa, Y, 2008
)
0.59
" Tolerability and safety were assessed by monitoring the frequency and severity of treatment-emergent adverse events, extrapyramidal symptoms (EPS), vital signs, weight, and laboratory tests."( Long-term efficacy and safety of aripiprazole in patients with schizophrenia, schizophreniform disorder, or schizoaffective disorder: 26-week prospective study.
Cho, SJ; Jang, JH; Kang, DH; Kim, YK; Kwon, JS; Yoo, SY, 2009
)
0.63
"Completion rates were between 84% and 90% and comparable across all subgroups, with low discontinuations due to adverse events."( Adjunctive aripiprazole in major depressive disorder: analysis of efficacy and safety in patients with anxious and atypical features.
Berman, RM; Carlson, BX; Fava, M; Marcus, RN; Nelson, CJ; Pikalov, A; Qi, Y; Thase, ME; Tran, QV; Trivedi, MH; Yang, H, 2008
)
0.74
" Safety and tolerability evaluations included incidence of treatment-emergent adverse events and extrapyramidal symptom assessments (SAS, BARS, and AIMS), and metabolic profile changes including weight and BMI."( The efficacy, safety, and tolerability of aripiprazole for the treatment of schizoaffective disorder: results from a pooled analysis of a sub-population of subjects from two randomized, double-blind, placebo-controlled, pivotal trials.
Assunção-Talbott, S; Eudicone, JM; Glick, ID; Mankoski, R; Marcus, RN; Tran, QV, 2009
)
0.62
"Aripiprazole was generally well tolerated, with agitation/activation the most common side effect reported in elderly inpatients."( Aripiprazole prescribing patterns and side effects in elderly psychiatric inpatients.
Coley, KC; Fabian, TJ; Lenze, EJ; Ruby, C; Scipio, TM, 2009
)
3.24
" Primary endpoint was rate of discontinuation due to adverse events (AEs) during the 12-week study."( Switching to aripiprazole in outpatients with schizophrenia experiencing insufficient efficacy and/or safety/tolerability issues with risperidone: a randomized, multicentre, open-label study.
Kahn, JP; Kerselaers, W; Lissens, J; McQuade, RD; Modell, S; Ryckmans, V; Sanchez, R; Werner, C, 2009
)
0.72
" The ultimate aim for this research is to determine whether this combination is safe and is superior to either drug taken alone in reducing alcohol use in alcohol dependent patients."( A safety and tolerability laboratory study of the combination of aripiprazole and topiramate in volunteers who drink alcohol.
Kenna, GA; Leggio, L; Swift, RM, 2009
)
0.59
" Participants reported adverse events (AEs) daily alcohol use and participated in an alcohol challenge session (ACS)."( A safety and tolerability laboratory study of the combination of aripiprazole and topiramate in volunteers who drink alcohol.
Kenna, GA; Leggio, L; Swift, RM, 2009
)
0.59
" Most common adverse effects included appetite increase and weight gain in 5 subjects, mild extrapyramidal effects in 7 subjects, and headaches and tiredness/fatigue in 7 subjects; 1 subject experienced akathisia and muscle cramps."( Aripiprazole in children and adolescents with Tourette's disorder: an open-label safety and tolerability study.
Coffey, BJ; Goldman, R; Hirsch, S; Jummani, R; Lyon, GJ; Samar, S; Spirgel, A, 2009
)
1.8
"Aripiprazole appears to be a safe and tolerable treatment in children and adolescents with TD that appears to reduce tics; it should be further investigated as a treatment option in controlled trials."( Aripiprazole in children and adolescents with Tourette's disorder: an open-label safety and tolerability study.
Coffey, BJ; Goldman, R; Hirsch, S; Jummani, R; Lyon, GJ; Samar, S; Spirgel, A, 2009
)
3.24
" Frequently reported adverse events (AEs) that occurred with ARI + LI vs."( Assessment of safety, tolerability and effectiveness of adjunctive aripiprazole to lithium/valproate in bipolar mania: a 46-week, open-label extension following a 6-week double-blind study.
Baudelet, C; Marcus, RN; McQuade, RD; Owen, R; Sanchez, R; Vieta, E, 2010
)
0.6
"Long-term aripiprazole adjunctive to lithium/valproate in bipolar mania was safe and well tolerated."( Assessment of safety, tolerability and effectiveness of adjunctive aripiprazole to lithium/valproate in bipolar mania: a 46-week, open-label extension following a 6-week double-blind study.
Baudelet, C; Marcus, RN; McQuade, RD; Owen, R; Sanchez, R; Vieta, E, 2010
)
1
" Early onset schizophrenia warrants effective pharmacological treatment that is safe and well tolerated by children and adolescent population."( The use of aripiprazole in early onset schizophrenia: safety and efficacy.
Hamidin, A; Normala, I, 2009
)
0.74
" Akathisia was the most common adverse event in both the older (17."( Efficacy and safety of adjunctive aripiprazole in major depressive disorder in older patients: a pooled subpopulation analysis.
Andersson, C; Berman, RM; Carlson, BX; Eudicone, JM; Forbes, RA; Nelson, JC; Steffens, DC; Tran, QV; Yang, H, 2011
)
0.65
" Safety and tolerability measures included incidences of adverse events, extrapyramidal symptoms, weight, metabolic measures, vital signs, and other clinical assessments."( Safety and tolerability of aripiprazole for irritability in pediatric patients with autistic disorder: a 52-week, open-label, multicenter study.
Carson, WH; Findling, RL; Kamen, L; Mankoski, R; Manos, G; Marcus, RN; McQuade, RD; Owen, R, 2011
)
0.67
" Adverse events were experienced by 286/330 subjects (86."( Safety and tolerability of aripiprazole for irritability in pediatric patients with autistic disorder: a 52-week, open-label, multicenter study.
Carson, WH; Findling, RL; Kamen, L; Mankoski, R; Manos, G; Marcus, RN; McQuade, RD; Owen, R, 2011
)
0.67
"Aripiprazole was generally safe and well tolerated in the long-term treatment of irritability associated with autistic disorder in pediatric subjects."( Safety and tolerability of aripiprazole for irritability in pediatric patients with autistic disorder: a 52-week, open-label, multicenter study.
Carson, WH; Findling, RL; Kamen, L; Mankoski, R; Manos, G; Marcus, RN; McQuade, RD; Owen, R, 2011
)
2.11
" The Systematic Assessment of Treatment Emergent Events-General Inquiry was used to assess adverse effects."( The effectiveness and safety of adjunctive aripiprazole in Taiwanese patients with antidepressant-refractory major depressive disorder: a prospective, open-label trial.
Chen, SJ; Chen, ST; Hsiao, YL; Shen, TW, 2012
)
0.64
" The most common adverse events (> 15% of patients; aripiprazole vs."( A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole for the treatment of acute manic or mixed episodes in Asian patients with bipolar I disorder (the AMAZE study).
Ishigooka, J; Kanba, S; Kawasaki, H; Kinoshita, T; Kuroki, T; Sakamoto, K, 2014
)
0.89
" Treatment was generally safe and well tolerated."( A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole for the treatment of acute manic or mixed episodes in Asian patients with bipolar I disorder (the AMAZE study).
Ishigooka, J; Kanba, S; Kawasaki, H; Kinoshita, T; Kuroki, T; Sakamoto, K, 2014
)
0.64
"Primary metabolic markers (body mass index, blood pressure, fasting blood glucose, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides), percentage of patients who stay on the randomly assigned atypical antipsychotic for at least 6 months, psychopathology, percentage of patients who develop metabolic syndrome, and percentage of patients who develop serious and nonserious adverse events."( Comparison of longer-term safety and effectiveness of 4 atypical antipsychotics in patients over age 40: a trial using equipoise-stratified randomization.
Arndt, S; Glorioso, DK; Golshan, S; Henry, R; Jeste, DV; Jin, H; Kraemer, HC; Mudaliar, S; Shih, PA, 2013
)
0.39
"Because of a high incidence of serious adverse events, quetiapine was discontinued midway through the trial."( Comparison of longer-term safety and effectiveness of 4 atypical antipsychotics in patients over age 40: a trial using equipoise-stratified randomization.
Arndt, S; Glorioso, DK; Golshan, S; Henry, R; Jeste, DV; Jin, H; Kraemer, HC; Mudaliar, S; Shih, PA, 2013
)
0.39
" Double-blind, randomized, controlled trials investigating the metabolic adverse effects (weight gain, lipid, glucose, and prolactin level abnormalities) associated with atypical antipsychotic use in children and adolescents aged ≤ 18 years were included, irrespective of whether the investigation of adverse effects was a primary or secondary endpoint."( Weight gain and other metabolic adverse effects associated with atypical antipsychotic treatment of children and adolescents: a systematic review and meta-analysis.
Aitchison, KJ; Almandil, NB; Besag, FM; Liu, Y; Murray, ML; Wong, IC, 2013
)
0.39
" Safety was assessed across study phases by the time of first onset of adverse events, as were objective measures of extrapyramidal symptoms, fasting metabolic parameters, and body weight."( Long-term safety and tolerability of aripiprazole once-monthly in maintenance treatment of patients with schizophrenia.
Baker, RA; Carson, W; Fleischhacker, WW; Forbes, RA; Jin, N; Johnson, B; Kane, JM; McQuade, R; Sanchez, R, 2013
)
0.66
"5%) in the SOC group discontinued due to adverse events (physician and subject decision combined, P = ."( A long-term, phase 2, multicenter, randomized, open-label, comparative safety study of pomaglumetad methionil (LY2140023 monohydrate) versus atypical antipsychotic standard of care in patients with schizophrenia.
Adams, DH; Baygani, S; Kinon, BJ; Kollack-Walker, S; Millen, BA; Velona, I; Walling, DP, 2013
)
0.39
"These data provide further evidence that the potential antipsychotic LY2140023 monohydrate, with a glutamatergic mechanism of action, may have a unique tolerability profile characterized by a low association with some adverse events such as extrapyramidal symptoms and weight gain that may characterize currently available dopaminergic antipsychotics."( A long-term, phase 2, multicenter, randomized, open-label, comparative safety study of pomaglumetad methionil (LY2140023 monohydrate) versus atypical antipsychotic standard of care in patients with schizophrenia.
Adams, DH; Baygani, S; Kinon, BJ; Kollack-Walker, S; Millen, BA; Velona, I; Walling, DP, 2013
)
0.39
" Adverse events were assessed."( A head-to-head comparison of aripiprazole and risperidone for safety and treating autistic disorders, a randomized double blind clinical trial.
Berk, M; Ghanizadeh, A; Sahraeizadeh, A, 2014
)
0.69
" Adverse events were similar irrespective of prior atypical antipsychotic and duration of oral antipsychotic overlap, suggesting that patients can be safely switched from their existing oral antipsychotic to aripiprazole once monthly without requiring an intermediate stabilization phase with oral aripiprazole."( Safety and tolerability of once monthly aripiprazole treatment initiation in adults with schizophrenia stabilized on selected atypical oral antipsychotics other than aripiprazole.
Baker, RA; Bricmont, P; Eramo, A; Kasper, W; Mallikaarjun, S; McQuade, R; Peters-Strickland, T; Potkin, SG; Raoufinia, A; Sanchez, R, 2013
)
0.84
" The most common treatment-emergent adverse events were vomiting (13."( Pharmacokinetics, tolerability and safety of aripiprazole once-monthly in adult schizophrenia: an open-label, parallel-arm, multiple-dose study.
Bricmont, P; Carson, W; Fleischhacker, WW; Forbes, RA; Kane, JM; Mallikaarjun, S; McQuade, R; Sanchez, R, 2013
)
0.65
" Subjects were stratified by PAE; adverse events (AEs), and changes in weight, and metabolic measures were evaluated."( Aripiprazole treatment of irritability associated with autistic disorder and the relationship between prior antipsychotic exposure, adverse events, and weight change.
Forbes, RA; Mankoski, R; Manos, G; Marcus, R; Marler, S; McQuade, R; Stockton, G, 2013
)
1.83
"The purpose of this project was to provide evidence-based guidance concerning when and how it is appropriate to undertake elective changes in antipsychotic medications in order to reduce adverse effects, with a focus on those adverse effects associated with increased long-term health risks."( Switching antipsychotic medications to reduce adverse event burden in schizophrenia: establishing evidence-based practice.
Buchanan, RW; Newcomer, JW; Weiden, PJ, 2013
)
0.39
" The most common adverse events during phase 1 were weight increase (25."( A randomized controlled trial investigating the safety and efficacy of aripiprazole in the long-term maintenance treatment of pediatric patients with irritability associated with autistic disorder.
Amatniek, J; Eudicone, JM; Findling, RL; Lears, K; Mankoski, R; Marcus, RN; McCartney, T; McQuade, RD; Sheehan, JJ; Timko, K, 2014
)
0.64
" Adverse events were assessed within each subgroup."( Effect of symptom severity on efficacy and safety of aripiprazole adjunctive to antidepressant monotherapy in major depressive disorder: a pooled analysis.
Berman, RM; Hatch, A; Largay, K; Marler, SV; Nelson, JC; Sheehan, JJ; Stewart, TD, 2014
)
0.65
" Common treatment-emergent adverse events included akathisia and restlessness."( Effect of symptom severity on efficacy and safety of aripiprazole adjunctive to antidepressant monotherapy in major depressive disorder: a pooled analysis.
Berman, RM; Hatch, A; Largay, K; Marler, SV; Nelson, JC; Sheehan, JJ; Stewart, TD, 2014
)
0.65
" Extrapyramidal symptoms (EPS), weight gain, serum prolactin level, QTc interval, and self-reported adverse events were also assessed as measures of safety and tolerability."( Efficacy and safety of aripiprazole in Chinese Han schizophrenia subjects: a randomized, double-blind, active parallel-controlled, multicenter clinical trial.
Gu, N; Kane, JM; Li, H; Luo, J; Wang, C; Wang, X; Xie, S; Xu, X; Yu, W, 2014
)
0.71
"The aim of this study was to compare the efficacy and side-effect profile of the typical antipsychotic haloperidol with that of the atypical antipsychotics risperidone, olanzapine, and aripiprazole in the management of delirium."( Haloperidol, risperidone, olanzapine and aripiprazole in the management of delirium: A comparison of efficacy, safety, and side effects.
Boettger, S; Breitbart, W; Jenewein, J, 2015
)
0.87
"The Memorial Delirium Assessment Scale (MDAS), the Karnofsky Performance Status (KPS) scale, and a side-effect rating were recorded at baseline (T1), after 2-3 days (T2), and after 4-7 days (T3)."( Haloperidol, risperidone, olanzapine and aripiprazole in the management of delirium: A comparison of efficacy, safety, and side effects.
Boettger, S; Breitbart, W; Jenewein, J, 2015
)
0.68
"Haloperidol, risperidone, aripiprazole, and olanzapine were equally effective in the management of delirium; however, they differed in terms of their side-effect profile."( Haloperidol, risperidone, olanzapine and aripiprazole in the management of delirium: A comparison of efficacy, safety, and side effects.
Boettger, S; Breitbart, W; Jenewein, J, 2015
)
0.98
" The most common adverse events were injection site pain in 20 subjects (43."( Relative bioavailability and safety of aripiprazole lauroxil, a novel once-monthly, long-acting injectable atypical antipsychotic, following deltoid and gluteal administration in adult subjects with schizophrenia.
Du, Y; Ehrich, EW; Hard, M; Risinger, R; Turncliff, R, 2014
)
0.67
" Risk assessment for the potential use of a drug, such as aripiprazole (Abilify), should not focus on any particular adverse effect, but rather should consider risk assessment in a broader context."( Atypical antipsychotics are not all alike: side effects and risk assessment.
Howland, RH, 2014
)
0.65
"The reports submitted to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from 1997 to 2011 were reviewed to assess serious adverse events induced by the administration of antipsychotics to children."( Antipsychotics-associated serious adverse events in children: an analysis of the FAERS database.
Brown, JB; Kadoyama, K; Kimura, G; Miki, I; Nakamura, T; Nisiguchi, K; Okuno, Y; Sakaeda, T, 2015
)
0.42
" Signals in the data that signified a drug-associated adverse event were detected via quantitative data mining algorithms."( Antipsychotics-associated serious adverse events in children: an analysis of the FAERS database.
Brown, JB; Kadoyama, K; Kimura, G; Miki, I; Nakamura, T; Nisiguchi, K; Okuno, Y; Sakaeda, T, 2015
)
0.42
" Significant signals of the QT prolongation adverse event were detected only for ziprasidone and risperidone."( Antipsychotics-associated serious adverse events in children: an analysis of the FAERS database.
Brown, JB; Kadoyama, K; Kimura, G; Miki, I; Nakamura, T; Nisiguchi, K; Okuno, Y; Sakaeda, T, 2015
)
0.42
"It was suggested that there is a level of diversity in the strength of the association between various first- and second-generation antipsychotics with associated serious adverse events, which possibly lead to fatal outcomes."( Antipsychotics-associated serious adverse events in children: an analysis of the FAERS database.
Brown, JB; Kadoyama, K; Kimura, G; Miki, I; Nakamura, T; Nisiguchi, K; Okuno, Y; Sakaeda, T, 2015
)
0.42
" The most common (>10% patients) treatment-emergent adverse events for paliperidone ER were akathisia, headache, somnolence, tremor, and weight gain, and for aripiprazole were worsening of schizophrenia and somnolence."( Efficacy and safety of paliperidone extended release in adolescents with schizophrenia: a randomized, double-blind study.
Gopal, S; Hough, D; Lane, R; Nuamah, I; Savitz, AJ, 2015
)
0.61
" EPS were assessed at baseline and 4, 8, and 12 weeks after naturalistic SGA initiation for schizophrenia, mood, disruptive behavior, and autism spectrum disorders using the Simpson-Angus Scale (SAS), Barnes Akathisia Scale, Abnormal Involuntary Movement Scale (AIMS), and Treatment Emergent Side Effect Scale."( Neuromotor Adverse Effects in 342 Youth During 12 Weeks of Naturalistic Treatment With 5 Second-Generation Antipsychotics.
Al-Jadiri, A; Azzo, S; Carbon, M; Correll, CU; Kane, JM; Kapoor, S; Saito, E; Sarkaria, T; Sheridan, E, 2015
)
0.42
" Akathisia was the most common adverse effect of aripiprazole (reported in 24 [26%] of 91 participants on aripiprazole vs 11 [12%] of 90 on placebo)."( Efficacy, safety, and tolerability of augmentation pharmacotherapy with aripiprazole for treatment-resistant depression in late life: a randomised, double-blind, placebo-controlled trial.
Anderson, SJ; Begley, AE; Blumberger, DM; Butters, MA; Dew, MA; Karp, JF; Lenze, EJ; Mulsant, BH; Newcomer, JW; Reynolds, CF; Stack, JA, 2015
)
0.9
" Case reports, case series, and prospective or cross-sectional studies including relevant data such as relative infant dose (RID), milk-to-plasma ratio (M/P ratio), infant drug plasma levels, and adverse events were identified."( Second-Generation Antipsychotics During the Lactation Period: A Comparative Systematic Review on Infant Safety.
Uguz, F, 2016
)
0.43
" Other than clozapine, adverse events were rarely reported in infants exposed to SGAs."( Second-Generation Antipsychotics During the Lactation Period: A Comparative Systematic Review on Infant Safety.
Uguz, F, 2016
)
0.43
"The current data suggest that SGAs seem to be relatively safe in the exposed breastfed infants for short-term usage."( Second-Generation Antipsychotics During the Lactation Period: A Comparative Systematic Review on Infant Safety.
Uguz, F, 2016
)
0.43
"Hyperprolactinemia is an important but often overlooked adverse effect of antipsychotics."( Comparing the Effectiveness and Safety of the Addition of and Switching to Aripiprazole for Resolving Antipsychotic-Induced Hyperprolactinemia: A Multicenter, Open-Label, Prospective Study.
Choi, WJ; Hong, CH; Kim, BR; Kim, TY; Lee, BO; Lee, JS; Lee, SK; Park, IH; Park, SJ; Roh, D; Seok, JH; Son, SJ; Yoon, HW,
)
0.36
"Both the addition and switching strategies were effective in resolving antipsychotic-induced hyperprolactinemia and hyperprolactinemia-related adverse events, including menstrual disturbances and sexual dysfunction."( Comparing the Effectiveness and Safety of the Addition of and Switching to Aripiprazole for Resolving Antipsychotic-Induced Hyperprolactinemia: A Multicenter, Open-Label, Prospective Study.
Choi, WJ; Hong, CH; Kim, BR; Kim, TY; Lee, BO; Lee, JS; Lee, SK; Park, IH; Park, SJ; Roh, D; Seok, JH; Son, SJ; Yoon, HW,
)
0.36
"Aripiprazole is a partial dopamine agonist with only minor neurological and psychiatric adverse effects, making it a potential first-line drug for the treatment of psychiatric disorders."( Neurological, Metabolic, and Psychiatric Adverse Events in Children and Adolescents Treated With Aripiprazole.
Bruhn, CH; Fink-Jensen, A; Jakobsen, KD; Nielsen, J; Pagsberg, AK, 2016
)
2.09
" The most common treatment-emergent adverse event (TEAE) was injection site pain (35."( [Pharmacokinetics and safety of aripiprazole long-acting injection, following multiple deltoid administrations in schizophrenia patients in Japan].
Ishigooka, J; Nishiyama, K; Noda, T; Shima, T; Tadori, Y; Tamaru, N; Yamasaki, Y, 2016
)
0.72
" The incidence of treatment-emergent adverse events (AEs) was evaluated."( Effect of Aripiprazole Lauroxil on Metabolic and Endocrine Profiles and Related Safety Considerations Among Patients With Acute Schizophrenia.
Bose, A; Du, Y; Ehrich, EW; Nasrallah, HA; Newcomer, JW; Risinger, R; Silverman, BL; Stankovic, S; Zummo, J, 2016
)
0.84
" Women and subjects with higher AUC and maximum plasma concentration values were more prone to experience adverse drug reactions and gastrointestinal adverse reactions."( Evaluation of the Relationship Between Pharmacokinetics and the Safety of Aripiprazole and Its Cardiovascular Effects in Healthy Volunteers.
Abad-Santos, F; Belmonte, C; Cabaleiro, T; Ochoa, D; Román, M; Sánchez-Rojas, SD; Talegón, M, 2016
)
0.67
" There is a directly proportional relationship between pharmacokinetic parameters and adverse drug reactions and effect on BP and HR."( Evaluation of the Relationship Between Pharmacokinetics and the Safety of Aripiprazole and Its Cardiovascular Effects in Healthy Volunteers.
Abad-Santos, F; Belmonte, C; Cabaleiro, T; Ochoa, D; Román, M; Sánchez-Rojas, SD; Talegón, M, 2016
)
0.67
" Adjunctive aripiprazole appears safe but better RCTs are needed to demonstrate efficacy."( Efficacy and Safety of Adjunctive Aripiprazole in Schizophrenia: Meta-Analysis of Randomized Controlled Trials.
de Leon, J; Li, XB; Tang, YL; Wang, CY; Xiang, YQ; Zheng, W; Zheng, YJ, 2016
)
1.09
"Overall, both treatments significantly improved depressive symptoms without causing serious adverse events."( Comparison of the Efficacy and Safety of Aripiprazole Versus Bupropion Augmentation in Patients With Major Depressive Disorder Unresponsive to Selective Serotonin Reuptake Inhibitors: A Randomized, Prospective, Open-Label Study.
Cheon, EJ; Koo, BH; Lee, JH; Lee, KH; Lee, SJ; Park, YW; Sung, HM, 2017
)
0.72
" Aripiprazole and bupropion may offer effective and safe augmentation strategies in patients with MDD who are unresponsive to SSRIs."( Comparison of the Efficacy and Safety of Aripiprazole Versus Bupropion Augmentation in Patients With Major Depressive Disorder Unresponsive to Selective Serotonin Reuptake Inhibitors: A Randomized, Prospective, Open-Label Study.
Cheon, EJ; Koo, BH; Lee, JH; Lee, KH; Lee, SJ; Park, YW; Sung, HM, 2017
)
1.63
" The treatment-emergent adverse events (incidence > 5%) that were reported at higher rates with AOM 400 than placebo were weight increase, akathisia, insomnia, and anxiety."( Efficacy and Safety of Aripiprazole Once-Monthly in the Maintenance Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled, 52-Week Randomized Withdrawal Study.
Amatniek, J; Calabrese, JR; Carson, WH; Cox, K; Hertel, P; Jin, N; Johnson, B; McQuade, RD; Nyilas, M; Perry, P; Salzman, PM; Sanchez, R; Such, P, 2017
)
0.77
"AOM 400 delayed the time to and reduced the rate of recurrence of mood episodes and was generally safe and well tolerated."( Efficacy and Safety of Aripiprazole Once-Monthly in the Maintenance Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled, 52-Week Randomized Withdrawal Study.
Amatniek, J; Calabrese, JR; Carson, WH; Cox, K; Hertel, P; Jin, N; Johnson, B; McQuade, RD; Nyilas, M; Perry, P; Salzman, PM; Sanchez, R; Such, P, 2017
)
0.77
"The deltoid muscle is a safe alternative injection site for aripiprazole once-monthly 400 mg in patients with schizophrenia."( Aripiprazole Once-Monthly 400 mg: Comparison of Pharmacokinetics, Tolerability, and Safety of Deltoid Versus Gluteal Administration.
Baker, RA; Bricmont, P; Eramo, A; Hertel, P; Jin, N; Larsen, F; McQuade, RD; Nylander, AG; Peters-Strickland, T; Raoufinia, A; Repella, J, 2017
)
2.14
" Common adverse events (>5%) were schizophrenia, akathisia, headache, insomnia, and anxiety."( Efficacy and safety of aripiprazole lauroxil in schizophrenic patients presenting with severe psychotic symptoms during an acute exacerbation.
Bose, A; Du, Y; Ehrich, E; Potkin, SG; Risinger, R; Silverman, B; Stankovic, S; Zummo, J, 2017
)
0.77
" In conclusion, these data provide moderate quality evidence that aripiprazole could be an effective and safe treatment option for TDs, and results from further trials are urgently needed to extend this evidence base."( The efficacy and safety of aripiprazole for tic disorders in children and adolescents: A systematic review and meta-analysis.
Cheng, YH; Wang, S; Wei, YZ; Yang, C; Yang, JH; Zheng, Y; Zhou, YM, 2017
)
0.99
" Our results suggest that aripiprazole is effective and safe in treating bipolar mania."( Efficacy, safety and tolerability of aripiprazole in bipolar disorder: An updated systematic review and meta-analysis of randomized controlled trials.
Carvalho, AF; Chang, HY; Chen, TY; Chen, YW; Chow, PC; Chu, CS; Fornaro, M; Li, DJ; Lin, PY; Solmi, M; Stubbs, B; Tseng, PT; Veronese, N; Vieta, E, 2017
)
1.03
" The most common adverse events (AEs) were sedation (low dose, 8/44 [18."( Randomized, Double-Blind, Placebo-Controlled Trial Demonstrates the Efficacy and Safety of Oral Aripiprazole for the Treatment of Tourette's Disorder in Children and Adolescents.
Carson, W; Cox, K; Kohegyi, E; Kurlan, R; McQuade, R; Nyilas, M; Sallee, F; Sanchez, R; van Beek, A; Zhao, J, 2017
)
0.67
"This study indicates that oral aripiprazole is a safe and effective treatment for tics in children and adolescents with TD."( Randomized, Double-Blind, Placebo-Controlled Trial Demonstrates the Efficacy and Safety of Oral Aripiprazole for the Treatment of Tourette's Disorder in Children and Adolescents.
Carson, W; Cox, K; Kohegyi, E; Kurlan, R; McQuade, R; Nyilas, M; Sallee, F; Sanchez, R; van Beek, A; Zhao, J, 2017
)
0.96
" Antipsychotics have important adverse effects, and systematic monitoring of drug safety is infrequently performed."( Feasibility and Relevance of Antipsychotic Safety Monitoring in Children With Tourette Syndrome: A Prospective Longitudinal Study.
Hammer, T; Ho, J; Patten, S; Pringsheim, T; Sarna, JR, 2017
)
0.46
" Children were monitored for extrapyramidal, metabolic, and hormonal adverse effects using the Canadian Alliance for Monitoring Effectiveness and Safety of Antipsychotic Medications guidelines."( Feasibility and Relevance of Antipsychotic Safety Monitoring in Children With Tourette Syndrome: A Prospective Longitudinal Study.
Hammer, T; Ho, J; Patten, S; Pringsheim, T; Sarna, JR, 2017
)
0.46
" The most common adverse event (AE) for all groups was injection-site reaction (pain)."( A Phase-1 Study Comparing Pharmacokinetic and Safety Profiles of Three Different Dose Intervals of Aripiprazole Lauroxil.
Hard, M; Risinger, R; Weiden, PJ, 2017
)
0.67
" The most common treatment-emergent adverse events (TEAE; ≥20%) included nasopharyngitis, somnolence, influenza, and increased weight."( An open-label extension long-term study of the safety and efficacy of aripiprazole for irritability in children and adolescents with autistic disorder in Japan.
Hiratani, M; Ichikawa, H; Ono, H; Oshimo, T; Tadori, Y; Tsujii, N; Yasuhara, A, 2018
)
0.71
" The analysis indirectly compared AL and AOM treatment groups for efficacy by mean change in Positive and Negative Syndrome Scale (PANSS) total score and ≥30% reduction in PANSS total score, as well as tolerability including adverse events, akathisia, and weight gain."( Efficacy and safety of aripiprazole lauroxil once-monthly versus aripiprazole once-monthly long-acting injectable formulations in patients with acute symptoms of schizophrenia: an indirect comparison of two double-blind placebo-controlled studies.
Cameron, C; Desai, D; Drake, C; Hutton, B; Kotb, A; Weiden, PJ; Zummo, J, 2018
)
0.79
" The most common (≥20% patients in any group) treatment-emergent adverse events (TEAE) were nausea, akathisia, insomnia, and somnolence."( Safety and efficacy from a 6-week double-blind study and a 52-week open-label extension of aripiprazole in adolescents with schizophrenia in Japan.
Ishigooka, J; Matsumoto, H; Ono, H; Tadori, Y, 2018
)
0.7
"These study results suggest that aripiprazole would be safe and well tolerated in both short- and long-term treatment for adolescents with SCZ in Japan."( Safety and efficacy from a 6-week double-blind study and a 52-week open-label extension of aripiprazole in adolescents with schizophrenia in Japan.
Ishigooka, J; Matsumoto, H; Ono, H; Tadori, Y, 2018
)
0.98
"Prolactin-related adverse effects contribute to nonadherence and adverse health consequences, particularly in women with severe mental illness."( Adjunct Aripiprazole Reduces Prolactin and Prolactin-Related Adverse Effects in Premenopausal Women With Psychosis: Results From the DAAMSEL Clinical Trial.
Adams, HA; Buchanan, RW; Buckley, PF; Dickerson, FB; Earl, AK; Feldman, SM; Hackman, AL; Kearns, AM; Kelly, DL; Koola, MM; Liu, F; Luttrell, SE; McEvoy, JP; McMahon, RP; Narang, S; Nichols, RB; Powell, MM; RachBeisel, JA; Richardson, CM; Sayer, MA; Sullivan, KM; Vyas, G; Wehring, HJ, 2018
)
0.92
" Psychiatric symptoms and adverse effects were closely monitored."( Adjunct Aripiprazole Reduces Prolactin and Prolactin-Related Adverse Effects in Premenopausal Women With Psychosis: Results From the DAAMSEL Clinical Trial.
Adams, HA; Buchanan, RW; Buckley, PF; Dickerson, FB; Earl, AK; Feldman, SM; Hackman, AL; Kearns, AM; Kelly, DL; Koola, MM; Liu, F; Luttrell, SE; McEvoy, JP; McMahon, RP; Narang, S; Nichols, RB; Powell, MM; RachBeisel, JA; Richardson, CM; Sayer, MA; Sullivan, KM; Vyas, G; Wehring, HJ, 2018
)
0.92
" No differences between groups in symptoms or adverse effects were noted."( Adjunct Aripiprazole Reduces Prolactin and Prolactin-Related Adverse Effects in Premenopausal Women With Psychosis: Results From the DAAMSEL Clinical Trial.
Adams, HA; Buchanan, RW; Buckley, PF; Dickerson, FB; Earl, AK; Feldman, SM; Hackman, AL; Kearns, AM; Kelly, DL; Koola, MM; Liu, F; Luttrell, SE; McEvoy, JP; McMahon, RP; Narang, S; Nichols, RB; Powell, MM; RachBeisel, JA; Richardson, CM; Sayer, MA; Sullivan, KM; Vyas, G; Wehring, HJ, 2018
)
0.92
"Building upon prior studies, this rigorous evaluation confirms the utility of adjunctive aripiprazole as a strategy for improving prolactin and managing prolactin-related adverse effects in premenopausal women with psychosis."( Adjunct Aripiprazole Reduces Prolactin and Prolactin-Related Adverse Effects in Premenopausal Women With Psychosis: Results From the DAAMSEL Clinical Trial.
Adams, HA; Buchanan, RW; Buckley, PF; Dickerson, FB; Earl, AK; Feldman, SM; Hackman, AL; Kearns, AM; Kelly, DL; Koola, MM; Liu, F; Luttrell, SE; McEvoy, JP; McMahon, RP; Narang, S; Nichols, RB; Powell, MM; RachBeisel, JA; Richardson, CM; Sayer, MA; Sullivan, KM; Vyas, G; Wehring, HJ, 2018
)
1.14
" Overall, adverse event (AE) rates experienced over 12 weeks were modest; no AEs were considered serious."( Switching stable patients with schizophrenia from their oral antipsychotics to aripiprazole lauroxil: a post hoc safety analysis of the initial 12-week crossover period.
Du, Y; Liu, CC; Stanford, AD; Weiden, PJ, 2019
)
0.74
" Safety endpoints included adverse events (AEs) and extrapyramidal symptoms (EPS) including akathisia, injection-site reactions (ISRs), and clinically relevant changes in metabolic and endocrine values."( Long-term safety and tolerability of aripiprazole lauroxil in patients with schizophrenia.
Aquila, R; Claxton, A; Du, Y; Nasrallah, HA; Stanford, AD; Weiden, PJ, 2019
)
0.79
" We further assess safety and tolerability and characterize adverse events (AEs) across the duration of aripiprazole exposure."( The safety and tolerability of aripiprazole once-monthly as maintenance treatment for bipolar I disorder: A double-blind, placebo-controlled, randomized withdrawal study.
Amatniek, J; Calabrese, JR; Carson, WH; Cox, K; Hertel, P; Jin, N; Johnson, B; McQuade, RD; Nyilas, M; Perry, PP; Sanchez, R; Such, P, 2018
)
0.98
" Safety was assessed by monitoring adverse events."( Real-world effectiveness and safety of aripiprazole augmentation therapy in patients with major depressive disorder.
Fukuta, Y; Kamijima, K; Yamamura, K; Yasuda, M, 2018
)
0.75
"8% of patients experienced at least one adverse event, but no new safety signals were identified."( Real-world effectiveness and safety of aripiprazole augmentation therapy in patients with major depressive disorder.
Fukuta, Y; Kamijima, K; Yamamura, K; Yasuda, M, 2018
)
0.75
"Aripiprazole augmentation therapy appears to be effective and safe in Japanese patients with depression/depressive symptoms treated in everyday clinical practice, taking into account factors associated with achieving remission."( Real-world effectiveness and safety of aripiprazole augmentation therapy in patients with major depressive disorder.
Fukuta, Y; Kamijima, K; Yamamura, K; Yasuda, M, 2018
)
2.19
"The scoring system is based on the following 6 safety parameters: reported total sample, reported maximum relative infant dose, reported sample size for relative infant dose, infant plasma drug levels, prevalence of reported any adverse effect, and reported serious adverse effects."( A New Safety Scoring System for the Use of Psychotropic Drugs During Lactation.
Uguz, F,
)
0.13
"The aim of the study is to find a relationship between the individual intervariability of CYP2D6 and the incidence of hyperprolactinemia as side effect of atypical antipsychotics."( Impact of the CYP2D6 phenotype on hyperprolactinemia development as an adverse event of treatment with atypical antipsychotic agents in pediatric patients.
Andreescu, N; Grădinaru, R; Nussbaum, L; Puiu, M; Suciu, L, 2019
)
0.51
"For the slow and intermediate metabolizers, atypical antipsychotics determined a significant increase of prolactinemia with high risk of adverse events."( Impact of the CYP2D6 phenotype on hyperprolactinemia development as an adverse event of treatment with atypical antipsychotic agents in pediatric patients.
Andreescu, N; Grădinaru, R; Nussbaum, L; Puiu, M; Suciu, L, 2019
)
0.51
" There was a significant difference between aripiprazole and placebo in the incidence rate of adverse events (AEs) for somnolence (RR = 6."( Safety of aripiprazole for tics in children and adolescents: A systematic review and meta-analysis.
Cui, H; Mao, J; Yang, C; Yi, Q; Zhang, L, 2019
)
1.18
" Compared with other atypical antipsychotics, it has a favorable side effect profile, but overdose experience is limited."( Aripiprazole Toxicity With a Biphasic Course of Somnolence.
Gupta, D; OʼHara, C, 2019
)
1.96
" The effect size, remission/response rate, and risk for discontinuation due to adverse events (AEs), weight gain (WG), nervous systems and gastrointestinal AEs were assessed and compared between two regions with Cohen's d or number needed to treat/harm."( Do Asian and North American patients with bipolar disorder have similar efficacy, tolerability, and safety profile during clinical trials with atypical antipsychotics?
Bai, Y; Chen, G; Gao, K; Yang, H, 2020
)
0.56
" Adverse events (AEs) and laboratory data were monitored."( Efficacy and Safety of a 2-Month Formulation of Aripiprazole Lauroxil With 1-Day Initiation in Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care: Phase 3, Randomized, Double-Blind, Active-Control ALPINE Study.
Bidollari, I; Cash, E; Claxton, A; Du, Y; Keane, E; Kunovac, J; Walling, DP; Weiden, PJ; Yagoda, S; Yao, B, 2020
)
0.81
" Overall incidence by group of any adverse events (AEs) throughout the study was 68."( Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study.
Du, Y; Hard, M; Marandi, M; von Moltke, L; Walling, DP; Wehr, A; Weiden, PJ, 2020
)
0.77
" Safety metrics included adverse events (AEs), AEs leading to study discontinuations, physical examinations, laboratory parameters, and extrapyramidal symptom (EPS) rating scales."( Beyond 52-Week Long-Term Safety: Long-Term Outcomes of Aripiprazole Lauroxil for Patients With Schizophrenia Continuing in an Extension Study.
Claxton, A; Du, Y; Lauriello, J; Weiden, PJ, 2020
)
0.81
"To assess adverse events (AEs) and safety of aripiprazole (ARI) and olanzapine (OLA) treatment."( Safety and cardiovascular effects of multiple-dose administration of aripiprazole and olanzapine in a randomised clinical trial.
Abad-Santos, F; Almenara, S; Koller, D; Martín, S; Mejía, G; Navares-Gómez, M; Ochoa, D; Román, M; Romero-Palacián, D; Saiz-Rodríguez, M; Wojnicz, A; Zubiaur, P, 2021
)
1.12
" The most frequent adverse drug reactions (ADRs) to ARI were somnolence, headache, insomnia, dizziness, restlessness, palpitations, akathisia and nausea while were somnolence, dizziness, asthenia, constipation, dry mouth, headache and nausea to OLA."( Safety and cardiovascular effects of multiple-dose administration of aripiprazole and olanzapine in a randomised clinical trial.
Abad-Santos, F; Almenara, S; Koller, D; Martín, S; Mejía, G; Navares-Gómez, M; Ochoa, D; Román, M; Romero-Palacián, D; Saiz-Rodríguez, M; Wojnicz, A; Zubiaur, P, 2021
)
0.86
"Aripiprazole is a generally well-tolerated third-generation antipsychotic with low rates of motor side effects and metabolic adverse effects that occur commonly with several alternative antipsychotics."( A safety evaluation of aripiprazole in the treatment of schizophrenia.
Preda, A; Shapiro, BB, 2020
)
2.31
" Secondary evaluations were related to efficacy, treatment emergent adverse events (TEAEs), extrapyramidal symptoms, and corrected QT interval (QTc)."( Safety of switching to brexpiprazole in Japanese patients with schizophrenia: A post-hoc analysis of a long-term open-label study.
Aoki, K; Inada, K; Ishigooka, J; Iwashita, S; Kojima, Y; Niidome, K; Yamada, S, 2021
)
0.62
" Patient-reported sexual and endocrine side effects were assessed on the UKU Side Effect Rating Scale sexual function subscale and analyzed in study completers."( Analysis of prolactin and sexual side effects in patients with schizophrenia who switched from paliperidone palmitate to aripiprazole lauroxil.
Bidollari, I; Claxton, A; Du, Y; Kelly, DL, 2021
)
0.83
"We conducted a chart review to investigate the detailed outcomes of patients with schizophrenia who discontinued long-acting injectable second-generation antipsychotic (LAI-SGA) therapy due to adverse events (AEs)."( Outcomes of patients with schizophrenia who discontinued long-acting injectable antipsychotic therapy due to adverse events: A chart review.
Hatano, M; Iwata, N; Kishi, T; Okuya, M; Sakuma, K, 2021
)
0.62
"In this systematic literature review (SLR), we qualitatively synthesized evidence on the comparative efficacy (based on neuropsychiatric inventory), tolerability (weight gain), and safety (cerebrovascular adverse events [CVAE], cardiovascular events, mortality, somnolence, extrapyramidal symptoms [EPS]) of AAPs used to treat DRP."( Comparative Efficacy, Safety, Tolerability, and Effectiveness of Antipsychotics in The Treatment of Dementia-Related Psychosis (DRP): A Systematic Literature Review.
Abler, V; Rajagopalan, K; Rashid, N; Yunusa, I, 2021
)
0.62
" The incidence of treatment-emergent adverse events (TEAEs) was similar in both groups."( Efficacy and safety of aripiprazole once-monthly versus oral aripiprazole in Chinese patients with acute schizophrenia: a multicenter, randomized, double-blind, non-inferiority study.
Guan, N; Li, AN; Li, K; Liu, T; Sun, J; Tan, Y; Uki, M; Wang, G; Wang, L; Wu, B; Xian, M; Xiao, L; Xie, S; Xu, X; Zhang, H; Zhang, K; Zhang, R; Zhang, W; Zhao, Q, 2022
)
1.03
"To report side effect frequency and severity in patients with major depressive disorder (MDD) receiving escitalopram and aripiprazole adjunctive therapy and to examine whether pretreatment anxious depression is associated with the number and presence of specific side effects."( Pretreatment anxious depression as a predictor of side effect frequency and severity in escitalopram and aripiprazole adjunctive therapy.
Bhat, V; Demchenko, I; Espinola, CW; Frey, BN; Ho, K; Kennedy, SH; Khoo, Y; Lam, RW; Lou, W; Milev, RV; Parikh, SV; Parmar, R; Ravindran, AV; Rotzinger, S, 2022
)
1.14
" Our study investigated the FDA Adverse Event Reporting System and the pharmacodynamic CHEMBL database to further characterize TGA-induced ICDs."( Impulse Control Disorders by Dopamine Partial Agonists: A Pharmacovigilance-Pharmacodynamic Assessment Through the FDA Adverse Event Reporting System.
De Ponti, F; Fusaroli, M; Giunchi, V; Menchetti, M; Poluzzi, E; Raschi, E; Rimondini Giorgini, R, 2022
)
0.72
"We downloaded and pre-processed the FDA Adverse Event Reporting System up to December 2020."( Impulse Control Disorders by Dopamine Partial Agonists: A Pharmacovigilance-Pharmacodynamic Assessment Through the FDA Adverse Event Reporting System.
De Ponti, F; Fusaroli, M; Giunchi, V; Menchetti, M; Poluzzi, E; Raschi, E; Rimondini Giorgini, R, 2022
)
0.72
"Retrospective studies using spontaneous reporting system databases have provided a great understanding of adverse drug reactions (ADRs) in the real world, complementing the data obtained from randomized controlled trials."( Characteristics of adverse reactions among antipsychotic drugs using the Korean Adverse Event Reporting System database from 2010 to 2019.
Byeon, SJ; Chung, SJ; Oh, S, 2022
)
0.72
"Data were collected from the Korea Adverse Event Reporting System database between 2010 and 2019."( Characteristics of adverse reactions among antipsychotic drugs using the Korean Adverse Event Reporting System database from 2010 to 2019.
Byeon, SJ; Chung, SJ; Oh, S, 2022
)
0.72
"In total, 5067 adverse events associated with antipsychotic drugs were reported."( Characteristics of adverse reactions among antipsychotic drugs using the Korean Adverse Event Reporting System database from 2010 to 2019.
Byeon, SJ; Chung, SJ; Oh, S, 2022
)
0.72
" Although there are some reports in literature, the side effect profile in this population remains poorly defined and there is a need to raise awareness among clinicians across specialties."( Recognising side effects of antipsychotics in children with intellectual disabilities.
Anand, G; Lee, J; Shepperd, R; Smith, M, 2023
)
0.91
" Primary safety endpoints included reported adverse events, injection site reactions, and extrapyramidal symptoms."( A Randomized, Open-Label, Multiple-Dose, Parallel-Arm, Pivotal Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole 2-Month Long-Acting Injectable in Adults With Schizophrenia or Bipolar I Disorder.
Harlin, M; Jan, M; Jin, N; Larsen, F; Madera-McDonough, J; Such, P; Watkin, S; Yildirim, M, 2023
)
1.11
" The incidence of treatment-emergent adverse events (TEAEs) was similar between Ari 2MRTU 960 (71."( A Randomized, Open-Label, Multiple-Dose, Parallel-Arm, Pivotal Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole 2-Month Long-Acting Injectable in Adults With Schizophrenia or Bipolar I Disorder.
Harlin, M; Jan, M; Jin, N; Larsen, F; Madera-McDonough, J; Such, P; Watkin, S; Yildirim, M, 2023
)
1.11
" The incidence of adverse events emerging during the treatment period was similar between Ari 2MRTU 960 and AOM 400 (71."( A Randomized, Open-Label, Multiple-Dose, Parallel-Arm, Pivotal Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole 2-Month Long-Acting Injectable in Adults With Schizophrenia or Bipolar I Disorder.
Harlin, M; Jan, M; Jin, N; Larsen, F; Madera-McDonough, J; Such, P; Watkin, S; Yildirim, M, 2023
)
1.11
" This pharmacovigilance study aimed to investigate reporting of OCD/OCS in association with the use of antipsychotics in comparison to one another, as well as treatment failure using data derived from the FDA Adverse Event Reporting System (FAERS)."( Antipsychotics and obsessive-compulsive disorder/obsessive-compulsive symptoms: A pharmacovigilance study of the FDA adverse event reporting system.
Birur, B; Burk, BG; DiGiacomo, T; Polancich, S; Pruett, BS; Sivaraman, S, 2023
)
0.91
"Data from January 1st, 2010 to December 31st, 2020 on suspected adverse drug reactions (ADRs) including OCD/OCS was obtained."( Antipsychotics and obsessive-compulsive disorder/obsessive-compulsive symptoms: A pharmacovigilance study of the FDA adverse event reporting system.
Birur, B; Burk, BG; DiGiacomo, T; Polancich, S; Pruett, BS; Sivaraman, S, 2023
)
0.91
"In contrast to prior reports noting clozapine as the antipsychotic most commonly associated with de novo or exacerbated OCD/OCS, this pharmacovigilance study found aripiprazole was most frequently reported for this adverse effect."( Antipsychotics and obsessive-compulsive disorder/obsessive-compulsive symptoms: A pharmacovigilance study of the FDA adverse event reporting system.
Birur, B; Burk, BG; DiGiacomo, T; Polancich, S; Pruett, BS; Sivaraman, S, 2023
)
1.11
" The adverse effects were headache, insomnia, restlessness, tremor, and akathisia."( Efficacy and Safety of Aripiprazole in Borderline Personality Disorder: A Systematic Review.
Benites-Zapata, VA; Campos-Rodriguez, SK; Fernández, MF; Ortiz-Saavedra, B; Pino-Zavaleta, DA; Valdivieso-Jiménez, G, 2023
)
1.22
" The primary outcome was occurrence of ADEs within 1 year, according to modified Common Terminology Criteria for Adverse Events (CTCAE)."( The INGENIOUS trial: Impact of pharmacogenetic testing on adverse events in a pragmatic clinical trial.
Benson, EA; Callaghan, JT; Desta, Z; Dexter, PR; Eadon, MT; Fulton, CR; Gufford, BT; Gupta, SK; Haas, DM; Holmes, AM; Kreutz, RP; Levy, KD; Pierson, RC; Pratt, VM; Rosenman, MB; Shugg, T; Skaar, TC; Tillman, EM; Vuppalanchi, R; Zang, Y; Zhang, P, 2023
)
0.91

Pharmacokinetics

Aripiprazole, perospirone, lurasidone and cariprazine share some of the pharmacokinetic characteristics of older, lipophilic antipsychotics. Coadministration with lithium increased mean Cmax and AUC values of aripipazole by about 19% and 15%.

ExcerptReferenceRelevance
" Coadministration with lithium increased mean Cmax and AUC values of aripiprazole by about 19% and 15%, respectively, whereas the apparent oral clearance decreased by 15%."( Pharmacokinetics of aripiprazole and concomitant lithium and valproate.
Bark, N; Citrome, L; Josiassen, R; Mallikaarjun, S; Salazar, DE, 2005
)
0.89
" The pharmacokinetic parameters of ARIPIPRAZOLE and its main metabolite OPC-14857 were determined."( Influence of itraconazole co-administration and CYP2D6 genotype on the pharmacokinetics of the new antipsychotic ARIPIPRAZOLE.
Azuma, J; Fukuda, T; Inaba, A; Koue, T; Kubo, M; Maune, H; Takeda, H, 2005
)
0.82
" Validated HPLC methods were successfully applied to pharmacokinetic study of aripiprazole in rats, demonstrating brain concentrations after oral administration five times higher than plasma concentrations."( High performance liquid chromatographic methods for the determination of aripiprazole with ultraviolet detection in rat plasma and brain: application to the pharmacokinetic study.
Akiyama, H; Kashiyama, E; Koga, T; Miyamoto, G; Shimokawa, Y, 2005
)
0.79
" This study investigated the pharmacokinetic variability of aripiprazole and the active metabolite dehydroaripiprazole on the basis of 155 drug monitoring samples from psychiatric patients treated with therapeutic doses of aripiprazole (10-30 mg/day)."( Pharmacokinetic variability of aripiprazole and the active metabolite dehydroaripiprazole in psychiatric patients.
Lunde, H; Lunder, N; Molden, E; Refsum, H, 2006
)
0.86
" The half-life of aripiprazole following repeated administration was similar to that following single administration, suggesting that pharmacokinetics was constant during 14-day administration."( Pharmacokinetics of aripiprazole, a new antipsychotic, following oral dosing in healthy adult Japanese volunteers: influence of CYP2D6 polymorphism.
Azuma, J; Fukuda, T; Koue, T; Kubo, M; Maune, H, 2007
)
1
"The population pharmacokinetic parameters of aripiprazole in healthy Japanese males were estimated using a nonlinear mixed effects model (NONMEM) program."( Nonlinear mixed effects model analysis of the pharmacokinetics of aripiprazole in healthy Japanese males.
Azuma, J; Fukuda, T; Funaki, T; Hashimoto, Y; Kayano, Y; Koue, T; Kubo, M; Takaai, M, 2007
)
0.84
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
"The noncompartmental pharmacokinetic parameters for plasma concentrations of aripiprazole and its active metabolite dehydro-aripiprazole were determined."( Pharmacokinetics and tolerability of intramuscular, oral and intravenous aripiprazole in healthy subjects and in patients with schizophrenia.
Boulton, DW; Kollia, G; Komoroski, B; Kovalick, LJ; Mallikaarjun, S; Reeves, RA; Sharma, A, 2008
)
0.81
" In study 2, the proportionality of the C(max) and AUC to doses ranging from 1 mg to 45 mg suggests a linear pharmacokinetic profile for intramuscular aripiprazole."( Pharmacokinetics and tolerability of intramuscular, oral and intravenous aripiprazole in healthy subjects and in patients with schizophrenia.
Boulton, DW; Kollia, G; Komoroski, B; Kovalick, LJ; Mallikaarjun, S; Reeves, RA; Sharma, A, 2008
)
0.78
" PHARMACOKINETIC ANALYSES: Noncompartmental pharmacokinetic analysis was performed using plasma aripiprazole and dehydro-aripiprazole concentration-time data."( Effects of hepatic or renal impairment on the pharmacokinetics of aripiprazole.
Boulton, DW; Bramer, SL; Mallikaarjun, S; Shoaf, SE, 2008
)
0.8
"Study 1 (hepatic impairment study): apparent oral clearance of unbound drug (CL/Fu) and the maximum plasma concentration (Cmax) of aripiprazole; Study 2 (renal impairment study): CL/Fu, Cmax and renal clearance (CL(R))."( Effects of hepatic or renal impairment on the pharmacokinetics of aripiprazole.
Boulton, DW; Bramer, SL; Mallikaarjun, S; Shoaf, SE, 2008
)
0.79
" Blood samples were collected for pharmacokinetic analysis of ADTs."( The pharmacokinetics of standard antidepressants with aripiprazole as adjunctive therapy: studies in healthy subjects and in patients with major depressive disorder.
Balch, AH; Berman, RM; Boulton, DW; Mallikaarjun, S; Patel, CG; Reeves, RA; Royzman, K, 2010
)
0.61
"The aims of this study were to develop a combined population pharmacokinetic model for both aripiprazole and its active metabolite, dehydroaripiprazole, in psychiatric patients and to identify to what extent the genetic polymorphisms of cytochrome P450 (CYP) enzymes contribute to the variability in pharmacokinetics (PK)."( Population pharmacokinetic modelling of aripiprazole and its active metabolite, dehydroaripiprazole, in psychiatric patients.
Bahk, WM; Cho, JY; Jang, IJ; Kang, DH; Kim, JR; Kim, YK; Kwon, JS; Seo, HB; Shin, SG; Yu, KS, 2008
)
0.83
"A population pharmacokinetic analysis was performed using NONMEM software based on 141 plasma concentrations at steady state from 80 patients receiving multiple oral doses of aripiprazole (10-30 mg day(-1))."( Population pharmacokinetic modelling of aripiprazole and its active metabolite, dehydroaripiprazole, in psychiatric patients.
Bahk, WM; Cho, JY; Jang, IJ; Kang, DH; Kim, JR; Kim, YK; Kwon, JS; Seo, HB; Shin, SG; Yu, KS, 2008
)
0.81
"This population pharmacokinetic model provided an adequate fit to the data for both aripiprazole and dehydroaripiprazole in psychiatric patients."( Population pharmacokinetic modelling of aripiprazole and its active metabolite, dehydroaripiprazole, in psychiatric patients.
Bahk, WM; Cho, JY; Jang, IJ; Kang, DH; Kim, JR; Kim, YK; Kwon, JS; Seo, HB; Shin, SG; Yu, KS, 2008
)
0.84
" Blood samples were collected on Days -1 and 14 for determination of lamotrigine steady-state pharmacokinetic parameters."( A non-randomized study to investigate the effects of the atypical antipsychotic aripiprazole on the steady-state pharmacokinetics of lamotrigine in patients with bipolar I disorder.
Balch, AH; Benson, J; Boulton, DW; Carlson, BX; Croop, R; Mallikaarjun, S; Schieber, FC, 2009
)
0.58
"Pharmacokinetic and pharmacodynamic interactions between carbamazepine and aripiprazole were studied in 18 inpatients with schizophrenia being treated with aripiprazole."( Pharmacokinetic and pharmacodynamic interactions between carbamazepine and aripiprazole in patients with schizophrenia.
Kondo, T; Mihara, K; Nagai, G; Nakamura, A; Suzuki, T, 2009
)
0.81
" Plural simultaneously - operant pharmacodynamic mechanisms may explain catatonia of unclear etiology and reconcile a seemingly contradictory literature (e."( Catatonia and CPK elevation in neurosyphilis: role of plural pharmacodynamic mechanisms.
Carter, WG; Lauterbach, EC; Norris, BK; Shillcutt, SD, 2009
)
0.35
" This method was applied to pharmacokinetic study in human volunteers and patients taking aripiprazole."( A sensitive column-switching HPLC method for aripiprazole and dehydroaripiprazole and its application to human pharmacokinetic studies.
Akamine, Y; Inoue, Y; Kojima, M; Uno, T; Yasui-Furukori, N, 2010
)
0.84
" The author provides the reader with knowledge of the fundamental pharmacokinetic characteristics and metabolic pathways of these new antipsychotics, emphasizing the clinically important common features and differences compared to other older agents."( Pharmacokinetics and metabolism update for some recent antipsychotics.
Caccia, S, 2011
)
0.37
"Aripiprazole, perospirone, lurasidone and cariprazine share some of the pharmacokinetic characteristics of older, lipophilic antipsychotics and, like these, each has some distinct pharmacokinetic features that are clinically beneficial and some that are not."( Pharmacokinetics and metabolism update for some recent antipsychotics.
Caccia, S, 2011
)
1.81
" Typically, studies of antipsychotics have applied pharmacodynamic (PD) modeling alone to characterize the relationship between antipsychotic dose and its effect on the brain."( Predicting brain occupancy from plasma levels using PET: superiority of combining pharmacokinetics with pharmacodynamics while modeling the relationship.
Howes, OD; Jang, IJ; Jeong, JM; Kapur, S; Kim, BH; Kim, E; Kwon, JS; Lee, JS; Shin, SG; Turkheimer, FE, 2012
)
0.38
" The main pharmacokinetic parameters were T(max) = (4."( Development and validation of an LC-ESI-MS method for quantitative determination of aripiprazole in human plasma and an application to pharmacokinetic study.
Bapuji, AT; Mukkanti, K; Raju, DR; Ravikiran, HL; Ravinder, S; Reddy, DC,
)
0.36
" The method was successfully applied to human pharmacokinetic study of urapidil and aripiprazole in healthy human male volunteers."( Liquid chromatography-tandem mass spectrometry method for simultaneous quantification of urapidil and aripiprazole in human plasma and its application to human pharmacokinetic study.
Ambavaram, VB; Gajulapalle, M; Kalluru, GR; Nandigam, V; Vemula, M, 2013
)
0.83
" Here we tested the pharmacodynamic consequences of these properties in a P-gp deficient mouse model by studying the effects of aripiprazole and of ziprasidone on motor coordination."( Pharmacodynamic effects of aripiprazole and ziprasidone with respect to p-glycoprotein substrate properties.
Frisch, J; Hiemke, C; Holthoewer, D; Kirschbaum, KM; Schmitt, U, 2013
)
0.89
"Evidence was given that P-gp substrate properties have pharmacodynamic consequences for aripiprazole but not for ziprasidone and thus affect dopamine receptor related motor behaviour."( Pharmacodynamic effects of aripiprazole and ziprasidone with respect to p-glycoprotein substrate properties.
Frisch, J; Hiemke, C; Holthoewer, D; Kirschbaum, KM; Schmitt, U, 2013
)
0.91
" In contrast, plasma concentrations following administration of aripiprazole once-monthly at a dose of 200mg were below the therapeutic range and pharmacokinetic parameters were not proportional to the administered dose compared with the 300 mg and 400mg doses."( Pharmacokinetics, tolerability and safety of aripiprazole once-monthly in adult schizophrenia: an open-label, parallel-arm, multiple-dose study.
Bricmont, P; Carson, W; Fleischhacker, WW; Forbes, RA; Kane, JM; Mallikaarjun, S; McQuade, R; Sanchez, R, 2013
)
0.89
" In dose response sessions, all doses were given 1 hr apart in ascending order for pharmacodynamic and pharmacokinetic assessment."( Aripiprazole effects on self-administration and pharmacodynamics of intravenous cocaine and cigarette smoking in humans.
Campbell, C; Lofwall, MR; Nuzzo, PA; Walsh, SL, 2014
)
1.85
" Pharmacokinetic parameters were derived from plasma concentrations of aripiprazole and its active metabolite, dehydro-aripiprazole, obtained over 16 days after each aripiprazole administration."( Evaluation of Potential Pharmacokinetic Drug-Drug Interaction between Armodafinil and Aripiprazole in Healthy Adults.
Bond, M; Darwish, M; Hellriegel, ET; Robertson, P; Yang, R, 2015
)
0.87
"Of 36 subjects enrolled, 24 were evaluable for pharmacokinetic analysis."( Evaluation of Potential Pharmacokinetic Drug-Drug Interaction between Armodafinil and Aripiprazole in Healthy Adults.
Bond, M; Darwish, M; Hellriegel, ET; Robertson, P; Yang, R, 2015
)
0.64
" The multiple dose of 200 or 100 mg/kg resveratrol significantly increased the AUC and Cmax of APZ."( The effect of resveratrol on pharmacokinetics of aripiprazole in vivo and in vitro.
Cai, JP; Dai, DP; Gu, EM; Hu, GX; Li, XY; Liang, BQ; Zhan, YY, 2016
)
0.69
"The main objective of this study was to compare the pharmacokinetic properties and relative bioavailability of two 15-mg aripiprazole formulations (an orally disintegrating tablet [ODT] as the test drug and a conventional tablet as the reference drug) in healthy middle-aged Korean subjects."( Pharmacokinetics of a New Orally Disintegrating Tablet Formulation of Aripiprazole 15 mg Administered Without Water in Healthy Middle-aged Korean Subjects.
Chung, YC; Jeon, JY; Kim, MG; Kim, Y, 2015
)
0.86
" Data on the pharmacokinetic parameters were recorded, and the 90% CIs of the ratios of the geometric means of the parameters were determined from the logarithmically transformed data by using an ANOVA model."( Pharmacokinetics of a New Orally Disintegrating Tablet Formulation of Aripiprazole 15 mg Administered Without Water in Healthy Middle-aged Korean Subjects.
Chung, YC; Jeon, JY; Kim, MG; Kim, Y, 2015
)
0.65
" This study aimed to develop a combined population pharmacokinetic model for aripiprazole in healthy Korean subjects and to identify the significant covariates in the pharmacokinetic variability of aripiprazole."( Population pharmacokinetics of aripiprazole in healthy Korean subjects.
Chae, SW; Jeon, JY; Kim, MG, 2016
)
0.95
" The population pharmacokinetic parameters of aripiprazole were estimated using nonlinear mixed-effect modeling with first-order conditional estimation with interaction method."( Population pharmacokinetics of aripiprazole in healthy Korean subjects.
Chae, SW; Jeon, JY; Kim, MG, 2016
)
0.98
" The bootstrap and visual predictive check results were evaluated, showing that the accuracy of the pharmacokinetic model was acceptable."( Population pharmacokinetics of aripiprazole in healthy Korean subjects.
Chae, SW; Jeon, JY; Kim, MG, 2016
)
0.72
"A population pharmacokinetic model of aripiprazole was developed for Korean subjects."( Population pharmacokinetics of aripiprazole in healthy Korean subjects.
Chae, SW; Jeon, JY; Kim, MG, 2016
)
0.99
" Increase in Cmax was observed which might help in dose reduction along with reduction in dose related side effects."( Aripiprazole loaded poly(caprolactone) nanoparticles: Optimization and in vivo pharmacokinetics.
Pandey, A; Patel, S; Sawant, K, 2016
)
1.88
" After the fifth AOM 400 injection, mean aripiprazole AUC(28d), C(max) and C(min) were 165 μg x h/ml, 331 ng/ml and 201 ng/ml, respectively, which were similar to previously published pharmacokinetic parameters after the fifth gluteal injection of AOM 400."( [Pharmacokinetics and safety of aripiprazole long-acting injection, following multiple deltoid administrations in schizophrenia patients in Japan].
Ishigooka, J; Nishiyama, K; Noda, T; Shima, T; Tadori, Y; Tamaru, N; Yamasaki, Y, 2016
)
0.98
" There is a directly proportional relationship between pharmacokinetic parameters and adverse drug reactions and effect on BP and HR."( Evaluation of the Relationship Between Pharmacokinetics and the Safety of Aripiprazole and Its Cardiovascular Effects in Healthy Volunteers.
Abad-Santos, F; Belmonte, C; Cabaleiro, T; Ochoa, D; Román, M; Sánchez-Rojas, SD; Talegón, M, 2016
)
0.67
" Multiple-dose pharmacokinetic results for the major metabolite, dehydro-aripiprazole, followed a similar pattern to that of the parent drug for both deltoid and gluteal injection sites."( Aripiprazole Once-Monthly 400 mg: Comparison of Pharmacokinetics, Tolerability, and Safety of Deltoid Versus Gluteal Administration.
Baker, RA; Bricmont, P; Eramo, A; Hertel, P; Jin, N; Larsen, F; McQuade, RD; Nylander, AG; Peters-Strickland, T; Raoufinia, A; Repella, J, 2017
)
2.13
" We developed a population pharmacokinetic (PopPK) model to characterize aripiprazole lauroxil PK and evaluate dosing scenarios likely to be encountered in clinical practice."( Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia.
Citrome, L; Hard, ML; Mills, RJ; Sadler, BM; Turncliff, RZ, 2017
)
2.13
"We examined the feasibility of a 2-month (every 8 weeks [q8wk]) dosing interval of AL in a phase I open-label pharmacokinetic study investigating AL 1064 mg administered q8wk for 24 weeks, followed by 20 weeks of safety and pharmacokinetic measurements (ClinicalTrials."( Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model.
Hard, ML; Mills, RJ; Sadler, BM; von Moltke, L; Wehr, AY; Weiden, PJ, 2017
)
0.7
" Pharmacokinetic samples were collected at various time points during the 24-week study period and the 20-week follow-up period."( Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model.
Hard, ML; Mills, RJ; Sadler, BM; von Moltke, L; Wehr, AY; Weiden, PJ, 2017
)
0.7
" Here, a 6-month pharmacokinetic study compared 2 different initiation regimens for starting AL."( Pharmacokinetic Evaluation of a 1-Day Treatment Initiation Option for Starting Long-Acting Aripiprazole Lauroxil for Schizophrenia.
Du, Y; Hard, ML; von Moltke, L; Walling, D; Wehr, AY; Weiden, PJ, 2018
)
0.7
" The pharmacokinetic profile of the 1-day initiation regimen was comparable to the 21-day initiation regimen; both achieved aripiprazole concentrations in the therapeutic range within 4 days and remained in a comparable concentration range during treatment initiation."( Pharmacokinetic Evaluation of a 1-Day Treatment Initiation Option for Starting Long-Acting Aripiprazole Lauroxil for Schizophrenia.
Du, Y; Hard, ML; von Moltke, L; Walling, D; Wehr, AY; Weiden, PJ, 2018
)
0.91
" The pharmacokinetic parameters were calculated using a non-compartmental analysis."( Effect of sinapic acid on aripiprazole pharmacokinetics in rats: Possible food drug interaction.
Ahad, A; Ahmad, A; Al-Mohizea, AM; Ali, N; Aljenobi, FI; Alkharfy, KM; Ansari, MA; Khan, A; Raish, M, 2019
)
0.81
" Population pharmacokinetic approach, based on nonlinear mixed effects modeling, is a useful tool to identify covariates explaining pharmacokinetic variability, as well as to characterize and distinguish unexplained residual and between-subject (interindividual) variability."( Understanding variability in the pharmacokinetics of atypical antipsychotics - focus on clozapine, olanzapine and aripiprazole population models.
Jovanović, M; Miljković, B; Vučićević, K, 2020
)
0.77
" Plasma concentration samples were obtained at regular intervals to provide pharmacokinetic data for the duration of AL exposure and to measure persistence of plasma aripiprazole concentrations after AL discontinuation."( Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study.
Du, Y; Hard, M; Marandi, M; von Moltke, L; Walling, DP; Wehr, A; Weiden, PJ, 2020
)
0.96
" Models were verified by assessing goodness-of-fit plots and ratios of predicted-to-observed pharmacokinetic parameters."( Dose Adjustment of Quetiapine and Aripiprazole for Pregnant Women Using Physiologically Based Pharmacokinetic Modeling and Simulation.
Jiang, X; Tang, R; Tang, S; Wang, L; Xu, M; Zheng, L, 2021
)
0.9
" In this study, phenotype-related physiologically based pharmacokinetic models were developed and evaluated to suggest phenotype-guided dose adjustments."( Influence of CYP2D6 Phenotypes on the Pharmacokinetics of Aripiprazole and Dehydro-Aripiprazole Using a Physiologically Based Pharmacokinetic Approach.
Abad-Santos, F; Hempel, G; Kneller, LA; Koller, D; Zubiaur, P, 2021
)
0.87
"Physiologically based pharmacokinetic models for single dose (oral and orodispersible formulation), multiple dose, and steady-state condition were built using trial data from genotyped healthy volunteers."( Influence of CYP2D6 Phenotypes on the Pharmacokinetics of Aripiprazole and Dehydro-Aripiprazole Using a Physiologically Based Pharmacokinetic Approach.
Abad-Santos, F; Hempel, G; Kneller, LA; Koller, D; Zubiaur, P, 2021
)
0.87
"Physiologically based pharmacokinetic models were able to accurately predict the pharmacokinetics of aripiprazole and dehydro-aripiprazole according to CYP2D6 phenotypes, illustrated by a minimal bias and a good precision."( Influence of CYP2D6 Phenotypes on the Pharmacokinetics of Aripiprazole and Dehydro-Aripiprazole Using a Physiologically Based Pharmacokinetic Approach.
Abad-Santos, F; Hempel, G; Kneller, LA; Koller, D; Zubiaur, P, 2021
)
1.08
" The rate of removal of LAIs is regulated by the slow rate of absorption in the site of injection and the phenomenon of their increased half-life is called flip-flop pharmacokinetics."( [Clinical pharmacokinetics and pharmaceutical forms of long-acting injectable antipsychotics].
Kyziridis, TC, 2022
)
0.72
" Our study investigated the FDA Adverse Event Reporting System and the pharmacodynamic CHEMBL database to further characterize TGA-induced ICDs."( Impulse Control Disorders by Dopamine Partial Agonists: A Pharmacovigilance-Pharmacodynamic Assessment Through the FDA Adverse Event Reporting System.
De Ponti, F; Fusaroli, M; Giunchi, V; Menchetti, M; Poluzzi, E; Raschi, E; Rimondini Giorgini, R, 2022
)
0.72
" A pilot pharmacokinetic (PK) open-labeled parallel study on healthy human volunteers was carried out to assess the PK of FDC of aripiprazole/divalproex sodium in comparison with its individual components with a view to rationalize therapeutic regimen and potentially improve compliance of bipolar patients in future."( Fixed Dose Combination Tablets of Aripiprazole and Divalproex Sodium: a Pilot Pharmacokinetic Study in Human Volunteers.
Ahmed, S; Ahmed, Z; Subhan, F, 2022
)
1.21
" These results indicate P-gp-mediated pharmacokinetic interaction increases pimozide accumulation in AC16 cells, and the subsequent elevated pimozide levels within the cells may result in an increased risk of hERG channel inhibition."( P-Glycoprotein-Mediated Pharmacokinetic Interactions Increase Pimozide hERG Channel Inhibition.
Ito, MA; Mizoi, K; Morishita, H; Ogihara, T; Perera, LMB; Yano, K; Zhang, X, 2022
)
0.72
" At the end of the study, aripiprazole concentrations were similar between treatment groups, based on the reported pharmacokinetic parameters."( A Randomized, Open-Label, Multiple-Dose, Parallel-Arm, Pivotal Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole 2-Month Long-Acting Injectable in Adults With Schizophrenia or Bipolar I Disorder.
Harlin, M; Jan, M; Jin, N; Larsen, F; Madera-McDonough, J; Such, P; Watkin, S; Yildirim, M, 2023
)
1.41

Compound-Compound Interactions

JAD combined with aripiprazole has definite effect in treating chronic schizophrenia. It shows advantages of quickly initiating effect, high safety and with no harm for increasing adverse reactions.

ExcerptReferenceRelevance
"To explore the efficacy and safety of Jieyu Anshen Decoction (JAD) combined with aripiprazole in treating chronic schizophrenia."( [Clinical observation on effect of Jieyu Anshen Decoction combined with aripiprazole in treating chronic schizophrenia].
Fan, XW; Luo, JW; Zeng, DZ, 2007
)
0.8
"All 100 patients with chronic schizophrenia diagnosed according to CCMD-3 criteria were equally randomly assigned to the study group (treated with JAD combined with aripiprazole) and the control group (treated with aripiprazole alone) for 12 weeks."( [Clinical observation on effect of Jieyu Anshen Decoction combined with aripiprazole in treating chronic schizophrenia].
Fan, XW; Luo, JW; Zeng, DZ, 2007
)
0.77
"JAD combined with aripiprazole has definite effect in treating chronic schizophrenia, shows advantages of quickly initiating effect, high safety and with no harm for increasing adverse reactions, so it is better than using aripiprazole alone."( [Clinical observation on effect of Jieyu Anshen Decoction combined with aripiprazole in treating chronic schizophrenia].
Fan, XW; Luo, JW; Zeng, DZ, 2007
)
0.91
" We conducted a randomized crossover trial with MPH and placebo (2 weeks each) combined with aripiprazole in children and adolescents (n = 16; 8-17 years old) with JBPD and ADHD who had a significant response in manic symptoms with aripiprazole but still presented clinically significant symptoms of ADHD."( Methylphenidate combined with aripiprazole in children and adolescents with bipolar disorder and attention-deficit/hyperactivity disorder: a randomized crossover trial.
Ketzer, CR; Pheula, GF; Rohde, LA; Tramontina, S; Zeni, CP, 2009
)
0.86
" The risk of adverse drug-drug interaction(s) is present when metabolic inhibitors are combined with known or suspected substrates of a given enzyme."( Identification of selected therapeutic agents as inhibitors of carboxylesterase 1: potential sources of metabolic drug interactions.
Appel, DI; Markowitz, JS; Peterson, YK; Wang, Z; Zhu, HJ, 2010
)
0.36
" After acquiring the discrimination, the effects of cocaine (0, 25, 50, 100 and 200 mg) administered alone and in combination with aripiprazole (15 mg) were determined."( Discriminative stimulus, subject-rated and cardiovascular effects of cocaine alone and in combination with aripiprazole in humans.
Glaser, PE; Hays, LR; Lile, JA; Rush, CR; Stoops, WW, 2011
)
0.79
" Safety and tolerability results revealed no unexpected adverse events for ARI combination with LTG."( Aripiprazole in combination with lamotrigine for the long-term treatment of patients with bipolar I disorder (manic or mixed): a randomized, multicenter, double-blind study (CN138-392).
Carlson, BX; Ketter, TA; Marcus, R; McQuade, RD; Sanchez, R; Sun, W; Timko, K; Vester-Blokland, E, 2012
)
1.82
" For these people, a number of treatment strategies have emerged, including the prescription of a second anti-psychotic drug in combination with clozapine."( Clozapine combined with different antipsychotic drugs for treatment-resistant schizophrenia.
Barber, S; Cipriani, A; Corsi, M; Olotu, U, 2017
)
0.46
"Dietary supplements and foods can interact with various drugs, leading to possible clinical concerns."( Effect of sinapic acid on aripiprazole pharmacokinetics in rats: Possible food drug interaction.
Ahad, A; Ahmad, A; Al-Mohizea, AM; Ali, N; Aljenobi, FI; Alkharfy, KM; Ansari, MA; Khan, A; Raish, M, 2019
)
0.81
" We describe a case of SILENT combined with NMS in this case report."( Subcortical Structure Disruption in Diffusion Tensor Tractography of the Patient With the Syndrome of Irreversible Lithium-Effectuated Neurotoxicity Combined With Neuroleptic Malignant Syndrome: A Case Report.
Kim, HS; Rhee, SY,
)
0.13
"This case suggests that the clinical use of diffusion tensor tractography could be helpful to explain the clinical features in the case of SILENT combined with NMS."( Subcortical Structure Disruption in Diffusion Tensor Tractography of the Patient With the Syndrome of Irreversible Lithium-Effectuated Neurotoxicity Combined With Neuroleptic Malignant Syndrome: A Case Report.
Kim, HS; Rhee, SY,
)
0.13
" In this study, we established schizophrenia mouse model with dizocilpine (MK-801); treated mice with ARI alone or in combination with NGF; assessed spontaneous activity and cognitive function using open field test and Morris water maze test; and measured brain-derived neurotrophic factor (BDNF) protein and mRNA expression levels using immunohistochemistry and molecular biology assays."( Aripiprazole combined with nerve growth factor improves cognitive function in mice with schizophrenia model.
Bai, M; Chen, H; Kang, L; Li, Q; Li, S; Lin, Y; Lu, C; Tang, Z; Xiong, P; Zhang, H, 2023
)
2.35

Bioavailability

Poor aqueous solubility and the unpleasant taste of aripiprazole (APZ) have been recurring problems, owing to its low bioavailability and low patient tolerance. The mean time to peak plasma concentration is 3 hours following multiple-dose administration of a Ripiprazoles 10 or 15 mg. The absolute oral bioavailability of the drug is 87%.

ExcerptReferenceRelevance
" It may be less well absorbed and/or less effective than Clozaril, although evidence is conflicting."( Advances in atypical antipsychotics for the treatment of schizophrenia: new formulations and new agents.
Albert, MJ; Baldessarini, RJ; Centorrino, F; Kelleher, JP, 2002
)
0.31
" The mean time to peak plasma concentration is 3 hours following multiple-dose administration of aripiprazole 10 or 15 mg and the absolute oral bioavailability of the drug is 87%."( Aripiprazole: a review of its use in schizophrenia and schizoaffective disorder.
Perry, CM; Swainston Harrison, T, 2004
)
1.98
"Study 1 was an open-label, randomized, three-treatment crossover study in healthy subjects (n = 18) to assess the bioavailability and pharmacokinetics of intramuscular aripiprazole 5 mg and oral aripiprazole 5 mg relative to intravenous aripiprazole 2 mg."( Pharmacokinetics and tolerability of intramuscular, oral and intravenous aripiprazole in healthy subjects and in patients with schizophrenia.
Boulton, DW; Kollia, G; Komoroski, B; Kovalick, LJ; Mallikaarjun, S; Reeves, RA; Sharma, A, 2008
)
0.77
"P-glycoprotein (Pgp or ABCB1) is an ABC transporter protein involved in intestinal absorption, drug metabolism, and brain penetration, and its inhibition can seriously alter a drug's bioavailability and safety."( A novel approach for predicting P-glycoprotein (ABCB1) inhibition using molecular interaction fields.
Broccatelli, F; Carosati, E; Cruciani, G; Frosini, M; Goracci, L; Neri, A; Oprea, TI, 2011
)
0.37
" APZ nanosuspensions got maximum absorption rate and extent comparing with APZ commercial tablet and suspensions with relative bioavailability of 123."( Enhanced dissolution and oral bioavailability of aripiprazole nanosuspensions prepared by nanoprecipitation/homogenization based on acid-base neutralization.
Lian, R; Liu, X; Lu, Y; Wu, W; Xu, Y; Yin, Z; Zheng, S, 2012
)
0.63
"98-fold) and bioavailability (3."( Aripiprazole in an animal model of chronic alcohol consumption and dopamine D₂ receptor occupancy in rats.
Abraham, R; Bhyrapuneni, G; Jayarajan, P; Kandikere, V; Muddana, N; Nirogi, R; Saralaya, R, 2013
)
1.83
"Poor aqueous solubility and the unpleasant taste of aripiprazole (APZ) have been recurring problems, owing to its low bioavailability and low patient tolerance, respectively."( Aripiprazole-montmorillonite: a new organic-inorganic nanohybrid material for biomedical applications.
Chang, HC; Choi, G; Choy, JH; Choy, YB; Lee, HJ; Oh, YJ; Park, JH; Park, JW; Yoon, YJ, 2013
)
2.08
" Bioavailability studies of the polymorphs of aripiprazole and their pharmaceutical preparations are very important to optimize the formulations of the dosage forms."( Aripiprazole.
Ardiana, F; Indrayanto, G; Lestari, ML, 2013
)
2.09
"The main objective of this study was to compare the pharmacokinetic properties and relative bioavailability of two 15-mg aripiprazole formulations (an orally disintegrating tablet [ODT] as the test drug and a conventional tablet as the reference drug) in healthy middle-aged Korean subjects."( Pharmacokinetics of a New Orally Disintegrating Tablet Formulation of Aripiprazole 15 mg Administered Without Water in Healthy Middle-aged Korean Subjects.
Chung, YC; Jeon, JY; Kim, MG; Kim, Y, 2015
)
0.86
"Cell membrane permeability is an important determinant for oral absorption and bioavailability of a drug molecule."( Highly predictive and interpretable models for PAMPA permeability.
Jadhav, A; Kerns, E; Nguyen, K; Shah, P; Sun, H; Xu, X; Yan, Z; Yu, KR, 2017
)
0.46
" To enhance in vivo efficacy and oral bioavailability of aripiprazole, aripiprazole-loaded solid lipid nanoparticles (SLNs) were developed using tristearin as solid lipid."( Enhancement of In Vivo Efficacy and Oral Bioavailability of Aripiprazole with Solid Lipid Nanoparticles.
Sinha, VR, 2018
)
0.97
"Dependence on antipsycotic drugs like aripriprazole (ARI) is increasing at alarming rate, hence, this study was undertaken to support the hypothesis that supplementation of Citrus paradisi (Grapefruit) juice having high concentration of polyphenols might potentiate and synergize the therapeutic effect of ARI, by increasing its bioavailability and inherent antioxidant potential."( Potentiating and synergistic effect of grapefruit juice on the antioxidant and anti-inflammatory activity of aripiprazole against hydrogen peroxide induced oxidative stress in mice.
Al-Majed, AA; Wani, TA; Zargar, S, 2018
)
0.69
"43, respectively, indicating similar in vitro release and in vivo bioavailability of rats between the ALSI and Abilify Maintena®."( Process control and in vitro/in vivo evaluation of aripiprazole sustained-release microcrystals for intramuscular injection.
Cai, Q; Chu, W; Gou, J; He, H; He, L; Jiang, S; Liang, X; Ma, D; Pan, W; Tang, X; Wang, S; Yin, T; Zhang, L; Zhang, Y; Zhou, L, 2018
)
0.73
"The objective of this study was to formulate aripiprazole (ARI)-loaded pH-modulated solid dispersions (SD) to enhance solubility, dissolution, and bioavailability via hot-melt extrusion (HME) technology."( Formulation of aripiprazole-loaded pH-modulated solid dispersions via hot-melt extrusion technology: In vitro and in vivo studies.
Bandari, S; Kim, DW; Kolter, K; Langley, N; McFall, H; Murthy, SN; Repka, MA; Sarabu, S; Shankar, V, 2019
)
1.13
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
" The rate of removal of LAIs is regulated by the slow rate of absorption in the site of injection and the phenomenon of their increased half-life is called flip-flop pharmacokinetics."( [Clinical pharmacokinetics and pharmaceutical forms of long-acting injectable antipsychotics].
Kyziridis, TC, 2022
)
0.72
" This antipsychotic drug has an inadequate therapeutic impact because of its minimal and idiosyncratic oral bioavailability to treat schizophrenia."( Enhanced Solubility and Stability of Aripiprazole in Binary and Ternary Inclusion Complexes Using Hydroxy Propyl Beta Cyclodextrin (HPβCD) and L-Arginine.
Afridi, M; Ahsan, H; Awais, S; El-Serehy, HA; Farooq, N; Ishtiaq, F; Muhammad, SA; Nadeem, T; Sultana, K; Ullah, A, 2023
)
1.18

Dosage Studied

Aripiprazole augmentation is proven effective for antidepressant-refractory depression, but its licensed dose range is wide and optimal dosage remains unclear. We evaluated the effect of daily dosing with armodafinil on the pharmacokinetics and safety of the CYP3A4 substrate aripipazole.

ExcerptRelevanceReference
"To investigate the efficacy, safety and tolerability of three dosing strategies for switching chronic, stable patients with schizophrenia from current oral antipsychotic monotherapy to once-daily oral aripiprazole monotherapy."( Switching patients to aripiprazole from other antipsychotic agents: a multicenter randomized study.
Ali, MW; Carson, WH; Casey, DE; Ingenito, GG; Jody, D; Liebeskind, A; Saha, AR, 2003
)
0.82
"Aripiprazole is a dopamine partial agonist and a serotonin-2A antagonist; it is dosed 10-30 mg/d, with no initial titration necessary."( Aripiprazole: a new atypical antipsychotic drug.
Bowles, TM; Levin, GM, 2003
)
3.2
"The pharmacology, pharmacokinetics, clinical efficacy, adverse effects, drug interactions, and dosage and administration of aripiprazole are discussed."( Aripiprazole.
Winans, E, 2003
)
1.97
" Although a recent dose-finding study in 22 pediatric patients (> or = 6 yrs old) described weight-based dosages that were safe and well tolerated, dosing of aripiprazole in children has not been well established."( Excessive somnolence from aripiprazole in a child.
Buck, ML; Davenport, JD; McCarthy, MW, 2004
)
0.82
" Dosage titration is not necessary and the drug is effective in the first few weeks of treatment."( Aripiprazole: a review of its use in schizophrenia and schizoaffective disorder.
Perry, CM; Swainston Harrison, T, 2004
)
1.77
" There is only limited information available on the use of aripiprazole in children and adolescents, and pilot data suggest that a revised dosing strategy, based on weight, is indicated in this population."( Aripiprazole: a novel atypical antipsychotic drug with a uniquely robust pharmacology.
Davies, MA; Roth, BL; Sheffler, DJ, 2004
)
2.01
" Steady-state concentrations are attained within 14 days of dosing for both active moieties."( Aripiprazole: an overview of a novel antipsychotic.
Folnegović-Smalc, V; Kozumplik, O; Mimica, N; Uzun, S, 2005
)
1.77
" Dosing could be reduced to 15 mg/day for tolerability and, subsequently, increased to 30 mg/day based on clinical response."( Aripiprazole in the treatment of acute manic or mixed episodes in patients with bipolar I disorder: a 3-week placebo-controlled study.
Abou-Gharbia, N; Carson, W; Impellizzeri, C; Iwamoto, T; Kaplita, S; Marcus, R; McQuade, R; Rollin, L; Sachs, G; Sanchez, R; Stock, E, 2006
)
1.78
" The SC medication was specifically selected for each patient by the clinician and dosed according to prescribing guidelines for that medication."( A prospective, multicenter, randomized, parallel-group, open-label study of aripiprazole in the management of patients with schizophrenia or schizoaffective disorder in general psychiatric practice: Broad Effectiveness Trial With Aripiprazole (BETA).
Crandall, DT; Iwamoto, T; Kostic, D; Marcus, RN; McQuade, RD; Nyilas, M; Pans, M; Riera, LC; Stock, EG; Tandon, R, 2006
)
0.56
" Also discussed are findings concerning the continuation of acute treatments, including antidepressants, into the maintenance phase; dosage adjustments for maintenance treatment; the rationale for combination treatments; and implications of comorbid substance abuse and strategies for its management."( Maintenance treatment of bipolar disorder: Applying research to clinical practice.
Chou, JC; Fazzio, L, 2006
)
0.33
"A 57-year-old man with a 30 year history of schizophrenia had been taking olanzapine for 4 years, with the dosage titrated to 20 mg/day, to control the psychosis."( Efficacy with high-dose aripiprazole after olanzapine-related metabolic disturbances.
Chavez, B; Poveda, RA, 2006
)
0.64
" Our recommendations for dosage and administration of aripiprazole are in agreement with the manufacturer's prescribing information."( Aripiprazole in the treatment of schizophrenia: a consensus report produced by schizophrenia experts in Italy.
Cassano, GB; Fagiolini, A; Lattanzi, L; Monteleone, P; Niolu, C; Sacchetti, E; Siracusano, A; Vita, A, 2007
)
2.03
" After 15 sessions, the dose-response function of methamphetamine was determined under either a progressive- or a fixed-ratio schedule."( Effect of aripiprazole, a partial dopamine D2 receptor agonist, on increased rate of methamphetamine self-administration in rats with prolonged session duration.
Koob, GF; Pulvirenti, L; Wang, Z; Wee, S; Woolverton, WL, 2007
)
0.74
" The dosage was increased to 10 mg daily two weeks later."( Potential aripiprazole-mediated extrapyramidal symptoms in an adult with developmental disabilities.
Brahm, NC; Brown, RC; McElwain, DL, 2007
)
0.74
"Twenty-four outpatients aged 7 to 18 years with DSM-IV-diagnosed tic disorders were treated with aripiprazole using an open-label, flexible dosing schedule for 8 weeks from January 2005 to August 2006."( An open-label study of the efficacy and tolerability of aripiprazole for children and adolescents with tic disorders.
Choi, SH; Hong, JP; Kim, CY; Park, S; Wang, HR; Yoo, HK, 2007
)
0.8
" Haloperidol dose was fixed; aripiprazole was dosed at 15 mg/day for the first 4 weeks, then 30 mg/day for the following 4 weeks."( Adjunctive treatment with a dopamine partial agonist, aripiprazole, for antipsychotic-induced hyperprolactinemia: a placebo-controlled trial.
Conley, RR; Jung, DU; Kelly, DL; Liu, KH; Seo, YS; Shim, JC; Shin, JG; Shon, JH, 2007
)
0.88
" The standard of care for treating schizophrenia is to first use monotherapy of adequate dosage and duration, including a trial of clozapine before adding a second agent."( Augmentation of aripiprazole with low-dose clozapine.
Berges, A; Dahmen, MM; Petry, WM; Stoner, SC, 2007
)
0.69
"5) enrolled in an open-label, single-site trial with fixed-flexible dosing of aripiprazole (5-30 mg/day) for 8 weeks."( Aripiprazole in the treatment of the psychosis prodrome: an open-label pilot study.
Callahan, JL; Cohen, SJ; Hawkins, KA; Mathalon, DH; McGlashan, TH; Miller, TJ; Tully, EM; Walsh, BC; Woods, SW, 2007
)
2.01
" Patients were randomized to placebo or aripiprazole (initiated at 10 mg/d, then flexibly dosed at 5-30 mg/d based on clinical effect and tolerability)."( Aripiprazole monotherapy in nonpsychotic bipolar I depression: results of 2 randomized, placebo-controlled studies.
Bowden, CL; Carson, WH; Jonas, A; Khan, A; Marcus, RN; McQuade, RD; Owen, R; Thase, ME; Wu, X, 2008
)
2.06
" Aripiprazole was dosed flexibly up to a maximum of 30 mg daily, based on tolerability and efficacy."( A prospective, open-label study of Aripiprazole mono- and adjunctive treatment in acute bipolar depression.
Chriki, LS; Dunn, RT; Filkowski, MM; Ghaemi, SN; Stan, VA, 2008
)
1.53
" At a mean dosage of 20."( Combined antipsychotic treatment involving clozapine and aripiprazole.
Englisch, S; Zink, M, 2008
)
0.59
" We measured regional occupancy attained across a range of clinical dosing by the partial D(2) agonist aripiprazole using these methods."( Dose-occupancy study of striatal and extrastriatal dopamine D2 receptors by aripiprazole in schizophrenia with PET and [18F]fallypride.
Abi-Dargham, A; Alvarez, B; Bae, SA; Frankle, WG; Gil, R; Gonzales, R; Hackett, E; Kegeles, LS; Kim, JH; Laruelle, M; Slifstein, M; Xu, X, 2008
)
0.79
"A 12-week, open-label trial with flexible dosing strategy of aripiprazole was performed with 15 participants, aged 7-19 years."( Aripiprazole treatment of children and adolescents with Tourette disorder or chronic tic disorder.
Bai, DS; Sea, HS; Seo, WS; Sung, HM, 2008
)
2.03
" Despite its potential clinical benefits, the management of aripiprazole-treated patients can be challenging due to the lack of a simple dosing strategy and guidelines for preventing and managing potential adverse effects."( Proposed strategies for successful clinical management with aripiprazole.
Mago, R, 2008
)
0.83
"The dosing strategy recommendations are based on clinical experience and a PubMed database search conducted with no date restrictions for English-language literature."( Proposed strategies for successful clinical management with aripiprazole.
Mago, R, 2008
)
0.59
"4 mg/kg, aripiprazole decreased rates of cocaine self-administration without shifting the peak of the dose-response function."( Aripiprazole blocks acute self-administration of cocaine and is not self-administered in mice.
Brennum, LT; Fink-Jensen, A; Hee Bengtsen, C; Petersen, JH; Sager, TN; Sørensen, G; Thomsen, M; Thøgersen, P; Woldbye, DP; Wörtwein, G, 2008
)
2.21
" The main objective of the two clinical pharmacology studies reported here was to evaluate the pharmacokinetics of aripiprazole after intramuscular dosing in healthy subjects and in patients with schizophrenia, and after intravenous and oral dosing in healthy subjects."( Pharmacokinetics and tolerability of intramuscular, oral and intravenous aripiprazole in healthy subjects and in patients with schizophrenia.
Boulton, DW; Kollia, G; Komoroski, B; Kovalick, LJ; Mallikaarjun, S; Reeves, RA; Sharma, A, 2008
)
0.79
" The results have confirmed that the D-optimal experimental design technique can be successfully employed for designing the long acting microsphere dosage form."( D-optimal designing and optimization of long acting microsphere-based injectable formulation of aripiprazole.
Nahata, T; Saini, TR, 2008
)
0.56
" Following baseline Meth dosing (15 mg and 30 mg), participants received 2 wk treatment with aripiprazole (n=8) or placebo (n=8)."( Evaluation of subjective effects of aripiprazole and methamphetamine in methamphetamine-dependent volunteers.
Abad, A; Anderson, A; Condos, R; De La Garza, R; Elkashef, A; Halkitis, PN; Li, SH; Mahoney, JJ; Mojisak, J; Newton, TF; Palamar, J; Reid, MS, 2008
)
0.84
"This study joins several others in demonstrating the utility of subacute dosing laboratory paradigms for evaluating medication effects in alcoholics."( Aripiprazole effects on alcohol consumption and subjective reports in a clinical laboratory paradigm--possible influence of self-control.
Anton, R; Myrick, H; Randall, P; Voronin, K, 2008
)
1.79
" Adverse effects were evaluated using the Dosage Record and Treatment Emergent Symptom Scale (DOTES)."( Efficacy and tolerability of aripiprazole augmentation in sertraline-resistant patients with borderline personality disorder.
Bellino, S; Bogetto, F; Paradiso, E, 2008
)
0.64
" Clinical factors such as gender, age, illness duration, education level, diagnostic subtype, and medication dosage were also recorded."( Effects of DRD2/ANKK1 gene variations and clinical factors on aripiprazole efficacy in schizophrenic patients.
Chen, CH; Chen, SF; Chen, SJ; Chen, YJ; Lin, CC; Luu, SU; Shen, YC, 2009
)
0.59
" Serotonergic antidepressants, used both continuously and with increased dosage in the late luteal phase, are believed to be effective for major depressive disorder with premenstrual exacerbation."( Effective treatment of premenstrual violence in major depression: augmentation with aripiprazole.
Chiang, PH; Hsiao, MC; Liu, CY; Yao, YC,
)
0.36
" A high kinetic stability was observed for three metastable polymorphs which can be categorized as suitable candidates for the development of solid dosage forms."( Conformational polymorphism in aripiprazole: Preparation, stability and structure of five modifications.
Braun, DE; Gelbrich, T; Griesser, UJ; Kahlenberg, V; Tessadri, R; Wieser, J, 2009
)
0.64
" Some principles for dosing and switching are provided to assist with a successful treatment outcome with aripiprazole in mania."( A UK consensus on the administration of aripiprazole for the treatment of mania.
Aitchison, KJ; Bienroth, M; Cookson, J; Goodwin, GM; Gray, R; Haddad, PM; Moore, B; Ratna, L; Sullivan, G; Taylor, D; Taylor, M, 2009
)
0.83
" This 5-day, randomized, double-blind trial evaluated relative improvements in agitation in hospitalized patients who received orally dosed olanzapine (n = 306, 20 mg/d) or aripiprazole (n = 298, 15 mg/d, increasing to 30 mg/d as needed)."( Olanzapine versus aripiprazole for the treatment of agitation in acutely ill patients with schizophrenia.
Chen, L; Kinon, BJ; Kollack-Walker, S; Sniadecki, J; Stauffer, VL, 2008
)
0.87
" No dosage adjustment of lamotrigine is required and the combination was generally safe and well tolerated."( A non-randomized study to investigate the effects of the atypical antipsychotic aripiprazole on the steady-state pharmacokinetics of lamotrigine in patients with bipolar I disorder.
Balch, AH; Benson, J; Boulton, DW; Carlson, BX; Croop, R; Mallikaarjun, S; Schieber, FC, 2009
)
0.58
" Escitalopram and aripiprazole were flexibly dosed for 7 weeks, with maximum dosages of 20 and 30 mg/d, respectively."( An open study of aripiprazole and escitalopram for psychotic major depressive disorder.
Denninger, JW; Dording, C; Fava, M; Hilliker, S; Homberger, C; Matthews, JD; Park, L; Rooney, K; Siefert, C; Sklarsky, K; van Nieuwenhuizen, AO, 2009
)
1.03
" To evaluate the role of P-glycoprotein (P-gp) in aripiprazole tissue distribution and penetration across the blood-brain barrier, mice deficient in the P-gp gene (Abcb1a/b-/-) were dosed intraperitoneally with 2 microg/g mouse of the antipsychotic drug aripiprazole."( Aripiprazole brain concentration is altered in P-glycoprotein deficient mice.
Devane, CL; Donovan, JL; Geesey, ME; Markowitz, JS; Wang, JS; Yuan, HJ; Zhu, HJ, 2009
)
2.05
" Clinical factors such as gender, age, duration of illness, education level, diagnostic subtype and medication dosage were recorded."( Effects of the DRD3 Ser9Gly polymorphism on aripiprazole efficacy in schizophrenic patients as modified by clinical factors.
Chen, CH; Chen, SF; Shen, YC, 2009
)
0.61
"This analysis examined dosing patterns and safety of aripiprazole in elderly inpatients."( Aripiprazole prescribing patterns and side effects in elderly psychiatric inpatients.
Coley, KC; Fabian, TJ; Lenze, EJ; Ruby, C; Scipio, TM, 2009
)
2.05
"A total of 52 elderly inpatients treated with aripiprazole over 3 years were retrospectively identified to examine dosing patterns and side effects associated with use of aripiprazole."( Aripiprazole prescribing patterns and side effects in elderly psychiatric inpatients.
Coley, KC; Fabian, TJ; Lenze, EJ; Ruby, C; Scipio, TM, 2009
)
2.05
" Clinical factors such as gender, age, duration of illness, education level, diagnostic subtype, and medication dosage were noted as well."( HTR2A A-1438G/T102C polymorphisms predict negative symptoms performance upon aripiprazole treatment in schizophrenic patients.
Chen, CH; Chen, SF; Shen, YC, 2009
)
0.58
" In addition, the clinical factors, including dosage of aripiprazole, age, duration of illness, and diagnostic subtype, were found to influence PANSS performance after aripiprazole treatment."( HTR2A A-1438G/T102C polymorphisms predict negative symptoms performance upon aripiprazole treatment in schizophrenic patients.
Chen, CH; Chen, SF; Shen, YC, 2009
)
0.83
" In such situations, clinicians may want to consider prescribing a different antipsychotic or adding another antipsychotic and decreasing the dosage of clozapine."( Aripiprazole in treatment-refractory schizophrenia.
Chiu, NY; Hsu, WY; Kahn, DA; Lee, CI, 2009
)
1.8
" Dosing was determined by clinical judgment."( Efficacy and tolerability of aripiprazole in first-episode drug-naive patients with schizophrenia: an open-label trial.
Ishigooka, J; Oshimo, T; Takahashi, H,
)
0.42
" The mean dosage of aripiprazole was 17."( Efficacy and tolerability of aripiprazole in first-episode drug-naive patients with schizophrenia: an open-label trial.
Ishigooka, J; Oshimo, T; Takahashi, H,
)
0.75
" The mean daily dosage of aripiprazole in completers was 11."( Aripiprazole augmentation of serotonin reuptake inhibitors in treatment-resistant obsessive-compulsive disorder: a 12-week open-label preliminary study.
Albert, U; Bogetto, F; Maina, G; Pessina, E, 2009
)
2.1
" The reasons for the change, course of illness, and types and dosage of antipsychotics previously used were collected."( Switching of antipsychotics to aripiprazole in the treatment of schizophrenia.
Chong, MY; Lee, Y; Lin, HC; Lin, PY; Yeh, WC,
)
0.42
" In this review we examined the efficacy data from short-term studies of aripiprazole in relapsed schizophrenia or schizoaffective disorder, in order to establish a dose-response relationship for aripiprazole."( Aripiprazole: dose-response relationship in schizophrenia and schizoaffective disorder.
Mace, S; Taylor, D, 2009
)
2.03
" Patients were randomly assigned (1:1) to flexibly dosed aripiprazole (target dosage: 5, 10, or 15 mg/day) or placebo."( Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder.
Carson, WH; Corey-Lisle, P; Findling, RL; Manos, G; Marcus, RN; McQuade, RD; Owen, R; Sikich, L, 2009
)
2.04
" Medication and dosing decisions were made by treating psychiatrists, constrained to once-a-day dosing, low initial doses and no clozapine."( Early intervention with second-generation antipsychotics in first-episode psychosis: results of an 8-week naturalistic study.
Audino, B; Curtis, J; Donohue, AM; Filymer, DM; Finkel, N; Josiassen, RC; Kacso, M; Shaughnessy, RA; Skuban, N, 2010
)
0.36
" Outpatients who met DSM-IV-TR criteria for schizophrenia, who were not optimally controlled while on stable dosage of clozapine for > or =3 months and had experienced weight gain of > or =2."( Effects of adjunctive treatment with aripiprazole on body weight and clinical efficacy in schizophrenia patients treated with clozapine: a randomized, double-blind, placebo-controlled trial.
Dewaele, P; Fleischhacker, WW; Heikkinen, ME; Hennicken, D; Kerselaers, W; Landsberg, W; Loze, JY; McQuade, RD; Olié, JP, 2010
)
0.63
" Dopamine receptor occupancy appears to reach a plateau at doses above 10 mg, supporting the observation found in dose-response studies that 10 mg/d is the optimal dose for aripiprazole."( A systematic review of aripiprazole--dose, plasma concentration, receptor occupancy, and response: implications for therapeutic drug monitoring.
Kapur, S; Patel, MX; Sparshatt, A; Taylor, D, 2010
)
0.86
" Mean effective dosage was 14."( [Aripiprazole - a medical treatment alternative for Tourette Syndrome in childhood and adolescence].
Banaschewski, T; Frölich, J; Lehmkuhl, G; Starck, M, 2010
)
1.27
"This was an 8-week, open-label trial with flexible dosing strategy of aripiprazole in children and adolescents with TD."( Effectiveness and tolerability of aripiprazole in children and adolescents with Tourette's disorder: a pilot study in China.
Cui, YH; Li, J; Liu, J; Yang, YP; Zheng, Y, 2010
)
0.87
" The effect occurs even when a low dosage (3 mg/d) of aripiprazole was used and achieves a plateau at dosages beyond 6 mg/d."( Dose-dependent effects of adjunctive treatment with aripiprazole on hyperprolactinemia induced by risperidone in female patients with schizophrenia.
Fujii, A; Furukori, H; Kaneko, S; Sugawara, N; Yasui-Furukori, N, 2010
)
0.86
" However, excessive dosing of the antipsychotic medications, in particular haloperidol, may have played an important role in accounting for the differences between aripiprazole and haloperidol in this study."( Aripiprazole versus haloperidol treatment in early-stage schizophrenia.
Girgis, RR; Lieberman, JA; Merrill, DB; Pikalov, A; Vorel, SR; Whitehead, R; You, M, 2011
)
2.01
"This was a post hoc analysis of data from two 8-week, randomized, double-blind, multicenter trials to evaluate the efficacy of aripiprazole dosed flexibly (2-15 mg/day, n=47) or fixed (5, 10, or 15 mg/day, n = 166) versus placebo (flexibly dosed, n = 51; fixed dose, n = 52)."( Line-item analysis of the Aberrant Behavior Checklist: results from two studies of aripiprazole in the treatment of irritability associated with autistic disorder.
Aman, MG; Kasper, W; Mankoski, R; Manos, G; Marcus, R; Mathew, S; Owen, R, 2010
)
0.79
" A month after the aripiprazole dosage was increased to 50 mg daily, the patient developed confusion and loss of coordination."( Increased aripiprazole concentrations in an HIV-positive male concurrently taking duloxetine, darunavir, and ritonavir.
Aung, GL; Kawamoto, LS; O'Brien, JG; Tien, PG, 2010
)
1.09
" The mean final aripiprazole dosage was 12."( Aripiprazole augmentation in 39 adolescents with medication-resistant obsessive-compulsive disorder.
Berloffa, S; Masi, G; Millepiedi, S; Pfanner, C, 2010
)
2.15
" In addition, specific issues associated with the use of aripiprazole as an adjunctive therapy in patients with MDD, including possible early treatment effect, appropriate timing of therapy initiation, appropriate dosing and duration of treatment, possible differential effect on depressive subgroups and long-term tolerability, are also discussed."( Aripiprazole as adjunctive therapy for patients with major depressive disorder: overview and implications of clinical trial data.
Forbes, A; Pae, CU; Patkar, AA, 2011
)
2.06
" Choosing the appropriate dosing and tapering strategy, addressing the side effects, controlling withdrawal symptoms from previous medications and using adjunctive medications when necessary are key to successful treatment with aripiprazole."( Aripiprazole for the treatment of bipolar disorder: a review of current evidence.
Casamassima, F; Fagiolini, A; Forgione, RN; Marra, FS; Nitti, M, 2011
)
2
" A smoked cocaine dose-response curve (0, 12, 25, 50 mg) was determined twice under placebo and aripiprazole maintenance."( Aripiprazole maintenance increases smoked cocaine self-administration in humans.
Foltin, RW; Haney, M; Rubin, E, 2011
)
2.03
"OCS were significantly more prevalent and severe in group I, in which OCS severity correlated with dosage of clozapine and duration of treatment."( Antiserotonergic antipsychotics are associated with obsessive-compulsive symptoms in schizophrenia.
Englisch, S; Esslinger, C; Meyer-Lindenberg, A; Rausch, F; Schirmbeck, F; Zink, M, 2011
)
0.37
" One patient required a dosage reduction of ropinirole because of sleepiness and one patient assigned to aripiprazole who reported moderate akathysia had the dosage reduced to 5 mg/day."( Aripiprazole and ropinirole treatment for cocaine dependence: evidence from a pilot study.
Ameglio, M; Biasci, L; Cecconi, D; Cellesi, V; Forgione, RN; Meini, M; Moncini, M; Pellegrini, M; Rucci, P; Simoni, G, 2011
)
2.03
"Patients with schizophrenia or schizoaffective disorder with a body mass index ≥ 27 and non-high-density lipoprotein (non-HDL) cholesterol ≥ 130 mg/dl who were on a stable treatment dosage of olanzapine, quetiapine, or risperidone were randomly assigned to switch to ari-piprazole (N=109) for 24 weeks or stay on their current medication (N=106)."( A randomized trial examining the effectiveness of switching from olanzapine, quetiapine, or risperidone to aripiprazole to reduce metabolic risk: comparison of antipsychotics for metabolic problems (CAMP).
Hamer, RH; LaVange, LM; Lieberman, JA; McEvoy, JP; Nussbaum, AM; Perkins, DO; Ring, KD; Rosenheck, RA; Stroup, TS; Swartz, MS, 2011
)
0.58
"A 52-week, open-label, flexibly dosed (2-15 mg/d) study of the safety and tolerability of aripiprazole in outpatients with a DSM-IV-TR diagnosis of autistic disorder who either had completed 1 of 2 antecedent, 8-week randomized trials or were enrolled de novo (ie, not treated in the randomized trials)."( Safety and tolerability of aripiprazole for irritability in pediatric patients with autistic disorder: a 52-week, open-label, multicenter study.
Carson, WH; Findling, RL; Kamen, L; Mankoski, R; Manos, G; Marcus, RN; McQuade, RD; Owen, R, 2011
)
0.89
" There was no difference in baseline PANSS scores or the daily dosage used between responders (n = 28) and nonresponders (n = 17) (15."( Aripiprazole and dehydroaripiprazole plasma concentrations and clinical responses in patients with schizophrenia.
Chen, CK; Lin, SK; Liu, YL, 2011
)
1.81
" He was started on aripiprazole 15 mg po daily for 4 days; the dosage was then increased to 30 mg po daily, with Valproic Acid 500 mg po tid."( Pituitary microadenoma treated with antipsychotic drug aripiprazole.
Capote, E; Ezequiel, U; Paez, R; Wix-Ramos, RJ, 2011
)
0.95
" The patients were assigned to two groups: aripiprazole group (n=98) and tiapride group (n=97), with the treatment dosage of 5-25 mg/d and 100-500 mg/d, respectively."( [A multicenter controlled study on aripiprazole treatment for children with Tourette syndrome in China].
Chen, YH; Liao, JX; Liu, ZS; Sun, D; Wang, DB; Wang, H; Zhong, YQ; Zou, LP, 2011
)
0.91
" The mean dosage of aripiprazole required was 18."( An open trial of aripiprazole for the treatment of delirium in hospitalized cancer patients.
Boettger, S; Breitbart, W, 2011
)
1.03
"The mean maximum daily dosage of aripiprazole in the completers was 10."( A case series of aripiprazole augmentation of selective serotonin reuptake inhibitors in treatment-refractory obsessive compulsive disorder.
Hayashida, K; Kiriike, N; Maebayashi, K; Matsunaga, H; Mito, H, 2011
)
0.99
"Positron emission tomography (PET) studies of dopamine receptor occupancy can be used to assess dosing of antipsychotics."( Predicting brain occupancy from plasma levels using PET: superiority of combining pharmacokinetics with pharmacodynamics while modeling the relationship.
Howes, OD; Jang, IJ; Jeong, JM; Kapur, S; Kim, BH; Kim, E; Kwon, JS; Lee, JS; Shin, SG; Turkheimer, FE, 2012
)
0.38
" We conducted a prospective, open-label nonrandomized, 4-week flexibly dosed (2."( The effectiveness and safety of adjunctive aripiprazole in Taiwanese patients with antidepressant-refractory major depressive disorder: a prospective, open-label trial.
Chen, SJ; Chen, ST; Hsiao, YL; Shen, TW, 2012
)
0.64
"We investigated the effects of the atypical antipsychotics risperidone, olanzapine, and aripiprazole on the cognitive functions of Japanese patients with schizophrenia with respect to dosage amounts and dosing schedules."( The cognitive profile of aripiprazole differs from that of other atypical antipsychotics in schizophrenia patients.
Hayashi, K; Hori, H; Ikenouchi-Sugita, A; Katsuki, A; Nakamura, J; Umene-Nakano, W; Yoshimura, R, 2012
)
0.9
", PTSD criteria participated in this 12-week, open-label, flexibly dosed monotherapy trial."( An open-label pilot study of aripiprazole for male and female veterans with chronic post-traumatic stress disorder who respond suboptimally to antidepressants.
Bradford, DW; Butterfield, MI; Hertzberg, MA; Kilts, JD; Marx, CE; Naylor, JC; Strauss, JL; Youssef, NA; Zinn, S, 2012
)
0.67
"4 weeks with a mean final aripiprazole dosage of 10."( A retrospective review of the effectiveness of aripiprazole in the treatment of sensory abnormalities in autism.
Bivas, R; Chahal, L; Fung, LK; Hardan, AY; Libove, RA, 2012
)
0.94
"The panel agreed that aripiprazole is effective in treating bipolar mania when prescribed and dosed appropriately, in both the short and long term, as monotherapy or in combination with a mood stabilizer."( A UK panel consensus on the initiation of aripiprazole for the treatment of bipolar mania.
Bobmanuel, S; Davies, W; Dratcu, L; Farmer, A; George, M; Rana, T; Singh, M; Turner, M, 2012
)
0.96
" Despite the lack of evidence, experts recommend an overlap strategy that includes maintaining the current antipsychotic dosage while titrating to a therapeutic dose of aripiprazole."( Strategies for transitioning therapy to aripiprazole from other antipsychotics in schizophrenia.
Robert, S; Wisniewski, CS,
)
0.59
"Patients were treated with aripiprazole monotherapy at a dosage of 10-30 mg/day."( Effect of aripiprazole on verbal memory and fluency in schizophrenic patients : results from the ESCAPE study.
Bervoets, C; Constant, E; de Patoul, A; Halkin, V; Kok, F; Morrens, M; Peuskens, J; Pitsi, D; Sabbe, B; Vansteelandt, K, 2012
)
1.08
" The dosage of pre-existing atypical antipsychotics was fixed, while the dosage of aripiprazole ranged from 5 to 20 mg/day during the study period."( Adjunctive effects of aripiprazole on metabolic profiles: comparison of patients treated with olanzapine to patients treated with other atypical antipsychotic drugs.
Chen, CK; Hsiao, CC; Huang, YS; Ree, SC; Wang, LJ, 2013
)
0.93
"All trials were industry supported, with some variability in dosage of haloperidol."( Lower rate of depressive switch following antimanic treatment with second-generation antipsychotics versus haloperidol.
Capapey, J; Colom, F; Goikolea, JM; Grande, I; Sanchez-Moreno, J; Torres, I; Undurraga, J; Valentí, M; Vieta, E, 2013
)
0.39
"The aim of this study was to investigate the dosing patterns of adjunctive quetiapine or adjunctive aripiprazole in the treatment of major depressive disorder from 2006 to 2010, and to evaluate the impact of Food and Drug Administration (FDA) approval on these dosing patterns."( Dosing patterns of aripiprazole and quetiapine for adjunctive treatment of major depressive disorder (2006-2010).
Forbes, RA; Guo, Z; Hebden, T; Jing, Y; Kalsekar, I; Thase, ME, 2013
)
0.93
" A flexible dosing strategy based on clinical improvement and tolerability with a target dose 15 mg/d by the end of the fourth week."( Aripiprazole for drug-naive or antipsychotic-short-exposure subjects with ultra-high risk state and first-episode psychosis: an open-label study.
Chien, YL; Hsieh, MH; Hwang, TJ; Hwu, HG; Liu, CC; Liu, CM, 2013
)
1.83
" They responded well to the reduction in dosage or to withdrawal of the apparent causing agent."( [Medication-related oculogyric crises: a description of four cases and a review of the literature].
Campistol, J; Darling, A; Perez-Duenas, B; Poo, P, 2013
)
0.39
" Bioavailability studies of the polymorphs of aripiprazole and their pharmaceutical preparations are very important to optimize the formulations of the dosage forms."( Aripiprazole.
Ardiana, F; Indrayanto, G; Lestari, ML, 2013
)
2.09
" This was the first 12-week prospective, multicentre, open-label study of the effectiveness and tolerability of flexibly dosed aripiprazole as an augmentation to ongoing antidepressant treatment in patients with chronic or recurrent MDD."( Aripiprazole augmentation for treatment of patients with chronic or recurrent major depressive disorder: a 12-week prospective open-label multicentre study.
Cho, SJ; Choi, JH; Hahn, SW; Han, C; Jeon, HJ; Jon, DI; Jun, TY; Kim, SG; Kim, W; Kwak, KP; Lee, BC; Pae, CU; Park, EJ; Seo, HJ, 2013
)
2.04
" Available experimental evidences and published patents are indicative of broadening the circle of the applications in point of both technological advantages and dosage forms."( [Pharmaceutical applications of sulfobuthylether-beta-cyclodextrin].
Sebestyén, Z; Szabó, B; Szepesi, K, 2013
)
0.39
" Lowering the dosage of aripiprazole or changing the antipsychotic medication might be helpful in this situation."( Aripiprazole associated urine retention in a male schizophrenia patient.
Chang, TG; Chiu, NY; Hsu, WY,
)
1.88
"This was a 6-week prospective, multicenter, open-label study with flexibly dosed adjunctive aripiprazole."( Augmentation of aripiprazole for depressed patients with an inadequate response to antidepressant treatment: a 6-week prospective, open-label, multicenter study.
Bahk, WM; Jon, DI; Kim, DH; Kim, MD; Kwon, YJ; Min, KJ; Pae, CU; Seo, HJ; Suh, HS; Yang, JC,
)
0.7
"This study investigated the dosing patterns for aripiprazole augmentation for major depressive disorder (MDD) in a naturalistic treatment setting."( Aripiprazole augmentation for major depressive disorder: dosing patterns in a naturalistic treatment setting.
Han, C; Lee, SJ; Masand, PS; Pae, CU; Patkar, AA; Wang, SM, 2014
)
2.1
"A 65-year-old man developed severe hyponatremia after an aripiprazole dosage increase."( Syndrome of inappropriate antidiuretic hormone associated with aripiprazole.
Jackson, EA; Kwan, BK; Yam, FK, 2013
)
0.87
" Ancillary analyses indicated that tolerability was less favourable in younger (10-12 years) than in older (≥13 years) subjects, and less favourable with the higher (30 mg/day) than the lower dosage (10 mg/day)."( Aripiprazole: a review of its use in the treatment of manic episodes in adolescents with bipolar I disorder.
McKeage, K, 2014
)
1.85
", self-administration) sessions and 1 dose-response session, were conducted (once during the lead-in and twice after randomization)."( Aripiprazole effects on self-administration and pharmacodynamics of intravenous cocaine and cigarette smoking in humans.
Campbell, C; Lofwall, MR; Nuzzo, PA; Walsh, SL, 2014
)
1.85
" In phase 1, single-blind aripiprazole was flexibly dosed (2-15 mg/d) for 13-26 weeks."( A randomized controlled trial investigating the safety and efficacy of aripiprazole in the long-term maintenance treatment of pediatric patients with irritability associated with autistic disorder.
Amatniek, J; Eudicone, JM; Findling, RL; Lears, K; Mankoski, R; Marcus, RN; McCartney, T; McQuade, RD; Sheehan, JJ; Timko, K, 2014
)
0.94
" All patients were titrated on iloperidone to 6mg BID by Day 4, then flexibly dosing between 6 and 12mg BID, as needed."( A trial evaluating gradual- or immediate-switch strategies from risperidone, olanzapine, or aripiprazole to iloperidone in patients with schizophrenia.
Alva, G; Brams, M; Citrome, L; Glick, ID; Hochfeld, M; Jackson, R; Kianifard, F; Mattingly, G; Meng, X; Pestreich, L; Weiden, PJ; Winseck, A, 2014
)
0.62
" Analyses were performed assuming dosing of clinical trials, real-world practice, PIs, and highest therapeutic dose available, because of variation in practice settings."( Cost-effectiveness of aripiprazole once-monthly compared with paliperidone palmitate once-monthly injectable for the treatment of schizophrenia in the United States.
Baker, RA; Bentley, TG; Citrome, L; Eramo, A; Gutierrez, B; Hansen, K; Kamat, SA; Ortendahl, J; Sapin, C, 2014
)
0.72
" When PI dosing was assumed, this ICER increased to US$19,968/relapse averted."( Cost-effectiveness of aripiprazole once-monthly compared with paliperidone palmitate once-monthly injectable for the treatment of schizophrenia in the United States.
Baker, RA; Bentley, TG; Citrome, L; Eramo, A; Gutierrez, B; Hansen, K; Kamat, SA; Ortendahl, J; Sapin, C, 2014
)
0.72
" Under various dosing scenarios, AOM results indicated fewer relapses at lower overall costs or a reasonable cost-effectiveness threshold (i."( Cost-effectiveness of aripiprazole once-monthly compared with paliperidone palmitate once-monthly injectable for the treatment of schizophrenia in the United States.
Baker, RA; Bentley, TG; Citrome, L; Eramo, A; Gutierrez, B; Hansen, K; Kamat, SA; Ortendahl, J; Sapin, C, 2014
)
0.72
" This finding suggests the need to increase the dosage during pregnancy in order to maintain stable PLs."( A safety evaluation of aripiprazole for treating schizophrenia during pregnancy and puerperium.
Gentile, S, 2014
)
0.71
" His TD always improved immediately after the dosage was shifted to aripiprazole."( Suppression of antipsychotic-induced tardive dyskinesia with aripiprazole in an elderly patient with bipolar I disorder.
Chan, HY; Tan, HK; Wu, WY, 2014
)
0.88
"The aim of this study is to assess urine levels of aripiprazole and metabolites among patients receiving steady-state dosing of aripiprazole."( Quantitative levels of aripiprazole parent drug and metabolites in urine.
Buckley, P; Corwin, MJ; Dretchen, K; McEvoy, J; Millet, RA; Morris, AA, 2014
)
0.96
"One hundred fifty adults, judged compliant with a stable aripiprazole regimen, had observed dosing for 5 consecutive days."( Quantitative levels of aripiprazole parent drug and metabolites in urine.
Buckley, P; Corwin, MJ; Dretchen, K; McEvoy, J; Millet, RA; Morris, AA, 2014
)
0.96
"In this multicenter, double-blind, phase 3 study (screening [≤3 weeks], with an acute treatment period [8 weeks] and a maintenance period [18 weeks]), adolescents (12-17 years old) with schizophrenia (DSM-IV diagnosis; Positive and Negative Symptom Score [PANSS] total score 60-120) were randomized (1:1) to once-daily paliperidone ER (6 mg per day [days 1-7], flexibly dosed 3, 6, or 9 mg per day from week 2 to end of study [EOS]), or to aripiprazole (2 mg per day [days 1 and 2], 5 mg per day [days 3 and 4], 10 mg per day [days 5-7], flexibly dosed 5, 10, or 15 mg per day [week 2 to EOS])."( Efficacy and safety of paliperidone extended release in adolescents with schizophrenia: a randomized, double-blind study.
Gopal, S; Hough, D; Lane, R; Nuamah, I; Savitz, AJ, 2015
)
0.58
" In case of a drug inhibition and/or of a slow metabolizing profile, dosage adjustment is necessary."( [Rational estimation of drug dosage through pharmacometric modeling: The case of a long-acting depot antipsychotic].
Azorin, JM; Simon, N, 2015
)
0.42
" This study confirmed that new dosage forms of aripiprazole in gummi drugs can be developed as hospital formulations, which will contribute to improve medication adherence of patients."( Development of gummi drugs of aripiprazole as hospital formulations.
Hiraoka, S; Namiki, N; Uchida, S, 2015
)
0.96
" However, the ideal dosing regimen for this purpose is unknown."( Adjunctive aripiprazole in the treatment of risperidone-induced hyperprolactinemia: A randomized, double-blind, placebo-controlled, dose-response study.
Bian, QT; Chen, JX; Correll, C; Liu, YH; Soares, JC; Su, YA; Wang, SL; Wei, LH; Yang, FD; Zhang, RZ; Zhang, XY, 2015
)
0.81
" An inadequate response to antidepressants was defined as a total score ≥ 14 on the Hamilton Depression Rating Scale-item 17 (HDRS-17) despite adequate antidepressant dosage for at least 6 weeks in the current depressive episode."( Aripiprazole augmentation versus antidepressant switching for patients with major depressive disorder: A 6-week, randomized, rater-blinded, prospective study.
Chang, CM; Han, C; Kwak, KP; Lee, H; Pae, CU; Tang, TC; Wang, SM; Won, WY,
)
1.57
" Aripiprazole produced a U-shaped dose-response curve on MK-801-induced bar pressing behavior, a dose-dependent decrease in locomotor activity but no changes in IL pERK1/2 labeling."( Attenuation of MK-801-induced behavioral perseveration by typical and atypical antipsychotic pretreatment in rats.
Holahan, MR; Stocco, MR; Tuplin, EW, 2015
)
1.33
" We evaluated the effect of daily dosing with armodafinil on the pharmacokinetics and safety of the CYP3A4 substrate aripiprazole, an atypical antipsychotic used to treat bipolar I disorder."( Evaluation of Potential Pharmacokinetic Drug-Drug Interaction between Armodafinil and Aripiprazole in Healthy Adults.
Bond, M; Darwish, M; Hellriegel, ET; Robertson, P; Yang, R, 2015
)
0.85
"Studies of the phase transitions in an active substance contained in a solid dosage form are very complicated but essential, especially if an active substance is classified as a BCS Class IV drug."( Studies of phase transitions in the aripiprazole solid dosage form.
Witkowska, A; Łaszcz, M, 2016
)
0.71
" The pharmacokinetic profile of AL also led to approval of dosing intervals of every 6 weeks for the 882 mg dose."( Aripiprazole long-acting injectable formulations for schizophrenia: aripiprazole monohydrate and aripiprazole lauroxil.
Citrome, L, 2016
)
1.88
" Moreover, available tools that guide dosing in neuropsychiatric pediatric patients are scant, leading to the possibility of reduced efficacy and/or increased risks of toxicity."( Therapeutic drug monitoring of second-generation antipsychotics in pediatric patients: an observational study in real-life settings.
Auricchio, F; Baldelli, S; Bernardini, R; Bertella, S; Bravaccio, C; Capuano, A; Carnovale, C; Cattaneo, D; Clementi, E; Ferrajolo, C; Fucile, S; Guastella, G; Mani, E; Molteni, M; Pascotto, A; Pisano, S; Pozzi, M; Radice, S; Rafaniello, C; Riccio, MP; Rizzo, R; Rossi, F; Scuderi, MG; Sperandeo, S; Sportiello, L; Villa, L, 2016
)
0.43
" In this study, the aripiprazole dosage ranged between 3 and 9 mg/day."( Aripiprazole Can Improve Apraxia of Eyelid Opening in Parkinson's Disease.
Fukunaga, K; Nakanishi, R; Tokisato, K; Tokunaga, M; Watanabe, S; Yamanaga, H, 2015
)
2.18
" Statistical analysis shows that in cases of complex diagnoses, dosage does not depend on age but depends on other factors."( CLINICAL EXPERIENCE OF LONG-TERM TREATMENT WITH ARIPIPRAZOLE (ABILIFY) IN CHILDREN AND ADOLESCENTS AT THE CHILD AND ADOLESCENT PSYCHIATRIC CLINIC 1 IN ROSKILDE, DENMARK.
Danilevičiütė, V; Diomšina, B; Rasmussen, PD,
)
0.39
" Analyses were conducted assuming pooled dosing from randomised clinical trials included in the MTCs."( Cost-effectiveness Analysis of Aripiprazole Once-Monthly for the Treatment of Schizophrenia in the UK.
Beillat, M; Robinson, P; Sapin, C; Tempest, M; Treur, M, 2015
)
0.7
" The dosage of risperidone and paliperidone were maintained; and aripiprazole was maintained at 5mg/day during the 8-week study period."( Add-on effects of a low-dose aripiprazole in resolving hyperprolactinemia induced by risperidone or paliperidone.
Guo, Q; Li, C; Ouyang, Q; Qiao, Y; Shen, W; Sheng, J; Wen, H; Yang, F; Zhu, S, 2016
)
0.96
" This open-label, parallel-group study was performed to compare finger-stick-based capillary with corresponding venous plasma concentrations for risperidone, paliperidone, quetiapine, olanzapine, and aripiprazole and their major metabolites after repeated dosing in patients with schizophrenia or related illnesses."( Comparison of Capillary and Venous Plasma Drug Concentrations After Repeated Administration of Risperidone, Paliperidone, Quetiapine, Olanzapine, or Aripiprazole.
Ariyawansa, J; De Meulder, M; Remmerie, B; Savitz, A, 2016
)
0.82
" Patients received flexibly dosed aripiprazole (1-15 mg/day) or placebo."( Aripiprazole in the Treatment of Irritability in Children and Adolescents with Autism Spectrum Disorder in Japan: A Randomized, Double-blind, Placebo-controlled Study.
Ichikawa, H; Ishizaki, Y; Mikami, K; Okada, T; Ono, H; Tadori, Y; Tomoda, A; Usuki, C; Yamashita, Y, 2017
)
2.18
" inverted U) association between changes in dentate gyrus/CA4 volume and cumulative antipsychotic dosage between the scans."( Hippocampal subregion volume changes associated with antipsychotic treatment in first-episode psychosis.
Gallego, JA; Malhotra, AK; Rhindress, K; Robinson, DG; Szeszko, PR; Wellington, R, 2017
)
0.46
" The finding of a non-linear relationship between changes in dentate gyrus/CA4 subregion volume and antipsychotic exposure may provide new avenues into understanding dosing strategies for therapeutic interventions relevant to neurobiological models of hippocampal dysfunction in psychosis."( Hippocampal subregion volume changes associated with antipsychotic treatment in first-episode psychosis.
Gallego, JA; Malhotra, AK; Rhindress, K; Robinson, DG; Szeszko, PR; Wellington, R, 2017
)
0.46
"The purpose of this study was to develop extemporaneously compounded oral liquid formulations of aripiprazole for use in pediatric patients and those patients unable to swallow the solid oral dosage forms."( Development of Extemporaneously Compounded Aripiprazole Oral Suspensions for Use in Children.
Davidow, LW; Funk, RS; Pramann, LA; van Haandel, L,
)
0.61
" We developed a population pharmacokinetic (PopPK) model to characterize aripiprazole lauroxil PK and evaluate dosing scenarios likely to be encountered in clinical practice."( Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia.
Citrome, L; Hard, ML; Mills, RJ; Sadler, BM; Turncliff, RZ, 2017
)
2.13
" The model was subsequently used to evaluate various dose levels and frequency and the impact of dosing delay on aripiprazole concentrations."( Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia.
Citrome, L; Hard, ML; Mills, RJ; Sadler, BM; Turncliff, RZ, 2017
)
2.11
" Based on the PopPK model simulations, a dosing interval of 882 mg every 6 weeks results in aripiprazole concentrations that fall within the concentration range associated with the efficacious aripiprazole lauroxil dose range (441-882 mg dosed monthly)."( Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia.
Citrome, L; Hard, ML; Mills, RJ; Sadler, BM; Turncliff, RZ, 2017
)
2.12
"This PopPK model and model-based simulations were effective means for evaluating aripiprazole lauroxil dosing regimens and management of missed doses."( Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia.
Citrome, L; Hard, ML; Mills, RJ; Sadler, BM; Turncliff, RZ, 2017
)
2.12
"We examined the feasibility of a 2-month (every 8 weeks [q8wk]) dosing interval of AL in a phase I open-label pharmacokinetic study investigating AL 1064 mg administered q8wk for 24 weeks, followed by 20 weeks of safety and pharmacokinetic measurements (ClinicalTrials."( Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model.
Hard, ML; Mills, RJ; Sadler, BM; von Moltke, L; Wehr, AY; Weiden, PJ, 2017
)
0.7
" Study limitations included use of a fixed dose for initial oral aripiprazole and fixed monthly AL doses without the option to individualize the oral initiation dosing or injection frequency for efficacy, tolerability, or safety."( Effect of aripiprazole lauroxil in patients with acute schizophrenia as assessed by the Positive and Negative Syndrome Scale-supportive analyses from a Phase 3 study.
Citrome, L; Cutler, AJ; Du, Y; Nasrallah, HA; Risinger, R; Silverman, BL; Zummo, J, 2018
)
1.12
" Comparable daily dose equivalents were achieved with two different formulations due to the Q3wks vs Q4wks dosing strategies, although the two agents have some differences in pharmacokinetic profiles."( Pharmacogenetic evaluation to assess breakthrough psychosis with aripiprazole long-acting injection: a case report.
Bishop, JR; Brown, JT; Eum, S; Lee, AM; Schneiderhan, ME, 2017
)
0.69
" Our case report suggests further investigations of altered dosing strategies and receptor genotype sensitivities to pharmacokinetic factors may be helpful in understanding symptom re-emergence observed in some patients taking LAI antipsychotics."( Pharmacogenetic evaluation to assess breakthrough psychosis with aripiprazole long-acting injection: a case report.
Bishop, JR; Brown, JT; Eum, S; Lee, AM; Schneiderhan, ME, 2017
)
0.69
" Well-known sources of secondary negative symptoms are psychotic symptoms, disorganisation, anxiety, depression, chronic abuse of illicit drugs and alcohol, an overly high dosage of antipsychotic medication, social deprivation, lack of stimulation and hospitalisation."( Treatment for Negative Symptoms in Schizophrenia: A Comprehensive Review.
de Haan, L; Schulte, PFJ; Veerman, SRT, 2017
)
0.46
" The PK results from this study show that a dosing interval of every 8 weeks for the 1064 mg dose resulted in aripiprazole concentrations within the established therapeutic window for AL."( A Phase-1 Study Comparing Pharmacokinetic and Safety Profiles of Three Different Dose Intervals of Aripiprazole Lauroxil.
Hard, M; Risinger, R; Weiden, PJ, 2017
)
0.88
"Second-generation long-acting injectable therapies (SGA-LAIs) may reduce health care resource utilization (HRU) and health care costs compared with daily oral atypical antipsychotics (OAAs) in patients with schizophrenia due to reduced dosing frequency, delivery/monitoring by a health care provider, and improved adherence."( Treatment Patterns, Health Care Resource Utilization, and Spending in Medicaid Beneficiaries Initiating Second-generation Long-acting Injectable Agents Versus Oral Atypical Antipsychotics.
Emond, B; Joshi, K; Kamstra, R; Lafeuille, MH; Lefebvre, P; Pilon, D; Tandon, N, 2017
)
0.46
"In this open-label extension study, patients who had completed a previous randomized, double-blind, placebo-controlled 8-week study were enrolled and were flexibly dosed with aripiprazole (1-15 mg/day) until the new indication of irritability in pediatric autism spectrum disorder was approved in Japan."( An open-label extension long-term study of the safety and efficacy of aripiprazole for irritability in children and adolescents with autistic disorder in Japan.
Hiratani, M; Ichikawa, H; Ono, H; Oshimo, T; Tadori, Y; Tsujii, N; Yasuhara, A, 2018
)
0.91
" Three months after the dosage increase, the patient was found to have an elevated IOP of 32 mm Hg and angle-closure with a plateau iris configuration in the left eye."( Acute Angle-closure Glaucoma Associated With Aripiprazole in the Setting of Plateau Iris Configuration.
Farukhi, S; Mosaed, S; Schmutz, M; Shen, E, 2018
)
0.74
" These benefits together might decrease the daily dosage of the ARI and thus alleviate the possible side effects of drug."( Potentiating and synergistic effect of grapefruit juice on the antioxidant and anti-inflammatory activity of aripiprazole against hydrogen peroxide induced oxidative stress in mice.
Al-Majed, AA; Wani, TA; Zargar, S, 2018
)
0.69
"Supplementing GFJ to ARI might increase an anti-oxidative potential of ARI due to inherent antioxidant and anti-inflammatory activity of GFJ and thus could alleviate the possible dosage dependent side effects of ARI."( Potentiating and synergistic effect of grapefruit juice on the antioxidant and anti-inflammatory activity of aripiprazole against hydrogen peroxide induced oxidative stress in mice.
Al-Majed, AA; Wani, TA; Zargar, S, 2018
)
0.69
" The aim of the present study was to design a mucoadhesive dosage form for buccal delivery of aripiprazole which could provide a rapid drug delivery to the systemic circulation."( Aripiprazole Nanocrystal Impregnated Buccoadhesive Films for Schizophrenia.
Al-Dhubiab, BE, 2017
)
2.12
"Concomitant administration of the 1-day initiation regimen with all approved AL dosing regimens (441, 662, or 882 mg monthly, 882 mg every 6 weeks, or 1064 mg every 2 months) is predicted to achieve aripiprazole concentrations associated with therapeutic doses of AL using the 21-day initiation regimen within 4 days, maintaining these concentrations until the next AL dose."( Population Pharmacokinetic Analysis and Model-Based Simulations of Aripiprazole for a 1-Day Initiation Regimen for the Long-Acting Antipsychotic Aripiprazole Lauroxil.
Hard, ML; Mills, RJ; Sadler, BM; von Moltke, L; Wehr, AY, 2018
)
0.91
" Long-acting injectable (LAI) antipsychotics offer an extended dosing interval option for patients, although the current options may require an oral overlap at initiation."( Aripiprazole Lauroxil NanoCrystal
Clark, C; Davis, E; Ehret, MJ; Luttrell, SE,
)
1.57
" With many advantages this method can be found as a new dosage form manufacturing technique, however low printing efficiency stays as one of the major limitations."( 3D printing of tablets containing amorphous aripiprazole by filaments co-extrusion.
Czech, A; Gawlak, K; Jachowicz, R; Jamróz, W; Kurek, M; Szafraniec, J, 2018
)
0.74
" Aripiprazole and ceftriaxone were used in a single- or repeated dosing protocol."( Interventional and preventive effects of aripiprazole and ceftriaxone used alone or in combination on oxaliplatin-induced tactile and cold allodynia in mice.
Furgała, A; Sałat, K; Sałat, R, 2019
)
1.69
"During a period of inflammation in patients taking quetiapine, according to our results, attention in dosing strategies is required to prevent toxic plasma concentrations."( Pathological Concentration of C-reactive Protein is Correlated to Increased Concentrations of Quetiapine, But Not of Risperidone, Olanzapine and Aripiprazole in a Naturalistic Setting.
Deckert, J; Menke, A; Scherf-Clavel, M; Unterecker, S; Weidner, A, 2020
)
0.76
" Department of Veterans Affairs (VA) Augmentation and Switching Treatments for Improving Depression Outcomes (VAST-D) study, a multisite, randomized, single-blind trial of 1,522 Veterans Health Administration patients who did not have an adequate response to at least one course of antidepressant treatment meeting minimal standards for dosage and duration."( General Predictors and Moderators of Depression Remission: A VAST-D Report.
Chen, P; Davis, L; Hicks, P; Johnson, GR; Mohamed, S; Tal, I; Thase, M; Vertrees, J; Zhao, Y; Zisook, S, 2019
)
0.51
" Pre-emptive CYP2D6 genotyping would be valuable for individualising risperidone and aripiprazole dosing and treatment optimisation."( Effect of CYP2D6 genotype on exposure and efficacy of risperidone and aripiprazole: a retrospective, cohort study.
Haslemo, T; Ingelman-Sundberg, M; Jukic, MM; Molden, E; Smith, RL, 2019
)
0.97
" At low dosage, aripiprazole outperformed ketoconazole in terms of inhibiting biofilm formation, hyphal filamentations, and yeast flocculation, whereas at higher dosage it mimicked ketoconazole."( Aripiprazole repurposed as an inhibitor of biofilm formation and sterol biosynthesis in multidrug-resistant Candida albicans.
Lee, J; Lee, JH; Rajasekharan, SK, 2019
)
2.3
" After treatment with aripiprazole long-acting injection at a dosage of 400 mg/mo intramuscularly, she has been relapse-free for over 2 years."( Concurrent, successful management of bipolar I disorder with comorbid alcohol dependence via aripiprazole long-acting injection: A case report.
Hashimoto, T; Kurata, T; Suzuki, H, 2019
)
1.05
"Tailoring medication dosing for the individual patient is complex, and many factors can influence drug exposure."( Impact of age and CYP2D6 genetics on exposure of aripiprazole and dehydroaripiprazole in patients using long-acting injectable versus oral formulation: relevance of poor and intermediate metabolizer status.
Correll, CU; Høiseth, G; Molden, E; Smith, RL; Tveito, M, 2020
)
0.81
"The dose-response relationships of antipsychotic drugs for schizophrenia are not well defined, but such information would be important for decision making by clinicians."( Dose-Response Meta-Analysis of Antipsychotic Drugs for Acute Schizophrenia.
Crippa, A; Davis, JM; Leucht, S; Orsini, N; Patel, MX; Siafis, S, 2020
)
0.56
" Dose-response curves were constructed with random-effects dose-response meta-analyses and a spline model."( Dose-Response Meta-Analysis of Antipsychotic Drugs for Acute Schizophrenia.
Crippa, A; Davis, JM; Leucht, S; Orsini, N; Patel, MX; Siafis, S, 2020
)
0.56
" For some drugs, higher than currently licensed doses might be tested in further trials, because their dose-response curves did not plateau."( Dose-Response Meta-Analysis of Antipsychotic Drugs for Acute Schizophrenia.
Crippa, A; Davis, JM; Leucht, S; Orsini, N; Patel, MX; Siafis, S, 2020
)
0.56
" Those with prior adequate trials were also more likely to require a higher dosage of venlafaxine to achieve remission."( Predicting Remission in Late-Life Major Depression: A Clinical Algorithm Based Upon Past Treatment History.
Blumberger, DM; Buchalter, ELF; Dixon, D; Karp, JF; Lenze, EJ; Miller, JP; Mulsant, BH; Oughli, HA; Reynolds, CF, 2019
)
0.51
" Various factors may influence their pharmacokinetics, particularly elimination, leading to highly variable drug concentrations between individual patients following the same dosing regimen."( Understanding variability in the pharmacokinetics of atypical antipsychotics - focus on clozapine, olanzapine and aripiprazole population models.
Jovanović, M; Miljković, B; Vučićević, K, 2020
)
0.77
" To evaluate the protocol, brain sections from mice dosed intraperitoneally with donepezil, tacrine, clozapine, haloperidol, and aripiprazole were used."( Development of an Integrated Tissue Pretreatment Protocol for Enhanced MALDI MS Imaging of Drug Distribution in the Brain.
Chen, Y; Gordon, A; Li, B; Tang, W, 2020
)
0.76
" Approved AL doses and dosing regimens include 441 mg monthly, 662 mg monthly, and 882 mg monthly or every 6 weeks (q6wk), as well as the most recently approved dose, 1064 mg, administered every 2 months."( Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study.
Du, Y; Hard, M; Marandi, M; von Moltke, L; Walling, DP; Wehr, A; Weiden, PJ, 2020
)
0.77
"This study evaluated pharmacokinetics of AL given at a higher dosage strength (1064 mg) and at a longer dose interval (every 8 weeks [q8wk]) than previously studied."( Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study.
Du, Y; Hard, M; Marandi, M; von Moltke, L; Walling, DP; Wehr, A; Weiden, PJ, 2020
)
0.77
"AL 1064 mg q8wk provided continuous exposure to aripiprazole throughout the 8-week dosing interval and had a safety profile consistent with the 4- and 6-week regimens."( Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study.
Du, Y; Hard, M; Marandi, M; von Moltke, L; Walling, DP; Wehr, A; Weiden, PJ, 2020
)
1.02
"Dopamine supersensitivity psychosis (DSP) in patients with schizophrenia is induced by treatment with a high dosage of antipsychotics for a long time period, and it is characterized by unstable psychotic symptoms."( The effectiveness of very slow switching to aripiprazole in schizophrenia patients with dopamine supersensitivity psychosis: a case series from an open study.
Fujita, Y; Honma, M; Iyo, M; Kanahara, N; Komatsu, N; Noda, S; Saiga, T; Sasaki, T; Simoyama, T; Suzuki, H; Tadokoro, S; Takase, M; Yamanaka, H; Yanahashi, S, 2020
)
0.82
" AL has five regimen options that offer three different injection intervals using four different dosage strengths."( Aripiprazole Lauroxil Dosing Regimens: Understanding Dosage Strengths and Injection Intervals.
Du, Y; Faldu, S; Rege, B; Sommi, RW; Wehr, A; Weiden, PJ, 2022
)
2.16
" Dosing strategies, discontinuation considerations, and side effects are discussed."( The Psychopharmacology Algorithm Project at the Harvard South Shore Program: An update on management of behavioral and psychological symptoms in dementia.
Chen, A; Cloutier, A; Copeli, F; Metzger, E; Osser, DN, 2021
)
0.62
"Delivering therapeutics to the brain using conventional dosage forms is always a challenge, thus the present study was aimed to formulate mucoadhesive nanoemulsion (MNE) of aripiprazole (ARP) for intranasal delivery to transport the drug directly to the brain."( Antipsychotic Potential and Safety Profile of TPGS-Based Mucoadhesive Aripiprazole Nanoemulsion: Development and Optimization for Nose-To-Brain Delivery.
Choudhury, H; Gorain, B; Kokare, CR; Kumbhar, SA; Shrivastava, B, 2021
)
1.05
" Eventually, he agreed to a higher dosage of aripiprazole and thus titrate antipsychotic therapy that he rejected when prescribed by the dermatology and psychiatry specialists."( Concurrent Delusions of Ocular Parasitosis and Complex Visual Hallucinations from Charles Bonnet Syndrome Treated Successfully with Aripiprazole in an Elderly Male: A Case Report.
Krasniak, AE; Nguyen, HT; Whitfield, NT, 2020
)
1.02
"In this post-marketing surveillance, patients were enrolled into the multicenter, prospective, non-interventional, observational study for 52 weeks, and were dosed with aripiprazole (1-15 mg/day) under daily clinical settings in Japan."( Aripiprazole in the real-world treatment for irritability associated with autism spectrum disorder in children and adolescents in Japan: 52-week post-marketing surveillance.
Aoki, K; Fukuta, Y; Mikami, K; Sugimoto, Y; Takayama, T; Tomoda, A; Yamamura, K, 2021
)
2.26
"This article aims to evaluate management options for antipsychotic-induced hyperprolactinemia and associated treatment considerations such as efficacy, tolerability, drug interactions, contraindications, and dosing regimens."( Guidance on the treatment of antipsychotic-induced hyperprolactinemia when switching the antipsychotic is not an option.
Alabbasi, AY; Nelson, LA; Rusgis, MM, 2021
)
0.62
" In conclusion, the limited data reported in this present study indicates that monitoring IS in the blood is a very important determinant in the dosage plan for the administration of site II drugs such as ARP, if the efficacy of the drug in renal disease is to be considered."( The Binding of Aripiprazole to Plasma Proteins in Chronic Renal Failure Patients.
Chuang, VTG; Hirata, K; Ikeda, T; Maruyama, T; Nishi, K; Otagiri, M; Sakurama, K; Tanaka, M; Uchida, Y; Watanabe, H; Yamasaki, K, 2021
)
0.97
"Aripiprazole augmentation is proven effective for antidepressant-refractory depression, but its licensed dose range is wide and optimal dosage remains unclear."( Optimal dose of aripiprazole for augmentation therapy of antidepressant-refractory depression: preliminary findings based on a systematic review and dose-effect meta-analysis.
Cipriani, A; Furukawa, TA; Furukawa, Y; Hamza, T; Ostinelli, EG; Salanti, G, 2022
)
2.51
"To find the optimal dosage of aripiprazole augmentation."( Optimal dose of aripiprazole for augmentation therapy of antidepressant-refractory depression: preliminary findings based on a systematic review and dose-effect meta-analysis.
Cipriani, A; Furukawa, TA; Furukawa, Y; Hamza, T; Ostinelli, EG; Salanti, G, 2022
)
1.36
"Risperidone and aripiprazole with no dosage restrictions."( Risperidone and aripiprazole for autism spectrum disorder in children: an overview of systematic reviews.
Chen, MH; Escobar Liquitay, CM; Fieiras, C; Franco, JVA; Madrid, E; Meza, N; Rojas, V, 2023
)
1.6
" They were administered aripiprazole 3 mg/day, with dosage increased or reduced as needed."( Safety and tolerability of aripiprazole in patients with psychosis associated with Parkinson's disease-Results of a multicenter open trial.
Kashihara, K; Maeda, T; Yoshida, K, 2022
)
1.33
" Despite no statistically significant differences between groups regarding clinical efficacy, aripiprazole required higher chlorpromazine equivalent dosage (χ 2 = 2."( Aripiprazole vs Risperidone Head-to-Head Effectiveness in First-Episode Non-Affective-Psychosis: A 3-Month Randomized, Flexible-Dose, Open-Label Clinical Trial.
Ayesa-Arriola, R; Crespo-Facorro, B; Garrido-Sánchez, L; Gómez-Revuelta, M; Juncal-Ruiz, M; Mayoral-Van Son, J; Ortiz-García de la Foz, V; Pelayo-Terán, JM; Ruiz-Veguilla, M; Vázquez-Bourgon, J, 2022
)
2.38
"In this work, a novel environment-friendly stability indicating capillary zone electrophoresis (CZE) method has been developed and validated for assaying the aripiprazole (ARP) in tablet dosage form."( Novel Eco-Friendly Stability Indicating Capillary Zone Electrophoresis Method for Determination of Aripiprazole in Tablet Dosage form: DoE Directed Optimization, Development and Method Validation.
Fajardo, FAG; Prado, MSA; Rashid, A; Tavares, MFM, 2022
)
1.14
" Our findings suggest that dosing based on CYP2C19 and CYP2D6 genotyping could improve safety and outcome in patients on ESC monotherapy."( Effects of CYP2C19 and CYP2D6 gene variants on escitalopram and aripiprazole treatment outcome and serum levels: results from the CAN-BIND 1 study.
Blier, P; Farzan, F; Foster, JA; Frey, BN; Hassel, S; Islam, F; Kennedy, SH; Lam, RW; Leri, F; Magarbeh, L; Marshe, VS; Milev, RV; Müller, DJ; Parikh, SV; Placenza, F; Rotzinger, S; Soares, CN; Strother, SC; Taylor, VH; Turecki, G; Uher, R, 2022
)
0.96
" In the TDM group, physicians will receive dosing advice based on plasma levels of risperidone and aripiprazole and its metabolites at 4 and 10 weeks."( The effect of therapeutic drug monitoring of risperidone and aripiprazole on weight gain in children and adolescents: the SPACe 2: STAR (trial) protocol of an international multicentre randomised controlled trial.
de Winter, BCM; Dierckx, B; Hermans, RA; Hillegers, MHJ; Kloosterboer, SM; Koch, BCP; Liang, K; Ringeling, LT, 2022
)
1.18
" Tailor-made pharmaceutical formulations can provide a suitable dosage form to meet the specific needs of individual patients who exhibit poor adherence to industrially manufactured products."( Palatability of Aripiprazole Gummies Prepared from Commercially Available Products: Pharmaceutical Formulation for Improving Patient Adherence.
Hakamata, A; Inui, N; Kamiya, C; Kashiwagura, Y; Kawamoto, S; Miura, M; Namiki, N; Odagiri, K; Tanaka, S; Uchida, S; Watanabe, H, 2023
)
1.26
"MK801 dose-response study was conducted in RHA and Roman Low-Avoidance (RLA) male rats."( Atypical antipsychotics attenuate MK801-induced social withdrawal and hyperlocomotion in the RHA rat model of schizophrenia-relevant features.
Cañete, T; Fernández-Teruel, A; Lavín, V; Oliveras, I; Río-Álamos, C; Sampedro-Viana, D; Sánchez-González, A; Sanna, F; Tapias-Espinosa, C; Tobeña, A; Torrecilla, P, 2023
)
0.91
" Herein, a green and highly sensitive spectrofluorimetric method was developed for the determination of aripiprazole in pharmaceutical dosage form and plasma matrix."( Application of a nucleophilic substitution reaction for spectrofluorimetric determination of aripiprazole in pharmaceutical dosage form and plasma matrix; greenness assessment.
Abdullah, O; Alaqel, SL; Alharbi, A; Almalki, AH; Almrasy, AA; Althobaiti, YS; Alturki, MS; Ramzy, S, 2023
)
1.34
" The intervention was a pharmacogenetic testing panel for 26 drugs with dosage and selection recommendations returned to the health record."( The INGENIOUS trial: Impact of pharmacogenetic testing on adverse events in a pragmatic clinical trial.
Benson, EA; Callaghan, JT; Desta, Z; Dexter, PR; Eadon, MT; Fulton, CR; Gufford, BT; Gupta, SK; Haas, DM; Holmes, AM; Kreutz, RP; Levy, KD; Pierson, RC; Pratt, VM; Rosenman, MB; Shugg, T; Skaar, TC; Tillman, EM; Vuppalanchi, R; Zang, Y; Zhang, P, 2023
)
0.91
" Evidence-based recommendations for female-specific pharmacotherapy for SSD consist of (1) female-specific dosing for antipsychotics (guided by therapeutic drug monitoring), (2) hormonal replacement with raloxifene in postmenopausal women, and (3) aripiprazole addition as best evidenced option in case of antipsychotic-induced hyperprolactinemia."( Evidence-Based Recommendations for the Pharmacological Treatment of Women with Schizophrenia Spectrum Disorders.
Brand, BA; Hamers, IMH; Sommer, IE; Willemse, EJM, 2023
)
1.09
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (4)

RoleDescription
H1-receptor antagonistH1-receptor antagonists are the drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine.
serotonergic agonistAn agent that has an affinity for serotonin receptors and is able to mimic the effects of serotonin by stimulating the physiologic activity at the cell receptors. Serotonin agonists are used as antidepressants, anxiolytics, and in the treatment of migraine disorders.
second generation antipsychoticAntipsychotic drugs which can have different modes of action but which tend to be less likely than first generation antipsychotics to cause extrapyramidal motor control disabilities such as body rigidity or Parkinson's disease-type movements.
drug metabolitenull
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (6)

ClassDescription
quinolone
N-arylpiperazine
N-alkylpiperazine
dichlorobenzeneAny member of the class of chlorobenzenes carrying two chloro groups at unspecified positions.
aromatic etherAny ether in which the oxygen is attached to at least one aryl substituent.
delta-lactamA lactam in which the amide bond is contained within a six-membered ring, which includes the amide nitrogen and the carbonyl carbon.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (1)

PathwayProteinsCompounds
Aripiprazole metabolic pathway02

Protein Targets (109)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, TYROSYL-DNA PHOSPHODIESTERASEHomo sapiens (human)Potency39.81070.004023.8416100.0000AID485290
Chain A, JmjC domain-containing histone demethylation protein 3AHomo sapiens (human)Potency56.23410.631035.7641100.0000AID504339
acetylcholinesteraseHomo sapiens (human)Potency22.22150.002541.796015,848.9004AID1347395; AID1347398
hypoxia-inducible factor 1 alpha subunitHomo sapiens (human)Potency30.10653.189029.884159.4836AID1224846
RAR-related orphan receptor gammaMus musculus (house mouse)Potency29.30330.006038.004119,952.5996AID1159521; AID1159523
SMAD family member 2Homo sapiens (human)Potency24.07320.173734.304761.8120AID1346859; AID1346924
Fumarate hydrataseHomo sapiens (human)Potency31.17000.00308.794948.0869AID1347053
USP1 protein, partialHomo sapiens (human)Potency39.81070.031637.5844354.8130AID504865
PPM1D proteinHomo sapiens (human)Potency18.55690.00529.466132.9993AID1347411
SMAD family member 3Homo sapiens (human)Potency24.07320.173734.304761.8120AID1346859; AID1346924
TDP1 proteinHomo sapiens (human)Potency15.47060.000811.382244.6684AID686978; AID686979
GLI family zinc finger 3Homo sapiens (human)Potency10.66120.000714.592883.7951AID1259369; AID1259392
Microtubule-associated protein tauHomo sapiens (human)Potency11.22020.180013.557439.8107AID1460
AR proteinHomo sapiens (human)Potency13.92210.000221.22318,912.5098AID1259243; AID1259247; AID743042; AID743053; AID743054
estrogen receptor 2 (ER beta)Homo sapiens (human)Potency26.77970.000657.913322,387.1992AID1259377; AID1259378
nuclear receptor subfamily 1, group I, member 3Homo sapiens (human)Potency16.51680.001022.650876.6163AID1224838; AID1224893
progesterone receptorHomo sapiens (human)Potency11.88320.000417.946075.1148AID1346795
EWS/FLI fusion proteinHomo sapiens (human)Potency13.04630.001310.157742.8575AID1259252; AID1259253; AID1259255; AID1259256
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency26.83250.000214.376460.0339AID720691
retinoic acid nuclear receptor alpha variant 1Homo sapiens (human)Potency26.60320.003041.611522,387.1992AID1159555
retinoid X nuclear receptor alphaHomo sapiens (human)Potency0.85540.000817.505159.3239AID1159527; AID1159531
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency11.83480.001530.607315,848.9004AID1224841; AID1224842; AID1224848; AID1224849; AID1259401; AID1259403
farnesoid X nuclear receptorHomo sapiens (human)Potency21.13000.375827.485161.6524AID743217
pregnane X nuclear receptorHomo sapiens (human)Potency9.91320.005428.02631,258.9301AID1346982; AID1346985
estrogen nuclear receptor alphaHomo sapiens (human)Potency24.23160.000229.305416,493.5996AID1259244; AID1259248; AID743069; AID743078; AID743079; AID743080; AID743091
GVesicular stomatitis virusPotency12.30180.01238.964839.8107AID1645842
cytochrome P450 2D6Homo sapiens (human)Potency3.09010.00108.379861.1304AID1645840
polyproteinZika virusPotency31.17000.00308.794948.0869AID1347053
67.9K proteinVaccinia virusPotency14.12540.00018.4406100.0000AID720579
peroxisome proliferator-activated receptor deltaHomo sapiens (human)Potency11.38720.001024.504861.6448AID743212; AID743215; AID743227
peroxisome proliferator activated receptor gammaHomo sapiens (human)Potency26.60110.001019.414170.9645AID743191
vitamin D (1,25- dihydroxyvitamin D3) receptorHomo sapiens (human)Potency26.36200.023723.228263.5986AID743222; AID743223; AID743241
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency8.37010.035520.977089.1251AID504332
heat shock 70kDa protein 5 (glucose-regulated protein, 78kDa)Homo sapiens (human)Potency50.11870.016525.307841.3999AID602332
thyroid stimulating hormone receptorHomo sapiens (human)Potency33.49150.001628.015177.1139AID1224843
nuclear factor of kappa light polypeptide gene enhancer in B-cells 1 (p105), isoform CRA_aHomo sapiens (human)Potency23.914519.739145.978464.9432AID1159509
v-jun sarcoma virus 17 oncogene homolog (avian)Homo sapiens (human)Potency16.19980.057821.109761.2679AID1159526; AID1159528
lysosomal alpha-glucosidase preproproteinHomo sapiens (human)Potency1.77830.036619.637650.1187AID1466; AID2242
nuclear factor erythroid 2-related factor 2 isoform 2Homo sapiens (human)Potency29.09290.00419.984825.9290AID504444
potassium voltage-gated channel subfamily H member 2 isoform dHomo sapiens (human)Potency1.77830.01789.637444.6684AID588834
transcriptional regulator ERG isoform 3Homo sapiens (human)Potency7.94330.794321.275750.1187AID624246
thyroid hormone receptor beta isoform 2Rattus norvegicus (Norway rat)Potency11.65950.000323.4451159.6830AID743065; AID743067
heat shock protein beta-1Homo sapiens (human)Potency29.84700.042027.378961.6448AID743210; AID743228
nuclear factor erythroid 2-related factor 2 isoform 1Homo sapiens (human)Potency16.08220.000627.21521,122.0200AID743202; AID743219
nuclear receptor ROR-gamma isoform 1Mus musculus (house mouse)Potency0.70790.00798.23321,122.0200AID2546
gemininHomo sapiens (human)Potency13.59370.004611.374133.4983AID624296; AID624297
peripheral myelin protein 22Rattus norvegicus (Norway rat)Potency22.79360.005612.367736.1254AID624032
histone acetyltransferase KAT2A isoform 1Homo sapiens (human)Potency28.18380.251215.843239.8107AID504327
neuropeptide S receptor isoform AHomo sapiens (human)Potency12.58930.015812.3113615.5000AID1461
Voltage-dependent calcium channel gamma-2 subunitMus musculus (house mouse)Potency26.60320.001557.789015,848.9004AID1259244
Interferon betaHomo sapiens (human)Potency16.99310.00339.158239.8107AID1347411; AID1645842
HLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)Potency12.30180.01238.964839.8107AID1645842
Cellular tumor antigen p53Homo sapiens (human)Potency31.67040.002319.595674.0614AID651631; AID720552
Neuronal acetylcholine receptor subunit alpha-4Rattus norvegicus (Norway rat)Potency1.77833.548118.039535.4813AID1466
Neuronal acetylcholine receptor subunit beta-2Rattus norvegicus (Norway rat)Potency1.77833.548118.039535.4813AID1466
Glutamate receptor 2Rattus norvegicus (Norway rat)Potency26.60320.001551.739315,848.9004AID1259244
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency29.49640.009610.525035.4813AID1479145; AID1479148
Inositol monophosphatase 1Rattus norvegicus (Norway rat)Potency7.94331.000010.475628.1838AID1457
Inositol hexakisphosphate kinase 1Homo sapiens (human)Potency12.30180.01238.964839.8107AID1645842
cytochrome P450 2C9, partialHomo sapiens (human)Potency12.30180.01238.964839.8107AID1645842
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
5-hydroxytryptamine receptor 3EHomo sapiens (human)Ki0.50120.00100.88359.9000AID298488
Solute carrier family 22 member 2Homo sapiens (human)IC50 (µMol)239.00000.40003.10009.7000AID721751
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
5-hydroxytryptamine receptor 3ACavia porcellus (domestic guinea pig)IC50 (µMol)630.00000.69004.19007.6900AID1889692
5-hydroxytryptamine receptor 3BHomo sapiens (human)Ki0.50120.00100.87119.9000AID298488
Bile salt export pumpHomo sapiens (human)IC50 (µMol)133.00000.11007.190310.0000AID1473738
ATP-dependent translocase ABCB1Homo sapiens (human)IC50 (µMol)0.78000.00022.318510.0000AID598251
Cytochrome P450 3A4Homo sapiens (human)Ki0.57400.00011.41629.9000AID599884
5-hydroxytryptamine receptor 1AHomo sapiens (human)Ki0.00930.00010.532610.0000AID1169862; AID1309129; AID1393366; AID1512153; AID1517957; AID1693542; AID1756799; AID1762056; AID1782426; AID1865874; AID1889690; AID298481; AID516806; AID595498; AID723184
5-hydroxytryptamine receptor 2CRattus norvegicus (Norway rat)Ki0.04710.00020.667710.0000AID1309133; AID1704720
D(2) dopamine receptorHomo sapiens (human)IC50 (µMol)0.01580.00000.74728.0000AID1153309; AID1301281; AID1373831; AID727074
D(2) dopamine receptorHomo sapiens (human)Ki0.00200.00000.651810.0000AID1153295; AID1153296; AID1169860; AID1232327; AID1245089; AID1309134; AID1393368; AID1442556; AID1442559; AID1443613; AID1447993; AID1447994; AID1464176; AID1464177; AID1512154; AID1517960; AID1693539; AID1756796; AID1762054; AID1769331; AID1782419; AID1865877; AID1889688; AID1889749; AID277677; AID298478; AID458632; AID458633; AID516804; AID595495; AID610678; AID698938; AID723179; AID727075
5-hydroxytryptamine receptor 2ARattus norvegicus (Norway rat)Ki0.00910.00010.601710.0000AID1704718; AID410335; AID457689; AID492640
Alpha-1B adrenergic receptorRattus norvegicus (Norway rat)Ki0.01320.00010.949010.0000AID1704719; AID298478; AID723177
Alpha-2C adrenergic receptorHomo sapiens (human)Ki0.03790.00030.483410.0000AID1865880
DRattus norvegicus (Norway rat)Ki0.98040.00010.610010.0000AID410331; AID492643
5-hydroxytryptamine receptor 1ARattus norvegicus (Norway rat)Ki0.01980.00010.739610.0000AID1704717
Muscarinic acetylcholine receptor M3Homo sapiens (human)IC50 (µMol)100.00000.00011.01049.9280AID1403798
D(1A) dopamine receptorHomo sapiens (human)Ki0.58900.00010.836310.0000AID1153294; AID1442557; AID1447992; AID1464175; AID1782424
D(4) dopamine receptorHomo sapiens (human)Ki0.15760.00000.436210.0000AID1153298; AID1232329; AID1442555; AID1447996; AID1464179; AID1693541; AID1756798; AID1782429; AID277674; AID298480; AID610680
D(1B) dopamine receptorHomo sapiens (human)Ki1.60000.00030.40177.9000AID1447997; AID1464180
Alpha-1D adrenergic receptorRattus norvegicus (Norway rat)Ki0.01320.00000.575110.0000AID1704719; AID298478; AID723177
Alpha-1D adrenergic receptorHomo sapiens (human)Ki0.05700.00000.360910.0000AID1682829
5-hydroxytryptamine receptor 2AHomo sapiens (human)IC50 (µMol)1.94500.00010.88018.8500AID1301283; AID1373833
5-hydroxytryptamine receptor 2AHomo sapiens (human)Ki0.01400.00000.385510.0000AID1153300; AID1169863; AID1242908; AID1245094; AID1309130; AID1393364; AID1442561; AID1447999; AID1464182; AID1517959; AID1693543; AID1756800; AID1762057; AID1782427; AID1865875; AID1889689; AID298482; AID516805; AID595497; AID616781; AID723183
5-hydroxytryptamine receptor 2CHomo sapiens (human)IC50 (µMol)1.38000.00011.03029.0000AID1301294; AID1373837; AID1403795
5-hydroxytryptamine receptor 2CHomo sapiens (human)Ki0.08290.00010.954910.0000AID1169864; AID1693544; AID1756801; AID1762058; AID1782428; AID298485; AID599883
D(4) dopamine receptorRattus norvegicus (Norway rat)Ki0.51000.00020.18872.0000AID1309136
Histamine H1 receptorCavia porcellus (domestic guinea pig)Ki0.04890.00261.783210.0000AID1704721
Sodium-dependent serotonin transporterHomo sapiens (human)Ki0.67390.00000.70488.1930AID1309138; AID1693546; AID1756803; AID298489; AID616780
5-hydroxytryptamine receptor 7 Rattus norvegicus (Norway rat)Ki0.08940.00000.14803.1800AID1704722
5-hydroxytryptamine receptor 7Homo sapiens (human)Ki0.02350.00030.380610.0000AID1309131; AID1393367; AID1693545; AID1756802; AID1889691; AID298487; AID6677; AID723182
Alpha-1A adrenergic receptorHomo sapiens (human)IC50 (µMol)0.17000.00020.56145.4000AID1301292; AID1373835; AID1403797
Alpha-1A adrenergic receptorHomo sapiens (human)Ki0.03290.00000.272610.0000AID1682829; AID1762060
Histamine H1 receptorHomo sapiens (human)IC50 (µMol)0.42000.00000.44365.1768AID1301293; AID1373836; AID1403796
Histamine H1 receptorHomo sapiens (human)Ki0.04000.00000.511010.0000AID1309137; AID1682828; AID1762061; AID1865879
Alpha-1B adrenergic receptorHomo sapiens (human)Ki0.05700.00000.471310.0000AID1682829
D(3) dopamine receptorHomo sapiens (human)Ki0.00540.00000.602010.0000AID1153297; AID1169861; AID1232328; AID1309135; AID1442560; AID1443614; AID1447995; AID1464178; AID1693540; AID1756797; AID1762055; AID1769332; AID1782425; AID1865878; AID277673; AID298479; AID410333; AID610679; AID722917
5-hydroxytryptamine receptor 2BHomo sapiens (human)Ki0.00240.00030.769310.0000AID1309132; AID1865876; AID298483
Alpha-1A adrenergic receptorRattus norvegicus (Norway rat)Ki0.01320.00000.965010.0000AID1704719; AID298478; AID723177
5-hydroxytryptamine receptor 3AHomo sapiens (human)Ki0.50120.00000.74119.9000AID298488
5-hydroxytryptamine receptor 6Homo sapiens (human)Ki0.26480.00020.522910.0000AID1393365; AID1704723; AID1762059; AID298486; AID599884; AID723181
3-hydroxy-3-methylglutaryl-coenzyme A reductase Rattus norvegicus (Norway rat)Ki0.02200.00100.01630.0330AID599883
D(2) dopamine receptorRattus norvegicus (Norway rat)Ki0.00460.00000.437510.0000AID1704716; AID410332; AID492642
Potassium voltage-gated channel subfamily H member 2Homo sapiens (human)IC50 (µMol)1.85720.00091.901410.0000AID1301295; AID1403799; AID1704724; AID1762063; AID539465; AID576612
Potassium voltage-gated channel subfamily H member 2Homo sapiens (human)Ki0.87930.00211.840710.0000AID410338; AID492638; AID516803
5-hydroxytryptamine receptor 3DHomo sapiens (human)Ki0.50120.00100.88359.9000AID298488
Multidrug and toxin extrusion protein 2Homo sapiens (human)IC50 (µMol)500.00000.16003.95718.6000AID721752
5-hydroxytryptamine receptor 3CHomo sapiens (human)Ki0.50120.00100.88359.9000AID298488
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
Multidrug and toxin extrusion protein 1Homo sapiens (human)IC50 (µMol)130.00000.01002.765610.0000AID721754
Histamine H3 receptorHomo sapiens (human)Ki2.36100.00010.33998.5110AID1762062
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
mu-type opioid receptor isoform MOR-1Homo sapiens (human)EC50 (µMol)92.46900.13203.30049.5690AID624499
5-hydroxytryptamine receptor 2AMus musculus (house mouse)EC50 (µMol)8.39300.00381.36218.3930AID624503
5-hydroxytryptamine receptor 1AHomo sapiens (human)EC50 (µMol)0.15450.00010.25718.0000AID1301282; AID1373832
D(2) dopamine receptorHomo sapiens (human)EC50 (µMol)0.82220.00000.18743.9000AID1153305; AID1245096; AID1245098; AID1442562; AID1442568; AID1442570; AID1442571; AID1442574; AID1442576; AID1442578; AID1443616; AID1443620; AID1443624; AID1443628; AID1448003; AID1448005; AID1448008; AID1573431; AID1573433; AID1782420; AID1782422; AID698935; AID698937
D(3) dopamine receptorHomo sapiens (human)EC50 (µMol)0.01970.00010.02470.6690AID1153307; AID1442564
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (566)

Processvia Protein(s)Taxonomy
serotonin receptor signaling pathway5-hydroxytryptamine receptor 3EHomo sapiens (human)
monoatomic ion transmembrane transport5-hydroxytryptamine receptor 3EHomo sapiens (human)
excitatory postsynaptic potential5-hydroxytryptamine receptor 3EHomo sapiens (human)
inorganic cation transmembrane transport5-hydroxytryptamine receptor 3EHomo sapiens (human)
regulation of membrane potential5-hydroxytryptamine receptor 3EHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 3EHomo sapiens (human)
activation of cysteine-type endopeptidase activity involved in apoptotic processSolute carrier family 22 member 2Homo sapiens (human)
positive regulation of gene expressionSolute carrier family 22 member 2Homo sapiens (human)
organic cation transportSolute carrier family 22 member 2Homo sapiens (human)
monoatomic cation transportSolute carrier family 22 member 2Homo sapiens (human)
neurotransmitter transportSolute carrier family 22 member 2Homo sapiens (human)
serotonin transportSolute carrier family 22 member 2Homo sapiens (human)
body fluid secretionSolute carrier family 22 member 2Homo sapiens (human)
organic cation transportSolute carrier family 22 member 2Homo sapiens (human)
quaternary ammonium group transportSolute carrier family 22 member 2Homo sapiens (human)
prostaglandin transportSolute carrier family 22 member 2Homo sapiens (human)
amine transportSolute carrier family 22 member 2Homo sapiens (human)
putrescine transportSolute carrier family 22 member 2Homo sapiens (human)
spermidine transportSolute carrier family 22 member 2Homo sapiens (human)
acetylcholine transportSolute carrier family 22 member 2Homo sapiens (human)
choline transportSolute carrier family 22 member 2Homo sapiens (human)
dopamine transportSolute carrier family 22 member 2Homo sapiens (human)
norepinephrine transportSolute carrier family 22 member 2Homo sapiens (human)
xenobiotic transportSolute carrier family 22 member 2Homo sapiens (human)
epinephrine transportSolute carrier family 22 member 2Homo sapiens (human)
histamine transportSolute carrier family 22 member 2Homo sapiens (human)
serotonin uptakeSolute carrier family 22 member 2Homo sapiens (human)
histamine uptakeSolute carrier family 22 member 2Homo sapiens (human)
norepinephrine uptakeSolute carrier family 22 member 2Homo sapiens (human)
thiamine transmembrane transportSolute carrier family 22 member 2Homo sapiens (human)
purine-containing compound transmembrane transportSolute carrier family 22 member 2Homo sapiens (human)
amino acid import across plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
dopamine uptakeSolute carrier family 22 member 2Homo sapiens (human)
L-arginine import across plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
export across plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
transport across blood-brain barrierSolute carrier family 22 member 2Homo sapiens (human)
L-alpha-amino acid transmembrane transportSolute carrier family 22 member 2Homo sapiens (human)
spermidine transmembrane transportSolute carrier family 22 member 2Homo sapiens (human)
L-arginine transmembrane transportSolute carrier family 22 member 2Homo sapiens (human)
cellular detoxificationSolute carrier family 22 member 2Homo sapiens (human)
xenobiotic transport across blood-brain barrierSolute carrier family 22 member 2Homo sapiens (human)
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 3BHomo sapiens (human)
monoatomic ion transmembrane transport5-hydroxytryptamine receptor 3BHomo sapiens (human)
excitatory postsynaptic potential5-hydroxytryptamine receptor 3BHomo sapiens (human)
inorganic cation transmembrane transport5-hydroxytryptamine receptor 3BHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 3BHomo sapiens (human)
regulation of membrane potential5-hydroxytryptamine receptor 3BHomo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell activation involved in immune responseInterferon betaHomo sapiens (human)
cell surface receptor signaling pathwayInterferon betaHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to virusInterferon betaHomo sapiens (human)
positive regulation of autophagyInterferon betaHomo sapiens (human)
cytokine-mediated signaling pathwayInterferon betaHomo sapiens (human)
natural killer cell activationInterferon betaHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT proteinInterferon betaHomo sapiens (human)
cellular response to interferon-betaInterferon betaHomo sapiens (human)
B cell proliferationInterferon betaHomo sapiens (human)
negative regulation of viral genome replicationInterferon betaHomo sapiens (human)
innate immune responseInterferon betaHomo sapiens (human)
positive regulation of innate immune responseInterferon betaHomo sapiens (human)
regulation of MHC class I biosynthetic processInterferon betaHomo sapiens (human)
negative regulation of T cell differentiationInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIInterferon betaHomo sapiens (human)
defense response to virusInterferon betaHomo sapiens (human)
type I interferon-mediated signaling pathwayInterferon betaHomo sapiens (human)
neuron cellular homeostasisInterferon betaHomo sapiens (human)
cellular response to exogenous dsRNAInterferon betaHomo sapiens (human)
cellular response to virusInterferon betaHomo sapiens (human)
negative regulation of Lewy body formationInterferon betaHomo sapiens (human)
negative regulation of T-helper 2 cell cytokine productionInterferon betaHomo sapiens (human)
positive regulation of apoptotic signaling pathwayInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell differentiationInterferon betaHomo sapiens (human)
natural killer cell activation involved in immune responseInterferon betaHomo sapiens (human)
adaptive immune responseInterferon betaHomo sapiens (human)
T cell activation involved in immune responseInterferon betaHomo sapiens (human)
humoral immune responseInterferon betaHomo sapiens (human)
positive regulation of T cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
adaptive immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class I via ER pathway, TAP-independentHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of T cell anergyHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
defense responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
detection of bacteriumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-12 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-6 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protection from natural killer cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
innate immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of dendritic cell differentiationHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class IbHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycle G2/M phase transitionCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
ER overload responseCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
mitophagyCellular tumor antigen p53Homo sapiens (human)
in utero embryonic developmentCellular tumor antigen p53Homo sapiens (human)
somitogenesisCellular tumor antigen p53Homo sapiens (human)
release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
hematopoietic progenitor cell differentiationCellular tumor antigen p53Homo sapiens (human)
T cell proliferation involved in immune responseCellular tumor antigen p53Homo sapiens (human)
B cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
T cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
response to ischemiaCellular tumor antigen p53Homo sapiens (human)
nucleotide-excision repairCellular tumor antigen p53Homo sapiens (human)
double-strand break repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
protein import into nucleusCellular tumor antigen p53Homo sapiens (human)
autophagyCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in cell cycle arrestCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in transcription of p21 class mediatorCellular tumor antigen p53Homo sapiens (human)
transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
Ras protein signal transductionCellular tumor antigen p53Homo sapiens (human)
gastrulationCellular tumor antigen p53Homo sapiens (human)
neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
protein localizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA replicationCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
determination of adult lifespanCellular tumor antigen p53Homo sapiens (human)
mRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
rRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
response to salt stressCellular tumor antigen p53Homo sapiens (human)
response to inorganic substanceCellular tumor antigen p53Homo sapiens (human)
response to X-rayCellular tumor antigen p53Homo sapiens (human)
response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
positive regulation of gene expressionCellular tumor antigen p53Homo sapiens (human)
cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
viral processCellular tumor antigen p53Homo sapiens (human)
glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
cerebellum developmentCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell growthCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
negative regulation of transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
mitotic G1 DNA damage checkpoint signalingCellular tumor antigen p53Homo sapiens (human)
negative regulation of telomere maintenance via telomeraseCellular tumor antigen p53Homo sapiens (human)
T cell differentiation in thymusCellular tumor antigen p53Homo sapiens (human)
tumor necrosis factor-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
regulation of tissue remodelingCellular tumor antigen p53Homo sapiens (human)
cellular response to UVCellular tumor antigen p53Homo sapiens (human)
multicellular organism growthCellular tumor antigen p53Homo sapiens (human)
positive regulation of mitochondrial membrane permeabilityCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
entrainment of circadian clock by photoperiodCellular tumor antigen p53Homo sapiens (human)
mitochondrial DNA repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
transcription initiation-coupled chromatin remodelingCellular tumor antigen p53Homo sapiens (human)
negative regulation of proteolysisCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of RNA polymerase II transcription preinitiation complex assemblyCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
response to antibioticCellular tumor antigen p53Homo sapiens (human)
fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
circadian behaviorCellular tumor antigen p53Homo sapiens (human)
bone marrow developmentCellular tumor antigen p53Homo sapiens (human)
embryonic organ developmentCellular tumor antigen p53Homo sapiens (human)
positive regulation of peptidyl-tyrosine phosphorylationCellular tumor antigen p53Homo sapiens (human)
protein stabilizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of helicase activityCellular tumor antigen p53Homo sapiens (human)
protein tetramerizationCellular tumor antigen p53Homo sapiens (human)
chromosome organizationCellular tumor antigen p53Homo sapiens (human)
neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
hematopoietic stem cell differentiationCellular tumor antigen p53Homo sapiens (human)
negative regulation of glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
type II interferon-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
cardiac septum morphogenesisCellular tumor antigen p53Homo sapiens (human)
positive regulation of programmed necrotic cell deathCellular tumor antigen p53Homo sapiens (human)
protein-containing complex assemblyCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to endoplasmic reticulum stressCellular tumor antigen p53Homo sapiens (human)
thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
necroptotic processCellular tumor antigen p53Homo sapiens (human)
cellular response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
cellular response to xenobiotic stimulusCellular tumor antigen p53Homo sapiens (human)
cellular response to ionizing radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to UV-CCellular tumor antigen p53Homo sapiens (human)
stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
cellular response to actinomycin DCellular tumor antigen p53Homo sapiens (human)
positive regulation of release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
cellular senescenceCellular tumor antigen p53Homo sapiens (human)
replicative senescenceCellular tumor antigen p53Homo sapiens (human)
oxidative stress-induced premature senescenceCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
oligodendrocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of execution phase of apoptosisCellular tumor antigen p53Homo sapiens (human)
negative regulation of mitophagyCellular tumor antigen p53Homo sapiens (human)
regulation of mitochondrial membrane permeability involved in apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of G1 to G0 transitionCellular tumor antigen p53Homo sapiens (human)
negative regulation of miRNA processingCellular tumor antigen p53Homo sapiens (human)
negative regulation of glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
negative regulation of pentose-phosphate shuntCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
regulation of fibroblast apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
positive regulation of cellular senescenceCellular tumor antigen p53Homo sapiens (human)
positive regulation of intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
G2/M transition of mitotic cell cycleATP-dependent translocase ABCB1Homo sapiens (human)
xenobiotic metabolic processATP-dependent translocase ABCB1Homo sapiens (human)
response to xenobiotic stimulusATP-dependent translocase ABCB1Homo sapiens (human)
phospholipid translocationATP-dependent translocase ABCB1Homo sapiens (human)
terpenoid transportATP-dependent translocase ABCB1Homo sapiens (human)
regulation of response to osmotic stressATP-dependent translocase ABCB1Homo sapiens (human)
transmembrane transportATP-dependent translocase ABCB1Homo sapiens (human)
transepithelial transportATP-dependent translocase ABCB1Homo sapiens (human)
stem cell proliferationATP-dependent translocase ABCB1Homo sapiens (human)
ceramide translocationATP-dependent translocase ABCB1Homo sapiens (human)
export across plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
transport across blood-brain barrierATP-dependent translocase ABCB1Homo sapiens (human)
positive regulation of anion channel activityATP-dependent translocase ABCB1Homo sapiens (human)
carboxylic acid transmembrane transportATP-dependent translocase ABCB1Homo sapiens (human)
xenobiotic detoxification by transmembrane export across the plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
xenobiotic transport across blood-brain barrierATP-dependent translocase ABCB1Homo sapiens (human)
regulation of chloride transportATP-dependent translocase ABCB1Homo sapiens (human)
lipid hydroxylationCytochrome P450 3A4Homo sapiens (human)
lipid metabolic processCytochrome P450 3A4Homo sapiens (human)
steroid catabolic processCytochrome P450 3A4Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 3A4Homo sapiens (human)
steroid metabolic processCytochrome P450 3A4Homo sapiens (human)
cholesterol metabolic processCytochrome P450 3A4Homo sapiens (human)
androgen metabolic processCytochrome P450 3A4Homo sapiens (human)
estrogen metabolic processCytochrome P450 3A4Homo sapiens (human)
alkaloid catabolic processCytochrome P450 3A4Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 3A4Homo sapiens (human)
calcitriol biosynthetic process from calciolCytochrome P450 3A4Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 3A4Homo sapiens (human)
vitamin D metabolic processCytochrome P450 3A4Homo sapiens (human)
vitamin D catabolic processCytochrome P450 3A4Homo sapiens (human)
retinol metabolic processCytochrome P450 3A4Homo sapiens (human)
retinoic acid metabolic processCytochrome P450 3A4Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 3A4Homo sapiens (human)
aflatoxin metabolic processCytochrome P450 3A4Homo sapiens (human)
oxidative demethylationCytochrome P450 3A4Homo sapiens (human)
behavioral fear response5-hydroxytryptamine receptor 1AHomo sapiens (human)
G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
adenylate cyclase-inhibiting serotonin receptor signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
gamma-aminobutyric acid signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
positive regulation of cell population proliferation5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of serotonin secretion5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of vasoconstriction5-hydroxytryptamine receptor 1AHomo sapiens (human)
exploration behavior5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of dopamine metabolic process5-hydroxytryptamine receptor 1AHomo sapiens (human)
serotonin metabolic process5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of hormone secretion5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of behavior5-hydroxytryptamine receptor 1AHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 1AHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 1AHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
temperature homeostasisD(2) dopamine receptorHomo sapiens (human)
response to hypoxiaD(2) dopamine receptorHomo sapiens (human)
negative regulation of protein phosphorylationD(2) dopamine receptorHomo sapiens (human)
response to amphetamineD(2) dopamine receptorHomo sapiens (human)
nervous system process involved in regulation of systemic arterial blood pressureD(2) dopamine receptorHomo sapiens (human)
regulation of heart rateD(2) dopamine receptorHomo sapiens (human)
regulation of sodium ion transportD(2) dopamine receptorHomo sapiens (human)
G protein-coupled receptor internalizationD(2) dopamine receptorHomo sapiens (human)
positive regulation of neuroblast proliferationD(2) dopamine receptorHomo sapiens (human)
positive regulation of receptor internalizationD(2) dopamine receptorHomo sapiens (human)
autophagyD(2) dopamine receptorHomo sapiens (human)
adenylate cyclase-inhibiting dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
neuron-neuron synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
neuroblast proliferationD(2) dopamine receptorHomo sapiens (human)
axonogenesisD(2) dopamine receptorHomo sapiens (human)
synapse assemblyD(2) dopamine receptorHomo sapiens (human)
sensory perception of smellD(2) dopamine receptorHomo sapiens (human)
long-term memoryD(2) dopamine receptorHomo sapiens (human)
grooming behaviorD(2) dopamine receptorHomo sapiens (human)
locomotory behaviorD(2) dopamine receptorHomo sapiens (human)
adult walking behaviorD(2) dopamine receptorHomo sapiens (human)
protein localizationD(2) dopamine receptorHomo sapiens (human)
negative regulation of cell population proliferationD(2) dopamine receptorHomo sapiens (human)
associative learningD(2) dopamine receptorHomo sapiens (human)
visual learningD(2) dopamine receptorHomo sapiens (human)
response to xenobiotic stimulusD(2) dopamine receptorHomo sapiens (human)
response to light stimulusD(2) dopamine receptorHomo sapiens (human)
response to toxic substanceD(2) dopamine receptorHomo sapiens (human)
response to iron ionD(2) dopamine receptorHomo sapiens (human)
response to inactivityD(2) dopamine receptorHomo sapiens (human)
Wnt signaling pathwayD(2) dopamine receptorHomo sapiens (human)
striatum developmentD(2) dopamine receptorHomo sapiens (human)
orbitofrontal cortex developmentD(2) dopamine receptorHomo sapiens (human)
cerebral cortex GABAergic interneuron migrationD(2) dopamine receptorHomo sapiens (human)
adenohypophysis developmentD(2) dopamine receptorHomo sapiens (human)
negative regulation of cell migrationD(2) dopamine receptorHomo sapiens (human)
peristalsisD(2) dopamine receptorHomo sapiens (human)
auditory behaviorD(2) dopamine receptorHomo sapiens (human)
regulation of synaptic transmission, GABAergicD(2) dopamine receptorHomo sapiens (human)
positive regulation of cytokinesisD(2) dopamine receptorHomo sapiens (human)
circadian regulation of gene expressionD(2) dopamine receptorHomo sapiens (human)
negative regulation of dopamine secretionD(2) dopamine receptorHomo sapiens (human)
response to histamineD(2) dopamine receptorHomo sapiens (human)
response to nicotineD(2) dopamine receptorHomo sapiens (human)
positive regulation of urine volumeD(2) dopamine receptorHomo sapiens (human)
positive regulation of renal sodium excretionD(2) dopamine receptorHomo sapiens (human)
positive regulation of multicellular organism growthD(2) dopamine receptorHomo sapiens (human)
response to cocaineD(2) dopamine receptorHomo sapiens (human)
negative regulation of circadian sleep/wake cycle, sleepD(2) dopamine receptorHomo sapiens (human)
dopamine metabolic processD(2) dopamine receptorHomo sapiens (human)
drinking behaviorD(2) dopamine receptorHomo sapiens (human)
regulation of potassium ion transportD(2) dopamine receptorHomo sapiens (human)
response to morphineD(2) dopamine receptorHomo sapiens (human)
pigmentationD(2) dopamine receptorHomo sapiens (human)
phosphatidylinositol 3-kinase/protein kinase B signal transductionD(2) dopamine receptorHomo sapiens (human)
positive regulation of G protein-coupled receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
negative regulation of blood pressureD(2) dopamine receptorHomo sapiens (human)
negative regulation of innate immune responseD(2) dopamine receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IID(2) dopamine receptorHomo sapiens (human)
negative regulation of insulin secretionD(2) dopamine receptorHomo sapiens (human)
acid secretionD(2) dopamine receptorHomo sapiens (human)
behavioral response to cocaineD(2) dopamine receptorHomo sapiens (human)
behavioral response to ethanolD(2) dopamine receptorHomo sapiens (human)
regulation of long-term neuronal synaptic plasticityD(2) dopamine receptorHomo sapiens (human)
response to axon injuryD(2) dopamine receptorHomo sapiens (human)
branching morphogenesis of a nerveD(2) dopamine receptorHomo sapiens (human)
arachidonic acid secretionD(2) dopamine receptorHomo sapiens (human)
epithelial cell proliferationD(2) dopamine receptorHomo sapiens (human)
negative regulation of epithelial cell proliferationD(2) dopamine receptorHomo sapiens (human)
negative regulation of protein secretionD(2) dopamine receptorHomo sapiens (human)
release of sequestered calcium ion into cytosolD(2) dopamine receptorHomo sapiens (human)
dopamine uptake involved in synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
regulation of dopamine uptake involved in synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
positive regulation of dopamine uptake involved in synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
regulation of synapse structural plasticityD(2) dopamine receptorHomo sapiens (human)
negative regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionD(2) dopamine receptorHomo sapiens (human)
negative regulation of synaptic transmission, glutamatergicD(2) dopamine receptorHomo sapiens (human)
excitatory postsynaptic potentialD(2) dopamine receptorHomo sapiens (human)
positive regulation of growth hormone secretionD(2) dopamine receptorHomo sapiens (human)
prepulse inhibitionD(2) dopamine receptorHomo sapiens (human)
negative regulation of dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeD(2) dopamine receptorHomo sapiens (human)
regulation of locomotion involved in locomotory behaviorD(2) dopamine receptorHomo sapiens (human)
postsynaptic modulation of chemical synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
presynaptic modulation of chemical synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
negative regulation of cellular response to hypoxiaD(2) dopamine receptorHomo sapiens (human)
positive regulation of glial cell-derived neurotrophic factor productionD(2) dopamine receptorHomo sapiens (human)
positive regulation of long-term synaptic potentiationD(2) dopamine receptorHomo sapiens (human)
hyaloid vascular plexus regressionD(2) dopamine receptorHomo sapiens (human)
negative regulation of neuron migrationD(2) dopamine receptorHomo sapiens (human)
negative regulation of cytosolic calcium ion concentrationD(2) dopamine receptorHomo sapiens (human)
regulation of dopamine secretionD(2) dopamine receptorHomo sapiens (human)
negative regulation of adenylate cyclase activityD(2) dopamine receptorHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
negative regulation of voltage-gated calcium channel activityD(2) dopamine receptorHomo sapiens (human)
positive regulation of MAPK cascadeD(2) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
regulation of smooth muscle contractionAlpha-2C adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of norepinephrine secretionAlpha-2C adrenergic receptorHomo sapiens (human)
regulation of vasoconstrictionAlpha-2C adrenergic receptorHomo sapiens (human)
platelet activationAlpha-2C adrenergic receptorHomo sapiens (human)
activation of protein kinase B activityAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of epinephrine secretionAlpha-2C adrenergic receptorHomo sapiens (human)
receptor transactivationAlpha-2C adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-2C adrenergic receptorHomo sapiens (human)
positive regulation of neuron differentiationAlpha-2C adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretionAlpha-2C adrenergic receptorHomo sapiens (human)
calcium-mediated signalingMuscarinic acetylcholine receptor M3Homo sapiens (human)
regulation of monoatomic ion transmembrane transporter activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
smooth muscle contractionMuscarinic acetylcholine receptor M3Homo sapiens (human)
signal transductionMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
phospholipase C-activating G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
synaptic transmission, cholinergicMuscarinic acetylcholine receptor M3Homo sapiens (human)
nervous system developmentMuscarinic acetylcholine receptor M3Homo sapiens (human)
positive regulation of insulin secretionMuscarinic acetylcholine receptor M3Homo sapiens (human)
protein modification processMuscarinic acetylcholine receptor M3Homo sapiens (human)
positive regulation of smooth muscle contractionMuscarinic acetylcholine receptor M3Homo sapiens (human)
saliva secretionMuscarinic acetylcholine receptor M3Homo sapiens (human)
acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
ion channel modulating, G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
ligand-gated ion channel signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
regulation of smooth muscle contractionMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M3Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M3Homo sapiens (human)
temperature homeostasisD(1A) dopamine receptorHomo sapiens (human)
conditioned taste aversionD(1A) dopamine receptorHomo sapiens (human)
behavioral fear responseD(1A) dopamine receptorHomo sapiens (human)
regulation of protein phosphorylationD(1A) dopamine receptorHomo sapiens (human)
synaptic transmission, dopaminergicD(1A) dopamine receptorHomo sapiens (human)
response to amphetamineD(1A) dopamine receptorHomo sapiens (human)
protein import into nucleusD(1A) dopamine receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerD(1A) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayD(1A) dopamine receptorHomo sapiens (human)
activation of adenylate cyclase activityD(1A) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating dopamine receptor signaling pathwayD(1A) dopamine receptorHomo sapiens (human)
synapse assemblyD(1A) dopamine receptorHomo sapiens (human)
memoryD(1A) dopamine receptorHomo sapiens (human)
mating behaviorD(1A) dopamine receptorHomo sapiens (human)
grooming behaviorD(1A) dopamine receptorHomo sapiens (human)
adult walking behaviorD(1A) dopamine receptorHomo sapiens (human)
visual learningD(1A) dopamine receptorHomo sapiens (human)
response to xenobiotic stimulusD(1A) dopamine receptorHomo sapiens (human)
astrocyte developmentD(1A) dopamine receptorHomo sapiens (human)
dopamine transportD(1A) dopamine receptorHomo sapiens (human)
transmission of nerve impulseD(1A) dopamine receptorHomo sapiens (human)
neuronal action potentialD(1A) dopamine receptorHomo sapiens (human)
dentate gyrus developmentD(1A) dopamine receptorHomo sapiens (human)
striatum developmentD(1A) dopamine receptorHomo sapiens (human)
cerebral cortex GABAergic interneuron migrationD(1A) dopamine receptorHomo sapiens (human)
positive regulation of cell migrationD(1A) dopamine receptorHomo sapiens (human)
peristalsisD(1A) dopamine receptorHomo sapiens (human)
operant conditioningD(1A) dopamine receptorHomo sapiens (human)
synaptic transmission, glutamatergicD(1A) dopamine receptorHomo sapiens (human)
regulation of dopamine metabolic processD(1A) dopamine receptorHomo sapiens (human)
vasodilationD(1A) dopamine receptorHomo sapiens (human)
dopamine metabolic processD(1A) dopamine receptorHomo sapiens (human)
maternal behaviorD(1A) dopamine receptorHomo sapiens (human)
positive regulation of potassium ion transportD(1A) dopamine receptorHomo sapiens (human)
glucose importD(1A) dopamine receptorHomo sapiens (human)
habituationD(1A) dopamine receptorHomo sapiens (human)
sensitizationD(1A) dopamine receptorHomo sapiens (human)
behavioral response to cocaineD(1A) dopamine receptorHomo sapiens (human)
positive regulation of release of sequestered calcium ion into cytosolD(1A) dopamine receptorHomo sapiens (human)
regulation of dopamine uptake involved in synaptic transmissionD(1A) dopamine receptorHomo sapiens (human)
positive regulation of synaptic transmission, glutamatergicD(1A) dopamine receptorHomo sapiens (human)
prepulse inhibitionD(1A) dopamine receptorHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(1A) dopamine receptorHomo sapiens (human)
long-term synaptic potentiationD(1A) dopamine receptorHomo sapiens (human)
long-term synaptic depressionD(1A) dopamine receptorHomo sapiens (human)
cellular response to catecholamine stimulusD(1A) dopamine receptorHomo sapiens (human)
modification of postsynaptic structureD(1A) dopamine receptorHomo sapiens (human)
presynaptic modulation of chemical synaptic transmissionD(1A) dopamine receptorHomo sapiens (human)
positive regulation of neuron migrationD(1A) dopamine receptorHomo sapiens (human)
positive regulation of MAPK cascadeD(1A) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayD(1A) dopamine receptorHomo sapiens (human)
dopamine receptor signaling pathwayD(1A) dopamine receptorHomo sapiens (human)
positive regulation of MAP kinase activityD(4) dopamine receptorHomo sapiens (human)
behavioral fear responseD(4) dopamine receptorHomo sapiens (human)
synaptic transmission, dopaminergicD(4) dopamine receptorHomo sapiens (human)
response to amphetamineD(4) dopamine receptorHomo sapiens (human)
intracellular calcium ion homeostasisD(4) dopamine receptorHomo sapiens (human)
adenylate cyclase-inhibiting dopamine receptor signaling pathwayD(4) dopamine receptorHomo sapiens (human)
dopamine receptor signaling pathwayD(4) dopamine receptorHomo sapiens (human)
adult locomotory behaviorD(4) dopamine receptorHomo sapiens (human)
positive regulation of sodium:proton antiporter activityD(4) dopamine receptorHomo sapiens (human)
positive regulation of kinase activityD(4) dopamine receptorHomo sapiens (human)
response to histamineD(4) dopamine receptorHomo sapiens (human)
social behaviorD(4) dopamine receptorHomo sapiens (human)
regulation of dopamine metabolic processD(4) dopamine receptorHomo sapiens (human)
dopamine metabolic processD(4) dopamine receptorHomo sapiens (human)
fear responseD(4) dopamine receptorHomo sapiens (human)
regulation of circadian rhythmD(4) dopamine receptorHomo sapiens (human)
positive regulation of MAP kinase activityD(4) dopamine receptorHomo sapiens (human)
behavioral response to cocaineD(4) dopamine receptorHomo sapiens (human)
behavioral response to ethanolD(4) dopamine receptorHomo sapiens (human)
rhythmic processD(4) dopamine receptorHomo sapiens (human)
arachidonic acid secretionD(4) dopamine receptorHomo sapiens (human)
negative regulation of protein secretionD(4) dopamine receptorHomo sapiens (human)
positive regulation of dopamine uptake involved in synaptic transmissionD(4) dopamine receptorHomo sapiens (human)
inhibitory postsynaptic potentialD(4) dopamine receptorHomo sapiens (human)
regulation of postsynaptic neurotransmitter receptor internalizationD(4) dopamine receptorHomo sapiens (human)
negative regulation of voltage-gated calcium channel activityD(4) dopamine receptorHomo sapiens (human)
adenylate cyclase-inhibiting serotonin receptor signaling pathwayD(4) dopamine receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerD(4) dopamine receptorHomo sapiens (human)
chemical synaptic transmissionD(4) dopamine receptorHomo sapiens (human)
synaptic transmission, dopaminergicD(1B) dopamine receptorHomo sapiens (human)
response to amphetamineD(1B) dopamine receptorHomo sapiens (human)
regulation of systemic arterial blood pressure by vasopressinD(1B) dopamine receptorHomo sapiens (human)
norepinephrine-epinephrine vasoconstriction involved in regulation of systemic arterial blood pressureD(1B) dopamine receptorHomo sapiens (human)
intracellular calcium ion homeostasisD(1B) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayD(1B) dopamine receptorHomo sapiens (human)
activation of adenylate cyclase activityD(1B) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating dopamine receptor signaling pathwayD(1B) dopamine receptorHomo sapiens (human)
chemical synaptic transmissionD(1B) dopamine receptorHomo sapiens (human)
associative learningD(1B) dopamine receptorHomo sapiens (human)
transmission of nerve impulseD(1B) dopamine receptorHomo sapiens (human)
negative regulation of NAD(P)H oxidase activityD(1B) dopamine receptorHomo sapiens (human)
wound healingD(1B) dopamine receptorHomo sapiens (human)
response to cocaineD(1B) dopamine receptorHomo sapiens (human)
positive regulation of adenylate cyclase activityD(1B) dopamine receptorHomo sapiens (human)
negative regulation of blood pressureD(1B) dopamine receptorHomo sapiens (human)
regulation of female receptivityD(1B) dopamine receptorHomo sapiens (human)
sensitizationD(1B) dopamine receptorHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(1B) dopamine receptorHomo sapiens (human)
long-term synaptic depressionD(1B) dopamine receptorHomo sapiens (human)
cellular response to catecholamine stimulusD(1B) dopamine receptorHomo sapiens (human)
reactive oxygen species metabolic processD(1B) dopamine receptorHomo sapiens (human)
positive regulation of MAPK cascadeD(1B) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayD(1B) dopamine receptorHomo sapiens (human)
dopamine receptor signaling pathwayD(1B) dopamine receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-1D adrenergic receptorHomo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayAlpha-1D adrenergic receptorHomo sapiens (human)
positive regulation of cell population proliferationAlpha-1D adrenergic receptorHomo sapiens (human)
neuron-glial cell signalingAlpha-1D adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-1D adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-1D adrenergic receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayAlpha-1D adrenergic receptorHomo sapiens (human)
positive regulation of cytosolic calcium ion concentrationAlpha-1D adrenergic receptorHomo sapiens (human)
positive regulation of vasoconstrictionAlpha-1D adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-1D adrenergic receptorHomo sapiens (human)
temperature homeostasis5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of cytokine production involved in immune response5-hydroxytryptamine receptor 2AHomo sapiens (human)
glycolytic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
intracellular calcium ion homeostasis5-hydroxytryptamine receptor 2AHomo sapiens (human)
activation of phospholipase C activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of cytosolic calcium ion concentration5-hydroxytryptamine receptor 2AHomo sapiens (human)
memory5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of cell population proliferation5-hydroxytryptamine receptor 2AHomo sapiens (human)
response to xenobiotic stimulus5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of phosphatidylinositol biosynthetic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
regulation of dopamine secretion5-hydroxytryptamine receptor 2AHomo sapiens (human)
artery smooth muscle contraction5-hydroxytryptamine receptor 2AHomo sapiens (human)
urinary bladder smooth muscle contraction5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of heat generation5-hydroxytryptamine receptor 2AHomo sapiens (human)
negative regulation of potassium ion transport5-hydroxytryptamine receptor 2AHomo sapiens (human)
phosphatidylinositol 3-kinase/protein kinase B signal transduction5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of neuron apoptotic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein localization to cytoskeleton5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of fat cell differentiation5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of glycolytic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of vasoconstriction5-hydroxytryptamine receptor 2AHomo sapiens (human)
symbiont entry into host cell5-hydroxytryptamine receptor 2AHomo sapiens (human)
sensitization5-hydroxytryptamine receptor 2AHomo sapiens (human)
behavioral response to cocaine5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of inflammatory response5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of peptidyl-tyrosine phosphorylation5-hydroxytryptamine receptor 2AHomo sapiens (human)
detection of temperature stimulus involved in sensory perception of pain5-hydroxytryptamine receptor 2AHomo sapiens (human)
detection of mechanical stimulus involved in sensory perception of pain5-hydroxytryptamine receptor 2AHomo sapiens (human)
release of sequestered calcium ion into cytosol5-hydroxytryptamine receptor 2AHomo sapiens (human)
negative regulation of synaptic transmission, glutamatergic5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 2AHomo sapiens (human)
presynaptic modulation of chemical synaptic transmission5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of execution phase of apoptosis5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of platelet aggregation5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of DNA biosynthetic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 2AHomo sapiens (human)
phospholipase C-activating serotonin receptor signaling pathway5-hydroxytryptamine receptor 2AHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 2AHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 2AHomo sapiens (human)
behavioral fear response5-hydroxytryptamine receptor 2CHomo sapiens (human)
intracellular calcium ion homeostasis5-hydroxytryptamine receptor 2CHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 2CHomo sapiens (human)
phospholipase C-activating serotonin receptor signaling pathway5-hydroxytryptamine receptor 2CHomo sapiens (human)
locomotory behavior5-hydroxytryptamine receptor 2CHomo sapiens (human)
feeding behavior5-hydroxytryptamine receptor 2CHomo sapiens (human)
positive regulation of phosphatidylinositol biosynthetic process5-hydroxytryptamine receptor 2CHomo sapiens (human)
cGMP-mediated signaling5-hydroxytryptamine receptor 2CHomo sapiens (human)
regulation of nervous system process5-hydroxytryptamine receptor 2CHomo sapiens (human)
regulation of appetite5-hydroxytryptamine receptor 2CHomo sapiens (human)
regulation of corticotropin-releasing hormone secretion5-hydroxytryptamine receptor 2CHomo sapiens (human)
positive regulation of fat cell differentiation5-hydroxytryptamine receptor 2CHomo sapiens (human)
positive regulation of calcium-mediated signaling5-hydroxytryptamine receptor 2CHomo sapiens (human)
release of sequestered calcium ion into cytosol5-hydroxytryptamine receptor 2CHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2CHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 2CHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 2CHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 2CHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 2CHomo sapiens (human)
monoamine transportSodium-dependent serotonin transporterHomo sapiens (human)
response to hypoxiaSodium-dependent serotonin transporterHomo sapiens (human)
neurotransmitter transportSodium-dependent serotonin transporterHomo sapiens (human)
response to nutrientSodium-dependent serotonin transporterHomo sapiens (human)
memorySodium-dependent serotonin transporterHomo sapiens (human)
circadian rhythmSodium-dependent serotonin transporterHomo sapiens (human)
response to xenobiotic stimulusSodium-dependent serotonin transporterHomo sapiens (human)
response to toxic substanceSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of gene expressionSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of serotonin secretionSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of cerebellar granule cell precursor proliferationSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of synaptic transmission, dopaminergicSodium-dependent serotonin transporterHomo sapiens (human)
response to estradiolSodium-dependent serotonin transporterHomo sapiens (human)
social behaviorSodium-dependent serotonin transporterHomo sapiens (human)
vasoconstrictionSodium-dependent serotonin transporterHomo sapiens (human)
sperm ejaculationSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of neuron differentiationSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of cell cycleSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of organ growthSodium-dependent serotonin transporterHomo sapiens (human)
behavioral response to cocaineSodium-dependent serotonin transporterHomo sapiens (human)
enteric nervous system developmentSodium-dependent serotonin transporterHomo sapiens (human)
brain morphogenesisSodium-dependent serotonin transporterHomo sapiens (human)
serotonin uptakeSodium-dependent serotonin transporterHomo sapiens (human)
membrane depolarizationSodium-dependent serotonin transporterHomo sapiens (human)
platelet aggregationSodium-dependent serotonin transporterHomo sapiens (human)
cellular response to retinoic acidSodium-dependent serotonin transporterHomo sapiens (human)
cellular response to cGMPSodium-dependent serotonin transporterHomo sapiens (human)
regulation of thalamus sizeSodium-dependent serotonin transporterHomo sapiens (human)
conditioned place preferenceSodium-dependent serotonin transporterHomo sapiens (human)
sodium ion transmembrane transportSodium-dependent serotonin transporterHomo sapiens (human)
amino acid transportSodium-dependent serotonin transporterHomo sapiens (human)
smooth muscle contraction5-hydroxytryptamine receptor 7Homo sapiens (human)
circadian rhythm5-hydroxytryptamine receptor 7Homo sapiens (human)
blood circulation5-hydroxytryptamine receptor 7Homo sapiens (human)
vasoconstriction5-hydroxytryptamine receptor 7Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 7Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 7Homo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 7Homo sapiens (human)
MAPK cascadeAlpha-1A adrenergic receptorHomo sapiens (human)
negative regulation of heart rate involved in baroreceptor response to increased systemic arterial blood pressureAlpha-1A adrenergic receptorHomo sapiens (human)
norepinephrine-epinephrine vasoconstriction involved in regulation of systemic arterial blood pressureAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of heart rate by epinephrine-norepinephrineAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of the force of heart contraction by epinephrine-norepinephrineAlpha-1A adrenergic receptorHomo sapiens (human)
apoptotic processAlpha-1A adrenergic receptorHomo sapiens (human)
smooth muscle contractionAlpha-1A adrenergic receptorHomo sapiens (human)
signal transductionAlpha-1A adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-1A adrenergic receptorHomo sapiens (human)
activation of phospholipase C activityAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of cytosolic calcium ion concentrationAlpha-1A adrenergic receptorHomo sapiens (human)
adult heart developmentAlpha-1A adrenergic receptorHomo sapiens (human)
negative regulation of cell population proliferationAlpha-1A adrenergic receptorHomo sapiens (human)
response to xenobiotic stimulusAlpha-1A adrenergic receptorHomo sapiens (human)
response to hormoneAlpha-1A adrenergic receptorHomo sapiens (human)
negative regulation of autophagyAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of cardiac muscle hypertrophyAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of synaptic transmission, GABAergicAlpha-1A adrenergic receptorHomo sapiens (human)
intracellular signal transductionAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of action potentialAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of vasoconstrictionAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of smooth muscle contractionAlpha-1A adrenergic receptorHomo sapiens (human)
calcium ion transport into cytosolAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of cardiac muscle contractionAlpha-1A adrenergic receptorHomo sapiens (human)
cell growth involved in cardiac muscle cell developmentAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of protein kinase C signalingAlpha-1A adrenergic receptorHomo sapiens (human)
pilomotor reflexAlpha-1A adrenergic receptorHomo sapiens (human)
neuron-glial cell signalingAlpha-1A adrenergic receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayAlpha-1A adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-1A adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-1A adrenergic receptorHomo sapiens (human)
inflammatory responseHistamine H1 receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayHistamine H1 receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayHistamine H1 receptorHomo sapiens (human)
memoryHistamine H1 receptorHomo sapiens (human)
visual learningHistamine H1 receptorHomo sapiens (human)
regulation of vascular permeabilityHistamine H1 receptorHomo sapiens (human)
positive regulation of vasoconstrictionHistamine H1 receptorHomo sapiens (human)
regulation of synaptic plasticityHistamine H1 receptorHomo sapiens (human)
cellular response to histamineHistamine H1 receptorHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayHistamine H1 receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerHistamine H1 receptorHomo sapiens (human)
chemical synaptic transmissionHistamine H1 receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-1B adrenergic receptorHomo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayAlpha-1B adrenergic receptorHomo sapiens (human)
regulation of vasoconstrictionAlpha-1B adrenergic receptorHomo sapiens (human)
intracellular signal transductionAlpha-1B adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-1B adrenergic receptorHomo sapiens (human)
regulation of cardiac muscle contractionAlpha-1B adrenergic receptorHomo sapiens (human)
neuron-glial cell signalingAlpha-1B adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-1B adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-1B adrenergic receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayAlpha-1B adrenergic receptorHomo sapiens (human)
positive regulation of cytosolic calcium ion concentrationAlpha-1B adrenergic receptorHomo sapiens (human)
response to ethanolD(3) dopamine receptorHomo sapiens (human)
synaptic transmission, dopaminergicD(3) dopamine receptorHomo sapiens (human)
G protein-coupled receptor internalizationD(3) dopamine receptorHomo sapiens (human)
intracellular calcium ion homeostasisD(3) dopamine receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
adenylate cyclase-inhibiting dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
learning or memoryD(3) dopamine receptorHomo sapiens (human)
learningD(3) dopamine receptorHomo sapiens (human)
locomotory behaviorD(3) dopamine receptorHomo sapiens (human)
visual learningD(3) dopamine receptorHomo sapiens (human)
response to xenobiotic stimulusD(3) dopamine receptorHomo sapiens (human)
regulation of dopamine secretionD(3) dopamine receptorHomo sapiens (human)
positive regulation of cytokinesisD(3) dopamine receptorHomo sapiens (human)
circadian regulation of gene expressionD(3) dopamine receptorHomo sapiens (human)
response to histamineD(3) dopamine receptorHomo sapiens (human)
social behaviorD(3) dopamine receptorHomo sapiens (human)
response to cocaineD(3) dopamine receptorHomo sapiens (human)
dopamine metabolic processD(3) dopamine receptorHomo sapiens (human)
response to morphineD(3) dopamine receptorHomo sapiens (human)
negative regulation of blood pressureD(3) dopamine receptorHomo sapiens (human)
positive regulation of mitotic nuclear divisionD(3) dopamine receptorHomo sapiens (human)
acid secretionD(3) dopamine receptorHomo sapiens (human)
behavioral response to cocaineD(3) dopamine receptorHomo sapiens (human)
negative regulation of oligodendrocyte differentiationD(3) dopamine receptorHomo sapiens (human)
arachidonic acid secretionD(3) dopamine receptorHomo sapiens (human)
negative regulation of protein secretionD(3) dopamine receptorHomo sapiens (human)
musculoskeletal movement, spinal reflex actionD(3) dopamine receptorHomo sapiens (human)
regulation of dopamine uptake involved in synaptic transmissionD(3) dopamine receptorHomo sapiens (human)
negative regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionD(3) dopamine receptorHomo sapiens (human)
prepulse inhibitionD(3) dopamine receptorHomo sapiens (human)
positive regulation of dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
negative regulation of adenylate cyclase activityD(3) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
negative regulation of voltage-gated calcium channel activityD(3) dopamine receptorHomo sapiens (human)
regulation of potassium ion transportD(3) dopamine receptorHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
positive regulation of MAPK cascadeD(3) dopamine receptorHomo sapiens (human)
negative regulation of cytosolic calcium ion concentrationD(3) dopamine receptorHomo sapiens (human)
negative regulation of synaptic transmission, glutamatergicD(3) dopamine receptorHomo sapiens (human)
neural crest cell migration5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of cytokine production5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of endothelial cell proliferation5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled receptor internalization5-hydroxytryptamine receptor 2BHomo sapiens (human)
heart morphogenesis5-hydroxytryptamine receptor 2BHomo sapiens (human)
cardiac muscle hypertrophy5-hydroxytryptamine receptor 2BHomo sapiens (human)
intracellular calcium ion homeostasis5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
activation of phospholipase C activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
protein kinase C-activating G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
phospholipase C-activating serotonin receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of cell population proliferation5-hydroxytryptamine receptor 2BHomo sapiens (human)
response to xenobiotic stimulus5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of phosphatidylinositol biosynthetic process5-hydroxytryptamine receptor 2BHomo sapiens (human)
neural crest cell differentiation5-hydroxytryptamine receptor 2BHomo sapiens (human)
intestine smooth muscle contraction5-hydroxytryptamine receptor 2BHomo sapiens (human)
phosphorylation5-hydroxytryptamine receptor 2BHomo sapiens (human)
calcium-mediated signaling5-hydroxytryptamine receptor 2BHomo sapiens (human)
cGMP-mediated signaling5-hydroxytryptamine receptor 2BHomo sapiens (human)
vasoconstriction5-hydroxytryptamine receptor 2BHomo sapiens (human)
negative regulation of apoptotic process5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of canonical NF-kappaB signal transduction5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of MAP kinase activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
phosphatidylinositol 3-kinase/protein kinase B signal transduction5-hydroxytryptamine receptor 2BHomo sapiens (human)
embryonic morphogenesis5-hydroxytryptamine receptor 2BHomo sapiens (human)
regulation of behavior5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of nitric-oxide synthase activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
release of sequestered calcium ion into cytosol5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of cell division5-hydroxytryptamine receptor 2BHomo sapiens (human)
ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2BHomo sapiens (human)
protein kinase C signaling5-hydroxytryptamine receptor 2BHomo sapiens (human)
cellular response to temperature stimulus5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 2BHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 2BHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 3AHomo sapiens (human)
monoatomic ion transmembrane transport5-hydroxytryptamine receptor 3AHomo sapiens (human)
excitatory postsynaptic potential5-hydroxytryptamine receptor 3AHomo sapiens (human)
inorganic cation transmembrane transport5-hydroxytryptamine receptor 3AHomo sapiens (human)
regulation of presynaptic membrane potential5-hydroxytryptamine receptor 3AHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 3AHomo sapiens (human)
regulation of membrane potential5-hydroxytryptamine receptor 3AHomo sapiens (human)
cerebral cortex cell migration5-hydroxytryptamine receptor 6Homo sapiens (human)
positive regulation of TOR signaling5-hydroxytryptamine receptor 6Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 6Homo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 6Homo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 6Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 6Homo sapiens (human)
regulation of heart rate by cardiac conductionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of heart rate by hormonePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of membrane potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
positive regulation of DNA-templated transcriptionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion homeostasisPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
cardiac muscle contractionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of membrane repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of ventricular cardiac muscle cell membrane repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
cellular response to xenobiotic stimulusPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
ventricular cardiac muscle cell action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane depolarization during action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarization during action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarization during cardiac muscle cell action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of heart rate by cardiac conductionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion export across plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarization during ventricular cardiac muscle cell action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
negative regulation of potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
positive regulation of potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
negative regulation of potassium ion export across plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion import across plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 3DHomo sapiens (human)
monoatomic ion transmembrane transport5-hydroxytryptamine receptor 3DHomo sapiens (human)
excitatory postsynaptic potential5-hydroxytryptamine receptor 3DHomo sapiens (human)
inorganic cation transmembrane transport5-hydroxytryptamine receptor 3DHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 3DHomo sapiens (human)
regulation of membrane potential5-hydroxytryptamine receptor 3DHomo sapiens (human)
organic cation transportMultidrug and toxin extrusion protein 2Homo sapiens (human)
transmembrane transportMultidrug and toxin extrusion protein 2Homo sapiens (human)
proton transmembrane transportMultidrug and toxin extrusion protein 2Homo sapiens (human)
xenobiotic detoxification by transmembrane export across the plasma membraneMultidrug and toxin extrusion protein 2Homo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 3CHomo sapiens (human)
monoatomic ion transmembrane transport5-hydroxytryptamine receptor 3CHomo sapiens (human)
excitatory postsynaptic potential5-hydroxytryptamine receptor 3CHomo sapiens (human)
inorganic cation transmembrane transport5-hydroxytryptamine receptor 3CHomo sapiens (human)
regulation of membrane potential5-hydroxytryptamine receptor 3CHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 3CHomo sapiens (human)
inositol phosphate metabolic processInositol hexakisphosphate kinase 1Homo sapiens (human)
phosphatidylinositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
negative regulation of cold-induced thermogenesisInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
organic cation transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
putrescine transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
xenobiotic transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
transmembrane transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
thiamine transmembrane transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
amino acid import across plasma membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
L-arginine import across plasma membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
L-alpha-amino acid transmembrane transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
proton transmembrane transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
L-arginine transmembrane transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
xenobiotic detoxification by transmembrane export across the plasma membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
neurotransmitter secretionHistamine H3 receptorHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayHistamine H3 receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerHistamine H3 receptorHomo sapiens (human)
chemical synaptic transmissionHistamine H3 receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayHistamine H3 receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (169)

Processvia Protein(s)Taxonomy
serotonin-gated monoatomic cation channel activity5-hydroxytryptamine receptor 3EHomo sapiens (human)
excitatory extracellular ligand-gated monoatomic ion channel activity5-hydroxytryptamine receptor 3EHomo sapiens (human)
transmitter-gated monoatomic ion channel activity involved in regulation of postsynaptic membrane potential5-hydroxytryptamine receptor 3EHomo sapiens (human)
amine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
acetylcholine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
neurotransmitter transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
monoamine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
organic anion transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
organic cation transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
prostaglandin transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
L-amino acid transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
pyrimidine nucleoside transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
choline transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
thiamine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
putrescine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
efflux transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
spermidine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
quaternary ammonium group transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
toxin transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
xenobiotic transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
L-arginine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
serotonin-gated monoatomic cation channel activity5-hydroxytryptamine receptor 3BHomo sapiens (human)
transmitter-gated monoatomic ion channel activity involved in regulation of postsynaptic membrane potential5-hydroxytryptamine receptor 3BHomo sapiens (human)
excitatory extracellular ligand-gated monoatomic ion channel activity5-hydroxytryptamine receptor 3BHomo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
cytokine activityInterferon betaHomo sapiens (human)
cytokine receptor bindingInterferon betaHomo sapiens (human)
type I interferon receptor bindingInterferon betaHomo sapiens (human)
protein bindingInterferon betaHomo sapiens (human)
chloramphenicol O-acetyltransferase activityInterferon betaHomo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
signaling receptor bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
peptide antigen bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein-folding chaperone bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
transcription cis-regulatory region bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
core promoter sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
TFIID-class transcription factor complex bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
protease bindingCellular tumor antigen p53Homo sapiens (human)
p53 bindingCellular tumor antigen p53Homo sapiens (human)
DNA bindingCellular tumor antigen p53Homo sapiens (human)
chromatin bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activityCellular tumor antigen p53Homo sapiens (human)
mRNA 3'-UTR bindingCellular tumor antigen p53Homo sapiens (human)
copper ion bindingCellular tumor antigen p53Homo sapiens (human)
protein bindingCellular tumor antigen p53Homo sapiens (human)
zinc ion bindingCellular tumor antigen p53Homo sapiens (human)
enzyme bindingCellular tumor antigen p53Homo sapiens (human)
receptor tyrosine kinase bindingCellular tumor antigen p53Homo sapiens (human)
ubiquitin protein ligase bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase regulator activityCellular tumor antigen p53Homo sapiens (human)
ATP-dependent DNA/DNA annealing activityCellular tumor antigen p53Homo sapiens (human)
identical protein bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase bindingCellular tumor antigen p53Homo sapiens (human)
protein heterodimerization activityCellular tumor antigen p53Homo sapiens (human)
protein-folding chaperone bindingCellular tumor antigen p53Homo sapiens (human)
protein phosphatase 2A bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II-specific DNA-binding transcription factor bindingCellular tumor antigen p53Homo sapiens (human)
14-3-3 protein bindingCellular tumor antigen p53Homo sapiens (human)
MDM2/MDM4 family protein bindingCellular tumor antigen p53Homo sapiens (human)
disordered domain specific bindingCellular tumor antigen p53Homo sapiens (human)
general transcription initiation factor bindingCellular tumor antigen p53Homo sapiens (human)
molecular function activator activityCellular tumor antigen p53Homo sapiens (human)
promoter-specific chromatin bindingCellular tumor antigen p53Homo sapiens (human)
protein bindingATP-dependent translocase ABCB1Homo sapiens (human)
ATP bindingATP-dependent translocase ABCB1Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
efflux transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
ATP hydrolysis activityATP-dependent translocase ABCB1Homo sapiens (human)
transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
ubiquitin protein ligase bindingATP-dependent translocase ABCB1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
carboxylic acid transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
phosphatidylcholine floppase activityATP-dependent translocase ABCB1Homo sapiens (human)
phosphatidylethanolamine flippase activityATP-dependent translocase ABCB1Homo sapiens (human)
ceramide floppase activityATP-dependent translocase ABCB1Homo sapiens (human)
floppase activityATP-dependent translocase ABCB1Homo sapiens (human)
monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
steroid bindingCytochrome P450 3A4Homo sapiens (human)
iron ion bindingCytochrome P450 3A4Homo sapiens (human)
protein bindingCytochrome P450 3A4Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
retinoic acid 4-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
oxidoreductase activityCytochrome P450 3A4Homo sapiens (human)
oxygen bindingCytochrome P450 3A4Homo sapiens (human)
enzyme bindingCytochrome P450 3A4Homo sapiens (human)
heme bindingCytochrome P450 3A4Homo sapiens (human)
vitamin D3 25-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
caffeine oxidase activityCytochrome P450 3A4Homo sapiens (human)
quinine 3-monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
testosterone 6-beta-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
1-alpha,25-dihydroxyvitamin D3 23-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 8,9 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 11,12 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 14,15 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
aromatase activityCytochrome P450 3A4Homo sapiens (human)
vitamin D 24-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
estrogen 16-alpha-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
estrogen 2-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
1,8-cineole 2-exo-monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 1AHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 1AHomo sapiens (human)
receptor-receptor interaction5-hydroxytryptamine receptor 1AHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 1AHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 1AHomo sapiens (human)
dopamine neurotransmitter receptor activity, coupled via Gi/GoD(2) dopamine receptorHomo sapiens (human)
G-protein alpha-subunit bindingD(2) dopamine receptorHomo sapiens (human)
protein bindingD(2) dopamine receptorHomo sapiens (human)
heterotrimeric G-protein bindingD(2) dopamine receptorHomo sapiens (human)
dopamine bindingD(2) dopamine receptorHomo sapiens (human)
ionotropic glutamate receptor bindingD(2) dopamine receptorHomo sapiens (human)
identical protein bindingD(2) dopamine receptorHomo sapiens (human)
heterocyclic compound bindingD(2) dopamine receptorHomo sapiens (human)
G protein-coupled receptor activityD(2) dopamine receptorHomo sapiens (human)
alpha2-adrenergic receptor activityAlpha-2C adrenergic receptorHomo sapiens (human)
protein bindingAlpha-2C adrenergic receptorHomo sapiens (human)
alpha-2A adrenergic receptor bindingAlpha-2C adrenergic receptorHomo sapiens (human)
protein homodimerization activityAlpha-2C adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-2C adrenergic receptorHomo sapiens (human)
epinephrine bindingAlpha-2C adrenergic receptorHomo sapiens (human)
guanyl-nucleotide exchange factor activityAlpha-2C adrenergic receptorHomo sapiens (human)
phosphatidylinositol phospholipase C activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
protein bindingMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
signaling receptor activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
acetylcholine bindingMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
dopamine neurotransmitter receptor activity, coupled via GsD(1A) dopamine receptorHomo sapiens (human)
G-protein alpha-subunit bindingD(1A) dopamine receptorHomo sapiens (human)
dopamine neurotransmitter receptor activityD(1A) dopamine receptorHomo sapiens (human)
protein bindingD(1A) dopamine receptorHomo sapiens (human)
heterotrimeric G-protein bindingD(1A) dopamine receptorHomo sapiens (human)
dopamine bindingD(1A) dopamine receptorHomo sapiens (human)
arrestin family protein bindingD(1A) dopamine receptorHomo sapiens (human)
G protein-coupled receptor activityD(1A) dopamine receptorHomo sapiens (human)
dopamine neurotransmitter receptor activity, coupled via Gi/GoD(4) dopamine receptorHomo sapiens (human)
dopamine neurotransmitter receptor activityD(4) dopamine receptorHomo sapiens (human)
protein bindingD(4) dopamine receptorHomo sapiens (human)
potassium channel regulator activityD(4) dopamine receptorHomo sapiens (human)
SH3 domain bindingD(4) dopamine receptorHomo sapiens (human)
dopamine bindingD(4) dopamine receptorHomo sapiens (human)
identical protein bindingD(4) dopamine receptorHomo sapiens (human)
metal ion bindingD(4) dopamine receptorHomo sapiens (human)
epinephrine bindingD(4) dopamine receptorHomo sapiens (human)
norepinephrine bindingD(4) dopamine receptorHomo sapiens (human)
G protein-coupled serotonin receptor activityD(4) dopamine receptorHomo sapiens (human)
neurotransmitter receptor activityD(4) dopamine receptorHomo sapiens (human)
serotonin bindingD(4) dopamine receptorHomo sapiens (human)
dopamine neurotransmitter receptor activity, coupled via GsD(1B) dopamine receptorHomo sapiens (human)
dopamine neurotransmitter receptor activityD(1B) dopamine receptorHomo sapiens (human)
protein bindingD(1B) dopamine receptorHomo sapiens (human)
dopamine bindingD(1B) dopamine receptorHomo sapiens (human)
G protein-coupled receptor activityD(1B) dopamine receptorHomo sapiens (human)
protein bindingAlpha-1D adrenergic receptorHomo sapiens (human)
identical protein bindingAlpha-1D adrenergic receptorHomo sapiens (human)
alpha1-adrenergic receptor activityAlpha-1D adrenergic receptorHomo sapiens (human)
Gq/11-coupled serotonin receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
virus receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein tyrosine kinase activator activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
identical protein binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein-containing complex binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
1-(4-iodo-2,5-dimethoxyphenyl)propan-2-amine binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
Gq/11-coupled serotonin receptor activity5-hydroxytryptamine receptor 2CHomo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 2CHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 2CHomo sapiens (human)
identical protein binding5-hydroxytryptamine receptor 2CHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 2CHomo sapiens (human)
1-(4-iodo-2,5-dimethoxyphenyl)propan-2-amine binding5-hydroxytryptamine receptor 2CHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 2CHomo sapiens (human)
integrin bindingSodium-dependent serotonin transporterHomo sapiens (human)
monoatomic cation channel activitySodium-dependent serotonin transporterHomo sapiens (human)
neurotransmitter transmembrane transporter activitySodium-dependent serotonin transporterHomo sapiens (human)
serotonin:sodium:chloride symporter activitySodium-dependent serotonin transporterHomo sapiens (human)
protein bindingSodium-dependent serotonin transporterHomo sapiens (human)
monoamine transmembrane transporter activitySodium-dependent serotonin transporterHomo sapiens (human)
antiporter activitySodium-dependent serotonin transporterHomo sapiens (human)
syntaxin-1 bindingSodium-dependent serotonin transporterHomo sapiens (human)
cocaine bindingSodium-dependent serotonin transporterHomo sapiens (human)
sodium ion bindingSodium-dependent serotonin transporterHomo sapiens (human)
identical protein bindingSodium-dependent serotonin transporterHomo sapiens (human)
nitric-oxide synthase bindingSodium-dependent serotonin transporterHomo sapiens (human)
actin filament bindingSodium-dependent serotonin transporterHomo sapiens (human)
serotonin bindingSodium-dependent serotonin transporterHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 7Homo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 7Homo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 7Homo sapiens (human)
alpha1-adrenergic receptor activityAlpha-1A adrenergic receptorHomo sapiens (human)
protein bindingAlpha-1A adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-1A adrenergic receptorHomo sapiens (human)
histamine receptor activityHistamine H1 receptorHomo sapiens (human)
G protein-coupled serotonin receptor activityHistamine H1 receptorHomo sapiens (human)
neurotransmitter receptor activityHistamine H1 receptorHomo sapiens (human)
protein bindingAlpha-1B adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-1B adrenergic receptorHomo sapiens (human)
alpha1-adrenergic receptor activityAlpha-1B adrenergic receptorHomo sapiens (human)
dopamine neurotransmitter receptor activity, coupled via Gi/GoD(3) dopamine receptorHomo sapiens (human)
protein bindingD(3) dopamine receptorHomo sapiens (human)
G protein-coupled receptor activityD(3) dopamine receptorHomo sapiens (human)
Gq/11-coupled serotonin receptor activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
G-protein alpha-subunit binding5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
GTPase activator activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 2BHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 2BHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 3AHomo sapiens (human)
serotonin-gated monoatomic cation channel activity5-hydroxytryptamine receptor 3AHomo sapiens (human)
identical protein binding5-hydroxytryptamine receptor 3AHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 3AHomo sapiens (human)
ligand-gated monoatomic ion channel activity involved in regulation of presynaptic membrane potential5-hydroxytryptamine receptor 3AHomo sapiens (human)
transmitter-gated monoatomic ion channel activity involved in regulation of postsynaptic membrane potential5-hydroxytryptamine receptor 3AHomo sapiens (human)
excitatory extracellular ligand-gated monoatomic ion channel activity5-hydroxytryptamine receptor 3AHomo sapiens (human)
histamine receptor activity5-hydroxytryptamine receptor 6Homo sapiens (human)
protein binding5-hydroxytryptamine receptor 6Homo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 6Homo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 6Homo sapiens (human)
transcription cis-regulatory region bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
inward rectifier potassium channel activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
delayed rectifier potassium channel activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
protein bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
ubiquitin protein ligase bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
identical protein bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
protein homodimerization activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
C3HC4-type RING finger domain bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel activity involved in cardiac muscle cell action potential repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
scaffold protein bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel activity involved in ventricular cardiac muscle cell action potential repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
protein binding5-hydroxytryptamine receptor 3DHomo sapiens (human)
serotonin-gated monoatomic cation channel activity5-hydroxytryptamine receptor 3DHomo sapiens (human)
excitatory extracellular ligand-gated monoatomic ion channel activity5-hydroxytryptamine receptor 3DHomo sapiens (human)
transmitter-gated monoatomic ion channel activity involved in regulation of postsynaptic membrane potential5-hydroxytryptamine receptor 3DHomo sapiens (human)
organic cation transmembrane transporter activityMultidrug and toxin extrusion protein 2Homo sapiens (human)
antiporter activityMultidrug and toxin extrusion protein 2Homo sapiens (human)
transmembrane transporter activityMultidrug and toxin extrusion protein 2Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug and toxin extrusion protein 2Homo sapiens (human)
polyspecific organic cation:proton antiporter activityMultidrug and toxin extrusion protein 2Homo sapiens (human)
protein binding5-hydroxytryptamine receptor 3CHomo sapiens (human)
serotonin-gated monoatomic cation channel activity5-hydroxytryptamine receptor 3CHomo sapiens (human)
excitatory extracellular ligand-gated monoatomic ion channel activity5-hydroxytryptamine receptor 3CHomo sapiens (human)
transmitter-gated monoatomic ion channel activity involved in regulation of postsynaptic membrane potential5-hydroxytryptamine receptor 3CHomo sapiens (human)
inositol-1,3,4,5,6-pentakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol heptakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
protein bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
ATP bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 1-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 3-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol 5-diphosphate pentakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol diphosphate tetrakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
protein bindingMultidrug and toxin extrusion protein 1Homo sapiens (human)
organic cation transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
L-amino acid transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
thiamine transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
antiporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
putrescine transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
L-arginine transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
polyspecific organic cation:proton antiporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
histamine receptor activityHistamine H3 receptorHomo sapiens (human)
G protein-coupled acetylcholine receptor activityHistamine H3 receptorHomo sapiens (human)
G protein-coupled serotonin receptor activityHistamine H3 receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (92)

Processvia Protein(s)Taxonomy
plasma membrane5-hydroxytryptamine receptor 3EHomo sapiens (human)
postsynaptic membrane5-hydroxytryptamine receptor 3EHomo sapiens (human)
serotonin-activated cation-selective channel complex5-hydroxytryptamine receptor 3EHomo sapiens (human)
neuron projection5-hydroxytryptamine receptor 3EHomo sapiens (human)
transmembrane transporter complex5-hydroxytryptamine receptor 3EHomo sapiens (human)
synapse5-hydroxytryptamine receptor 3EHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3EHomo sapiens (human)
plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
basal plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
membraneSolute carrier family 22 member 2Homo sapiens (human)
basolateral plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
apical plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
extracellular exosomeSolute carrier family 22 member 2Homo sapiens (human)
presynapseSolute carrier family 22 member 2Homo sapiens (human)
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3BHomo sapiens (human)
postsynaptic membrane5-hydroxytryptamine receptor 3BHomo sapiens (human)
serotonin-activated cation-selective channel complex5-hydroxytryptamine receptor 3BHomo sapiens (human)
cell surface5-hydroxytryptamine receptor 3BHomo sapiens (human)
transmembrane transporter complex5-hydroxytryptamine receptor 3BHomo sapiens (human)
synapse5-hydroxytryptamine receptor 3BHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3BHomo sapiens (human)
neuron projection5-hydroxytryptamine receptor 3BHomo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
Golgi membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
endoplasmic reticulumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
Golgi apparatusHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
cell surfaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
ER to Golgi transport vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
secretory granule membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
phagocytic vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
early endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
recycling endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular exosomeHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
lumenal side of endoplasmic reticulum membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
MHC class I protein complexHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular spaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
external side of plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
nuclear bodyCellular tumor antigen p53Homo sapiens (human)
nucleusCellular tumor antigen p53Homo sapiens (human)
nucleoplasmCellular tumor antigen p53Homo sapiens (human)
replication forkCellular tumor antigen p53Homo sapiens (human)
nucleolusCellular tumor antigen p53Homo sapiens (human)
cytoplasmCellular tumor antigen p53Homo sapiens (human)
mitochondrionCellular tumor antigen p53Homo sapiens (human)
mitochondrial matrixCellular tumor antigen p53Homo sapiens (human)
endoplasmic reticulumCellular tumor antigen p53Homo sapiens (human)
centrosomeCellular tumor antigen p53Homo sapiens (human)
cytosolCellular tumor antigen p53Homo sapiens (human)
nuclear matrixCellular tumor antigen p53Homo sapiens (human)
PML bodyCellular tumor antigen p53Homo sapiens (human)
transcription repressor complexCellular tumor antigen p53Homo sapiens (human)
site of double-strand breakCellular tumor antigen p53Homo sapiens (human)
germ cell nucleusCellular tumor antigen p53Homo sapiens (human)
chromatinCellular tumor antigen p53Homo sapiens (human)
transcription regulator complexCellular tumor antigen p53Homo sapiens (human)
protein-containing complexCellular tumor antigen p53Homo sapiens (human)
cytoplasmATP-dependent translocase ABCB1Homo sapiens (human)
plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
cell surfaceATP-dependent translocase ABCB1Homo sapiens (human)
membraneATP-dependent translocase ABCB1Homo sapiens (human)
apical plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
extracellular exosomeATP-dependent translocase ABCB1Homo sapiens (human)
external side of apical plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
cytoplasmCytochrome P450 3A4Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 3A4Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 3A4Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 1AHomo sapiens (human)
synapse5-hydroxytryptamine receptor 1AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 1AHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 1AHomo sapiens (human)
Golgi membraneD(2) dopamine receptorHomo sapiens (human)
acrosomal vesicleD(2) dopamine receptorHomo sapiens (human)
plasma membraneD(2) dopamine receptorHomo sapiens (human)
ciliumD(2) dopamine receptorHomo sapiens (human)
lateral plasma membraneD(2) dopamine receptorHomo sapiens (human)
endocytic vesicleD(2) dopamine receptorHomo sapiens (human)
axonD(2) dopamine receptorHomo sapiens (human)
dendriteD(2) dopamine receptorHomo sapiens (human)
synaptic vesicle membraneD(2) dopamine receptorHomo sapiens (human)
sperm flagellumD(2) dopamine receptorHomo sapiens (human)
dendritic spineD(2) dopamine receptorHomo sapiens (human)
perikaryonD(2) dopamine receptorHomo sapiens (human)
axon terminusD(2) dopamine receptorHomo sapiens (human)
postsynaptic membraneD(2) dopamine receptorHomo sapiens (human)
ciliary membraneD(2) dopamine receptorHomo sapiens (human)
non-motile ciliumD(2) dopamine receptorHomo sapiens (human)
dopaminergic synapseD(2) dopamine receptorHomo sapiens (human)
GABA-ergic synapseD(2) dopamine receptorHomo sapiens (human)
G protein-coupled receptor complexD(2) dopamine receptorHomo sapiens (human)
glutamatergic synapseD(2) dopamine receptorHomo sapiens (human)
presynaptic membraneD(2) dopamine receptorHomo sapiens (human)
plasma membraneD(2) dopamine receptorHomo sapiens (human)
cytoplasmAlpha-2C adrenergic receptorHomo sapiens (human)
endosomeAlpha-2C adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2C adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2C adrenergic receptorHomo sapiens (human)
plasma membraneGlutamate receptor 2Rattus norvegicus (Norway rat)
endoplasmic reticulum membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
basal plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
basolateral plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
postsynaptic membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M3Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M3Homo sapiens (human)
nucleusD(1A) dopamine receptorHomo sapiens (human)
endoplasmic reticulum membraneD(1A) dopamine receptorHomo sapiens (human)
plasma membraneD(1A) dopamine receptorHomo sapiens (human)
ciliumD(1A) dopamine receptorHomo sapiens (human)
presynaptic membraneD(1A) dopamine receptorHomo sapiens (human)
dendritic spineD(1A) dopamine receptorHomo sapiens (human)
postsynaptic membraneD(1A) dopamine receptorHomo sapiens (human)
ciliary membraneD(1A) dopamine receptorHomo sapiens (human)
non-motile ciliumD(1A) dopamine receptorHomo sapiens (human)
glutamatergic synapseD(1A) dopamine receptorHomo sapiens (human)
GABA-ergic synapseD(1A) dopamine receptorHomo sapiens (human)
G protein-coupled receptor complexD(1A) dopamine receptorHomo sapiens (human)
plasma membraneD(1A) dopamine receptorHomo sapiens (human)
centrosomeD(4) dopamine receptorHomo sapiens (human)
plasma membraneD(4) dopamine receptorHomo sapiens (human)
membraneD(4) dopamine receptorHomo sapiens (human)
postsynapseD(4) dopamine receptorHomo sapiens (human)
glutamatergic synapseD(4) dopamine receptorHomo sapiens (human)
plasma membraneD(4) dopamine receptorHomo sapiens (human)
dendriteD(4) dopamine receptorHomo sapiens (human)
plasma membraneD(1B) dopamine receptorHomo sapiens (human)
ciliumD(1B) dopamine receptorHomo sapiens (human)
brush border membraneD(1B) dopamine receptorHomo sapiens (human)
synapseD(1B) dopamine receptorHomo sapiens (human)
ciliary membraneD(1B) dopamine receptorHomo sapiens (human)
non-motile ciliumD(1B) dopamine receptorHomo sapiens (human)
plasma membraneD(1B) dopamine receptorHomo sapiens (human)
plasma membraneAlpha-1D adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1D adrenergic receptorHomo sapiens (human)
neurofilament5-hydroxytryptamine receptor 2AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
caveola5-hydroxytryptamine receptor 2AHomo sapiens (human)
axon5-hydroxytryptamine receptor 2AHomo sapiens (human)
cytoplasmic vesicle5-hydroxytryptamine receptor 2AHomo sapiens (human)
presynaptic membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
neuronal cell body5-hydroxytryptamine receptor 2AHomo sapiens (human)
dendritic shaft5-hydroxytryptamine receptor 2AHomo sapiens (human)
postsynaptic membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
cell body fiber5-hydroxytryptamine receptor 2AHomo sapiens (human)
glutamatergic synapse5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled serotonin receptor complex5-hydroxytryptamine receptor 2AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 2AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2CHomo sapiens (human)
synapse5-hydroxytryptamine receptor 2CHomo sapiens (human)
G protein-coupled serotonin receptor complex5-hydroxytryptamine receptor 2CHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2CHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 2CHomo sapiens (human)
plasma membraneSodium-dependent serotonin transporterHomo sapiens (human)
focal adhesionSodium-dependent serotonin transporterHomo sapiens (human)
endosome membraneSodium-dependent serotonin transporterHomo sapiens (human)
endomembrane systemSodium-dependent serotonin transporterHomo sapiens (human)
presynaptic membraneSodium-dependent serotonin transporterHomo sapiens (human)
membrane raftSodium-dependent serotonin transporterHomo sapiens (human)
synapseSodium-dependent serotonin transporterHomo sapiens (human)
postsynaptic membraneSodium-dependent serotonin transporterHomo sapiens (human)
serotonergic synapseSodium-dependent serotonin transporterHomo sapiens (human)
synapseSodium-dependent serotonin transporterHomo sapiens (human)
plasma membraneSodium-dependent serotonin transporterHomo sapiens (human)
neuron projectionSodium-dependent serotonin transporterHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 7Homo sapiens (human)
trans-Golgi network membrane5-hydroxytryptamine receptor 7Homo sapiens (human)
synapse5-hydroxytryptamine receptor 7Homo sapiens (human)
dendrite5-hydroxytryptamine receptor 7Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 7Homo sapiens (human)
nucleusAlpha-1A adrenergic receptorHomo sapiens (human)
nucleoplasmAlpha-1A adrenergic receptorHomo sapiens (human)
cytoplasmAlpha-1A adrenergic receptorHomo sapiens (human)
cytosolAlpha-1A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1A adrenergic receptorHomo sapiens (human)
caveolaAlpha-1A adrenergic receptorHomo sapiens (human)
nuclear membraneAlpha-1A adrenergic receptorHomo sapiens (human)
intracellular membrane-bounded organelleAlpha-1A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1A adrenergic receptorHomo sapiens (human)
cytosolHistamine H1 receptorHomo sapiens (human)
plasma membraneHistamine H1 receptorHomo sapiens (human)
synapseHistamine H1 receptorHomo sapiens (human)
dendriteHistamine H1 receptorHomo sapiens (human)
plasma membraneHistamine H1 receptorHomo sapiens (human)
nucleusAlpha-1B adrenergic receptorHomo sapiens (human)
cytoplasmAlpha-1B adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1B adrenergic receptorHomo sapiens (human)
caveolaAlpha-1B adrenergic receptorHomo sapiens (human)
nuclear membraneAlpha-1B adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1B adrenergic receptorHomo sapiens (human)
plasma membraneD(3) dopamine receptorHomo sapiens (human)
synapseD(3) dopamine receptorHomo sapiens (human)
plasma membraneD(3) dopamine receptorHomo sapiens (human)
nucleoplasm5-hydroxytryptamine receptor 2BHomo sapiens (human)
cytoplasm5-hydroxytryptamine receptor 2BHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2BHomo sapiens (human)
synapse5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled serotonin receptor complex5-hydroxytryptamine receptor 2BHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 2BHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2BHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3AHomo sapiens (human)
cleavage furrow5-hydroxytryptamine receptor 3AHomo sapiens (human)
postsynaptic membrane5-hydroxytryptamine receptor 3AHomo sapiens (human)
serotonin-activated cation-selective channel complex5-hydroxytryptamine receptor 3AHomo sapiens (human)
synapse5-hydroxytryptamine receptor 3AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3AHomo sapiens (human)
transmembrane transporter complex5-hydroxytryptamine receptor 3AHomo sapiens (human)
neuron projection5-hydroxytryptamine receptor 3AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 6Homo sapiens (human)
cilium5-hydroxytryptamine receptor 6Homo sapiens (human)
synapse5-hydroxytryptamine receptor 6Homo sapiens (human)
dendrite5-hydroxytryptamine receptor 6Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 6Homo sapiens (human)
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
cell surfacePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
perinuclear region of cytoplasmPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel complexPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
inward rectifier potassium channel complexPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3DHomo sapiens (human)
postsynaptic membrane5-hydroxytryptamine receptor 3DHomo sapiens (human)
serotonin-activated cation-selective channel complex5-hydroxytryptamine receptor 3DHomo sapiens (human)
synapse5-hydroxytryptamine receptor 3DHomo sapiens (human)
transmembrane transporter complex5-hydroxytryptamine receptor 3DHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3DHomo sapiens (human)
neuron projection5-hydroxytryptamine receptor 3DHomo sapiens (human)
plasma membraneMultidrug and toxin extrusion protein 2Homo sapiens (human)
apical plasma membraneMultidrug and toxin extrusion protein 2Homo sapiens (human)
membraneMultidrug and toxin extrusion protein 2Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3CHomo sapiens (human)
postsynaptic membrane5-hydroxytryptamine receptor 3CHomo sapiens (human)
serotonin-activated cation-selective channel complex5-hydroxytryptamine receptor 3CHomo sapiens (human)
synapse5-hydroxytryptamine receptor 3CHomo sapiens (human)
transmembrane transporter complex5-hydroxytryptamine receptor 3CHomo sapiens (human)
neuron projection5-hydroxytryptamine receptor 3CHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3CHomo sapiens (human)
fibrillar centerInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
cytosolInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleusInositol hexakisphosphate kinase 1Homo sapiens (human)
cytoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
plasma membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
basolateral plasma membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
apical plasma membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
plasma membraneHistamine H3 receptorHomo sapiens (human)
presynapseHistamine H3 receptorHomo sapiens (human)
plasma membraneHistamine H3 receptorHomo sapiens (human)
synapseHistamine H3 receptorHomo sapiens (human)
dendriteHistamine H3 receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (604)

Assay IDTitleYearJournalArticle
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID1704723Displacement of [3H]lysergic acid diethylamide from human recombinant 5HT6 receptor stably expressed in CHO cell membranes measured after 30 mins by liquid scintillation counting method
AID458652Reduction in amphetamine-induced locomotor activity in Sprague-Dawley rat striatum at 7.68 umol/kg, sc relative to control2010Journal of medicinal chemistry, Mar-25, Volume: 53, Issue:6
Synthesis and evaluation of a set of 4-phenylpiperidines and 4-phenylpiperazines as D2 receptor ligands and the discovery of the dopaminergic stabilizer 4-[3-(methylsulfonyl)phenyl]-1-propylpiperidine (huntexil, pridopidine, ACR16).
AID1220560Fraction unbound in human occipital cortex at 1 uM after 6 hrs by equilibrium dialysis method2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Species independence in brain tissue binding using brain homogenates.
AID1442607Antagonist activity at ARMS2-PK2 tagged D2S receptor (unknown origin) expressed in HEK293 cells assessed as inhibition of quinpirole-induced EA-tagged beta-arrestin-2 recruitment at 10 uM incubated for 5 hrs measured after 60 mins by PathHunter assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1458650Antagonist activity at human recombinant D2S receptor expressed in HEK-293 cells assessed as inhibition of dopamine-induced response at 1 x 10'-6 M by cellular dielectric spectroscopy2017Journal of medicinal chemistry, 09-14, Volume: 60, Issue:17
Novel 3-(1,2,3,6-Tetrahydropyridin-4-yl)-1H-indole-Based Multifunctional Ligands with Antipsychotic-Like, Mood-Modulating, and Procognitive Activity.
AID1865875Displacement of [3H]-ketanserin from human 5-HT2A receptor incubated for 1 hr by liquid scintillation counting method
AID610678Displacement of [125I]ABN from human recombinant D2L receptor expressed in HEK cells after 60 mins by gamma counter2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
Synthesis and characterization of selective dopamine D₂ receptor ligands using aripiprazole as the lead compound.
AID457688Displacement of [3H]-8-OH-DPAT from 5HT1A receptor in Wistar rat hippocampus homogenate2010Bioorganic & medicinal chemistry, Mar-01, Volume: 18, Issue:5
Searching for multi-target antipsychotics: Discovery of orally active heterocyclic N-phenylpiperazine ligands of D2-like and 5-HT1A receptors.
AID1152660Antipsychotic-like activity in po dosed Wistar rat assessed as inhibition of DOI-induced head twitches measured after 60 mins2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Novel arylsulfonamide derivatives with 5-HT₆/5-HT₇ receptor antagonism targeting behavioral and psychological symptoms of dementia.
AID1442604Effect on basal anxiety level in Sprague-Dawley rat at 1.5 mg//day for 7 days administered via osmotic Alzet mini pump measured 20 mins post dose by open field test2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1889691Displacement of [3H]-5-CT from human 5-HT7b receptor expressed in HEK293 cells measured after 1 hr by Microbeta plate reader method2022European journal of medicinal chemistry, Mar-15, Volume: 232Novel D
AID1153300Displacement of [3H]-ketanserin from human 5HT2A receptor expressed in HEK293 cells by competitive binding assay2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Functionally selective dopamine D₂, D₃ receptor partial agonists.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID516816Antipsychotic activity in po dosed mouse assessed as inhibition of spontaneous locomotor activity2010Bioorganic & medicinal chemistry letters, Oct-01, Volume: 20, Issue:19
6-Alkoxyisoindolin-1-one based dopamine D2 partial agonists as potential antipsychotics.
AID1693542Displacement of [3H]-8-OH-DPAT from human 5HT1A receptor by liquid scintillation counting2021Bioorganic & medicinal chemistry, 01-15, Volume: 30A study of the structure-affinity relationship in SYA16263; is a D
AID595495Displacement of [3H]Spiperone from human dopamine D2L receptor expressed in CHO cells2011Bioorganic & medicinal chemistry letters, May-01, Volume: 21, Issue:9
Discovery of PF-00217830: aryl piperazine napthyridinones as D2 partial agonists for schizophrenia and bipolar disorder.
AID595494Intrinsic activity at human dopamine D2 receptor expressed in CHO cells by [3H]-thymidine uptake assay relative to quinpirole2011Bioorganic & medicinal chemistry letters, May-01, Volume: 21, Issue:9
Discovery of PF-00217830: aryl piperazine napthyridinones as D2 partial agonists for schizophrenia and bipolar disorder.
AID1309137Displacement of [3H]Pyrilamine from human H1 receptor expressed in cell membranes after 1 hr by liquid scintillation counting2016Bioorganic & medicinal chemistry, 08-15, Volume: 24, Issue:16
Design and synthesis of dual 5-HT1A and 5-HT7 receptor ligands.
AID1782424Displacement of [3H]-SCH23390 from D1 receptor (unknown origin) expressed in HEK293T cell membranes measured after 2 hrs by microbeta scintillation counting method2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
2-Phenylcyclopropylmethylamine Derivatives as Dopamine D
AID6677Binding affinity towards human 5-hydroxytryptamine 7 receptor2003Journal of medicinal chemistry, Jul-03, Volume: 46, Issue:14
Higher-end serotonin receptors: 5-HT(5), 5-HT(6), and 5-HT(7).
AID492646Antipsychotic activity in NMRI mouse assessed as increase of PCP-induced locomotor activity at 3 mg/kg, ip administered 30 mins prior to testing measured for 60 mins2010Journal of medicinal chemistry, Jun-24, Volume: 53, Issue:12
Discovery of bishomo(hetero)arylpiperazines as novel multifunctional ligands targeting dopamine D(3) and serotonin 5-HT(1A) and 5-HT(2A) receptors.
AID1703846Antipsychotic activity in ICR mouse assessed as reduction of PCP induced hyperactivity at 3 mg/kg, ig pretreated with compound for 30 mins followed by PCP challenge for 10 mins and measured after 60 mins2020European journal of medicinal chemistry, Oct-15, Volume: 204Automated design and optimization of multitarget schizophrenia drug candidates by deep learning.
AID330561Displacement of [3H]mepyramine from H1R in rat brain2007Proceedings of the National Academy of Sciences of the United States of America, Feb-27, Volume: 104, Issue:9
From the Cover: Antipsychotic drug-induced weight gain mediated by histamine H1 receptor-linked activation of hypothalamic AMP-kinase.
AID1782419Displacement of [3H]-N-methylspiperone from D2 receptor (unknown origin) expressed in HEK293T cell membranes measured after 2 hrs by microbeta scintillation counting method2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
2-Phenylcyclopropylmethylamine Derivatives as Dopamine D
AID1283242Decrease in lanosterol levels in mouse Neuro2a cells by LC-MS analysis2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID595520Ratio of MED for catalepsy induction to in mouse to MED for inhibition of spontaneous locomotor activity in mouse2011Bioorganic & medicinal chemistry letters, May-01, Volume: 21, Issue:9
Discovery of PF-00217830: aryl piperazine napthyridinones as D2 partial agonists for schizophrenia and bipolar disorder.
AID457689Displacement of [3H]ketanserin from 5HT2A receptor in Wistar rat cortex homogenate2010Bioorganic & medicinal chemistry, Mar-01, Volume: 18, Issue:5
Searching for multi-target antipsychotics: Discovery of orally active heterocyclic N-phenylpiperazine ligands of D2-like and 5-HT1A receptors.
AID1517959Displacement of [3H]-Ketanserin from human 5-HT2A receptor expressed in rat cortex tissue incubated for 30 mins by liquid scintillation counting method
AID113543Induction of catalepsy in mice1998Journal of medicinal chemistry, Feb-26, Volume: 41, Issue:5
Novel antipsychotic agents with dopamine autoreceptor agonist properties: synthesis and pharmacology of 7-[4-(4-phenyl-1-piperazinyl)butoxy]-3,4-dihydro-2(1H)-quinolinone derivatives.
AID1762063Inhibition of human ERG by automated patch method relative to control2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1782438Metabolic stability in mouse liver microsomes assessed as half life preincubated for 5 mins followed by NADPH addition measured after 10 mins by LC-MS analysis2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
2-Phenylcyclopropylmethylamine Derivatives as Dopamine D
AID458647Reduction in spontaneous locomotor activity in Sprague-Dawley rat striatum at 7.68 umol/kg, sc relative to control2010Journal of medicinal chemistry, Mar-25, Volume: 53, Issue:6
Synthesis and evaluation of a set of 4-phenylpiperidines and 4-phenylpiperazines as D2 receptor ligands and the discovery of the dopaminergic stabilizer 4-[3-(methylsulfonyl)phenyl]-1-propylpiperidine (huntexil, pridopidine, ACR16).
AID1704749Antipsychotic activity in Kunming mouse assessed as inhibition of DOI-induced head twitch administered orally 60 mins prior to DOI challenge incubated for 5 mins and measured for 15 mins
AID516826Ex vivo D2 receptor occupancy in po dosed rat striatum assessed as inhibition [3H]-raclopride binding at 158 ng/ml plasma concentration2010Bioorganic & medicinal chemistry letters, Oct-01, Volume: 20, Issue:19
6-Alkoxyisoindolin-1-one based dopamine D2 partial agonists as potential antipsychotics.
AID1474756Agonist activity at D2 long receptor (unknown origin) expressed in Flp-In-CHO cells co-expressing Rluc8-tagged GalphaoB assessed as change in transduction coefficient by measuring GalphaoB activation in presence of coelenterazine by BRET assay2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
Pharmacological property optimization for allosteric ligands: A medicinal chemistry perspective.
AID1374517Intrinsic clearance in mouse liver microsomes at 50 uM preincubated for 5 mins followed by NADPH addition measured up to 30 mins2018Bioorganic & medicinal chemistry letters, 03-01, Volume: 28, Issue:5
MF-8, a novel promising arylpiperazine-hydantoin based 5-HT
AID1762054Binding affinity to dopamine D2 receptor (unknown origin)2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID234393ratio between ED50 values of DA receptor antagonist activity and catalepsy.1998Journal of medicinal chemistry, Feb-26, Volume: 41, Issue:5
Novel antipsychotic agents with dopamine autoreceptor agonist properties: synthesis and pharmacology of 7-[4-(4-phenyl-1-piperazinyl)butoxy]-3,4-dihydro-2(1H)-quinolinone derivatives.
AID1157846Intrinsic activity at human D2L receptor expressed in FlpIn CHO cells assessed as inhibition of forskolin-stimulated cAMP production treated for 30 mins by AlphaScreen assay relative to control2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Structure-activity relationships of privileged structures lead to the discovery of novel biased ligands at the dopamine D₂ receptor.
AID1690414Induction of memory deficit in CD-1 mouse assessed as effect on latency to enter dark compartment at 0.3125 to 2.5 mg/kg, ip administered 30 mins prior to acquisition trial by step-through passive avoidance test2020European journal of medicinal chemistry, Apr-01, Volume: 191Multifunctional 6-fluoro-3-[3-(pyrrolidin-1-yl)propyl]-1,2-benzoxazoles targeting behavioral and psychological symptoms of dementia (BPSD).
AID1448009Partial agonist activity at human D2SR expressed in HEK293T cells co-expressing (EA)beta-arrestin2 and GRK2 assessed as induction of beta-arrestin2 recruitment after 5 hrs by chemiluminescence assay relative to quinpirole2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID113715Inhibition of the GBL-induced increase in DOPA accumulation in mice(DA auto receptor agonist activity)1998Journal of medicinal chemistry, Feb-26, Volume: 41, Issue:5
Novel antipsychotic agents with dopamine autoreceptor agonist properties: synthesis and pharmacology of 7-[4-(4-phenyl-1-piperazinyl)butoxy]-3,4-dihydro-2(1H)-quinolinone derivatives.
AID1301283Antagonistic activity at human 5-HT2A receptor assessed as calcium flux after 10 mins by FLIPR assay2016Bioorganic & medicinal chemistry letters, 07-01, Volume: 26, Issue:13
Synthesis, structure-activity relationships, and biological evaluation of a series of benzamides as potential multireceptor antipsychotics.
AID1153295Displacement of [3H]Spiperone from human dopamine D2 long receptor expressed in CHO cells by competitive binding assay2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Functionally selective dopamine D₂, D₃ receptor partial agonists.
AID1442585Agonist activity at ARMS2-PK2 tagged D2S receptor (unknown origin) expressed in HEK293 cells assessed as induction of EA-tagged beta-arrestin-2 recruitment incubated for 5 hrs measured after 60 mins by PathHunter assay relative to quinpirole2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1210213Total drug level in mdr1a-deficient mouse brain at 3 mg/kg/day administered through continuous minipump treatment for 3 days by UPLC-MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID1373833Antagonistic activity at human 5-HT2A receptor assessed as calcium flux after 10 mins by FLIPR assay2018Bioorganic & medicinal chemistry letters, 02-15, Volume: 28, Issue:4
Synthesis and biological evaluation of a series of novel pyridinecarboxamides as potential multi-receptor antipsychotic drugs.
AID458630Reduction in 3,4-dihydroxyphenylacetic acid level in Sprague-Dawley rat striatum at 7.68 umol/kg, sc relative to saline treated control2010Journal of medicinal chemistry, Mar-25, Volume: 53, Issue:6
Synthesis and evaluation of a set of 4-phenylpiperidines and 4-phenylpiperazines as D2 receptor ligands and the discovery of the dopaminergic stabilizer 4-[3-(methylsulfonyl)phenyl]-1-propylpiperidine (huntexil, pridopidine, ACR16).
AID599883Displacement of [3H]mesulergine from human 5HT2C receptor in human tsA201 cells2010Bioorganic & medicinal chemistry letters, Sep-15, Volume: 20, Issue:18
Novel 7-phenylsulfanyl-1,2,3,4,10,10a-hexahydro-pyrazino[1,2-a]indoles as dual serotonin 5-HT2C and 5-HT6 receptor ligands.
AID298486Displacement of [3H]LSD from human 5HT6 receptor expressed in HEK293 cells2007Journal of medicinal chemistry, Oct-18, Volume: 50, Issue:21
Principal component analysis differentiates the receptor binding profiles of three antipsychotic drug candidates from current antipsychotic drugs.
AID610683Displacement of [3H](+)-pentazocine from guinea pig brain sigma-1 receptor after 90 mins by liquid scintillation counter2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
Synthesis and characterization of selective dopamine D₂ receptor ligands using aripiprazole as the lead compound.
AID539464Solubility of the compound in 0.1 M phosphate buffer at 600 uM at pH 7.4 after 24 hrs by LC/MS/MS analysis2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Experimental solubility profiling of marketed CNS drugs, exploring solubility limit of CNS discovery candidate.
AID1301296Partial agonist activity at human dopamine D2 receptor assessed as intrinsic activity2016Bioorganic & medicinal chemistry letters, 07-01, Volume: 26, Issue:13
Synthesis, structure-activity relationships, and biological evaluation of a series of benzamides as potential multireceptor antipsychotics.
AID1283241Decrease in desmosterol levels in mouse Neuro2a cells by LC-MS analysis2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID1464181Displacement of [3H]WAY100635 from 5-HT1AR in porcine cerebral cortex homogenates2017Bioorganic & medicinal chemistry, 10-15, Volume: 25, Issue:20
β-Arrestin biased dopamine D2 receptor partial agonists: Synthesis and pharmacological evaluation.
AID301041Antipsychotic activity in orally dosed Wistar rat assessed as inhibition of conditioned avoidance response after 1 hr2007Bioorganic & medicinal chemistry letters, Oct-01, Volume: 17, Issue:19
Novel sulfonamides having dual dopamine D2 and D3 receptor affinity show in vivo antipsychotic efficacy with beneficial cognitive and EPS profile.
AID1442554Displacement of [3H]prazosin from adrenergic alpha 1 receptor in porcine cerebral cortex after 2 hrs by scintillation counting analysis2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID516805Binding affinity to human 5HT2A receptor2010Bioorganic & medicinal chemistry letters, Oct-01, Volume: 20, Issue:19
6-Alkoxyisoindolin-1-one based dopamine D2 partial agonists as potential antipsychotics.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1403798Antagonist activity at M3 receptor (unknown origin) after 10 mins by calcium 5 dye based FLIPR assay
AID1153308Agonist activity at human dopamine D3 receptor transiently expressed in HEK293 cells co-expressing Galphao1 after 30 mins by [35S]GTPgammaS binding assay relative to quinpirole2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Functionally selective dopamine D₂, D₃ receptor partial agonists.
AID1442558Displacement of [3H]WAY100635 from 5-HT1A receptor in porcine cerebral cortex after 2 hrs by scintillation counting analysis2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1443625Agonist activity at human dopamine D2 receptor expressed in HEK293 cells coexpressing renilla luciferase-fused Galphai1/GFP10-fused Ggamma2 by BRET assay relative to quinpirole
AID1403805Inhibition of quipazine-induced head twitches in ICR mouse assessed as reduction in number of stereotyped head twitch movements at 3 mg/kg, ig administered 30 mins prior to quipazine challenge measured for 15 mins at 30 mins post quipazine challenge relat
AID1782423Partial agonist activity at D2 receptor (unknown origin) expressed in HEK293T cells co-expressing GFP2-beta-arrestin2 assessed as beta-arrestin2 recruitment preincubated for 2 mins with coelenterazine followed by compound addition and measured after 2 min2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
2-Phenylcyclopropylmethylamine Derivatives as Dopamine D
AID1762086Therapeutic index, ratio of ED50 for induction of catalepsy in po dosed mouse to ED50 for antipsychotic activity in po dosed mouse assessed as suppression of apomorphine-induced climbing2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID1808020Inhibition of porcine heart malate dehydrogenase preincubated for 5 min followed by nicotinamide adenine dinucleotide addition and monitered for 90 sec by spectrophotometric method2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
Colloidal Aggregators in Biochemical SARS-CoV-2 Repurposing Screens.
AID1210178Percentage unbound in Crl:NMRI(Han) mouse brain at 1 uM after 5 hrs by equilibrium dialysis method2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID516818Apparent intrinsic clearance in human liver microsomes2010Bioorganic & medicinal chemistry letters, Oct-01, Volume: 20, Issue:19
6-Alkoxyisoindolin-1-one based dopamine D2 partial agonists as potential antipsychotics.
AID1442577Agonist activity at N-terminal flag-tagged D2S receptor (unknown origin) expressed in HEK293 cells coexpressing renilla luciferase 2-tagged GalphaoA after 10 mins by BRET assay relative to quinpirole2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1169862Binding affinity to 5HT1A receptor (unknown origin)2014Journal of medicinal chemistry, Nov-26, Volume: 57, Issue:22
Targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors for developing effective antipsychotics: synthesis, biological characterization, and behavioral studies.
AID1210177Unbound brain to plasma partition coefficient of the compound in mdr1a-deficient rat at 6 mg/kg/day administered through continuous minipump treatment for 3 days2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID1157848Ratio of intrinsic efficacy to KA for human D2L receptor expressed in FlpIn CHO cells assessed as inhibition of forskolin-stimulated cAMP production treated for 30 mins by AlphaScreen assay2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Structure-activity relationships of privileged structures lead to the discovery of novel biased ligands at the dopamine D₂ receptor.
AID516804Displacement of [3H]-Spiperone from human dopamine D2L receptor expressed in CHO cells2010Bioorganic & medicinal chemistry letters, Oct-01, Volume: 20, Issue:19
6-Alkoxyisoindolin-1-one based dopamine D2 partial agonists as potential antipsychotics.
AID492643Displacement of [3H]SCH23390 from dopamine D1 receptor in CRL:CD(SD)BR-COBS rat striatum by scintillation spectrometry2010Journal of medicinal chemistry, Jun-24, Volume: 53, Issue:12
Discovery of bishomo(hetero)arylpiperazines as novel multifunctional ligands targeting dopamine D(3) and serotonin 5-HT(1A) and 5-HT(2A) receptors.
AID1443613Displacement of [3H]-(R)-(+)-7-OH-DPAT from human dopamine D2 receptor expressed in HEK293 cell membranes after 90 mins by micro beta scintillation counting analysis
AID1245099Activity at dopamine D2S receptor (unknown origin) expressed in HEK293 cell membranes co-expressing Galpha protein subunit Galphai2 by [35S]GTPgammaS binding assay relative to quinpirole2015Bioorganic & medicinal chemistry, Sep-15, Volume: 23, Issue:18
1,4-Disubstituted aromatic piperazines with high 5-HT2A/D2 selectivity: Quantitative structure-selectivity investigations, docking, synthesis and biological evaluation.
AID1448005Agonist activity at human D2S receptor expressed in HEK293T cell membranes coexpressing Galphao1 assessed as induction of nucleotide exchange preincubated for 30 mins followed by addition of [35S]GTPgammaS measured after 30 mins by [35S]GTPgammaS binding 2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID1233026Antianxiety-like activity in Swiss albino mouse assessed as number of punished crossings at 0.06 to 0.5 mg/kg, ip by four-plate test2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Novel spirohydantoin derivative as a potent multireceptor-active antipsychotic and antidepressant agent.
AID492638Binding affinity to human ERG expressed in HEK293 cells2010Journal of medicinal chemistry, Jun-24, Volume: 53, Issue:12
Discovery of bishomo(hetero)arylpiperazines as novel multifunctional ligands targeting dopamine D(3) and serotonin 5-HT(1A) and 5-HT(2A) receptors.
AID1703855Toxicity in ICR mouse assessed as induction of sedation by measuring spontaneous locomotor activity at 3 mg/kg, po measured for 30 mins following drug administration2020European journal of medicinal chemistry, Oct-15, Volume: 204Automated design and optimization of multitarget schizophrenia drug candidates by deep learning.
AID1373832Agonistic activity at human 5-HT1A receptor measured after 60 mins by Ultra Lance cAMP assay2018Bioorganic & medicinal chemistry letters, 02-15, Volume: 28, Issue:4
Synthesis and biological evaluation of a series of novel pyridinecarboxamides as potential multi-receptor antipsychotic drugs.
AID1762061Binding affinity to histamine H1 receptor (unknown origin)2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID1782428Displacement of [3H]-LSD from 5HT2C receptor (unknown origin) expressed in HEK293T cell membranes measured after 2 hrs by microbeta scintillation counting method2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
2-Phenylcyclopropylmethylamine Derivatives as Dopamine D
AID1210167Unbound brain to plasma partition coefficient of the compound in mdr1a-deficient mouse at 3 mg/kg/day administered through continuous minipump treatment for 3 days2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID1458675Inhibition of SERT expressed in rat brain synaptosomes assessed as decrease in incorporation of [3H]serotonin measured after 15 mins by scintillation counting method2017Journal of medicinal chemistry, 09-14, Volume: 60, Issue:17
Novel 3-(1,2,3,6-Tetrahydropyridin-4-yl)-1H-indole-Based Multifunctional Ligands with Antipsychotic-Like, Mood-Modulating, and Procognitive Activity.
AID723182Displacement of [3H]-5-CT from human 5HT7 receptor expressed in HEK293 after 1 hr2013European journal of medicinal chemistry, Feb, Volume: 60Antidepressant and antipsychotic activity of new quinoline- and isoquinoline-sulfonamide analogs of aripiprazole targeting serotonin 5-HT₁A/5-HT₂A/5-HT₇ and dopamine D₂/D₃ receptors.
AID1210232Total drug level in wild type Sprague-Dawley rat brain expressing Abcb1a at 6 mg/kg/day administered through continuous minipump treatment for 3 days by UPLC-MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID1393365Displacement of [3H]-LSD from human 5-HT6R expressed in HEK293 cell membranes after 1 hr at 37 degC by microbeta counting method
AID1865877Displacement of [3H]-N-methylspiperone from human D2 receptor incubated for 1 hr by liquid scintillation counting method
AID1442556Displacement of [3H]spiperone from human Dopamine D2S receptor expressed in CHO cell membranes after 2 hrs by scintillation counting analysis2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1573432Inverse agonist activity at dopamine D2 receptor (unknown origin) assessed as inhibition of forskolin-mediated cAMP accumulation after 20 mins by radiometric assay relative to control2018Journal of medicinal chemistry, 11-21, Volume: 61, Issue:22
Biased Ligands of G Protein-Coupled Receptors (GPCRs): Structure-Functional Selectivity Relationships (SFSRs) and Therapeutic Potential.
AID1447997Displacement of [3H]SCH23390 from human D5R expressed in HEK293T cell membranes by radioligand binding assay2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID1442584Agonist activity at ARMS2-PK2 tagged D2S receptor (unknown origin) expressed in HEK293 cells assessed as induction of EA-tagged beta-arrestin-2 recruitment incubated for 5 hrs measured after 60 mins by PathHunter assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1693545Displacement of [3H]-LSD from human 5HT7 receptor by liquid scintillation counting2021Bioorganic & medicinal chemistry, 01-15, Volume: 30A study of the structure-affinity relationship in SYA16263; is a D
AID1301292Antagonistic activity at alpha-1A adrenergic receptor (unknown origin) after 10 mins by FLIPR assay2016Bioorganic & medicinal chemistry letters, 07-01, Volume: 26, Issue:13
Synthesis, structure-activity relationships, and biological evaluation of a series of benzamides as potential multireceptor antipsychotics.
AID1693543Displacement of [3H]-ketanserin from human 5HT2A receptor by liquid scintillation counting2021Bioorganic & medicinal chemistry, 01-15, Volume: 30A study of the structure-affinity relationship in SYA16263; is a D
AID1659271Antipsychotic activity in ICR mouse assessed as inhibition of quipazine-induced head-twitch response at 0.3 mg/kg, po administered with compound after quipazine administration measured for 15 mins2020Bioorganic & medicinal chemistry letters, 04-15, Volume: 30, Issue:8
Synthesis and biological investigation of triazolopyridinone derivatives as potential multireceptor atypical antipsychotics.
AID705598Oral bioavailability in human2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
Mechanism-based inactivation (MBI) of cytochrome P450 enzymes: structure-activity relationships and discovery strategies to mitigate drug-drug interaction risks.
AID1071695Induction of catalepsy in albino mouse at 15 mg/kg, ip relative to control2014European journal of medicinal chemistry, Mar-03, Volume: 74Design, synthesis, pharmacological evaluation and computational studies of 1-(biphenyl-4-yl)-2-[4-(substituted phenyl)-piperazin-1-yl]ethanones as potential antipsychotics.
AID298479Displacement of [3H]spiperone from human dopamine D3 receptor expressed in CHO cells2007Journal of medicinal chemistry, Oct-18, Volume: 50, Issue:21
Principal component analysis differentiates the receptor binding profiles of three antipsychotic drug candidates from current antipsychotic drugs.
AID516825Ex vivo D2 receptor occupancy in po dosed rat striatum assessed as inhibition [3H]-raclopride binding at 21 ng/ml plasma concentration2010Bioorganic & medicinal chemistry letters, Oct-01, Volume: 20, Issue:19
6-Alkoxyisoindolin-1-one based dopamine D2 partial agonists as potential antipsychotics.
AID1462322Antipsychotic activity in PCP-induced hyperactivity ICR mouse model assessed as inhibition of hyper-locomotion administered ig incubated for 10 mins followed by PCP challenge measured after 10 mins for 75 mins2017Bioorganic & medicinal chemistry, 09-01, Volume: 25, Issue:17
Synthesis and biological investigation of tetrahydropyridopyrimidinone derivatives as potential multireceptor atypical antipsychotics.
AID1659264Antagonist activity at SERT receptor (unknown origin) at 400 nM by fluorescence based assay relative to control2020Bioorganic & medicinal chemistry letters, 04-15, Volume: 30, Issue:8
Synthesis and biological investigation of triazolopyridinone derivatives as potential multireceptor atypical antipsychotics.
AID1782421Partial agonist activity at D2 receptor (unknown origin) expressed in HEK293T cells co-expressing Rluc8-tagged Galpahi1 assessed as Galphai1 dissociation preincubated for 2 mins with coelenterazine followed by compound addition and measured after 2 mins b2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
2-Phenylcyclopropylmethylamine Derivatives as Dopamine D
AID1153307Agonist activity at human dopamine D3 receptor transiently expressed in HEK293 cells co-expressing Galphao1 after 30 mins by [35S]GTPgammaS binding assay2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Functionally selective dopamine D₂, D₃ receptor partial agonists.
AID1157847Agonist activity at human D2L receptor expressed in FlpIn CHO cells assessed as induction of ERK1/2 phosphorylation by AlphaScreen assay2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Structure-activity relationships of privileged structures lead to the discovery of novel biased ligands at the dopamine D₂ receptor.
AID1309130Displacement of [3H]Ketanserin from human 5-HT2A receptor expressed in cell membranes after 1 hr by liquid scintillation counting2016Bioorganic & medicinal chemistry, 08-15, Volume: 24, Issue:16
Design and synthesis of dual 5-HT1A and 5-HT7 receptor ligands.
AID722918Toxicity in CD1 mouse assessed as induction of sedation at 1 mg/kg, ip2013European journal of medicinal chemistry, Feb, Volume: 60Antidepressant and antipsychotic activity of new quinoline- and isoquinoline-sulfonamide analogs of aripiprazole targeting serotonin 5-HT₁A/5-HT₂A/5-HT₇ and dopamine D₂/D₃ receptors.
AID1782429Displacement of [3H]-SCH23390 from D4 receptor (unknown origin) expressed in HEK293T cell membranes measured after 2 hrs by microbeta scintillation counting method2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
2-Phenylcyclopropylmethylamine Derivatives as Dopamine D
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1233027Toxicity in ip dosed CD-1 mouse assessed as minimum dose required for induction of catalepsy by bar test2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Novel spirohydantoin derivative as a potent multireceptor-active antipsychotic and antidepressant agent.
AID1762066Induction of catalepsy in po dosed mouse by Horizontal grid and elevated bar test2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID705591Lipophilicity, log D of the compound2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
Mechanism-based inactivation (MBI) of cytochrome P450 enzymes: structure-activity relationships and discovery strategies to mitigate drug-drug interaction risks.
AID1448000Displacement of [3H]prazosin from alpha1-adrenergic receptor in porcine cerebral cortex by radioligand binding assay2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID1301291Therapeutic index, ratio of ED50 for toxicity in orally dosed mouse by catalepsy test to ED50 for antipsychotic activity in mouse2016Bioorganic & medicinal chemistry letters, 07-01, Volume: 26, Issue:13
Synthesis, structure-activity relationships, and biological evaluation of a series of benzamides as potential multireceptor antipsychotics.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1474758Agonist activity at D2 long receptor (unknown origin) expressed in Flp-In-CHO cells assessed as change in transduction coefficient by measuring induction of ERK1/2 phosphorylation after 5 mins by Alphascreen assay2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
Pharmacological property optimization for allosteric ligands: A medicinal chemistry perspective.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1573431Inverse agonist activity at dopamine D2 receptor (unknown origin) assessed as inhibition of forskolin-mediated cAMP accumulation after 20 mins by radiometric assay2018Journal of medicinal chemistry, 11-21, Volume: 61, Issue:22
Biased Ligands of G Protein-Coupled Receptors (GPCRs): Structure-Functional Selectivity Relationships (SFSRs) and Therapeutic Potential.
AID723168Antipsychotic activity in ip dosed Swiss albino mouse assessed as inhibition of (+/-)DOI-induced head twitch response after 20 mins2013European journal of medicinal chemistry, Feb, Volume: 60Antidepressant and antipsychotic activity of new quinoline- and isoquinoline-sulfonamide analogs of aripiprazole targeting serotonin 5-HT₁A/5-HT₂A/5-HT₇ and dopamine D₂/D₃ receptors.
AID492634Antipsychotic activity in ip dosed NMRI mouse assessed as reduction in spontaneous exploratory locomotor activity administered 30 mins prior to testing measured for 60 mins2010Journal of medicinal chemistry, Jun-24, Volume: 53, Issue:12
Discovery of bishomo(hetero)arylpiperazines as novel multifunctional ligands targeting dopamine D(3) and serotonin 5-HT(1A) and 5-HT(2A) receptors.
AID1283240Increase in 7-DHC levels in mouse Neuro2a cells at 100 nM by LC-MS analysis2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID1220556Fraction unbound in CD-1 mouse brain homogenates at 1 uM after 6 hrs by equilibrium dialysis method2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Species independence in brain tissue binding using brain homogenates.
AID1739156Plasma protein binding in human2020European journal of medicinal chemistry, Aug-01, Volume: 199Privileged scaffold-based design to identify a novel drug-like 5-HT
AID410532Antipsychotic activity in NMRI mouse assessed as reduction in phencyclidine-induced locomotor activity administered 30 mins prior to testing measured for 60 mins2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Discovery of a new class of potential multifunctional atypical antipsychotic agents targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors: design, synthesis, and effects on behavior.
AID610679Displacement of [125I]ABN from human recombinant D3 receptor expressed in HEK cells after 60 mins by gamma counter2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
Synthesis and characterization of selective dopamine D₂ receptor ligands using aripiprazole as the lead compound.
AID1442592Agonist activity at Dopamine D2L receptor (unknown origin) expressed in HEK293T cells coexpressing GFP-fused GIRK1/2 channels assessed as induction of inwardly rectifying K+ current at -70 mV holding potential at 1 uM measured up to 1.1 secs in presence o2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1704724Inhibition of human ERG expressed in HEK293 cells by whole-cell patch clamp method
AID698934Agonist activity at D2L receptor in human HTLA cells assessed as beta arrestin recruitment at 6 uM after 18 hrs by luminescence assay relative to Quinpirole2012Journal of medicinal chemistry, Aug-23, Volume: 55, Issue:16
Structure-functional selectivity relationship studies of β-arrestin-biased dopamine D₂ receptor agonists.
AID1220559Fraction unbound in cynomolgus monkey brain homogenates at 1 uM after 6 hrs by equilibrium dialysis method2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Species independence in brain tissue binding using brain homogenates.
AID516806Displacement of [3H]-8-OH-DPAT from human 5HT1A receptor expressed in HeLa cells2010Bioorganic & medicinal chemistry letters, Oct-01, Volume: 20, Issue:19
6-Alkoxyisoindolin-1-one based dopamine D2 partial agonists as potential antipsychotics.
AID721752Inhibition of human MATE2K-mediated ASP+ uptake expressed in HEK293 cells after 1.5 mins by fluorescence assay2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Discovery of potent, selective multidrug and toxin extrusion transporter 1 (MATE1, SLC47A1) inhibitors through prescription drug profiling and computational modeling.
AID727075Displacement of [3H]raclopride from human D2 dopamine receptor expressed in CHO cell membranes2013Bioorganic & medicinal chemistry letters, Jan-15, Volume: 23, Issue:2
Synthesis and SAR of aminothiazole fused benzazepines as selective dopamine D2 partial agonists.
AID1443624Agonist activity at human dopamine D2 receptor expressed in HEK293 cells coexpressing renilla luciferase-fused Galphai1/GFP10-fused Ggamma2 by BRET assay
AID539465Inhibition of human ERG2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Experimental solubility profiling of marketed CNS drugs, exploring solubility limit of CNS discovery candidate.
AID1782425Displacement of [3H]-SCH23390 from D3 receptor (unknown origin) expressed in HEK293T cell membranes measured after 2 hrs by microbeta scintillation counting method2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
2-Phenylcyclopropylmethylamine Derivatives as Dopamine D
AID1458651Agonist activity at human recombinant D2S receptor expressed in HEK-293 cells at 1 x 10'-6 M by cellular dielectric spectroscopy2017Journal of medicinal chemistry, 09-14, Volume: 60, Issue:17
Novel 3-(1,2,3,6-Tetrahydropyridin-4-yl)-1H-indole-Based Multifunctional Ligands with Antipsychotic-Like, Mood-Modulating, and Procognitive Activity.
AID1782427Displacement of [3H]-LSD from 5HT2A receptor (unknown origin) expressed in HEK293T cell membranes measured after 2 hrs by microbeta scintillation counting method2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
2-Phenylcyclopropylmethylamine Derivatives as Dopamine D
AID1458670Toxicity in CD-1 mouse assessed as effect on spontaneous locomotory activity by measuring number of areas crossed administered for 30 mins measured every 1 min for first 5 mins2017Journal of medicinal chemistry, 09-14, Volume: 60, Issue:17
Novel 3-(1,2,3,6-Tetrahydropyridin-4-yl)-1H-indole-Based Multifunctional Ligands with Antipsychotic-Like, Mood-Modulating, and Procognitive Activity.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID610682Selectivity ratio of Ki for human recombinant D4 receptor to Ki for human recombinant D2L receptor2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
Synthesis and characterization of selective dopamine D₂ receptor ligands using aripiprazole as the lead compound.
AID410333Displacement of [3H]7OH-DPAT from dopamine D3 receptor expressed in Sf9 cells by scintillation spectrometry2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Discovery of a new class of potential multifunctional atypical antipsychotic agents targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors: design, synthesis, and effects on behavior.
AID1782426Displacement of [3H]-LSD from 5HT1A receptor (unknown origin) expressed in HEK293T cell membranes measured after 2 hrs by microbeta scintillation counting method2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
2-Phenylcyclopropylmethylamine Derivatives as Dopamine D
AID1823849Antipsychotic activity in ip dosed Wistar rat assessed as induction of MK801-induced hyperlocomotor activity by measuring minimum effective dose measured for 15 mins
AID1443614Displacement of [3H]-(R)-(+)-7-OH-DPAT from human dopamine D3 receptor expressed in HEK293 cell membranes after 90 mins by micro beta scintillation counting analysis
AID1373831Antagonistic activity at human dopamine D2 receptor measured after 60 mins by Lance Ultra cAMP assay2018Bioorganic & medicinal chemistry letters, 02-15, Volume: 28, Issue:4
Synthesis and biological evaluation of a series of novel pyridinecarboxamides as potential multi-receptor antipsychotic drugs.
AID1865876Displacement of [3H]-LSD from human 5-HT2B receptor incubated for 1 hr by liquid scintillation counting method
AID1393366Displacement of [3H]-8-OH-DPAT from human 5-HT1AR expressed in HEK293 cell membranes after 1 hr by microbeta counting method
AID1756801Displacement of [3H]-Mesulergine from human 5-HT2C receptor incubated for 1 hr by liquid scintillation counting method2021European journal of medicinal chemistry, Mar-15, Volume: 214New dual 5-HT1A and 5-HT7 receptor ligands derived from SYA16263.
AID1704753Therapeutic index, ratio of ED50 for toxicity in po dosed Kunming mouse assessed as catalepsy to ED50 for antipsychotic activity in Kunming mouse assessed as inhibition of DOI-induced head twitch
AID1157845Agonist activity at human D2L receptor expressed in FlpIn CHO cells assessed as inhibition of forskolin-stimulated cAMP production treated for 30 mins by AlphaScreen assay2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Structure-activity relationships of privileged structures lead to the discovery of novel biased ligands at the dopamine D₂ receptor.
AID1283243Increase in 7-DHC levels in Dhcr7-deficient mouse Neuro2a cells at 200 nM after 24 hrs by by LC-MS analysis2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID1442576Agonist activity at N-terminal flag-tagged D2S receptor (unknown origin) expressed in HEK293 cells coexpressing renilla luciferase 2-tagged GalphaoA after 10 mins by BRET assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1157851Biased agonist activity at human D2L receptor expressed in FlpIn CHO cells assessed as inhibition of forskolin-stimulated cAMP production treated for 30 mins by AlphaScreen assay relative to dopamine2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Structure-activity relationships of privileged structures lead to the discovery of novel biased ligands at the dopamine D₂ receptor.
AID1169869Antipsychotic-like activity in sc dosed NMRI mouse assessed as reduction in methamphetamine-induced locomotor activity dosed 15 to 30 mins before administration of methamphetamine measured for 60 mins2014Journal of medicinal chemistry, Nov-26, Volume: 57, Issue:22
Targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors for developing effective antipsychotics: synthesis, biological characterization, and behavioral studies.
AID1808021Inhibition of porcine heart malate dehydrogenase assessed as reduction in enzyme inhibition at 3 times IC50 preincubated for 5 min followed by nicotinamide adenine dinucleotide addition and monitered for 90 sec in presence of 0.01% Triton-X100 by spectrop2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
Colloidal Aggregators in Biochemical SARS-CoV-2 Repurposing Screens.
AID1762072Toxicity in mouse assessed as effect on serum prolactin level at 0.05 to 1.35 mg/kg administered for 28 days2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID516803Displacement of [3H]dofetilide from human ERG2010Bioorganic & medicinal chemistry letters, Oct-01, Volume: 20, Issue:19
6-Alkoxyisoindolin-1-one based dopamine D2 partial agonists as potential antipsychotics.
AID1769331Displacement of [3H]N-methylspiperone from human D2L receptor expressed in HEK293 cell membranes measured after 60 mins by MicroBeta scintillation counting method
AID1704751Therapeutic index, ratio of ED50 for toxicity in po dosed Kunming mouse assessed as catalepsy to ED50 for antipsychotic activity in Kunming mouse assessed as inhibition of apomorphine-induced climbing behavior
AID1153299Displacement of [3H]WAY-100635 from 5-HT1A receptor in pig cerebral cortex homogenates by competitive binding assay2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Functionally selective dopamine D₂, D₃ receptor partial agonists.
AID457691Selectivity index, ratio of Ki for Wistar rat striatum D2-like receptor to Ki for Wistar rat cortex 5HT2A receptor2010Bioorganic & medicinal chemistry, Mar-01, Volume: 18, Issue:5
Searching for multi-target antipsychotics: Discovery of orally active heterocyclic N-phenylpiperazine ligands of D2-like and 5-HT1A receptors.
AID1464179Displacement of [3H]spiperone from human D4R expressed in CHO cell membranes2017Bioorganic & medicinal chemistry, 10-15, Volume: 25, Issue:20
β-Arrestin biased dopamine D2 receptor partial agonists: Synthesis and pharmacological evaluation.
AID1373836Antagonistic activity at histamine 1 receptor (unknown origin) after 10 mins by FLIPR assay2018Bioorganic & medicinal chemistry letters, 02-15, Volume: 28, Issue:4
Synthesis and biological evaluation of a series of novel pyridinecarboxamides as potential multi-receptor antipsychotic drugs.
AID1210248Total brain to plasma partition coefficient of the compound in mdr1a-deficient rat at 6 mg/kg/day administered through continuous minipump treatment for 3 days2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID1196356Effect on water consumption in intraperitoneally dosed Wistar rat by free drinking test2015European journal of medicinal chemistry, Mar-06, Volume: 92Novel 5-HT6 receptor antagonists/D2 receptor partial agonists targeting behavioral and psychological symptoms of dementia.
AID458634Selectivity ratio of Ki for human dopamine D2 receptor at low affinity state to Ki for human dopamine D2 receptor at high affinity state2010Journal of medicinal chemistry, Mar-25, Volume: 53, Issue:6
Synthesis and evaluation of a set of 4-phenylpiperidines and 4-phenylpiperazines as D2 receptor ligands and the discovery of the dopaminergic stabilizer 4-[3-(methylsulfonyl)phenyl]-1-propylpiperidine (huntexil, pridopidine, ACR16).
AID610681Selectivity ratio of Ki for human recombinant D3 receptor to Ki for human recombinant D2L receptor2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
Synthesis and characterization of selective dopamine D₂ receptor ligands using aripiprazole as the lead compound.
AID727076Intrinsic agonist activity at human D2 dopamine receptor expressed in CHO cell membrane using cellular CD spectroscopy by Cell-Key assay2013Bioorganic & medicinal chemistry letters, Jan-15, Volume: 23, Issue:2
Synthesis and SAR of aminothiazole fused benzazepines as selective dopamine D2 partial agonists.
AID723184Displacement of [3H]-8-OH-DPAT from human 5HT1A receptor expressed in HEK293 after 1 hr2013European journal of medicinal chemistry, Feb, Volume: 60Antidepressant and antipsychotic activity of new quinoline- and isoquinoline-sulfonamide analogs of aripiprazole targeting serotonin 5-HT₁A/5-HT₂A/5-HT₇ and dopamine D₂/D₃ receptors.
AID298489Displacement of [3H]paraxetine from human 5HT transporter expressed in HEK293 cells2007Journal of medicinal chemistry, Oct-18, Volume: 50, Issue:21
Principal component analysis differentiates the receptor binding profiles of three antipsychotic drug candidates from current antipsychotic drugs.
AID698935Agonist activity at D2L receptor in human HTLA cells assessed as beta arrestin recruitment at 6 uM after 18 hrs by luminescence assay2012Journal of medicinal chemistry, Aug-23, Volume: 55, Issue:16
Structure-functional selectivity relationship studies of β-arrestin-biased dopamine D₂ receptor agonists.
AID1682828Binding affinity to H1 histamine receptor (unknown origin)
AID1301294Antagonistic activity at 5-HT2c receptor (unknown origin) after 10 mins by FLIPR assay2016Bioorganic & medicinal chemistry letters, 07-01, Volume: 26, Issue:13
Synthesis, structure-activity relationships, and biological evaluation of a series of benzamides as potential multireceptor antipsychotics.
AID1889699Cytotoxicity against HEK293 cells measured after 24 hrs by MTT assay2022European journal of medicinal chemistry, Mar-15, Volume: 232Novel D
AID1458672Cognitive enhancement activity in iv dosed CD-1 mouse assessed as increase in step-through latency time treated for 30 mins before training measured 24 hrs after training trial by passive avoidance test2017Journal of medicinal chemistry, 09-14, Volume: 60, Issue:17
Novel 3-(1,2,3,6-Tetrahydropyridin-4-yl)-1H-indole-Based Multifunctional Ligands with Antipsychotic-Like, Mood-Modulating, and Procognitive Activity.
AID410339Sedative activity in NMRI mouse assessed as reduction in spontaneous locomotor activity administered 30 mins prior to testing2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Discovery of a new class of potential multifunctional atypical antipsychotic agents targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors: design, synthesis, and effects on behavior.
AID1442564Agonist activity at human Dopamine D3 receptor expressed in HEK293T cell membranes coexpressing GalphaoA incubated for 30 mins measured after 75 mins by [35S]GTPgammaS binding assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1453901Antipsychotic activity in CD-1 mouse assessed as inhibition of dizocilpine-induced hyperlocomotor activity at 0.5 mg/kg, ip pretreated with dizocilpine for 15 mins followed by compound administration for 60 mins
AID1762070Cognitive enhancement effect in rat assessed as increase in novelty discrimination index at 0.3 mg/kg, po administered 1 hr prior to acquisition trial by novel object recognition test2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID1403796Antagonist activity at histamine H1 receptor (unknown origin) after 10 mins by calcium 5 dye based FLIPR assay
AID492641Displacement of [3H]8OH-DPAT from 5HT1A receptor in rat CRL:CD(SD)BR-COBS hippocampus by scintillation spectrometry2010Journal of medicinal chemistry, Jun-24, Volume: 53, Issue:12
Discovery of bishomo(hetero)arylpiperazines as novel multifunctional ligands targeting dopamine D(3) and serotonin 5-HT(1A) and 5-HT(2A) receptors.
AID1782422Partial agonist activity at D2 receptor (unknown origin) expressed in HEK293T cells co-expressing GFP2-beta-arrestin2 assessed as beta-arrestin2 recruitment preincubated for 2 mins with coelenterazine followed by compound addition and measured after 2 min2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
2-Phenylcyclopropylmethylamine Derivatives as Dopamine D
AID1393368Displacement of [3H]-raclopride from human D2LR expressed in HEK293 cell membranes after 1 hr at 37 degC by microbeta counting method
AID1210196Total brain to plasma partition coefficient of the compound in wild type Crl:CF1 mouse expressing Abcb1a mutant at 3 mg/kg/day administered through continuous minipump treatment for 3 days2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID1442575Agonist activity at N-terminal flag-tagged D2S receptor (unknown origin) expressed in HEK293 cells coexpressing renilla luciferase 2-tagged Galphai3 after 10 mins by BRET assay relative to quinpirole2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID298490Displacement of [3H]pirenzepine from human M1 receptor expressed in CHO cells2007Journal of medicinal chemistry, Oct-18, Volume: 50, Issue:21
Principal component analysis differentiates the receptor binding profiles of three antipsychotic drug candidates from current antipsychotic drugs.
AID1762087Therapeutic index, ratio of ED50 for induction of catalepsy in po dosed mouse to ED50 for antipsychotic activity in po dosed mouse assessed as reduction in MK-801-induced hyperlocomotor activity2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID1442608Antagonist activity at ARMS2-PK2 tagged D2L receptor (unknown origin) expressed in HEK293 cells assessed as inhibition of quinpirole-induced EA-tagged beta-arrestin-2 recruitment at 10 uM incubated for 5 hrs measured after 60 mins by PathHunter assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID598252Inhibition of human ABCB1-mediated rhodamine 123 efflux in mouse L5178 cells expressing human MDR1 at 0.1 mM after 20 mins by FACS analysis relative to 5 mM sodium orthovanadate2011Journal of medicinal chemistry, Mar-24, Volume: 54, Issue:6
A novel approach for predicting P-glycoprotein (ABCB1) inhibition using molecular interaction fields.
AID595503Induction of catalepsy in mouse2011Bioorganic & medicinal chemistry letters, May-01, Volume: 21, Issue:9
Discovery of PF-00217830: aryl piperazine napthyridinones as D2 partial agonists for schizophrenia and bipolar disorder.
AID1301282Agonistic activity at human 5-HT1A receptor measured after 60 mins by Ultra Lance cAMP assay2016Bioorganic & medicinal chemistry letters, 07-01, Volume: 26, Issue:13
Synthesis, structure-activity relationships, and biological evaluation of a series of benzamides as potential multireceptor antipsychotics.
AID721751Inhibition of human OCT2-mediated ASP+ uptake expressed in HEK293 cells after 3 mins by fluorescence assay2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Discovery of potent, selective multidrug and toxin extrusion transporter 1 (MATE1, SLC47A1) inhibitors through prescription drug profiling and computational modeling.
AID1153301Displacement of [3Hprazosin from adrenergic alpha1 receptor in pig cerebral cortex homogenates by competitive binding assay2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Functionally selective dopamine D₂, D₃ receptor partial agonists.
AID610684Displacement of [3H]DTG from rat liver sigma-2 receptor in presence of (+)-pentazocine after 120 mins by liquid scintillation counter2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
Synthesis and characterization of selective dopamine D₂ receptor ligands using aripiprazole as the lead compound.
AID1443616Agonist activity at human dopamine D2 receptor expressed in HEK293 cells assessed as cAMP inhibition by BRET assay
AID516817Selectivity ratio of Ki for human dopamine D2L receptor to Ki for human 5HT2A receptor2010Bioorganic & medicinal chemistry letters, Oct-01, Volume: 20, Issue:19
6-Alkoxyisoindolin-1-one based dopamine D2 partial agonists as potential antipsychotics.
AID298491Displacement of [3H]4-DAMP from human M4 receptor expressed in CHO cells2007Journal of medicinal chemistry, Oct-18, Volume: 50, Issue:21
Principal component analysis differentiates the receptor binding profiles of three antipsychotic drug candidates from current antipsychotic drugs.
AID1442603Antipsychotic activity in Sprague-Dawley rat assessed as inhibition of AMPH-induced rearing at 1.5 mg/kg/day administered via osmotic Alzet mini pump for 7 days post 6 days challenge with AMPH by open field test2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID298492Displacement of [3H]prazosin from adrenergic alpha1 receptor in rat cerebral cortex2007Journal of medicinal chemistry, Oct-18, Volume: 50, Issue:21
Principal component analysis differentiates the receptor binding profiles of three antipsychotic drug candidates from current antipsychotic drugs.
AID1233023Anti-depressant like activity in Swiss albino mouse assessed as shortening of immobility time at 0.01 to 0.1 mg/kg, ip by forced swim test2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Novel spirohydantoin derivative as a potent multireceptor-active antipsychotic and antidepressant agent.
AID410334Displacement of [3H]8OH-DPAT from 5HT1A receptor in CRL:CD(SD)BR-COBS rat hippocampus by scintillation spectrometry2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Discovery of a new class of potential multifunctional atypical antipsychotic agents targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors: design, synthesis, and effects on behavior.
AID595504In vivo antagonist activity at 5-HT2A receptor in rat assessed as inhibition of 2,5-dimethoxy-4-iodoamphetamine-induced head twitch at 3 x sLMA MED2011Bioorganic & medicinal chemistry letters, May-01, Volume: 21, Issue:9
Discovery of PF-00217830: aryl piperazine napthyridinones as D2 partial agonists for schizophrenia and bipolar disorder.
AID113713Inhibition of the APO-induced stereotyped behavior in mice1998Journal of medicinal chemistry, Feb-26, Volume: 41, Issue:5
Novel antipsychotic agents with dopamine autoreceptor agonist properties: synthesis and pharmacology of 7-[4-(4-phenyl-1-piperazinyl)butoxy]-3,4-dihydro-2(1H)-quinolinone derivatives.
AID1153296Displacement of [3H]Spiperone from human dopamine D2 short receptor expressed in CHO cells by competitive binding assay2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Functionally selective dopamine D₂, D₃ receptor partial agonists.
AID1474769Agonist activity at D2 long receptor (unknown origin) expressed in Flp-In-CHO cells assessed as ratio of cellular impedance to GalphaoB activation at 90 mins post dose2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
Pharmacological property optimization for allosteric ligands: A medicinal chemistry perspective.
AID1373839Antipsychotic-like activity in ICR mouse assessed as inhibition of PCP-induced hyperlocomotion at 3 mg/kg, ig followed by animal habituation for 10 mins before 60 mins measurement period2018Bioorganic & medicinal chemistry letters, 02-15, Volume: 28, Issue:4
Synthesis and biological evaluation of a series of novel pyridinecarboxamides as potential multi-receptor antipsychotic drugs.
AID723169Antipsychotic activity in ip dosed Swiss albino mouse assessed as inhibition of apomorphine-induced climbing behavior administered 10 mins before apomorphine-challenge measured after 2 mins2013European journal of medicinal chemistry, Feb, Volume: 60Antidepressant and antipsychotic activity of new quinoline- and isoquinoline-sulfonamide analogs of aripiprazole targeting serotonin 5-HT₁A/5-HT₂A/5-HT₇ and dopamine D₂/D₃ receptors.
AID1756799Displacement of [3H]-8-OH-DPAT from human 5-HT1A receptor incubated for 1 hr by liquid scintillation counting method2021European journal of medicinal chemistry, Mar-15, Volume: 214New dual 5-HT1A and 5-HT7 receptor ligands derived from SYA16263.
AID457690Selectivity index, ratio of Ki for Wistar rat striatum D2-like receptor to Ki for Wistar rat hippocampus 5HT1A receptor2010Bioorganic & medicinal chemistry, Mar-01, Volume: 18, Issue:5
Searching for multi-target antipsychotics: Discovery of orally active heterocyclic N-phenylpiperazine ligands of D2-like and 5-HT1A receptors.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1865879Displacement of [3H]-pyrilamine from human histamine H1 receptor incubated for 1 hr by liquid scintillation counting method
AID1442560Displacement of [3H]spiperone from human Dopamine D3 receptor expressed in CHO cell membranes after 2 hrs by scintillation counting analysis2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1153305Agonist activity at human dopamine D2 short receptor transiently expressed in HEK293 cells co-expressing Galphai2 after 30 mins by [35S]GTPgammaS binding assay2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Functionally selective dopamine D₂, D₃ receptor partial agonists.
AID1196350Anti-depressant-like activity in intraperitoneally dosed >18-months old Wistar rat by Porsolt's forced swim test2015European journal of medicinal chemistry, Mar-06, Volume: 92Novel 5-HT6 receptor antagonists/D2 receptor partial agonists targeting behavioral and psychological symptoms of dementia.
AID1447999Displacement of [3H]ketanserin from human 5-HT2AR expressed in HEK293T cell membranes by radioligand binding assay2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID1464176Displacement of [3H]spiperone from human D2LR expressed in CHO cell membranes2017Bioorganic & medicinal chemistry, 10-15, Volume: 25, Issue:20
β-Arrestin biased dopamine D2 receptor partial agonists: Synthesis and pharmacological evaluation.
AID1474754Displacement of [3H]spiperone from D2 long receptor (unknown origin) expressed in Flp-In-CHO cell membranes assessed as transduction coefficient by measuring dissociation half life after 5 mins by liquid scintillation counter method2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
Pharmacological property optimization for allosteric ligands: A medicinal chemistry perspective.
AID1442593Agonist activity at Dopamine D2L receptor (unknown origin) expressed in HEK293T cells coexpressing GFP-fused GIRK1/2 channels assessed as induction of inwardly rectifying K+ current at -70 mV holding potential at 0.1 uM measured up to 1.1 secs by patch cl2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1373835Antagonistic activity at alpha-1A adrenergic receptor (unknown origin) after 10 mins by FLIPR assay2018Bioorganic & medicinal chemistry letters, 02-15, Volume: 28, Issue:4
Synthesis and biological evaluation of a series of novel pyridinecarboxamides as potential multi-receptor antipsychotic drugs.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID723177Displacement of [3H]-Prazosin from adrenergic alpha1 receptor in rat cortex after 30 mins by scintillation counting2013European journal of medicinal chemistry, Feb, Volume: 60Antidepressant and antipsychotic activity of new quinoline- and isoquinoline-sulfonamide analogs of aripiprazole targeting serotonin 5-HT₁A/5-HT₂A/5-HT₇ and dopamine D₂/D₃ receptors.
AID1823851Sedative activity in ip dosed Wistar rat assessed as effect on spontaneous locomotor activity measured for 10 mins by social interaction test
AID1153298Displacement of [3H]Spiperone from human dopamine D4.4 receptor expressed in CHO cells by competitive binding assay2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Functionally selective dopamine D₂, D₃ receptor partial agonists.
AID1762059Binding affinity to 5-HT6 receptor (unknown origin)2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID1210247Total drug level in mdr1a-deficient rat brain at 6 mg/kg/day administered through continuous minipump treatment for 3 days by UPLC-MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID1676001Intrinsic clearance in rat liver microsomes at 50 uM measured up to 45 mins by HPLC analysis
AID1374530Drug metabolism in mouse liver microsomes assessed as hydroxylated main metabolite formation at 50 uM preincubated for 5 mins followed by NADPH addition measured after 30 mins by UPLC-MS analysis2018Bioorganic & medicinal chemistry letters, 03-01, Volume: 28, Issue:5
MF-8, a novel promising arylpiperazine-hydantoin based 5-HT
AID1374518Intrinsic clearance in rat liver microsomes at 50 uM preincubated for 5 mins followed by NADPH addition measured up to 30 mins2018Bioorganic & medicinal chemistry letters, 03-01, Volume: 28, Issue:5
MF-8, a novel promising arylpiperazine-hydantoin based 5-HT
AID1889689Displacement of [3H]-ketanserin from human 5-HT2A receptor expressed in CHO-K1 cells measured after 1.5 hrs by Microbeta plate reader method2022European journal of medicinal chemistry, Mar-15, Volume: 232Novel D
AID298487Displacement of [3H]LSD from human 5HT7 receptor expressed in CHO cells2007Journal of medicinal chemistry, Oct-18, Volume: 50, Issue:21
Principal component analysis differentiates the receptor binding profiles of three antipsychotic drug candidates from current antipsychotic drugs.
AID1704747Antipsychotic activity in Kunming mouse assessed as inhibition of apomorphine-induced climbing behavior administered orally 30 mins prior to apomorphine challenge and measured for 10 to 30 mins
AID1458667Anxiolytic-like activity in Swiss albino mouse assessed as suppression of movement administered for 30 mins by four-plate test2017Journal of medicinal chemistry, 09-14, Volume: 60, Issue:17
Novel 3-(1,2,3,6-Tetrahydropyridin-4-yl)-1H-indole-Based Multifunctional Ligands with Antipsychotic-Like, Mood-Modulating, and Procognitive Activity.
AID1411902Oral bioavailability in human2018MedChemComm, May-01, Volume: 9, Issue:5
Schizophrenia: synthetic strategies and recent advances in drug design.
AID410335Displacement of [3H]ketanserin from 5HT2A receptor in CRL:CD(SD)BR-COBS rat cortex by scintillation spectrometry2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Discovery of a new class of potential multifunctional atypical antipsychotic agents targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors: design, synthesis, and effects on behavior.
AID1403797Antagonist activity at adrenergic alpha1A receptor (unknown origin) after 10 mins by calcium 5 dye based FLIPR assay
AID330537Increase in phospho-AMPK levels in H1RKO mouse hyphalamic slices at 500 nM after 30 mins by Western blotting2007Proceedings of the National Academy of Sciences of the United States of America, Feb-27, Volume: 104, Issue:9
From the Cover: Antipsychotic drug-induced weight gain mediated by histamine H1 receptor-linked activation of hypothalamic AMP-kinase.
AID1447998Displacement of [3H]WAY100635 from 5-HT1AR in porcine cerebral cortex by radioligand binding assay2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID1309136Displacement of [3H]N-methylspiperone from rat D4 receptor expressed in cell membranes after 1 hr by liquid scintillation counting2016Bioorganic & medicinal chemistry, 08-15, Volume: 24, Issue:16
Design and synthesis of dual 5-HT1A and 5-HT7 receptor ligands.
AID1443617Agonist activity at human dopamine D2 receptor expressed in HEK293 cells assessed as cAMP inhibition by BRET assay relative to quinpirole
AID113720Inhibition of the lethal effects of noradrenaline in mice (alpha-1 induced adrenoceptor antagonist activity)1998Journal of medicinal chemistry, Feb-26, Volume: 41, Issue:5
Novel antipsychotic agents with dopamine autoreceptor agonist properties: synthesis and pharmacology of 7-[4-(4-phenyl-1-piperazinyl)butoxy]-3,4-dihydro-2(1H)-quinolinone derivatives.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1704720Displacement of [3H]mesulergine from rat cerebral cortex 5HT2C receptor measured after 15 mins by liquid scintillation counting method
AID1442605Antipsychotic activity in Sprague-Dawley rat assessed as reversal of AMPH-induced anxiety level at 1.5 mg/kg/day administered via osmotic Alzet mini pump for 7 days post 6 days challenge with AMPH measured 20 mins after compound treatment by open field te2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1756797Displacement of [3H]N-methylspiperone from human dopamine D3 receptor incubated for 1 hr by liquid scintillation counting method2021European journal of medicinal chemistry, Mar-15, Volume: 214New dual 5-HT1A and 5-HT7 receptor ligands derived from SYA16263.
AID277677Binding affinity to dopamine D22007Journal of medicinal chemistry, Feb-08, Volume: 50, Issue:3
Structure-selectivity investigations of D2-like receptor ligands by CoMFA and CoMSIA guiding the discovery of D3 selective PET radioligands.
AID1232329Displacement of [3H]N-methylspiperone from human dopamine D4 receptor expressed in HEK293 cells2015Journal of medicinal chemistry, Jul-23, Volume: 58, Issue:14
Identifying Medication Targets for Psychostimulant Addiction: Unraveling the Dopamine D3 Receptor Hypothesis.
AID1573434Inverse agonist activity at dopamine D2 receptor (unknown origin) assessed as increase in beta-arrestin-2 recruitment relative to control2018Journal of medicinal chemistry, 11-21, Volume: 61, Issue:22
Biased Ligands of G Protein-Coupled Receptors (GPCRs): Structure-Functional Selectivity Relationships (SFSRs) and Therapeutic Potential.
AID1447994Displacement of [3H]spiperone from human D2SR expressed in CHO cell membranes by radioligand binding assay2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID298482Displacement of [3H]ketanserin from human 5HT2A receptor expressed in CHO cells2007Journal of medicinal chemistry, Oct-18, Volume: 50, Issue:21
Principal component analysis differentiates the receptor binding profiles of three antipsychotic drug candidates from current antipsychotic drugs.
AID1762057Binding affinity to 5-HT2A receptor (unknown origin)2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1442568Agonist activity at human Dopamine D2S receptor expressed in HEK293T cell membranes coexpressing Galphai2 incubated for 30 mins measured after 75 mins by [35S]GTPgammaS binding assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1169863Binding affinity to 5HT2A receptor (unknown origin)2014Journal of medicinal chemistry, Nov-26, Volume: 57, Issue:22
Targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors for developing effective antipsychotics: synthesis, biological characterization, and behavioral studies.
AID705599Clearance in human2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
Mechanism-based inactivation (MBI) of cytochrome P450 enzymes: structure-activity relationships and discovery strategies to mitigate drug-drug interaction risks.
AID595501Antipsychotic activity in po dosed mouse assessed as inhibition of spontaneous locomotor activity2011Bioorganic & medicinal chemistry letters, May-01, Volume: 21, Issue:9
Discovery of PF-00217830: aryl piperazine napthyridinones as D2 partial agonists for schizophrenia and bipolar disorder.
AID1889742Antipsychotic activity in male Wistar rat assessed as effect on non-anogenital social contact at 1 mg/kg, ip2022European journal of medicinal chemistry, Mar-15, Volume: 232Novel D
AID1245100Activity at pro-link-tagged D2S-ARMS2PK2 (unknown origin) expressed in HEK293 cells by beta-arrestin-2 recruitment assay2015Bioorganic & medicinal chemistry, Sep-15, Volume: 23, Issue:18
1,4-Disubstituted aromatic piperazines with high 5-HT2A/D2 selectivity: Quantitative structure-selectivity investigations, docking, synthesis and biological evaluation.
AID1309138Displacement of [3H]Citalopram from human SERT expressed in cell membranes after 1 hr by liquid scintillation counting2016Bioorganic & medicinal chemistry, 08-15, Volume: 24, Issue:16
Design and synthesis of dual 5-HT1A and 5-HT7 receptor ligands.
AID1318827Half life in ip dosed mouse2016European journal of medicinal chemistry, Sep-14, Volume: 120Structural modifications of the serotonin 5-HT7 receptor agonist N-(4-cyanophenylmethyl)-4-(2-biphenyl)-1-piperazinehexanamide (LP-211) to improve in vitro microsomal stability: A case study.
AID1762069Cognitive enhancement effect in rat assessed as increase in time spent in exploring novel object at 0.3 mg/kg, po administered 1 hr prior to acquisition trial by novel object recognition test2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID298480Displacement of [3H]spiperone from human dopamine D4.4 receptor expressed in CHO cells2007Journal of medicinal chemistry, Oct-18, Volume: 50, Issue:21
Principal component analysis differentiates the receptor binding profiles of three antipsychotic drug candidates from current antipsychotic drugs.
AID1301290Toxicity in ig dosed mouse assessed as induction of catalepsy by horizontal bar method2016Bioorganic & medicinal chemistry letters, 07-01, Volume: 26, Issue:13
Synthesis, structure-activity relationships, and biological evaluation of a series of benzamides as potential multireceptor antipsychotics.
AID1865880Displacement of [3H]-clonidine from human alpha 2C receptor incubated for 1 hr by liquid scintillation counting method
AID721754Inhibition of human MATE1-mediated ASP+ uptake expressed in HEK293 cells after 1.5 mins by fluorescence assay2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Discovery of potent, selective multidrug and toxin extrusion transporter 1 (MATE1, SLC47A1) inhibitors through prescription drug profiling and computational modeling.
AID1458659Antidepressant activity in Swiss albino mouse assessed as decrease in immobility time administered for 30 mins measured last 4 mins of 6 mins test by forced swimming test2017Journal of medicinal chemistry, 09-14, Volume: 60, Issue:17
Novel 3-(1,2,3,6-Tetrahydropyridin-4-yl)-1H-indole-Based Multifunctional Ligands with Antipsychotic-Like, Mood-Modulating, and Procognitive Activity.
AID1704719Displacement of [3H]prazosin from rat cerebral cortex alpha1 adrenergic receptor measured after 60 mins by liquid scintillation counting method
AID1210194Total plasma concentration in wild type Crl:CF1 mouse expressing Abcb1a mutant at 3 mg/kg/day administered through continuous minipump treatment for 3 days by UPLC-MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID1373837Antagonistic activity at 5-HT2c receptor (unknown origin) after 10 mins by FLIPR assay2018Bioorganic & medicinal chemistry letters, 02-15, Volume: 28, Issue:4
Synthesis and biological evaluation of a series of novel pyridinecarboxamides as potential multi-receptor antipsychotic drugs.
AID1442582Agonist activity at N-terminal flag-tagged D2S receptor (unknown origin) expressed in HEK293 cells assessed as induction of renilla luciferase 2-tagged beta-arrestin-2 recruitment after 15 mins by BRET assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1756800Displacement of [3H]-Ketanserin from human 5-HT2A receptor incubated for 1 hr by liquid scintillation counting method2021European journal of medicinal chemistry, Mar-15, Volume: 214New dual 5-HT1A and 5-HT7 receptor ligands derived from SYA16263.
AID298493Displacement of [3H]RX 821002 from adrenergic alpha-2 receptor in rat cerebral cortex2007Journal of medicinal chemistry, Oct-18, Volume: 50, Issue:21
Principal component analysis differentiates the receptor binding profiles of three antipsychotic drug candidates from current antipsychotic drugs.
AID298483Displacement of [3H]LSD from 5HT2B receptor expressed in CHO cells2007Journal of medicinal chemistry, Oct-18, Volume: 50, Issue:21
Principal component analysis differentiates the receptor binding profiles of three antipsychotic drug candidates from current antipsychotic drugs.
AID1462325Therapeutic index, ratio of ED50 for induction of catalepsy in ig dosed ICR mouse to ED50 for inhibition of PCP-induced hyper-locomotion in ig dosed ICR mouse2017Bioorganic & medicinal chemistry, 09-01, Volume: 25, Issue:17
Synthesis and biological investigation of tetrahydropyridopyrimidinone derivatives as potential multireceptor atypical antipsychotics.
AID1447993Displacement of [3H]spiperone from human D2LR expressed in CHO cell membranes by radioligand binding assay2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID1153310Antagonist activity at human dopamine D2 short receptor transiently expressed in HEK293 cells assessed as inhibition of beta-arrestin recruitment after 6 hrs by chemiluminescence assay relative to qunipirole2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Functionally selective dopamine D₂, D₃ receptor partial agonists.
AID1442559Displacement of [3H]spiperone from human Dopamine D2L receptor expressed in CHO cell membranes after 2 hrs by scintillation counting analysis2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1071697Antipsychotic activity in albino mouse assessed as inhibition of apomorphine-induced climbing behaviour at 15 mg/kg, ip measured after 10 mins at 5 mins interval for 30 mins relative to control2014European journal of medicinal chemistry, Mar-03, Volume: 74Design, synthesis, pharmacological evaluation and computational studies of 1-(biphenyl-4-yl)-2-[4-(substituted phenyl)-piperazin-1-yl]ethanones as potential antipsychotics.
AID1374521Drug metabolism in human liver microsomes assessed as OPC-14857 formation at 50 uM preincubated for 5 mins followed by NADPH addition measured after 30 mins by UPLC-MS analysis2018Bioorganic & medicinal chemistry letters, 03-01, Volume: 28, Issue:5
MF-8, a novel promising arylpiperazine-hydantoin based 5-HT
AID410535Toxicity in sc dosed NMRI mouse assessed as cataleptogenic potential administered 30 mins prior to testing measured every 15 mins for 60 mins by horizontal bar test2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Discovery of a new class of potential multifunctional atypical antipsychotic agents targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors: design, synthesis, and effects on behavior.
AID1301289Antipsychotic activity in ig dosed mouse assessed as inhibition of PCP-induced hyperactivity2016Bioorganic & medicinal chemistry letters, 07-01, Volume: 26, Issue:13
Synthesis, structure-activity relationships, and biological evaluation of a series of benzamides as potential multireceptor antipsychotics.
AID1309129Displacement of [3H]8-OH-DPAT from human 5-HT1A receptor expressed in cell membranes after 1 hr by liquid scintillation counting2016Bioorganic & medicinal chemistry, 08-15, Volume: 24, Issue:16
Design and synthesis of dual 5-HT1A and 5-HT7 receptor ligands.
AID1411907Tmax in human at 9.75 mg, im administered as single dose2018MedChemComm, May-01, Volume: 9, Issue:5
Schizophrenia: synthetic strategies and recent advances in drug design.
AID1393364Displacement of [3H]-ketanserin from human 5-HT2AR expressed in CHO-K1 cell membranes after 1.5 hrs by microbeta counting method
AID1442579Agonist activity at N-terminal flag-tagged D2S receptor (unknown origin) expressed in HEK293 cells coexpressing renilla luciferase 2-tagged GalphaoB after 10 mins by BRET assay relative to quinpirole2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1458660Agonist activity at human recombinant 5-HT6 receptor expressed in CHO cells at 1 x 10'-6 M after 45 mins by HTRF method2017Journal of medicinal chemistry, 09-14, Volume: 60, Issue:17
Novel 3-(1,2,3,6-Tetrahydropyridin-4-yl)-1H-indole-Based Multifunctional Ligands with Antipsychotic-Like, Mood-Modulating, and Procognitive Activity.
AID1573433Inverse agonist activity at dopamine D2 receptor (unknown origin) assessed as increase in beta-arrestin-2 recruitment2018Journal of medicinal chemistry, 11-21, Volume: 61, Issue:22
Biased Ligands of G Protein-Coupled Receptors (GPCRs): Structure-Functional Selectivity Relationships (SFSRs) and Therapeutic Potential.
AID113717Inhibition of the GBL-induced increase in DOPA synthesis in mice.1998Journal of medicinal chemistry, Feb-26, Volume: 41, Issue:5
Novel antipsychotic agents with dopamine autoreceptor agonist properties: synthesis and pharmacology of 7-[4-(4-phenyl-1-piperazinyl)butoxy]-3,4-dihydro-2(1H)-quinolinone derivatives.
AID1309133Displacement of [3H]Mesulergine from rat 5-HT2C receptor expressed in cell membranes after 1 hr by liquid scintillation counting2016Bioorganic & medicinal chemistry, 08-15, Volume: 24, Issue:16
Design and synthesis of dual 5-HT1A and 5-HT7 receptor ligands.
AID1210231Total plasma concentration in wild type Sprague-Dawley rat expressing Abcb1a at 6 mg/kg/day administered through continuous minipump treatment for 3 days by UPLC-MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID1458673Toxicity in ip dosed CD-1 mouse assessed as induction of catalepsy administered for 30 mins measured after 30 to 120 mins by bar test2017Journal of medicinal chemistry, 09-14, Volume: 60, Issue:17
Novel 3-(1,2,3,6-Tetrahydropyridin-4-yl)-1H-indole-Based Multifunctional Ligands with Antipsychotic-Like, Mood-Modulating, and Procognitive Activity.
AID114205post-synaptic DA receptor antagonist activity was evaluated by inhibition of the apomorphine-induced stereotyped behavior in mice. inactive at single given dose1998Journal of medicinal chemistry, Feb-26, Volume: 41, Issue:5
Novel antipsychotic agents with dopamine autoreceptor agonist properties: synthesis and pharmacology of 7-[4-(4-phenyl-1-piperazinyl)butoxy]-3,4-dihydro-2(1H)-quinolinone derivatives.
AID1196349Anti-depressant-like activity in intraperitoneally dosed 3-months old Wistar rat by Porsolt's forced swim test2015European journal of medicinal chemistry, Mar-06, Volume: 92Novel 5-HT6 receptor antagonists/D2 receptor partial agonists targeting behavioral and psychological symptoms of dementia.
AID1157849Intrinsic activity at human D2L receptor expressed in FlpIn CHO cells assessed as induction of ERK1/2 phosphorylation by AlphaScreen assay2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Structure-activity relationships of privileged structures lead to the discovery of novel biased ligands at the dopamine D₂ receptor.
AID1196355Effect on pain threshold in intraperitoneally dosed Wistar rat by hot plate test2015European journal of medicinal chemistry, Mar-06, Volume: 92Novel 5-HT6 receptor antagonists/D2 receptor partial agonists targeting behavioral and psychological symptoms of dementia.
AID705600Half life in human2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
Mechanism-based inactivation (MBI) of cytochrome P450 enzymes: structure-activity relationships and discovery strategies to mitigate drug-drug interaction risks.
AID1512154Displacement of [3H]methylspiperone from human D2 receptor by radio ligand binding assay2019Bioorganic & medicinal chemistry letters, 11-01, Volume: 29, Issue:21
Design, synthesis and biological evaluation of novel serotonin and dopamine receptor ligands being 6-bromohexyl saccharine derivatives.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1442562Agonist activity at human Dopamine D2S receptor expressed in HEK293T cell membranes coexpressing GalphaoA incubated for 30 mins measured after 75 mins by [35S]GTPgammaS binding assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1889739Antipsychotic activity in male Wistar rat assessed as restoration of prepulse inhibition of acoustic startle response at 1 mg/kg, ip2022European journal of medicinal chemistry, Mar-15, Volume: 232Novel D
AID1704752Therapeutic index, ratio of ED50 for toxicity in po dosed Kunming mouse assessed as catalepsy to ED50 for antipsychotic activity in Kunming mouse assessed as inhibition of MK801-induced locomotor activity
AID492645Antipsychotic activity in NMRI mouse assessed as increase of PCP-induced locomotor activity at 10 mg/kg, ip administered 30 mins prior to testing measured for 60 mins2010Journal of medicinal chemistry, Jun-24, Volume: 53, Issue:12
Discovery of bishomo(hetero)arylpiperazines as novel multifunctional ligands targeting dopamine D(3) and serotonin 5-HT(1A) and 5-HT(2A) receptors.
AID1210216Percentage unbound in Sprague-Dawley rat brain at 1 uM after 5 hrs by equilibrium dialysis method2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID1769332Displacement of [3H]N-methylspiperone from human D3 receptor expressed in HEK293 cell membranes measured after 60 mins by MicroBeta scintillation counting method
AID1442602Antipsychotic activity in Sprague-Dawley rat assessed as inhibition of AMPH-induced locomotion at 1.5 mg/kg/day administered via osmotic Alzet mini pump for 7 days post 6 days challenge with AMPH by open field test2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID669782Antibacterial activity against Staphylococcus aureus SA-1199B harboring grlA A116E mutant by microdilution techniques2012ACS medicinal chemistry letters, Mar-08, Volume: 3, Issue:3
Ligand Promiscuity between the Efflux Pumps Human P-Glycoprotein and S. aureus NorA.
AID1693539Displacement of [3H]-N-methylspiperone from human dopamine D2 receptor by liquid scintillation counting2021Bioorganic & medicinal chemistry, 01-15, Volume: 30A study of the structure-affinity relationship in SYA16263; is a D
AID723179Displacement of [3H]-raclopride from human dopamine D2L receptor expressed in HEK293 after 1 hr2013European journal of medicinal chemistry, Feb, Volume: 60Antidepressant and antipsychotic activity of new quinoline- and isoquinoline-sulfonamide analogs of aripiprazole targeting serotonin 5-HT₁A/5-HT₂A/5-HT₇ and dopamine D₂/D₃ receptors.
AID1403795Antagonist activity at 5-HT2C receptor (unknown origin) after 10 mins by calcium 5 dye based FLIPR assay
AID1233019Antipsychotic activity in ip dosed CD-1 mouse assessed as inhibition of D-amphetamine-induced hyperlocomotor activity2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Novel spirohydantoin derivative as a potent multireceptor-active antipsychotic and antidepressant agent.
AID1442583Agonist activity at N-terminal flag-tagged D2S receptor (unknown origin) expressed in HEK293 cells assessed as induction of renilla luciferase 2-tagged beta-arrestin-2 recruitment after 15 mins by BRET assay relative to quinpirole2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1447996Displacement of [3H]spiperone from human D4R expressed in CHO cell membranes by radioligand binding assay2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID698938Displacement of [3H]N-methylspiperone from human D2L receptor expressed in CHO cells after 1.5 hrs by microbeta counting method2012Journal of medicinal chemistry, Aug-23, Volume: 55, Issue:16
Structure-functional selectivity relationship studies of β-arrestin-biased dopamine D₂ receptor agonists.
AID1153297Displacement of [3H]Spiperone from human dopamine D3 receptor expressed in CHO cells by competitive binding assay2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Functionally selective dopamine D₂, D₃ receptor partial agonists.
AID298494Displacement of [3H]pyrilamine from histaminergic H1 receptor guinea pig cerebellum2007Journal of medicinal chemistry, Oct-18, Volume: 50, Issue:21
Principal component analysis differentiates the receptor binding profiles of three antipsychotic drug candidates from current antipsychotic drugs.
AID1865874Displacement of [3H]-8-OH-DPAT from human 5-HT1A receptor incubated for 1 hr by liquid scintillation counting method
AID1196348Anti-depressant-like activity in intraperitoneally dosed 3-months old Wistar rat assessed as reduction in saccharin self-administration2015European journal of medicinal chemistry, Mar-06, Volume: 92Novel 5-HT6 receptor antagonists/D2 receptor partial agonists targeting behavioral and psychological symptoms of dementia.
AID1245098Activity at dopamine D2S receptor (unknown origin) expressed in HEK293 cell membranes co-expressing Galpha protein subunit Galphai2 by [35S]GTPgammaS binding assay2015Bioorganic & medicinal chemistry, Sep-15, Volume: 23, Issue:18
1,4-Disubstituted aromatic piperazines with high 5-HT2A/D2 selectivity: Quantitative structure-selectivity investigations, docking, synthesis and biological evaluation.
AID1517960Displacement of [3H]-raclopride from human D2L receptor expressed in HEK293 cells incubated for 1 hr by liquid scintillation counting method
AID1442569Agonist activity at human Dopamine D2S receptor expressed in HEK293T cell membranes coexpressing Galphai2 incubated for 30 mins measured after 75 mins by [35S]GTPgammaS binding assay relative to quinpirole2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1756802Displacement of [3H]-LSD from human 5-HT7 receptor incubated for 1 hr by liquid scintillation counting method2021European journal of medicinal chemistry, Mar-15, Volume: 214New dual 5-HT1A and 5-HT7 receptor ligands derived from SYA16263.
AID1442565Agonist activity at human Dopamine D3 receptor expressed in HEK293T cell membranes coexpressing GalphaoA incubated for 30 mins measured after 75 mins by [35S]GTPgammaS binding assay relative to quinpirole2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1403799Inhibition of human ERG by auomated patch clamp assay
AID1169861Binding affinity to dopamine D3 receptor (unknown origin)2014Journal of medicinal chemistry, Nov-26, Volume: 57, Issue:22
Targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors for developing effective antipsychotics: synthesis, biological characterization, and behavioral studies.
AID1762060Binding affinity to alpha1 adrenoceptor (unknown origin)2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID1393473Reversal of ketamine-induced working social withdrawal in ip dosed Sprague-Dawley rat pretreated for 60 mins followed by ketamine administration
AID722917Displacement of [3H]-methylspiperone from human dopamine D3 receptor expressed in HEK293 after 1 hr2013European journal of medicinal chemistry, Feb, Volume: 60Antidepressant and antipsychotic activity of new quinoline- and isoquinoline-sulfonamide analogs of aripiprazole targeting serotonin 5-HT₁A/5-HT₂A/5-HT₇ and dopamine D₂/D₃ receptors.
AID1210215Percentage unbound in Sprague-Dawley rat plasma at 1 uM after 5 hrs by equilibrium dialysis method2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID1153304Agonist activity at human dopamine D2 short receptor transiently expressed in HEK293 cells co-expressing Galphao1 after 30 mins by [35S]GTPgammaS binding assay relative to quinpirole2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Functionally selective dopamine D₂, D₃ receptor partial agonists.
AID1762067Antipsychotic activity in po dosed rat assessed as suppression in conditioned avoidance response by CAR test2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID1210172Unbound brain to plasma partition coefficient of the compound in wild type Sprague-Dawley rat expressing Abcb1a at 6 mg/kg/day administered through continuous minipump treatment for 3 days2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID1442578Agonist activity at N-terminal flag-tagged D2S receptor (unknown origin) expressed in HEK293 cells coexpressing renilla luciferase 2-tagged GalphaoB after 10 mins by BRET assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1210214Total brain to plasma partition coefficient of the compound in mdr1a-deficient mouse at 3 mg/kg/day administered through continuous minipump treatment for 3 days2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID516812In vivo intrinsic activity at D2 receptor in mouse brain assessed as inhibition of gamma-butyrolactone-induced increase in DOPA synthesis at 30 mg/kg, po administered 60 mins before gamma-butyrolactone challenge measured after 30 mins2010Bioorganic & medicinal chemistry letters, Oct-01, Volume: 20, Issue:19
6-Alkoxyisoindolin-1-one based dopamine D2 partial agonists as potential antipsychotics.
AID298478Displacement of [3H]spiperone from human dopamine D2 receptor short form expressed in CHO cells2007Journal of medicinal chemistry, Oct-18, Volume: 50, Issue:21
Principal component analysis differentiates the receptor binding profiles of three antipsychotic drug candidates from current antipsychotic drugs.
AID1153294Displacement of [3H]SCH23390 from human dopamine D1 receptor expressed in HEK293 cells by competitive binding assay2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Functionally selective dopamine D₂, D₃ receptor partial agonists.
AID1301295Inhibition of human ERG after 10 mins2016Bioorganic & medicinal chemistry letters, 07-01, Volume: 26, Issue:13
Synthesis, structure-activity relationships, and biological evaluation of a series of benzamides as potential multireceptor antipsychotics.
AID1693544Displacement of [3H]-mesulergine from human 5HT2C receptor by liquid scintillation counting2021Bioorganic & medicinal chemistry, 01-15, Volume: 30A study of the structure-affinity relationship in SYA16263; is a D
AID1762064Antipsychotic activity in po dosed mouse assessed as suppression of apomorphine-induced climbing behaviour2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID595497Binding affinity to human 5HT2A receptor2011Bioorganic & medicinal chemistry letters, May-01, Volume: 21, Issue:9
Discovery of PF-00217830: aryl piperazine napthyridinones as D2 partial agonists for schizophrenia and bipolar disorder.
AID1682829Binding affinity to adrenergic alpha1 receptor (unknown origin)
AID516820Induction of catalepsy in mouse at 30 mg/kg, po2010Bioorganic & medicinal chemistry letters, Oct-01, Volume: 20, Issue:19
6-Alkoxyisoindolin-1-one based dopamine D2 partial agonists as potential antipsychotics.
AID1865878Displacement of [3H]-N-methylspiperone from human D3 receptor incubated for 1 hr by liquid scintillation counting method
AID1232331Selectivity index, ratio of Ki for human dopamine D4 receptor to KI for human dopamine D3 receptor2015Journal of medicinal chemistry, Jul-23, Volume: 58, Issue:14
Identifying Medication Targets for Psychostimulant Addiction: Unraveling the Dopamine D3 Receptor Hypothesis.
AID1245096Activity at dopamine D2S receptor (unknown origin) expressed in HEK293 cell membranes co-expressing Galpha protein subunit Galphao1 by [35S]GTPgammaS binding assay2015Bioorganic & medicinal chemistry, Sep-15, Volume: 23, Issue:18
1,4-Disubstituted aromatic piperazines with high 5-HT2A/D2 selectivity: Quantitative structure-selectivity investigations, docking, synthesis and biological evaluation.
AID1210212Total plasma concentration in mouse at 3 mg/kg/day administered through continuous minipump treatment for 3 days by UPLC-MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID1220558Fraction unbound in Beagle dog brain homogenates at 1 uM after 6 hrs by equilibrium dialysis method2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Species independence in brain tissue binding using brain homogenates.
AID1704748Antipsychotic activity in Kunming mouse assessed as inhibition of MK801-induced locomotor activity administered orally 30 mins prior to MK801 challenge and measured for 90 mins
AID458633Displacement of [3H]spiperone from human dopamine D2 receptor at high affinity state expressed in HEK293 cells2010Journal of medicinal chemistry, Mar-25, Volume: 53, Issue:6
Synthesis and evaluation of a set of 4-phenylpiperidines and 4-phenylpiperazines as D2 receptor ligands and the discovery of the dopaminergic stabilizer 4-[3-(methylsulfonyl)phenyl]-1-propylpiperidine (huntexil, pridopidine, ACR16).
AID1309135Displacement of [3H]N-methylspiperone from human D3 receptor expressed in cell membranes after 1 hr by liquid scintillation counting2016Bioorganic & medicinal chemistry, 08-15, Volume: 24, Issue:16
Design and synthesis of dual 5-HT1A and 5-HT7 receptor ligands.
AID1458663Antagonist activity at human recombinant 5-HT7 receptor expressed in CHO cells assessed as inhibition of 5-HT induced response at 1 x 10'-6 M after 30 mins by HTRF method2017Journal of medicinal chemistry, 09-14, Volume: 60, Issue:17
Novel 3-(1,2,3,6-Tetrahydropyridin-4-yl)-1H-indole-Based Multifunctional Ligands with Antipsychotic-Like, Mood-Modulating, and Procognitive Activity.
AID1232328Displacement of [3H]N-methylspiperone from human dopamine D3 receptor expressed in HEK293 cells2015Journal of medicinal chemistry, Jul-23, Volume: 58, Issue:14
Identifying Medication Targets for Psychostimulant Addiction: Unraveling the Dopamine D3 Receptor Hypothesis.
AID1196353Anxiolytic activity in intraperitoneally dosed >18-months old Wistar rat by open-field test2015European journal of medicinal chemistry, Mar-06, Volume: 92Novel 5-HT6 receptor antagonists/D2 receptor partial agonists targeting behavioral and psychological symptoms of dementia.
AID698936Agonist activity at human D2L receptor expressed in HEK293T cells coexpressing Gi subunit assessed as inhibition of isoproterenol-stimulated cAMP production by luminescence assay relative to quinpirole2012Journal of medicinal chemistry, Aug-23, Volume: 55, Issue:16
Structure-functional selectivity relationship studies of β-arrestin-biased dopamine D₂ receptor agonists.
AID516811Intrinsic activity at human dopamine 5HT1A receptor expressed in HeLa cells by FLIPR assay2010Bioorganic & medicinal chemistry letters, Oct-01, Volume: 20, Issue:19
6-Alkoxyisoindolin-1-one based dopamine D2 partial agonists as potential antipsychotics.
AID298485Displacement of [3H]mesulergine from 5HT2C receptor expressed in CHO cells2007Journal of medicinal chemistry, Oct-18, Volume: 50, Issue:21
Principal component analysis differentiates the receptor binding profiles of three antipsychotic drug candidates from current antipsychotic drugs.
AID1756798Displacement of [3H]N-methylspiperone from human dopamine D4 receptor incubated for 1 hr by liquid scintillation counting method2021European journal of medicinal chemistry, Mar-15, Volume: 214New dual 5-HT1A and 5-HT7 receptor ligands derived from SYA16263.
AID595498Displacement of [3H]-8-OH-DPAT from human 5HT1A receptor expressed in HeLa cells2011Bioorganic & medicinal chemistry letters, May-01, Volume: 21, Issue:9
Discovery of PF-00217830: aryl piperazine napthyridinones as D2 partial agonists for schizophrenia and bipolar disorder.
AID298488Displacement of [3H]BLR-43694 from human 5HT3 receptor expressed in HEK293 cells2007Journal of medicinal chemistry, Oct-18, Volume: 50, Issue:21
Principal component analysis differentiates the receptor binding profiles of three antipsychotic drug candidates from current antipsychotic drugs.
AID1443628Agonist activity at human dopamine D2 receptor expressed in HEK293 cells coexpressing renilla luciferase-fused GalphaoA/GFP10-fused Ggamma2 by BRET assay
AID1762102Cognitive enhancement effect in rat assessed as effect on total exploration time at 0.05 to 0.3 mg/kg, po administered 1 hr prior to acquisition trial and by novel object recognition test2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID1245094Displacement of [3H]ketanserin from human 5-HT2A receptor expressed in HEK293 cell membranes by radioligand competition binding assay2015Bioorganic & medicinal chemistry, Sep-15, Volume: 23, Issue:18
1,4-Disubstituted aromatic piperazines with high 5-HT2A/D2 selectivity: Quantitative structure-selectivity investigations, docking, synthesis and biological evaluation.
AID616780Binding affinity to SERT2011Journal of medicinal chemistry, Sep-22, Volume: 54, Issue:18
Design and synthesis of novel arylpiperazine derivatives containing the imidazole core targeting 5-HT(2A) receptor and 5-HT transporter.
AID1245089Displacement of [3H]spiperone from human dopamine D2L receptor expressed in CHO cell membranes by radioligand competition binding assay2015Bioorganic & medicinal chemistry, Sep-15, Volume: 23, Issue:18
1,4-Disubstituted aromatic piperazines with high 5-HT2A/D2 selectivity: Quantitative structure-selectivity investigations, docking, synthesis and biological evaluation.
AID1153309Antagonist activity at human dopamine D2 short receptor transiently expressed in HEK293 cells assessed as inhibition of beta-arrestin recruitment after 6 hrs by chemiluminescence assay2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Functionally selective dopamine D₂, D₃ receptor partial agonists.
AID1220555Fraction unbound in Sprague-Dawley rat brain homogenates at 1 uM after 6 hrs by equilibrium dialysis method2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Species independence in brain tissue binding using brain homogenates.
AID599884Displacement of [3H]5-LSD from human 5HT6 receptor expressed in human HeLa cells2010Bioorganic & medicinal chemistry letters, Sep-15, Volume: 20, Issue:18
Novel 7-phenylsulfanyl-1,2,3,4,10,10a-hexahydro-pyrazino[1,2-a]indoles as dual serotonin 5-HT2C and 5-HT6 receptor ligands.
AID114076post-synaptic dopamine autoreceptor antagonist activity evaluated by inhibition of the apomorphine-induced stereotyped behavior in mice.1998Journal of medicinal chemistry, Feb-26, Volume: 41, Issue:5
Novel antipsychotic agents with dopamine autoreceptor agonist properties: synthesis and pharmacology of 7-[4-(4-phenyl-1-piperazinyl)butoxy]-3,4-dihydro-2(1H)-quinolinone derivatives.
AID1458669Antipsychotic activity in CD-1 mouse assessed as reduction in MK-801-induced hyperlocomotion administered 30 mins followed by 15 mins of MK-801 challenge2017Journal of medicinal chemistry, 09-14, Volume: 60, Issue:17
Novel 3-(1,2,3,6-Tetrahydropyridin-4-yl)-1H-indole-Based Multifunctional Ligands with Antipsychotic-Like, Mood-Modulating, and Procognitive Activity.
AID1403801Antipsychotic activity in ig dosed ICR mouse assessed as inhibition of PCP-induced hyper-locomotion pretreated for 45 mins followed by PCP challenge measured after 10 mins for 75 mins
AID410529Antipsychotic activity in NMRI mouse assessed as reduction in methamphetamine-induced locomotor activity administered 30 mins prior to testing measured for 60 mins2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Discovery of a new class of potential multifunctional atypical antipsychotic agents targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors: design, synthesis, and effects on behavior.
AID1693540Displacement of [3H]-N-methylspiperone from human dopamine D3 receptor by liquid scintillation counting2021Bioorganic & medicinal chemistry, 01-15, Volume: 30A study of the structure-affinity relationship in SYA16263; is a D
AID723183Displacement of [3H]-ketanserin from human 5HT2A receptor expressed in HEK293 after 1.5 hrs2013European journal of medicinal chemistry, Feb, Volume: 60Antidepressant and antipsychotic activity of new quinoline- and isoquinoline-sulfonamide analogs of aripiprazole targeting serotonin 5-HT₁A/5-HT₂A/5-HT₇ and dopamine D₂/D₃ receptors.
AID1462324Induction of catalepsy in ig dosed ICR mouse assessed as incidence of unwanted extrapyramidal motor disturbances2017Bioorganic & medicinal chemistry, 09-01, Volume: 25, Issue:17
Synthesis and biological investigation of tetrahydropyridopyrimidinone derivatives as potential multireceptor atypical antipsychotics.
AID1442591Agonist activity at Dopamine D2L receptor (unknown origin) expressed in HEK293T cells coexpressing GFP-fused GIRK1/2 channels assessed as induction of inwardly rectifying K+ current at -70 mV holding potential at 1 uM measured up to 1.1 secs by patch clam2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID458632Displacement of [3H]spiperone from human dopamine D2 receptor at low affinity state expressed in HEK293 cells2010Journal of medicinal chemistry, Mar-25, Volume: 53, Issue:6
Synthesis and evaluation of a set of 4-phenylpiperidines and 4-phenylpiperazines as D2 receptor ligands and the discovery of the dopaminergic stabilizer 4-[3-(methylsulfonyl)phenyl]-1-propylpiperidine (huntexil, pridopidine, ACR16).
AID492642Displacement of [3H]spiperone from dopamine D2 receptor in CRL:CD(SD)BR-COBS rat striatum by scintillation spectrometry2010Journal of medicinal chemistry, Jun-24, Volume: 53, Issue:12
Discovery of bishomo(hetero)arylpiperazines as novel multifunctional ligands targeting dopamine D(3) and serotonin 5-HT(1A) and 5-HT(2A) receptors.
AID1309134Displacement of [3H]N-methylspiperone from human D2 receptor expressed in cell membranes after 1 hr by liquid scintillation counting2016Bioorganic & medicinal chemistry, 08-15, Volume: 24, Issue:16
Design and synthesis of dual 5-HT1A and 5-HT7 receptor ligands.
AID1464178Displacement of [3H]spiperone from human D3R expressed in CHO cell membranes2017Bioorganic & medicinal chemistry, 10-15, Volume: 25, Issue:20
β-Arrestin biased dopamine D2 receptor partial agonists: Synthesis and pharmacological evaluation.
AID1889688Displacement of [3H]-raclopride from human D2L receptor expressed in HEK293 cells measured after 1 hr by Microbeta plate reader method2022European journal of medicinal chemistry, Mar-15, Volume: 232Novel D
AID410338Binding affinity to human ERG expressed in HEK293 cells by whole cell patch clamp method2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Discovery of a new class of potential multifunctional atypical antipsychotic agents targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors: design, synthesis, and effects on behavior.
AID723181Displacement of [3H]-LSD from human 5HT6 receptor expressed in HEK293 after 1 hr2013European journal of medicinal chemistry, Feb, Volume: 60Antidepressant and antipsychotic activity of new quinoline- and isoquinoline-sulfonamide analogs of aripiprazole targeting serotonin 5-HT₁A/5-HT₂A/5-HT₇ and dopamine D₂/D₃ receptors.
AID595499In vivo intrinsic activity at D2 receptor in po dosed mouse brain assessed as inhibition of gamma-butyrolactone-induced increase in DOPA synthesis2011Bioorganic & medicinal chemistry letters, May-01, Volume: 21, Issue:9
Discovery of PF-00217830: aryl piperazine napthyridinones as D2 partial agonists for schizophrenia and bipolar disorder.
AID1474757Agonist activity at D2 long receptor (unknown origin) expressed in Flp-In-CHO cells co-expressing Rluc8-tagged Galphai1 assessed as change in transduction coefficient by measuring Galphai1 activation after 5 mins in presence of coelenterazine by BRET assa2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
Pharmacological property optimization for allosteric ligands: A medicinal chemistry perspective.
AID1808022Inhibition of porcine heart malate dehydrogenase assessed as critical aggregation concentration preincubated for 5 min followed by nicotinamide adenine dinucleotide addition and monitered for 90 sec by spectrophotometric method2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
Colloidal Aggregators in Biochemical SARS-CoV-2 Repurposing Screens.
AID516809Intrinsic activity at human dopamine D2L receptor expressed in CHO cells by FLIPR assay relative to quinpirole2010Bioorganic & medicinal chemistry letters, Oct-01, Volume: 20, Issue:19
6-Alkoxyisoindolin-1-one based dopamine D2 partial agonists as potential antipsychotics.
AID1762058Binding affinity to 5-HT2C receptor (unknown origin)2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID1210233Total brain to plasma partition coefficient of the compound in wild type Sprague-Dawley rat expressing Abcb1a at 6 mg/kg/day administered through continuous minipump treatment for 3 days2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID1393369Selectivity index, ratio of pKi for 5-HT2AR to pKi for human D2LR
AID1704718Displacement of [3H]ketanserin from rat cerebral cortex 5HT2A receptor measured after 15 mins by liquid scintillation counting method
AID410336Displacement of [3H]mesulergine from 5HT2C receptor in CRL:(HA) BR albino guinea pig cortex by scintillation spectrometry2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Discovery of a new class of potential multifunctional atypical antipsychotic agents targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors: design, synthesis, and effects on behavior.
AID1704717Displacement of [3H](+)8-OH-DPAT from rat cerebral cortex 5HT1A receptor measured after 30 mins by liquid scintillation counting method
AID1443615Selectivity ratio of Ki for human dopamine D3 receptor expressed in HEK293 cell membranes to Ki for human dopamine D2 receptor expressed in HEK293 cell membranes
AID1442555Displacement of [3H]spiperone from human Dopamine D4 receptor expressed in CHO cell membranes after 2 hrs by scintillation counting analysis2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1448008Partial agonist activity at human D2SR expressed in HEK293T cells co-expressing (EA)beta-arrestin2 and GRK2 assessed as induction of beta-arrestin2 recruitment after 5 hrs by chemiluminescence assay2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID1233028Ratio of MED for catalepsy in CD-1 mouse to ED50 for antipsychotic activity in CD-1 mouse2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Novel spirohydantoin derivative as a potent multireceptor-active antipsychotic and antidepressant agent.
AID463570Partial agonistic activity at dopamine D2 receptor relative to aripiprazole2010Bioorganic & medicinal chemistry letters, Mar-15, Volume: 20, Issue:6
The identification of a selective dopamine D2 partial agonist, D3 antagonist displaying high levels of brain exposure.
AID1458664Agonist activity at human recombinant 5-HT1A receptor expressed in HEK-293 cells at 1 x 10'-6 M by cellular dielectric spectroscopy2017Journal of medicinal chemistry, 09-14, Volume: 60, Issue:17
Novel 3-(1,2,3,6-Tetrahydropyridin-4-yl)-1H-indole-Based Multifunctional Ligands with Antipsychotic-Like, Mood-Modulating, and Procognitive Activity.
AID1169867Antipsychotic-like activity in sc dosed NMRI mouse assessed as reduction in MK801-induced locomotor activity dosed 15 to 30 mins before administration of MK801 measured for 60 mins2014Journal of medicinal chemistry, Nov-26, Volume: 57, Issue:22
Targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors for developing effective antipsychotics: synthesis, biological characterization, and behavioral studies.
AID1448006Agonist activity at human D2S receptor expressed in HEK293T cell membranes coexpressing Galphao1 assessed as induction of nucleotide exchange at 0.1 pM to 100 uM preincubated for 30 mins followed by addition of [35S]GTPgammaS measured after 30 mins by [352017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID1464175Displacement of [3H]SCH23390 from human D1R expressed in HEK293T cell membranes2017Bioorganic & medicinal chemistry, 10-15, Volume: 25, Issue:20
β-Arrestin biased dopamine D2 receptor partial agonists: Synthesis and pharmacological evaluation.
AID1220557Fraction unbound in Hartley guinea pig brain homogenates at 1 uM after 6 hrs by equilibrium dialysis method2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Species independence in brain tissue binding using brain homogenates.
AID1442572Agonist activity at N-terminal flag-tagged D2S receptor (unknown origin) expressed in HEK293 cells coexpressing renilla luciferase 2-tagged Galphai1 after 10 mins by BRET assay relative to quinpirole2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1442597Agonist activity at Dopamine D3 receptor (unknown origin) expressed in HEK293T cells coexpressing GFP-fused GIRK1/2 channels assessed as induction of inwardly rectifying K+ current at -70 mV holding potential at 1 uM measured up to 1.1 secs by patch clamp2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1245087Selectivity index, ratio of Ki for human 5HT2A receptor to Ki for human dopamine D2 receptor2015Bioorganic & medicinal chemistry, Sep-15, Volume: 23, Issue:18
1,4-Disubstituted aromatic piperazines with high 5-HT2A/D2 selectivity: Quantitative structure-selectivity investigations, docking, synthesis and biological evaluation.
AID1169865Effect on spontaneous exploratory locomotor activity in sc dosed NMRI mouse measured for 30 mins with activity counts each 5 mins2014Journal of medicinal chemistry, Nov-26, Volume: 57, Issue:22
Targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors for developing effective antipsychotics: synthesis, biological characterization, and behavioral studies.
AID1442557Displacement of [3H]SCH23390 from human Dopamine D1 receptor expressed in HEK293T cell membranes after 2 hrs by scintillation counting analysis2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1512153Displacement of [3H]8-OH-DPAT from human 5HT1A receptor by radio ligand binding assay2019Bioorganic & medicinal chemistry letters, 11-01, Volume: 29, Issue:21
Design, synthesis and biological evaluation of novel serotonin and dopamine receptor ligands being 6-bromohexyl saccharine derivatives.
AID1762056Binding affinity to 5-HT1A receptor (unknown origin)2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID1442598Increase in inwardly rectifying K+ current in human HEK293T cells coexpressing GFP-fused GIRK1/2 channels at -70 mV holding potential at 1 uM measured up to 1.1 secs by patch clamp electrophysiology assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1474768Agonist activity at D2 long receptor (unknown origin) expressed in Flp-In-CHO cells assessed as ratio of GalphaoB activation to cellular impedance at 2 mins post dose2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
Pharmacological property optimization for allosteric ligands: A medicinal chemistry perspective.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1889692Antagonist activity at 5-HT3 receptor in guinea-pig ileum assessed as inhibition of 5HT-induced contraction2022European journal of medicinal chemistry, Mar-15, Volume: 232Novel D
AID1196352Anxiolytic activity in intraperitoneally dosed 3-months old Wistar rat by open-field test2015European journal of medicinal chemistry, Mar-06, Volume: 92Novel 5-HT6 receptor antagonists/D2 receptor partial agonists targeting behavioral and psychological symptoms of dementia.
AID1210246Total plasma concentration in mdr1a-deficient Sprague-Dawley rat at 6 mg/kg/day administered through continuous minipump treatment for 3 days by UPLC-MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID1442563Agonist activity at human Dopamine D2S receptor expressed in HEK293T cell membranes coexpressing GalphaoA incubated for 30 mins measured after 75 mins by [35S]GTPgammaS binding assay relative to quinpirole2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1374529Drug metabolism in mouse liver microsomes assessed as DM1451 formation at 50 uM preincubated for 5 mins followed by NADPH addition measured after 30 mins by UPLC-MS analysis2018Bioorganic & medicinal chemistry letters, 03-01, Volume: 28, Issue:5
MF-8, a novel promising arylpiperazine-hydantoin based 5-HT
AID669781Inhibition of human recombinant MDR1 expressed in mouse L5178Y cells assessed as inhibition of rhodamine-123 efflux at 10'-4 M preincubated for 10 mins measured after 20 mins by FACS analysis2012ACS medicinal chemistry letters, Mar-08, Volume: 3, Issue:3
Ligand Promiscuity between the Efflux Pumps Human P-Glycoprotein and S. aureus NorA.
AID1464182Displacement of [3H]ketanserin from human 5-HT2AR expressed in HEK293T cell membranes12017Bioorganic & medicinal chemistry, 10-15, Volume: 25, Issue:20
β-Arrestin biased dopamine D2 receptor partial agonists: Synthesis and pharmacological evaluation.
AID1442561Displacement of [3H]ketanserin from human 5-HT2A receptor expressed in HEK293T cell membranes after 2 hrs by scintillation counting analysis2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID492640Displacement of [3H]ketanserin from 5HT2A receptor in CRL:CD(SD)BR-COBS rat cortex by scintillation spectrometry2010Journal of medicinal chemistry, Jun-24, Volume: 53, Issue:12
Discovery of bishomo(hetero)arylpiperazines as novel multifunctional ligands targeting dopamine D(3) and serotonin 5-HT(1A) and 5-HT(2A) receptors.
AID1442574Agonist activity at N-terminal flag-tagged D2S receptor (unknown origin) expressed in HEK293 cells coexpressing renilla luciferase 2-tagged Galphai3 after 10 mins by BRET assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1301293Antagonistic activity at histamine1 receptor (unknown origin) after 10 mins by FLIPR assay2016Bioorganic & medicinal chemistry letters, 07-01, Volume: 26, Issue:13
Synthesis, structure-activity relationships, and biological evaluation of a series of benzamides as potential multireceptor antipsychotics.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1442580Agonist activity at N-terminal flag-tagged D2S receptor (unknown origin) expressed in HEK293 cells assessed as induction of renilla luciferase 2-tagged beta-arrestin-1 recruitment after 15 mins by BRET assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID616781Binding affinity to 5-HT2A2011Journal of medicinal chemistry, Sep-22, Volume: 54, Issue:18
Design and synthesis of novel arylpiperazine derivatives containing the imidazole core targeting 5-HT(2A) receptor and 5-HT transporter.
AID1823850Anxiolytic activity in stress-induced anxiety ip dosed Wistar rat model assessed as increase in open arm entry measured after 30 mins by elevated plus maze test
AID1704716Displacement of [3H]spiperone from D2 receptor in rat striatum measured after 15 mins by liquid scintillation counting method
AID723175Displacement of [3H]-citalopram from SERT in rat cerebral cortex after 1 hr by scintillation counting2013European journal of medicinal chemistry, Feb, Volume: 60Antidepressant and antipsychotic activity of new quinoline- and isoquinoline-sulfonamide analogs of aripiprazole targeting serotonin 5-HT₁A/5-HT₂A/5-HT₇ and dopamine D₂/D₃ receptors.
AID1210218Percentage unbound in Crl:NMRI(Han) mouse plasma at 1 uM after 5 hrs by equilibrium dialysis method2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID1210195Total drug level in wild type Crl:CF1 mouse brain expressing Abcb1a mutant at 3 mg/kg/day administered through continuous minipump treatment for 3 days by UPLC-MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1693546Displacement of [3H]-citalopram from human SERT by liquid scintillation counting2021Bioorganic & medicinal chemistry, 01-15, Volume: 30A study of the structure-affinity relationship in SYA16263; is a D
AID1152659Antipsychotic-like activity in po dosed Wistar rat assessed as inhibition of MK-801-induced hyperlocomotion administered 45 mins prior to MK-801 challenge measured 60 mins post-drug administration2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Novel arylsulfonamide derivatives with 5-HT₆/5-HT₇ receptor antagonism targeting behavioral and psychological symptoms of dementia.
AID1442601Effect on basal rearing in Sprague-Dawley rat at 1.5 mg/kg/day for 7 days administered via osmotic Alzet mini pump measured 20 mins post dose by open field test2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID298481Displacement of [3H]8-OH-DPAT from human 5HT1A receptor expressed in CHO cells2007Journal of medicinal chemistry, Oct-18, Volume: 50, Issue:21
Principal component analysis differentiates the receptor binding profiles of three antipsychotic drug candidates from current antipsychotic drugs.
AID1756803Displacement of [3H]-citalopram from human SERT receptor incubated for 1 hr by liquid scintillation counting method2021European journal of medicinal chemistry, Mar-15, Volume: 214New dual 5-HT1A and 5-HT7 receptor ligands derived from SYA16263.
AID1474755Agonist activity at Rluc8-tagged D2 long receptor (unknown origin) expressed in Flp-In-CHO cells co-expressing YFP-tagged beta-arrestin2 assessed as change in transduction coefficient by measuring beta-arrestin2 recruitment measured after 5 mins by BRET a2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
Pharmacological property optimization for allosteric ligands: A medicinal chemistry perspective.
AID1889746Antipsychotic activity in male Wistar rat assessed as effect on anogenital sniffing at 1 mg/kg, ip2022European journal of medicinal chemistry, Mar-15, Volume: 232Novel D
AID1704722Displacement of [3H]5-CT from rat cerebral cortex 5HT7 receptor measured after 30 mins by liquid scintillation counting method
AID1210184Unbound brain to plasma partition coefficient of the compound in wild type Crl:CF1 mouse expressing Abcb1a mutant at 3 mg/kg/day administered through continuous minipump treatment for 3 days2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
Species comparison of in vivo P-glycoprotein-mediated brain efflux using mdr1a-deficient rats and mice.
AID1517957Displacement of [3H]-8-OH-DPAT from human 5HT1A receptor expressed in CHO-K1 cell membranes incubated for 60 mins by microbeta scintillation counting analysis
AID1464180Displacement of [3H]SCH23390 from human D5R expressed in HEK293T cell membranes2017Bioorganic & medicinal chemistry, 10-15, Volume: 25, Issue:20
β-Arrestin biased dopamine D2 receptor partial agonists: Synthesis and pharmacological evaluation.
AID576612Inhibition of human ERG2011European journal of medicinal chemistry, Feb, Volume: 46, Issue:2
Predicting hERG activities of compounds from their 3D structures: development and evaluation of a global descriptors based QSAR model.
AID1443629Agonist activity at human dopamine D2 receptor expressed in HEK293 cells coexpressing renilla luciferase-fused GalphaoA/GFP10-fused Ggamma2 by BRET assay relative to quinpirole
AID1447992Displacement of [3H]SCH23390 from human D1R expressed in HEK293T cell membranes by radioligand binding assay2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID1309132Displacement of [3H]LSD from human 5-HT2B receptor expressed in cell membranes after 1 hr by liquid scintillation counting2016Bioorganic & medicinal chemistry, 08-15, Volume: 24, Issue:16
Design and synthesis of dual 5-HT1A and 5-HT7 receptor ligands.
AID277673Displacement of [3H]spiperone from human dopamine D3 expressed in CHO cell membrane2007Journal of medicinal chemistry, Feb-08, Volume: 50, Issue:3
Structure-selectivity investigations of D2-like receptor ligands by CoMFA and CoMSIA guiding the discovery of D3 selective PET radioligands.
AID1157850Ratio of intrinsic efficacy to KA for human D2L receptor expressed in FlpIn CHO cells assessed as induction of ERK1/2 phosphorylation by AlphaScreen assay2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Structure-activity relationships of privileged structures lead to the discovery of novel biased ligands at the dopamine D₂ receptor.
AID698937Agonist activity at human D2L receptor expressed in HEK293T cells coexpressing Gi subunit assessed as inhibition of isoproterenol-stimulated cAMP production by luminescence assay2012Journal of medicinal chemistry, Aug-23, Volume: 55, Issue:16
Structure-functional selectivity relationship studies of β-arrestin-biased dopamine D₂ receptor agonists.
AID277674Displacement of [3H]spiperone from human dopamine D4.4 expressed in CHO cell membrane2007Journal of medicinal chemistry, Feb-08, Volume: 50, Issue:3
Structure-selectivity investigations of D2-like receptor ligands by CoMFA and CoMSIA guiding the discovery of D3 selective PET radioligands.
AID1442600Effect on basal locomotion in Sprague-Dawley rat at 1.5 mg/kg/day for 7 days administered via osmotic Alzet mini pump measured 20 mins post dose by open field test2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1442573Agonist activity at N-terminal flag-tagged D2S receptor (unknown origin) expressed in HEK293 cells coexpressing renilla luciferase 2-tagged Galphai2 after 10 mins by BRET assay relative to quinpirole2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1782420Partial agonist activity at D2 receptor (unknown origin) expressed in HEK293T cells co-expressing Rluc8-tagged Galpahi1 assessed as Galphai1 dissociation preincubated for 2 mins with coelenterazine followed by compound addition and measured after 2 mins b2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
2-Phenylcyclopropylmethylamine Derivatives as Dopamine D
AID1232327Displacement of [3H]N-methylspiperone from human dopamine D2 receptor expressed in HEK293 cells2015Journal of medicinal chemistry, Jul-23, Volume: 58, Issue:14
Identifying Medication Targets for Psychostimulant Addiction: Unraveling the Dopamine D3 Receptor Hypothesis.
AID492639Displacement of [3H]mesulergine from 5HT2C receptor in CRL:(HA) BR albino guinea pig cortex by scintillation spectrometry2010Journal of medicinal chemistry, Jun-24, Volume: 53, Issue:12
Discovery of bishomo(hetero)arylpiperazines as novel multifunctional ligands targeting dopamine D(3) and serotonin 5-HT(1A) and 5-HT(2A) receptors.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1196354Procognitive effect in intraperitoneally dosed 3-months old Wistar rat assessed as extinction of non-reinforced responding for sweet reward2015European journal of medicinal chemistry, Mar-06, Volume: 92Novel 5-HT6 receptor antagonists/D2 receptor partial agonists targeting behavioral and psychological symptoms of dementia.
AID1169864Binding affinity to 5HT2C receptor (unknown origin)2014Journal of medicinal chemistry, Nov-26, Volume: 57, Issue:22
Targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors for developing effective antipsychotics: synthesis, biological characterization, and behavioral studies.
AID1782439Metabolic stability in human liver microsomes assessed as half life preincubated for 5 mins followed by NADPH addition measured after 10 mins by LC-MS analysis2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
2-Phenylcyclopropylmethylamine Derivatives as Dopamine D
AID277669Selectivity for dopamine D3 over dopamine D42007Journal of medicinal chemistry, Feb-08, Volume: 50, Issue:3
Structure-selectivity investigations of D2-like receptor ligands by CoMFA and CoMSIA guiding the discovery of D3 selective PET radioligands.
AID1889734Antipsychotic activity in male Wistar rat assessed as inhibition of amphetamine-stimulated locomotor activity at 1 mg/kg, ip2022European journal of medicinal chemistry, Mar-15, Volume: 232Novel D
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1309131Displacement of [3H]LSD from human 5-HT7 receptor expressed in cell membranes after 1 hr by liquid scintillation counting2016Bioorganic & medicinal chemistry, 08-15, Volume: 24, Issue:16
Design and synthesis of dual 5-HT1A and 5-HT7 receptor ligands.
AID1704750Toxicity in po dosed Kunming mouse assessed as catalepsy
AID1448004Partial agonist activity at human D2SR expressed in HEK293T cells co-expressing (EA)beta-arrestin2 assessed as induction of beta-arrestin2 recruitment after 5 hrs by chemiluminescence assay relative to quinpirole2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID1220554Fraction unbound in Wistar Han rat brain homogenates at 1 uM after 6 hrs by equilibrium dialysis method2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Species independence in brain tissue binding using brain homogenates.
AID1447995Displacement of [3H]spiperone from human D3R expressed in CHO cell membranes by radioligand binding assay2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID1153306Agonist activity at human dopamine D2 short receptor transiently expressed in HEK293 cells co-expressing Galphai2 after 30 mins by [35S]GTPgammaS binding assay relative to quinpirole2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Functionally selective dopamine D₂, D₃ receptor partial agonists.
AID1071696Antiserotogenic activity in albino mouse assessed as inhibition of 5HTP-induced head twitches at 15 mg/kg, ip measured for 5 mins at every 5 mins interval for 1 hr relative to control2014European journal of medicinal chemistry, Mar-03, Volume: 74Design, synthesis, pharmacological evaluation and computational studies of 1-(biphenyl-4-yl)-2-[4-(substituted phenyl)-piperazin-1-yl]ethanones as potential antipsychotics.
AID1756796Displacement of [3H]N-methylspiperone from human dopamine D2 receptor incubated for 1 hr by liquid scintillation counting method2021European journal of medicinal chemistry, Mar-15, Volume: 214New dual 5-HT1A and 5-HT7 receptor ligands derived from SYA16263.
AID598251Inhibition of human ABCB1-mediated rhodamine 123 efflux in mouse L5178 cells expressing human MDR1 after 20 mins by FACS analysis2011Journal of medicinal chemistry, Mar-24, Volume: 54, Issue:6
A novel approach for predicting P-glycoprotein (ABCB1) inhibition using molecular interaction fields.
AID1458661Antagonist activity at human recombinant 5-HT6 receptor expressed in CHO cells assessed as inhibition of 5-HT induced response at 1 x 10'-6 M after 30 mins by HTRF method2017Journal of medicinal chemistry, 09-14, Volume: 60, Issue:17
Novel 3-(1,2,3,6-Tetrahydropyridin-4-yl)-1H-indole-Based Multifunctional Ligands with Antipsychotic-Like, Mood-Modulating, and Procognitive Activity.
AID1442609Antagonist activity at N-terminal flag-tagged D2S receptor (unknown origin) expressed in HEK293 cells incubated for 1 h and followed by challenge with agonist for 15 mins BRET assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1245097Activity at dopamine D2S receptor (unknown origin) expressed in HEK293 cell membranes co-expressing Galpha protein subunit Galphao1 by [35S]GTPgammaS binding assay relative to quinpirole2015Bioorganic & medicinal chemistry, Sep-15, Volume: 23, Issue:18
1,4-Disubstituted aromatic piperazines with high 5-HT2A/D2 selectivity: Quantitative structure-selectivity investigations, docking, synthesis and biological evaluation.
AID1823848Anti-conflict activity in ip dosed Wistar rat assessed as number of shocks measured during 5 mins experimental period by measuring minimum effective dose by Vogel conflict drinking test
AID1442571Agonist activity at N-terminal flag-tagged D2S receptor (unknown origin) expressed in HEK293 cells coexpressing renilla luciferase 2-tagged Galphai1 after 10 mins by BRET assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1889749Modulation of human D2L receptor2022European journal of medicinal chemistry, Mar-15, Volume: 232Novel D
AID330538Orexigenic activity in H1RKO mouse2007Proceedings of the National Academy of Sciences of the United States of America, Feb-27, Volume: 104, Issue:9
From the Cover: Antipsychotic drug-induced weight gain mediated by histamine H1 receptor-linked activation of hypothalamic AMP-kinase.
AID1374525Drug metabolism in rat liver microsomes assessed as DM1451 formation at 50 uM preincubated for 5 mins followed by NADPH addition measured after 30 mins by UPLC-MS analysis2018Bioorganic & medicinal chemistry letters, 03-01, Volume: 28, Issue:5
MF-8, a novel promising arylpiperazine-hydantoin based 5-HT
AID1474767Agonist activity at D2 long receptor (unknown origin) expressed in Flp-In-CHO cells assessed as change in transduction coefficient by measuring cellular impedance measured immediately at 15 secs interval for 90 mins by xCELLigence assay2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
Pharmacological property optimization for allosteric ligands: A medicinal chemistry perspective.
AID723174Antipsychotic activity in Swiss albino mouse assessed as inhibition of apomorphine-induced climbing behavior at 1 mg/kg, ip administered 10 mins before apomorphine-challenge measured after 2 mins2013European journal of medicinal chemistry, Feb, Volume: 60Antidepressant and antipsychotic activity of new quinoline- and isoquinoline-sulfonamide analogs of aripiprazole targeting serotonin 5-HT₁A/5-HT₂A/5-HT₇ and dopamine D₂/D₃ receptors.
AID1301281Antagonistic activity at human dopamine D2 receptor measured after 60 mins by Ultra Lance cAMP assay2016Bioorganic & medicinal chemistry letters, 07-01, Volume: 26, Issue:13
Synthesis, structure-activity relationships, and biological evaluation of a series of benzamides as potential multireceptor antipsychotics.
AID1232330Selectivity index, ratio of Ki for human dopamine D2 receptor to KI for human dopamine D3 receptor2015Journal of medicinal chemistry, Jul-23, Volume: 58, Issue:14
Identifying Medication Targets for Psychostimulant Addiction: Unraveling the Dopamine D3 Receptor Hypothesis.
AID1233020Toxicity in ip dosed spontaneous locomotor activity CD-1 mouse model assessed as dose required to cause sedation2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Novel spirohydantoin derivative as a potent multireceptor-active antipsychotic and antidepressant agent.
AID1693541Displacement of [3H]-N-methylspiperone from human dopamine D4 receptor by liquid scintillation counting2021Bioorganic & medicinal chemistry, 01-15, Volume: 30A study of the structure-affinity relationship in SYA16263; is a D
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID457692Selectivity index, ratio of Ki for Wistar rat hippocampus 5HT1A receptor to Ki for Wistar rat cortex 5HT2A receptor2010Bioorganic & medicinal chemistry, Mar-01, Volume: 18, Issue:5
Searching for multi-target antipsychotics: Discovery of orally active heterocyclic N-phenylpiperazine ligands of D2-like and 5-HT1A receptors.
AID1808027Inhibition of ACE2 (unknown origin) expressed in HEK293T cells membrane2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
Colloidal Aggregators in Biochemical SARS-CoV-2 Repurposing Screens.
AID277668Selectivity for dopamine D3 over dopamine D22007Journal of medicinal chemistry, Feb-08, Volume: 50, Issue:3
Structure-selectivity investigations of D2-like receptor ligands by CoMFA and CoMSIA guiding the discovery of D3 selective PET radioligands.
AID410331Displacement of [3H]SCH23390 from dopamine D1 receptor in CRL:CD(SD)BR-COBS rat striatum by scintillation spectrometry2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Discovery of a new class of potential multifunctional atypical antipsychotic agents targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors: design, synthesis, and effects on behavior.
AID1442566Partial agonist activity at ARMS2-PK2 tagged D2S receptor (unknown origin) expressed in HEK293 cells assessed as induction of EA-tagged beta-arrestin-2 recruitment at 10 uM incubated for 5 hrs measured after 60 mins by PathHunter assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1704721Displacement of [3H]pyrilamine from guinea pig cerebellum histamine H1 receptor measured after 60 mins by liquid scintillation counting method
AID458635Activity at dopamine D2L receptor expressed in HEK293 cells coexpressing Galphaqi5 assessed as maximal efficacy relative to control2010Journal of medicinal chemistry, Mar-25, Volume: 53, Issue:6
Synthesis and evaluation of a set of 4-phenylpiperidines and 4-phenylpiperazines as D2 receptor ligands and the discovery of the dopaminergic stabilizer 4-[3-(methylsulfonyl)phenyl]-1-propylpiperidine (huntexil, pridopidine, ACR16).
AID1762065Antipsychotic activity in po dosed mouse assessed as reduction in MK-801-induced hyperlocomotor activity2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID1448003Partial agonist activity at human D2SR expressed in HEK293T cells co-expressing (EA)beta-arrestin2 assessed as induction of beta-arrestin2 recruitment after 5 hrs by chemiluminescence assay2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID1393367Displacement of [3H]-5-CT from human 5-HT7R expressed in HEK293 cell membranes after 1 hr at 37 degC by microbeta counting method
AID1458665Antagonist activity at human recombinant 5-HT1A receptor expressed in HEK-293 cells assessed as inhibition of 8-OH-DPAT induced response at 1 x 10'-6 M by cellular dielectric spectroscopy2017Journal of medicinal chemistry, 09-14, Volume: 60, Issue:17
Novel 3-(1,2,3,6-Tetrahydropyridin-4-yl)-1H-indole-Based Multifunctional Ligands with Antipsychotic-Like, Mood-Modulating, and Procognitive Activity.
AID1762055Binding affinity to dopamine D3 receptor (unknown origin)2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1403802Induction of catalepsy in po dosed ICR mouse assessed as reduction in ability to remain hanging onto the bar
AID1169860Binding affinity to dopamine D2 receptor (unknown origin)2014Journal of medicinal chemistry, Nov-26, Volume: 57, Issue:22
Targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors for developing effective antipsychotics: synthesis, biological characterization, and behavioral studies.
AID1458671Cognitive enhancement activity in iv dosed scopolamine-induced memory deficit CD-1 mouse assessed as increase in step-through latency time treated for 30 mins before training measured 24 hrs after training trial by passive avoidance test2017Journal of medicinal chemistry, 09-14, Volume: 60, Issue:17
Novel 3-(1,2,3,6-Tetrahydropyridin-4-yl)-1H-indole-Based Multifunctional Ligands with Antipsychotic-Like, Mood-Modulating, and Procognitive Activity.
AID1464177Displacement of [3H]spiperone from human D2SR expressed in CHO cell membranes2017Bioorganic & medicinal chemistry, 10-15, Volume: 25, Issue:20
β-Arrestin biased dopamine D2 receptor partial agonists: Synthesis and pharmacological evaluation.
AID610680Displacement of [125I]ABN from human recombinant D4 receptor expressed in HEK cells after 60 mins by gamma counter2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
Synthesis and characterization of selective dopamine D₂ receptor ligands using aripiprazole as the lead compound.
AID1458662Agonist activity at human recombinant 5-HT7 receptor expressed in CHO cells at 1 x 10'-6 M after 30 mins by HTRF method2017Journal of medicinal chemistry, 09-14, Volume: 60, Issue:17
Novel 3-(1,2,3,6-Tetrahydropyridin-4-yl)-1H-indole-Based Multifunctional Ligands with Antipsychotic-Like, Mood-Modulating, and Procognitive Activity.
AID1169871Antipsychotic-like activity in sc dosed NMRI mouse assessed as reduction in PCP-induced locomotor activity dosed 15 to 30 mins before administration of methamphetamine measured for 60 mins2014Journal of medicinal chemistry, Nov-26, Volume: 57, Issue:22
Targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors for developing effective antipsychotics: synthesis, biological characterization, and behavioral studies.
AID1823847Anti-antidepressant like activity in Wistar rat assessed as reduction in locomotor activity by measuring total immobility time by Forced swim test
AID1474759Agonist activity at D2 long receptor (unknown origin) expressed in Flp-In-CHO cells assessed as change in transduction coefficient by measuring inhibition of forskolin-induced cAMP production measured after 5 mins in presence of coelenterazine by BRET ass2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
Pharmacological property optimization for allosteric ligands: A medicinal chemistry perspective.
AID1403803Therapeutic index, ratio of ED50 for induction of catalepsy in po dosed ICR mouse to ED50 for inhibition of PCP-induced hyper-locomotion in ig dosed ICR mouse
AID1442570Agonist activity at N-terminal flag-tagged D2S receptor (unknown origin) expressed in HEK293 cells coexpressing renilla luciferase 2-tagged Galphai2 after 10 mins by BRET assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1443620Agonist activity at renilla luciferase-tagged human dopamine D2 receptor expressed in HEK293 cells coexpressing mVenus-fused beta-arrestin 2 assessed as induction of beta-arrestin 2 recruitment by BRET assay
AID410332Displacement of [3H]spiperone from dopamine D2 receptor in CRL:CD(SD)BR-COBS rat striatum by scintillation spectrometry2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Discovery of a new class of potential multifunctional atypical antipsychotic agents targeting dopamine D3 and serotonin 5-HT1A and 5-HT2A receptors: design, synthesis, and effects on behavior.
AID1442581Agonist activity at N-terminal flag-tagged D2S receptor (unknown origin) expressed in HEK293 cells assessed as induction of renilla luciferase 2-tagged beta-arrestin-1 recruitment after 15 mins by BRET assay relative to quinpirole2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1443621Agonist activity at renilla luciferase-tagged human dopamine D2 receptor expressed in HEK293 cells coexpressing mVenus-fused beta-arrestin 2 assessed as induction of beta-arrestin 2 recruitment by BRET assay relative to quinpirole
AID1196351Anxiolytic activity in intraperitoneally dosed 3-months old Wistar rat by Vogel's conflict drinking test2015European journal of medicinal chemistry, Mar-06, Volume: 92Novel 5-HT6 receptor antagonists/D2 receptor partial agonists targeting behavioral and psychological symptoms of dementia.
AID669779Inhibition of norA-mediated ethidium bromide efflux in Staphylococcus aureus SA-1199B harboring grlA A116E mutant at 50 uM after 5 mins by fluorometric analysis2012ACS medicinal chemistry letters, Mar-08, Volume: 3, Issue:3
Ligand Promiscuity between the Efflux Pumps Human P-Glycoprotein and S. aureus NorA.
AID1458668Toxicity in Swiss albino mouse assessed as effect on spontaneous locomotory activity measuring number of areas crossed administered for 30 mins measured every 2 mins up to 6 mins2017Journal of medicinal chemistry, 09-14, Volume: 60, Issue:17
Novel 3-(1,2,3,6-Tetrahydropyridin-4-yl)-1H-indole-Based Multifunctional Ligands with Antipsychotic-Like, Mood-Modulating, and Procognitive Activity.
AID722919Antipsychotic activity in CD1 mouse assessed as inhibition MK-801-evoked hyperactivity at 0.5 mg/kg, ip after 30 mins2013European journal of medicinal chemistry, Feb, Volume: 60Antidepressant and antipsychotic activity of new quinoline- and isoquinoline-sulfonamide analogs of aripiprazole targeting serotonin 5-HT₁A/5-HT₂A/5-HT₇ and dopamine D₂/D₃ receptors.
AID457687Displacement of [3H]nemonapride from D2-like receptor in Wistar rat striatum homogenate2010Bioorganic & medicinal chemistry, Mar-01, Volume: 18, Issue:5
Searching for multi-target antipsychotics: Discovery of orally active heterocyclic N-phenylpiperazine ligands of D2-like and 5-HT1A receptors.
AID1762062Binding affinity to histamine H3 receptor (unknown origin)2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40Discovery of a new class of multi-target heterocycle piperidine derivatives as potential antipsychotics with pro-cognitive effect.
AID727074Antagonist activity at human D2 dopamine receptor expressed in CHO cell membrane by GTPgammaS-binding assay2013Bioorganic & medicinal chemistry letters, Jan-15, Volume: 23, Issue:2
Synthesis and SAR of aminothiazole fused benzazepines as selective dopamine D2 partial agonists.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1464183Displacement of [3H]prazosin from 5-sigma1 receptor in porcine cerebral cortex homogenates2017Bioorganic & medicinal chemistry, 10-15, Volume: 25, Issue:20
β-Arrestin biased dopamine D2 receptor partial agonists: Synthesis and pharmacological evaluation.
AID1442606Protection against AMPH-sensitization induced disruptions in sensorimotor gating in Sprague-Dawley rat at 1.5 mg/kg/day administered via osmotic Alzet mini pump for 7 days post 6 days challenge with AMPH measured on day 5 by light-induced activity test2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Discovery of G Protein-Biased Dopaminergics with a Pyrazolo[1,5-a]pyridine Substructure.
AID1889690Displacement of [3H]-8-OH-DPAT from human 5-HT1A receptor expressed in HEK293 cells measured after 1 hr by Microbeta plate reader method2022European journal of medicinal chemistry, Mar-15, Volume: 232Novel D
AID1242908Binding affinity to 5-HT2A receptor (unknown origin)2015Bioorganic & medicinal chemistry letters, Sep-15, Volume: 25, Issue:18
Discovery of novel potent and selective ligands for 5-HT2A receptor with quinazoline scaffold.
AID1152663Effect on cognition in Wistar rat assessed as memory disruption at 100 mg/kg, po administered 60 mins prior to training session measured during test session 24 hrs after training session by step-through passive avoidance test2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Novel arylsulfonamide derivatives with 5-HT₆/5-HT₇ receptor antagonism targeting behavioral and psychological symptoms of dementia.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID1508612NCATS Parallel Artificial Membrane Permeability Assay (PAMPA) Profiling2017Bioorganic & medicinal chemistry, 02-01, Volume: 25, Issue:3
Highly predictive and interpretable models for PAMPA permeability.
AID1508591NCATS Rat Liver Microsome Stability Profiling2020Scientific reports, 11-26, Volume: 10, Issue:1
Retrospective assessment of rat liver microsomal stability at NCATS: data and QSAR models.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1645848NCATS Kinetic Aqueous Solubility Profiling2019Bioorganic & medicinal chemistry, 07-15, Volume: 27, Issue:14
Predictive models of aqueous solubility of organic compounds built on A large dataset of high integrity.
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID624210Agonists at Human 5-Hydroxytryptamine receptor 5-HT1A2003Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, Aug, Volume: 28, Issue:8
Aripiprazole, a novel atypical antipsychotic drug with a unique and robust pharmacology.
AID1345788Human D2 receptor (Dopamine receptors)2013European journal of medicinal chemistry, Feb, Volume: 60Antidepressant and antipsychotic activity of new quinoline- and isoquinoline-sulfonamide analogs of aripiprazole targeting serotonin 5-HT₁A/5-HT₂A/5-HT₇ and dopamine D₂/D₃ receptors.
AID1259419Human 5-HT2A receptor (5-Hydroxytryptamine receptors)2003Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, Mar, Volume: 28, Issue:3
H1-histamine receptor affinity predicts short-term weight gain for typical and atypical antipsychotic drugs.
AID1347024Rat D4 receptor (Dopamine receptors)2000Molecular pharmacology, Jan, Volume: 57, Issue:1
Nonconserved residues in the second transmembrane-spanning domain of the D(4) dopamine receptor are molecular determinants of D(4)-selective pharmacology.
AID1345154Rat 5-HT6 receptor (5-Hydroxytryptamine receptors)1999Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, Jun, Volume: 20, Issue:6
Interactions of the novel antipsychotic aripiprazole (OPC-14597) with dopamine and serotonin receptor subtypes.
AID1346528Human 5-HT1D receptor (5-Hydroxytryptamine receptors)2003Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, Aug, Volume: 28, Issue:8
Aripiprazole, a novel atypical antipsychotic drug with a unique and robust pharmacology.
AID624235Agonists at Human 5-Hydroxytryptamine receptor 5-HT2A2003Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, Aug, Volume: 28, Issue:8
Aripiprazole, a novel atypical antipsychotic drug with a unique and robust pharmacology.
AID1346264Human 5-HT1B receptor (5-Hydroxytryptamine receptors)2003Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, Aug, Volume: 28, Issue:8
Aripiprazole, a novel atypical antipsychotic drug with a unique and robust pharmacology.
AID624216Agonists at Human 5-Hydroxytryptamine receptor 5-HT2C2003Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, Mar, Volume: 28, Issue:3
H1-histamine receptor affinity predicts short-term weight gain for typical and atypical antipsychotic drugs.
AID624235Agonists at Human 5-Hydroxytryptamine receptor 5-HT2A2003Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, Mar, Volume: 28, Issue:3
H1-histamine receptor affinity predicts short-term weight gain for typical and atypical antipsychotic drugs.
AID1345783Rat D2 receptor (Dopamine receptors)2000Molecular pharmacology, Jan, Volume: 57, Issue:1
Nonconserved residues in the second transmembrane-spanning domain of the D(4) dopamine receptor are molecular determinants of D(4)-selective pharmacology.
AID624234Agonists at Rat 5-Hydroxytryptamine receptor 5-HT2A2003Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, Aug, Volume: 28, Issue:8
Aripiprazole, a novel atypical antipsychotic drug with a unique and robust pharmacology.
AID1345615Human 5-HT1A receptor (5-Hydroxytryptamine receptors)2003Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, Aug, Volume: 28, Issue:8
Aripiprazole, a novel atypical antipsychotic drug with a unique and robust pharmacology.
AID1346893Human 5-HT2C receptor (5-Hydroxytryptamine receptors)2003Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, Mar, Volume: 28, Issue:3
H1-histamine receptor affinity predicts short-term weight gain for typical and atypical antipsychotic drugs.
AID1346037Human H1 receptor (Histamine receptors)2003Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, Mar, Volume: 28, Issue:3
H1-histamine receptor affinity predicts short-term weight gain for typical and atypical antipsychotic drugs.
AID1345788Human D2 receptor (Dopamine receptors)2011Proceedings of the National Academy of Sciences of the United States of America, Nov-08, Volume: 108, Issue:45
Discovery of β-arrestin-biased dopamine D2 ligands for probing signal transduction pathways essential for antipsychotic efficacy.
AID1345235Rat 5-HT7 receptor (5-Hydroxytryptamine receptors)1999Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, Jun, Volume: 20, Issue:6
Interactions of the novel antipsychotic aripiprazole (OPC-14597) with dopamine and serotonin receptor subtypes.
AID1346919Rat 5-HT2A receptor (5-Hydroxytryptamine receptors)2003Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, Aug, Volume: 28, Issue:8
Aripiprazole, a novel atypical antipsychotic drug with a unique and robust pharmacology.
AID1259419Human 5-HT2A receptor (5-Hydroxytryptamine receptors)2003Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, Aug, Volume: 28, Issue:8
Aripiprazole, a novel atypical antipsychotic drug with a unique and robust pharmacology.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (2,762)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's15 (0.54)18.2507
2000's796 (28.82)29.6817
2010's1493 (54.06)24.3611
2020's458 (16.58)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 126.92

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index126.92 (24.57)
Research Supply Index8.16 (2.92)
Research Growth Index6.86 (4.65)
Search Engine Demand Index235.72 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (126.92)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials509 (17.03%)5.53%
Reviews462 (15.46%)6.00%
Case Studies772 (25.83%)4.05%
Observational28 (0.94%)0.25%
Other1,218 (40.75%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (369)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Neurocognitive Effectiveness in Treatment of First-episode Non-affective Psychosis: a Randomized Comparison of Aripiprazole, Quetiapine and Ziprasidone Over 1 Year [NCT02534363]Phase 4136 participants (Actual)Interventional2005-10-31Completed
Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis- An Investigator-initiated, Phase IV, Randomised Double-blind Multi-centre Trial of the Benefits and Harms of Aripiprazole Versus Quetiapine in Children and Adolescents With [NCT01119014]Phase 4300 participants (Anticipated)Interventional2010-05-31Active, not recruiting
A Multicenter Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study With Three Fixed Doses of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD) [NCT00337571]Phase 3218 participants (Actual)Interventional2006-06-30Completed
Open Flexible-dose Randomized Study of the Effectiveness of Second Generation Antipsychotics in First Episode Psychosis Patients: A 1-year Follow-up [NCT02532491]Phase 4200 participants (Anticipated)Interventional2014-05-31Enrolling by invitation
Aripiprazole Effects on Reward Processing in Deficit Syndrome Schizophrenia [NCT00209027]20 participants (Actual)Interventional2005-04-30Terminated(stopped due to difficulty with technical aspect of fMRI, resources to complete the study ran out)
Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children [NCT00468130]13 participants (Actual)Interventional2006-05-31Completed
Easy Identification, Treatment Response Prediction, and Molecular Mechanism Exploration of Antipsychotic-related Metabolic Syndrome [NCT00956189]132 participants (Actual)Interventional2009-11-30Completed
Phase IV Study of Effectiveness of Aripiprazole, Quetiapine, and Ziprasidone in the Treatment of First Episode of Non-affective Psychosis Individuals Included in the First Episode Psychosis Clinical Program II (PAFIP II): a 3-year Follow-up [NCT02526030]Phase 4203 participants (Actual)Interventional2008-10-31Completed
A Twelve-Month, Prospective, Randomized, Active-Controlled, Open-Label, Flexible-Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric H [NCT01193166]Phase 40 participants (Actual)Interventional2010-08-31Withdrawn(stopped due to This study was stopped due to an internal reconsideration of priorities of the product portfolio.)
The Relationship Between D2 Occupancy and Change in Frontal Metabolism and Working Memory Induced by Aripiprazole [NCT01562808]15 participants (Actual)Interventional2009-01-31Completed
A Multicentre, 8-week, Single-arm, Open-label, Pragmatic Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adult Subjects With Schizophrenia, Schizoaffective Disorder, or First Episode Psychos [NCT03568500]Phase 444 participants (Actual)Interventional2018-05-21Completed
Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS): the Effects of D2 Antagonism on Candidate Endophenotypes [NCT01154829]136 participants (Actual)Interventional2008-12-31Completed
Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia [NCT01338298]60 participants (Actual)Interventional2011-01-31Completed
An Open-label, Single- and Multiple-dose, Pharmacokinetic, Safety, and Tolerability Trial of Aripiprazole Long-acting Injectable Administered in the Deltoid or Gluteal Muscle in Adult Subjects With Schizophrenia or Bipolar I Disorder [NCT03854409]Phase 172 participants (Actual)Interventional2019-01-31Completed
A Phase 3b, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia in Subjects Hospitalized for Acute Exacerbation [NCT03345979]Phase 3200 participants (Actual)Interventional2017-11-15Completed
Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI [NCT02334904]60 participants (Anticipated)Observational2014-07-31Recruiting
An Observational Drug Utilization Study of SYCREST^® (Asenapine) in the United Kingdom [NCT01498770]42 participants (Actual)Observational2013-04-01Completed
Biomarkers in Autism of Aripiprazole and Risperidone Treatment [NCT01333072]Phase 480 participants (Actual)Interventional2011-07-31Completed
Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode [NCT04203056]Phase 415 participants (Actual)Interventional2019-12-16Terminated(stopped due to Withdraw of financial support by industry collaborator)
A Randomized, Placebo-controlled Trial to Evaluate the Long-term (ie, Maintenance) Efficacy of Oral Aripiprazole in the Treatment of Pediatric Subjects With Tourette's Disorder [NCT03661983]Phase 436 participants (Actual)Interventional2018-10-13Terminated(stopped due to Lack of feasibility for completion of the trial within a reasonable time frame.)
Effectiveness of Antipsychotic Drugs to Treat Psychosis Syndrome: an Open Label, Controlled Study [NCT02137616]300 participants (Anticipated)Interventional2012-06-30Recruiting
Neurocognitive Effectiveness in Treatment of First-episode Non-affective Psychosis: a Randomized Comparison of Aripiprazole and Risperidone Over 3 Years [NCT03883204]Phase 4115 participants (Anticipated)Interventional2015-01-01Enrolling by invitation
Evaluation of Negative Symptoms and Cognitive Function After Administration of Antipsychotics in Healthy Volunteer: a Double-blind, Randomized Trial of a Single Dose of Placebo, Haloperidol, Amisulpride, Risperidone and Aripiprazole [NCT01185418]80 participants (Actual)Observational2009-03-31Completed
12- Week Open Label Treatment of Refractory Bipolar Depression (BD) With Combination of Depakote ER (DEP) and Aripiprazole (AZP) [NCT00223496]Phase 432 participants (Actual)Interventional2004-09-30Completed
EFFECT OF RISPERIDONE vs ARIPIPRAZOLE ON OXIDATIVE STRESS IN PATIENTS WITH AUTISM SPECTRUM DISORDER: A RANDOMIZED CONTROLLED TRIAL [NCT05868720]42 participants (Anticipated)Interventional2023-07-01Not yet recruiting
Real-life Assessment of Aripiprazole Long-acting Injection (Abilify Maintena) Combined With Brexpiprazole (Rexulti) in Schizophrenia: a Naturalistic Non-interventional Prospective Follow-up Study [NCT05169268]10 participants (Anticipated)Observational2022-02-01Recruiting
Substance Misuse To Psychosis for Stimulants (SToP-S)--An Early Assertive Pharmacotherapy Intervention Study [NCT03485417]Phase 2/Phase 3240 participants (Anticipated)Interventional2019-06-01Recruiting
Aripiprazole in Adolescents With Schizophrenia [NCT00102063]Phase 3302 participants (Actual)Interventional2004-07-31Completed
Changes of Heart Rate Variability in Schizophrenic and Bipolar Patients Under the Medication of Aripiprazole and Quetiapine [NCT01047215]Phase 4120 participants (Anticipated)Interventional2009-08-31Recruiting
A Phase 1, Randomized, Open-Label Study Evaluating the Pharmacokinetics of Various Dosing Regimens of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia [NCT02320032]Phase 1140 participants (Actual)Interventional2014-12-31Completed
Impact of Preoperative Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy: A Randomized Controlled Clinical Trial [NCT05103410]Phase 480 participants (Actual)Interventional2021-11-10Completed
A Multicenter, Randomized, Double-blind, Flexible-dosed, Placebo-controlled, Parallel-group Clinical Trial Evaluating the Efficacy and Safety of Aripiprazole Oral Solution in Children and Adolescents With Autistic Disorder [NCT03487770]Phase 3111 participants (Actual)Interventional2018-04-09Completed
A Randomized, Multi-site, Parallel-group, Rater-blind Study Comparing Response With Aripiprazole Once Monthly and Standard of Care Oral Antipsychotics in Non-adherent Outpatients With Schizophrenia Identified Using the Brief Adherence Rating Scale [NCT02282085]Phase 4200 participants (Anticipated)Interventional2014-12-31Recruiting
A Phase 2, Multicenter, Double-Blind, Randomized, Fixed Dose, Parallel Group, 3-Week Inpatient Treatment Study To Evaluate The Dose-Response Relationship, Safety, Efficacy, And Pharmacokinetics Of PF-00217830 Compared With Placebo, Using Aripiprazole As A [NCT00580125]Phase 2164 participants (Actual)Interventional2007-11-30Completed
A Multicenter, 52-week, Open-label Study to Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder [NCT01123707]Phase 3173 participants (Actual)Interventional2010-11-18Terminated(stopped due to The study was terminated early due to Sponsor decision; no safety issues.)
VA Aripiprazole vs. Esketamine for Treatment of Depression VAST-D II [NCT05554627]Phase 4940 participants (Anticipated)Interventional2023-12-07Not yet recruiting
Efficacy and Safety of Aripiprazole in Patients With First Episode Psychosis: an Open-label, Prospective Multi-center Study [NCT01026584]Phase 455 participants (Actual)Interventional2009-10-31Completed
Safety and Tolerability of Multiple Ascending Doses of LY2140023 in Subjects With Schizophrenia [NCT01354353]Phase 175 participants (Actual)Interventional2011-05-31Completed
A Long-Term, Open-Label, Multicenter Study of LY2140023 Compared to Atypical Antipsychotic Standard of Care in Patients With DSM-IV-TR Schizophrenia [NCT01129674]Phase 2/Phase 31,210 participants (Anticipated)Interventional2010-06-30Terminated(stopped due to The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.)
Efficacy of Aripiprazole in Combination With Lithium or Valproate in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients Partially Nonresponsive to Lithium or Valproate Monotherapy [NCT00261443]Phase 41,270 participants (Actual)Interventional2005-09-30Completed
A Long-Term, Phase 2, Multicenter, Randomized, Open-Label Comparative Safety Study of LY2140023 Versus Atypical Antipsychotic Standard of Care in Patients With DSM-IV-TR Schizophrenia [NCT00845026]Phase 2261 participants (Actual)Interventional2009-03-31Completed
The Characteristics of Treatment Resistant Schizophrenia From the Illness Onset [NCT06128408]300 participants (Anticipated)Observational2023-12-01Not yet recruiting
A Prospective, Matched-Control, Randomized, Open-Label, Flexible-Dose, Study in Subjects With Recent-Onset Schizophrenia or Schizophreniform Disorder to Compare Disease Progression and Disease Modification Following Treatment With Paliperidone Palmitate L [NCT02431702]Phase 3337 participants (Actual)Interventional2015-07-08Completed
A Multicenter, 52-week, Provider- Randomized, Pragmatic Trial to Assess the Differences in ABILIFY MYCITE - a Digital Medicine System (DMS) Versus Treatment as Usual (TAU) for Adults With Schizophrenia, Bipolar I Disorder, or Major Depression Currently Us [NCT03881449]Phase 446 participants (Actual)Interventional2019-04-04Active, not recruiting
Effects of Aripiprazole and Haloperidol on Mesolimbic System Functioning: A Pharmacological fMRI Study [NCT01161277]Phase 454 participants (Actual)Interventional2010-08-31Completed
Enhancing Adherence and Outcomes in Bipolar Disorder With Abilify Maintena + a Targeted Behavioral Approach to Promote Sustained Adherence and Behavioral Change [NCT03408873]Phase 430 participants (Actual)Interventional2018-04-01Completed
A Single-center, Open-label, Randomized, Two-treatment, Two-period Crossover Trial to Investigate Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and S [NCT03342963]Phase 174 participants (Actual)Interventional2017-11-21Completed
Clinical Effectiveness Of The Newer Antipsychotic Compounds Olanzapine, Quetiapine And Aripiprazole In Comparison With Low Dose Conventional Antipsychotics (Haloperidol And Flupentixol) In Patients With Schizophrenia [NCT01164059]Phase 4149 participants (Actual)Interventional2010-02-28Completed
Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism [NCT03179787]528 participants (Actual)Observational2017-04-01Completed
A Multicenter, 180-day Pragmatic Clinical Trial to Measure the Difference in All-cause Hospitalizations for Patients Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disord [NCT03643159]Phase 42 participants (Actual)Interventional2018-06-28Terminated(stopped due to Difficulty in participant recruitment)
A 38-week, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Schizophrenia [NCT00706654]Phase 3937 participants (Actual)Interventional2008-09-30Completed
Continuation Electroconvulsive Therapy Associated With Pharmacotherapy Versus Pharmacotherapy Alone for Relapse Prevention in Major Depression. A Clinical, Controlled, Prospective and Randomized Trial [NCT01305707]Phase 4104 participants (Actual)Interventional2009-07-31Terminated(stopped due to Difficulties in recruiting)
Identification of Multi-modal Bio-markers for Early Diagnosis and Treatment Prediction in Schizophrenia Individuals [NCT03790085]Early Phase 12,700 participants (Anticipated)Interventional2018-09-01Recruiting
A Randomized Clinical Trial of Response to Psychopharmacotherapy According to Multimodal Serum Biomarkers in Depressive Patients [NCT06054321]400 participants (Anticipated)Interventional2022-08-03Recruiting
Nautralsitic, Open-label, Single Arm Study Evaluating Effects of Aripiprazole LAI on Phychosocial&Congitive Functioning, Patient Reported Acceptability of Treatment Regarding QoL, Subjective Well-being Under Neuroleptic Medication in Sch [NCT02697045]Phase 423 participants (Actual)Interventional2017-01-04Completed
Aripiprazole for Bipolar Disorder and Alcohol Use Disorder [NCT02918370]Phase 3132 participants (Anticipated)Interventional2016-11-30Completed
Effect of add-on Aripiprazole on Cardiometabolic Profile in Treatment Resistant Schizophrenia With Metabolic Syndrome: A Randomized Controlled Trial [NCT05766540]Phase 460 participants (Anticipated)Interventional2023-08-20Not yet recruiting
A Single-Centre, Double-Blind, Randomised, Parallel Group Study of Repeated Oral Doses of AZD3480/Placebo and a Single Dose of Aripiprazole to Evaluate the Pharmacokinetic Interaction Between AZD3480 and Aripiprazole in Healthy Subjects (Phase I) [NCT00689559]Phase 152 participants (Anticipated)Interventional2008-03-31Completed
A Randomized Placebo Controlled Clinical Trial of Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents Ages 6-17 With Bipolar Spectrum Disorder [NCT00592683]Phase 420 participants (Actual)Interventional2007-12-31Terminated(stopped due to Supply Omega-3 Fatty Acids expired and supplier no longer made same composition.)
Irritability in Children With ADHD and Emotion Dysregulation: Clinical Profiles, Neuropsychological Characteristics , and Pharmacological Treatment: A Cross-over Study [NCT05974241]Phase 436 participants (Actual)Interventional2017-04-21Completed
Intramuscular Ketamine Versus Escitalopram and Aripiprazole in Acute and Maintenance Treatment of Patients With Treatment-resistant Depression [NCT04234776]Phase 488 participants (Anticipated)Interventional2018-04-03Enrolling by invitation
A 12-week, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia [NCT01663532]Phase 3340 participants (Actual)Interventional2012-10-31Completed
A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia [NCT00705783]Phase 3843 participants (Actual)Interventional2008-07-31Completed
European Long-acting Antipsychotics in Schizophrenia Trial [NCT02146547]Phase 4536 participants (Actual)Interventional2015-02-28Completed
Effectiveness of 6 Antipsychotic Drugs in the Treatment of Acute Exacerbations of Chronic Inpatients With Schizophrenia: a Randomized Double-blind Study [NCT02192723]550 participants (Actual)Interventional2012-06-30Completed
A Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel Group, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Treatment of Major Depressive Episode Associ [NCT03423680]Phase 3390 participants (Anticipated)Interventional2018-02-22Recruiting
A Single-dose, Randomized, Three-period, Crossover Comparative Bioavailability Study of a Novel Formulation of Aripiprazole 10 mg Oral Soluble Film vs the Marketed Formulation Abilify® 10 mg Tablet in Healthy Volunteers [NCT02501109]Phase 136 participants (Actual)Interventional2015-10-31Completed
An Open-label Study to Determine the Effect of Switching to Aripiprazole Once Monthly for Subjects With Schizophrenia Experiencing Worsening Sexual Dysfunction With Invega Sustenna or Risperdal Consta [NCT02472652]Phase 42 participants (Actual)Interventional2015-06-30Terminated(stopped due to Lack of adequate enrollment)
A Multinational, Multicenter, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Aripiprazole in Asian Pediatric Patients With Autism Spectrum Disorder and Behavior Problems [NCT02069977]Phase 479 participants (Anticipated)Interventional2014-02-28Recruiting
Evaluation of Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation by Single Administration in Chinese Patients With Schizophrenia: a Single-center, Uncontrolled, Open -Label Trial [NCT03287505]Phase 124 participants (Actual)Interventional2017-06-23Completed
An Open-Label Follow-on Study of the Long-Term Safety of Aripiprazole in Patients With Chronic Schizophrenia [NCT02435836]Phase 3631 participants (Actual)Interventional1998-04-30Terminated(stopped due to Study terminated when aripiprazole available commercially per protocol)
Safety and Tolerability of Initiating Aripiprazole Lauroxil in Subjects With Schizophrenia Who Are Inadequately Treated With Paliperidone Palmitate or Risperidone Long Acting Injection [NCT02634320]Phase 451 participants (Actual)Interventional2015-12-31Completed
Open-Label Pharmacokinetic Study to Evaluate the Steady-State Venous and Capillary Plasma Concentrations of Five Antipsychotics: Aripiprazole, Olanzapine, Paliperidone, Quetiapine and Risperidone [NCT02087579]Phase 1305 participants (Actual)Interventional2014-02-28Completed
A Double-Blind, Randomized, Multiple Dose Study of Weight Associated Parameters: SEP-363856 vs Prior Antipsychotic (PA) Standard of Care in Subjects With Schizophrenia Suffering From Metabolic Dysregulation [NCT05542264]Phase 160 participants (Anticipated)Interventional2022-11-15Recruiting
A Randomized, Single Oral Dose, Two-way Crossover, Open-label, Laboratory Blind, Bioequivalence Study Comparing Aripiprazole From Two Different Drug Products After Oral Administration to Healthy Adult Subjects Under Fasting Conditions [NCT05532254]Phase 131 participants (Actual)Interventional2021-02-14Completed
RCT of Neurocognitive and Neuroimaging Biomarkers: Predicting Progression Towards Dementia in Patients With Treatment-resistant Late-life Depression (OPTIMUM-Neuro RCT) [NCT05531591]Phase 4600 participants (Anticipated)Interventional2019-08-01Active, not recruiting
Interventions to Test the Alpha7 Nicotinic Receptor Model in Schizophrenia [NCT00509067]Phase 243 participants (Actual)Interventional2007-11-30Completed
A Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial to Evaluate the Efficacy of Brexpiprazole Monotherapy for the Treatment in Adolescents (13-17 Years Old) With Schizophrenia [NCT03198078]Phase 3316 participants (Actual)Interventional2017-06-30Completed
Aripiprazole Treatment for Antipsychotic Induced Hyperprolactinaemia in Patients With Severe Mental Illness and Learning Disabilities [NCT01085383]Phase 415 participants (Actual)Interventional2010-04-30Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode [NCT00338273]Phase 30 participants (Actual)Interventional2006-12-31Withdrawn
A Multicenter Investigative Study of the Safety and Efficacy of Long-term Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode [NCT00606229]Phase 341 participants (Actual)Interventional2008-01-31Completed
Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study [NCT00167817]Phase 415 participants Interventional2003-07-31Completed
A Canadian Non-interventional Study of Aripiprazole Once-Monthly (AOM) Administration in Hospitalized Patients With Schizophrenia, Schizoaffective Disorder and Bipolar I Disorder [NCT04907279]200 participants (Anticipated)Observational2021-11-01Recruiting
Aripiprazole for Pre-Existing Neuroleptic-Induced Tardive Dyskinesia: a Prospective 26-Week Observational Study [NCT00837707]Phase 425 participants (Anticipated)Interventional2008-06-30Recruiting
Aripiprazole Augmentation of SSRI Antidepressant Therapy in Treatment Refractory Depression: Assessment of Symptom Reduction, Psychosocial Function, and Cognitive Function [NCT00608543]Phase 417 participants (Actual)Interventional2005-10-31Completed
A Randomized Double-Blind Study of Olanzapine Versus Aripiprazole in the Treatment of Schizophrenia [NCT00088049]Phase 4560 participants Interventional2003-10-31Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group-Comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode [NCT00606281]Phase 3258 participants (Actual)Interventional2008-01-31Completed
A Prospective Open-Label Trial of Aripiprazole Monotherapy in the Autism Spectrum Disorders (ASD) [NCT00308074]Phase 214 participants (Actual)Interventional2006-02-28Completed
Therapeutic Drug Monitoring (TDM) in Child & Adolescent Psychiatry [NCT01057329]200 participants (Actual)Observational2010-01-31Completed
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-group Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication [NCT03557931]Phase 2233 participants (Actual)Interventional2018-07-13Completed
A Double-Blind Randomized Placebo Controlled Study of Aripiprazole Augmentation for Clozapine-Treated Patients With Refractory Schizophrenia [NCT00328367]Phase 461 participants (Actual)Interventional2005-12-31Completed
Investigating Metabolic Side Effects of Antipsychotic Medications in Children [NCT00746252]5 participants (Actual)Interventional2008-06-30Terminated(stopped due to Due low rate of participation and lack of funding)
Augmenting Language Interventions in ASD: A Translational Approach (ACE Project 3) [NCT02574741]Phase 258 participants (Actual)Interventional2012-06-30Completed
Atypical Antipsychotics and Hyperglycemic Emergencies: Multicentre, Retrospective Cohort Study of Administrative Data [NCT02582736]725,489 participants (Actual)Observational2012-04-30Completed
Broad Effectiveness: Study With Aripiprazole [NCT00036361]Phase 3444 participants Interventional2002-07-31Completed
A Randomized, Multicenter, Double-Blind, Active-Controlled, Flexible-Dose, Parallel-Group Study of the Efficacy and Safety of Extended Release Paliperidone for the Treatment of Symptoms of Schizophrenia in Adolescent Subjects, 12 to 17 Years of Age [NCT01009047]Phase 3228 participants (Actual)Interventional2009-12-31Completed
An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence [NCT00667875]Phase 265 participants (Actual)Interventional2008-04-30Completed
A Multicenter, Double-Blind, Randomized, Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia [NCT00712686]Phase 3690 participants (Actual)Interventional2000-06-30Completed
Dopaminergic Effects of Adjunctive Aripiprazole on the Brain in Treatment-Resistant Depression: A Raclopride/F-DOPA Positron Emission Tomography and Functional MRI Study [NCT00953745]43 participants (Actual)Interventional2009-05-31Completed
Whole Blood and Plasma Sample Collection for the Development of Antipsychotic Immunoassays From Participants Taking Aripiprazole, Olanzapine, Paliperidone, or Risperidone [NCT02634463]Phase 181 participants (Actual)Interventional2015-11-30Completed
A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine Dependence [NCT00737256]Phase 244 participants (Anticipated)Interventional2008-08-31Recruiting
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode [NCT00080314]Phase 3400 participants Interventional2004-01-31Completed
Placebo-Controlled, Double-Blind, Parallel Group-Comparison Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder [NCT00876343]Phase 3586 participants (Actual)Interventional2009-03-31Completed
A Four-Week Double Blind Multicenter Study Comparing The Efficacy And Safety Of Ziprasidone To Aripiprazole In Subjects With Schizophrenia Or Schizoaffective Disorder Needing Inpatient Care [NCT00634348]Phase 4256 participants (Actual)Interventional2004-04-30Completed
Pharmacotherapy of Pervasive Developmental Disorders [NCT00870727]Phase 333 participants (Actual)Interventional2009-02-28Completed
An Open-Label, 2-Period Sequential Drug Interaction Study To Evaluate The Effect Of A 100 Mg Dose Of Desvenlafaxine SR On The Pharmacokinetics Of Aripiprazole When Coadministered In Healthy Subjects [NCT01188668]Phase 438 participants (Actual)Interventional2010-08-31Completed
Post Marketing Clinical Study of Aripiprazole in Patients With Schizophrenia - Effects on Glucose Metabolism- [NCT00392197]Phase 4111 participants (Actual)Interventional2006-11-30Completed
Multi-center, Double-blind, Randomized, Comparative Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of Abilify and Depakote in 24-week Treatment of Mania in Patients With Bipolar Disorder Remitted After 6-week Treatment Wit [NCT00545675]Phase 4146 participants (Anticipated)Interventional2007-12-31Completed
Augmentation Therapy of Resistant Postpartum Depression With Aripiprazole [NCT01386086]Phase 310 participants (Actual)Interventional2011-06-30Completed
Efficacy and Safety of Aripiprazole 2.5mg Combine Sertraline 50mg in Major Depression [NCT00873795]41 participants (Actual)Interventional2007-04-30Completed
A Multicenter, Placebo-controlled, Double-blind Investigative Extension Trial of the Safety and Efficacy of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode [NCT00606177]Phase 399 participants (Actual)Interventional2008-01-31Completed
Metabolic Effects of Antipsychotics in Children [NCT00205699]Phase 4144 participants (Actual)Interventional2006-04-30Completed
GiSAS Trial: Aripiprazole, Olanzapine, and Haloperidol in the Long Term Treatment of Schizophrenia. [NCT01052389]Phase 4300 participants (Actual)Interventional2007-07-31Completed
A Multicenter, Investigative Study of the Safety and Efficacy of Extended Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode [NCT00606320]Phase 359 participants (Actual)Interventional2008-01-31Completed
A Phase 2, 6-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 Once Daily and Aripiprazole Once Daily for Treatment of Hospitalized Adult Patients With Acute Schizoph [NCT00905307]Phase 2459 participants (Actual)Interventional2009-07-31Completed
[NCT00036127]Phase 2/Phase 30 participants Interventional2002-04-30Completed
Incomplete Response in Late Life Depression: Getting to Remission [NCT00892047]Phase 4468 participants (Actual)Interventional2009-08-31Completed
A Study to Investigate the Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder (MDD) Patients [NCT00926835]Phase 4692 participants (Actual)Interventional2009-05-31Terminated(stopped due to due to patient recruitment difficulties)
Comparative Randomized, Single Dose, Two-way Crossover Bioequivalence Study to Determine the Bioequivalence Aripiprazole From Apipe 10 mg Orally Disintegrating Tablets (Man. by: P&C Labs (Pellets & CR Products), Egypt) Versus Abilify 10 mg Orodispersible [NCT05804721]Phase 129 participants (Actual)Interventional2022-10-10Completed
Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa [NCT00685334]Phase 422 participants (Actual)Interventional2003-11-30Completed
Sequenced Atypical Antipsychotics Therapy With Intensive or Basic Psychosocial Intervention for First-episode Schizophrenia: An Effectiveness Study [NCT01057849]600 participants (Anticipated)Interventional2008-09-30Recruiting
A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated on Valproate or Lithium and in Need of Furth [NCT00665366]Phase 3493 participants (Actual)Interventional2008-06-30Completed
A 12-Month Randomized, Open-Label Study of Caregiver Psycho-education and Skills Training in Patients Recently Diagnosed With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder and Receiving Paliperidone Palmitate or Oral Antipsychotic [NCT02600741]296 participants (Actual)Observational2015-07-24Completed
Optimizing Outcomes of Treatment-Resistant Depression in Older Adults [NCT02960763]Phase 4742 participants (Actual)Interventional2017-02-24Completed
Phase 4 Study of Efficacy and Safety of Tandospirone Combined With Atypical Antipsychotic Drugs to Improve Cognitive Function in Schizophrenia [NCT02040883]Phase 4100 participants (Anticipated)Interventional2014-02-28Not yet recruiting
Open Label Trial of Aripiprazole in the Treatment of CD in Adolescents [NCT00250705]Phase 412 participants (Actual)Interventional2004-11-17Completed
Reducing Medical Risks in Individuals With Bipolar Disorder: Enhancing Outcomes With Aripiprazole [NCT00665444]3 participants (Actual)Interventional2008-04-30Terminated(stopped due to The study was terminated by the sponser due to low study enrollment.)
An Open-Label Study of Aripiprazole (Abilify) as an Augmentation Agent in Patients With Treatment-Resistant Depression [NCT00174876]Phase 220 participants Interventional2004-07-31Completed
A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia [NCT00731549]Phase 31,081 participants (Actual)Interventional2008-12-31Completed
Open-Label Pilot Study of Aripiprazole for the Treatment of Mania in Children and Adolescents With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder [NCT00181779]Phase 420 participants Interventional2003-02-28Completed
Evaluation of the Strategies of Switching Schizophrenia Patients to Aripiprazole From Other Antipsychotic Agents: Combination of Pharmacogenomics and Therapeutic Drug Monitoring [NCT00545467]Phase 479 participants (Actual)Interventional2007-08-31Completed
A Phase IIIb Multi-Center, Open-Label, Mirror-Image, Trial in Adult Subjects With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite® [NCT03892889]Phase 3277 participants (Actual)Interventional2019-04-29Terminated(stopped due to Study has stopped for having met the primary endpoint.)
A Multicenter Double-Blind, Randomized, Placebo-Controlled, Flexible-Dosed, Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder (AD) [NCT00332241]Phase 398 participants (Actual)Interventional2006-06-30Completed
Aripiprazole (BMS-337039) for Outpatients With Schizophrenia Completing Aripiprazole Clinical Trials: A Non-Comparative Rollover Protocol [NCT00239356]Phase 3119 participants (Actual)Interventional2003-03-31Completed
Abilify (Aripiprazole) as an Adjunctive Treatment for Refractory Unipolar Depression [NCT00220636]Phase 415 participants (Actual)Interventional2005-03-31Completed
Effects of Aripiprazole on Cocaine Craving and Self-Administration [NCT00373880]Phase 226 participants (Actual)Interventional2005-04-30Completed
Efficacy of Aripiprazole in the Treatment of Anorexia Nervosa in Teenagers: a Pilot, Randomised, Double Blind, Placebo-controlled Clinical Trial [NCT01082848]Phase 360 participants (Anticipated)Interventional2010-03-31Recruiting
A Study of Aripiprazole in Patients With Major Depressive Disorder [NCT00105196]Phase 3349 participants (Actual)Interventional2005-03-31Completed
A 16-Week, Multicenter, Randomized, Open-label Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome [NCT00508157]Phase 4125 participants (Actual)Interventional2007-11-30Terminated(stopped due to Slow Accrual)
A 2-year, Prospective, Blinded-rater, Open-label, Active-controlled, Multicenter, Randomized Study of Long-term Efficacy and Effectiveness Comparing Risperdal® Consta® and Abilify® (Aripiprazole) in Adults With Schizophrenia [NCT00299702]Phase 4355 participants (Actual)Interventional2006-02-28Completed
A Multicenter, Double-blind, Study of the Efficacy and Safety of Aripiprazole in Combination With Lamotrigine in the Long-term Maintenance Treatment of Patients With Bipolar I Disorder With a Recent Manic or Mixed Episode [NCT00277212]Phase 41,169 participants (Actual)Interventional2005-12-31Completed
Aripiprazole in the Treatment of Tourette's Syndrome [NCT00282139]40 participants (Anticipated)Interventional2004-01-31Terminated
An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine Versus Non-Clozapine Antipsychotics in Individuals With Treatment-resistant Schizophrenia [NCT05741502]Phase 460 participants (Anticipated)Interventional2023-08-16Recruiting
Phase 4 Study: An Open Prospective Study of the Safety and Effectiveness of Aripiprazole in the Treatment of Bipolar Depression [NCT00226317]20 participants (Actual)Interventional2004-04-30Completed
Aripiprazole in Children With Autism: A Pilot Study [NCT00208533]Phase 211 participants (Actual)Interventional2004-02-29Completed
A Comparison of Medication Augmentation and Problem Solving Therapy [NCT01942187]Phase 40 participants (Actual)Interventional2013-08-31Withdrawn(stopped due to No participants enrolled.)
Aripiprazole (Abilify) Therapy for Reducing Comorbid Substance Abuse [NCT00208169]Phase 430 participants (Actual)Interventional2005-03-31Completed
A Prospective, Multicenter, Open-Label Study of Aripiprazole in the Management of Patients With Schizophrenia in General Psychiatric Practices (Broad Effectiveness Trial With Aripiprazole- BETA) [NCT00237939]Phase 31,200 participants Interventional2002-09-30Completed
A Phase II Study to Test PK Tolerability in Children and Adolescents [NCT00102479]Phase 20 participants Interventional2004-07-31Completed
A Randomized, Open-Label, Single Dose, Cross-over Study of Gastric Emptying Rate: SEP-363856 vs Prior Antipsychotic Standard of Care in Subjects With Schizophrenia [NCT05402111]Phase 131 participants (Actual)Interventional2022-06-13Completed
Risk of Breakthrough Symptoms On Antipsychotic Maintenance Medication When Remitted Patients Are Treated With Long-Acting Injectable Medications [NCT05473741]180 participants (Anticipated)Observational2023-01-09Recruiting
A Single-arm Study to Evaluate Adherence to Treatment With, and Safety and Tolerability of, the Medical Information Device #1 (MIND1) System in Subjects With Schizophrenia or Bipolar I Disorder Who Are Currently Treated With Oral Aripiprazole [NCT01981811]Phase 20 participants (Actual)Interventional2014-03-31Withdrawn(stopped due to The trial was terminated because it was determined that the usability of the MIND1 System in the intended population was necessary before conducting this trial.)
The Effect of Switching to Aripiprazole on Indices of Cardiovascular Health in Overweight and Obese Patients With Schizophrenia [NCT00222833]Phase 430 participants Interventional2004-10-31Completed
Do Patients Taking Aripiprazole Learn More in Vocational Skills Training Than Patients Taking Olanzapine? [NCT00223418]43 participants (Actual)Interventional2004-01-31Completed
"The Effects of Aripiprazole on Patients With Metabolic Syndrome: An Open-Label Trial" [NCT00224822]Phase 427 participants (Actual)Interventional2004-03-31Completed
Assessment of Incidence of Adverse Events in a Naive Pediatric Population Treated With an (Typical and Atypical) Antipsychotic Drug Over 12 Months Follow-up [NCT02007928]200 participants (Actual)Interventional2013-04-30Completed
The Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants in the Acute Treatment of Psychotic Major Depression: Efficacy and Tolerability [NCT00556140]Phase 316 participants (Actual)Interventional2003-06-30Completed
Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study [NCT02013232]120 participants (Anticipated)Interventional2013-02-28Recruiting
Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole [NCT00567099]20 participants (Anticipated)Interventional2003-08-31Recruiting
A Long-Term Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole (OPC 14597) as Maintenance Treatment in Adolescent Patients With Schizophrenia [NCT01149655]Phase 3252 participants (Actual)Interventional2011-07-31Completed
Aripiprazole in At-Risk Children With Symptoms of Bipolar Disorder [NCT00194012]Phase 362 participants (Actual)Interventional2004-08-31Completed
Novel Pharmacological Strategies in Autism [NCT00198107]Phase 381 participants (Actual)Interventional2005-09-30Completed
A Random Assignment,Parallel Group, Open Label Comparison of Clinical Outcomes and Resource Utilization Among Bipolar Disorder Patients Receiving Either Long Acting Injectable Risperidone Microspheres (Risperdal Consta® ) or Other Second Generation Oral A [NCT00177164]Phase 350 participants (Actual)Interventional2003-11-30Completed
An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Patients With Schizophrenia [NCT01129882]Phase 3709 participants (Actual)Interventional2010-06-24Completed
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies [NCT02893371]1,037,352 participants (Actual)Observational2016-09-30Completed
Comparison of Single-Dose Plasma and Blood Concentrations of Aripiprazole, Olanzapine, Quetiapine, Paliperidone and Risperidone After Capillary and Venous Blood Sample Collection [NCT01607762]Phase 131 participants (Actual)Interventional2012-02-29Completed
A Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder [NCT01111552]Phase 3237 participants (Actual)Interventional2010-07-29Terminated(stopped due to The study was terminated early due to Sponsor decision, closure of this combination therapy program is unrelated to any safety issues, no signals of concern.)
A Double-Blind, Placebo and Active-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia [NCT01104766]Phase 3617 participants (Actual)Interventional2010-04-23Completed
Double-blind Placebo Controlled Trial of Aripiprazole for Amphetamine [NCT00728312]Phase 40 participants (Actual)Interventional2009-08-31Withdrawn(stopped due to PI left the VA.)
Aripiprazole and Topiramate on Free-Choice Alcohol Use [NCT00884884]Phase 2/Phase 390 participants (Actual)Interventional2007-09-30Completed
A Phase 1b, Open-label, Multiple-dose, Randomized, Parallel-arm, Safety, Tolerability, and Pharmacokinetic Trial of Aripiprazole Intramuscular Depot Administered in the Gluteal Muscle in Adult Subjects With Schizophrenia or Bipolar I Disorder [NCT04030143]Phase 1/Phase 2266 participants (Actual)Interventional2019-08-01Completed
A Randomized Double-blind Trial of Aripiprazole and Risperidone in Schizophrenia: An Evaluation of Neuroimaging, Neuropsychological, and Pharmacogenomic Markers of Differential Treatment Response [NCT00712270]Phase 421 participants (Actual)Interventional2005-04-30Terminated(stopped due to Study terminated due to failure to meet sufficient enrollment for valid analysis)
Long-Term Administration Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder [NCT00882362]Phase 3155 participants (Actual)Interventional2009-03-31Completed
Safety and Efficacy of Aripiprazole in the Long-term Maintenance Treatment of Pediatric Patients With Irritability Associated With Autistic Disorder [NCT01227668]Phase 4215 participants (Actual)Interventional2011-03-31Completed
A Fifteen-month, Prospective, Randomized, Active-controlled, Open-label, Flexible Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Delaying Time to Treatment Failure in Adults With Schizophrenia Who Have Been Incarcerated [NCT01157351]Phase 4450 participants (Actual)Interventional2010-05-31Completed
The Role of miR-30 Family Dysregulation in Response to Antipsychotic Treatment [NCT02650102]Phase 1/Phase 2200 participants (Anticipated)Interventional2013-01-31Recruiting
Metabolic Effects of Antipsychotic Substitution in Children [NCT00910780]Phase 2/Phase 30 participants (Actual)Interventional2009-11-30Withdrawn(stopped due to Study was not funded.)
A Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder [NCT01111539]Phase 3211 participants (Actual)Interventional2010-07-13Terminated(stopped due to The study was terminated early due to Sponsor decision, closure of this combination therapy program is unrelated to any safety issues, no signals of concern.)
A Phase 1, Randomized, Open-label, Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole Lauroxil Following Administration to the Deltoid or Gluteal Muscle in Adults With Schizophrenia or Schizoaffective Disorder [NCT02636842]Phase 147 participants (Actual)Interventional2015-12-31Completed
Open Label Trial of Aripiprazole in Trichotillomania. [NCT00947154]12 participants (Actual)Interventional2009-07-31Completed
The Impact of Aripiprazole Long-acting on Myelin and Cognition in the Onset of Schizophrenia [NCT05322031]Phase 415 participants (Anticipated)Interventional2022-01-01Recruiting
Acute Impact of IM Aripiprazole and Olanzapine on Insulin Resistance in High Risk Prediabetics [NCT01411930]Phase 415 participants (Actual)Interventional2009-03-31Completed
A Prospective, Multicenter, Open-Label Study to Evaluate the Effectiveness and the Effect on Cognitive Function of a Treatment With Aripiprazole in a Board Range of Schizophrenic Patients [NCT00329810]Phase 4500 participants (Actual)Interventional2005-03-31Completed
A Positron Emission Tomography Study in Healthy Male Subjects to Examine the Test-retest Reliability of the D2/3 Agonist Radiotracer [11C]PHNO [NCT01424449]Phase 17 participants (Actual)Interventional2010-01-31Completed
Aripiprazole for the Augmentation of Antidepressant Therapy: An Observational, Outpatients Study in Inadequate Responders Diagnosed With Major Depressive Disorder [NCT01429831]Phase 4300 participants (Actual)Interventional2011-09-30Completed
Bioequivalence Study of Atazanavir Single 300 mg Capsule Relative to Two Atazanavir 150 mg Capsules in Healthy Subjects [NCT00393328]Phase 146 participants Interventional2006-11-30Completed
[NCT00036348]Phase 30 participants Interventional2000-03-31Completed
Preventing Cocaine Relapse: Developing Pharmacotherapies [NCT00276874]Phase 141 participants (Actual)Interventional2006-01-31Completed
Assessment of Interactions Between IV Methamphetamine and Aripiprazole [NCT00089440]Phase 117 participants Interventional2004-06-30Active, not recruiting
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode. CN138-146 LT is the 26-week Open Label Extension Phase of the Above Titled Protocol, CN [NCT00094432]Phase 3650 participants Interventional2004-06-30Completed
A Multicenter, Randomized, Double-Blind Study on the Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder [NCT00095524]Phase 3300 participants Interventional2004-03-31Completed
A Safety & Tolerability Study of Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia [NCT00095719]Phase 3125 participants Interventional2003-12-31Completed
A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder [NCT00095758]Phase 31,200 participants Interventional2004-09-30Completed
A 16-Week, Randomized, Controlled Trial of the Effect of Aripiprazole Versus Standard of Care on Non-HDL Cholesterol Among Patients With Schizophrenia and Bipolar I Disorder Who Have Pre-existing Metabolic Syndrome [NCT00857818]Phase 364 participants (Actual)Interventional2009-04-30Terminated(stopped due to Slow Accrual)
An Open- Label Rollover Study for Subjects With Schizophrenia Completing ABILIFY® (Aripiprazole) Clinical Study 31-03-241 [NCT01001702]Phase 385 participants (Actual)Interventional2006-04-30Completed
Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety [NCT00177008]Phase 418 participants Interventional2004-03-31Completed
Cognitive Improvement With Aripiprazole (Abilify) in Patients With Schizophrenia. (BMS) [NCT00211302]8 participants (Actual)Interventional2003-08-31Terminated(stopped due to Enrollment too difficult)
Cognitive Improvement With Aripiprazole (Abilify) in Patients With Schizophrenia, (SFBRI). [NCT00211380]8 participants (Actual)Interventional2003-08-31Terminated(stopped due to Recruitment was too difficult)
Phase 1 Study of Insulin Sensitivity, Adjusted β-Cell Function and Adiponectin Among Lean Drug-naïve Schizophrenic Subjects Treated With Atypical Antipsychotic Drugs [NCT00528359]36 participants (Actual)Observational2005-10-31Completed
Comparison of Aripiprazole Augmentation vs Switching to Different Class of Antidepressants for Patients With MDD Who Are Partially/Minimally Responsive to Current Antidepressants:Randomized, Rater-blinded, Prospective Study [NCT01488266]90 participants (Anticipated)Interventional2011-11-30Active, not recruiting
Aripiprazole for the Treatment of Refractory Anxiety: Impact on Clinical Outcomes, Resilience and Neuroendocrinologic Parameters [NCT00438386]Phase 40 participants Interventional2005-04-30Completed
The Monitor of Serum Prolactin Level and Related Clinical Observations Among Individuals With Schizophrenia Spectrum Illnesses in a 3 Months Aripiprazole Trial [NCT00468533]Phase 450 participants (Anticipated)Interventional2006-05-31Recruiting
Health Evaluation of Abilify Long-term Therapy [NCT00520650]Phase 4245 participants (Actual)Interventional2006-08-31Completed
Aripiprazole as an Adjunct to Atypical Antipsychotics for Weight Reduction and Improvement in Metabolic Profile [NCT02949752]Phase 467 participants (Actual)Interventional2016-08-31Completed
The Cognitive Effects of Aripiprazole in Children [NCT00221962]Phase 423 participants (Actual)Interventional2005-04-30Completed
Pediatric Trials Network Long-term Antipsychotic Pediatric Safety Trial (LAPS) NICHD-2016-LAP01 Phase 4 Trial [NCT03522168]509 participants (Actual)Observational2019-01-10Active, not recruiting
Multi-center, Single Arm, Open Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of Abilify With Depakote in the 6-week Treatment of Acute Mania in Patients With Bipolar Disorder [NCT00545142]Phase 4280 participants (Anticipated)Interventional2007-10-31Completed
Reversal of Antipsychotic-Induced Hyperprolactinemia, Weight Gain, Hyperglycemia and Dyslipidemia by Aripiprazole Add-on Therapy in the Treatment of Schizophrenia and Bipolar Disorder: An Open-Label Trial [NCT00541554]Phase 40 participants Interventional2007-10-31Not yet recruiting
The Optimal Treatment for Treatment-resistant Schizophrenia [NCT02926976]150 participants (Anticipated)Interventional2016-11-30Recruiting
ARIQUELI: Potentiation of Quetiapine Treatment in Bipolar 1 Nonresponders Patients With Lithium or Aripiprazole [NCT01710163]Phase 450 participants (Anticipated)Interventional2012-06-30Recruiting
Study on the Clinical Efficacy and Change of Life Quality Through Using the Comprehensive Behavioral Intervention Treatment for Tics (CBIT) [NCT04765085]0 participants (Actual)Interventional2021-03-31Withdrawn(stopped due to Lacking of funding)
A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder [NCT00097266]Phase 3615 participants Interventional2004-12-31Completed
A Comparative, Randomized, Open-Label, Multicenter Study on the Efficacy and Safety of Switch Treatment With Aripiprazole in Schizophrenic Out-patients Who Are Experiencing Insufficient Efficacy With Risperidone and/or Safety and Tolerability Issues, Whil [NCT00232687]Phase 4450 participants (Actual)Interventional2005-06-30Completed
Aripiprazole Treatment of Prodromal Patients [NCT00237874]Phase 2/Phase 315 participants (Actual)Interventional2004-02-29Completed
A Multicenter, Randomized, Naturalistic, Open-Label Study Between Aripiprazole and Standard of Care in the Management of Community-Treated Schizophrenic Patients (Schizophrenia Trial of Aripiprazole - STAR) [NCT00237913]Phase 3700 participants Interventional2004-07-31Completed
Metabolic Effects of Newer Antipsychotics in Older Patients [NCT00245206]Phase 4406 participants (Actual)Interventional2005-08-31Completed
A Placebo-Controlled Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia [NCT00080327]Phase 4370 participants Interventional2003-11-30Completed
A Randomized, Multicenter, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Aripiprazole in the Maintenance of Abstinence From Alcohol in Subjects With Alcoholism [NCT00082199]Phase 4400 participants Interventional2004-04-30Completed
Investigation of Body Mass Index, Body Composition, Resting Energy Expenditure, Respiratory Quotient and Metabolic Changes Following a Switch From Olanzapine, Quetiapine or Risperidone to Aripiprazole [NCT00312598]30 participants (Actual)Observational2005-08-31Completed
A Multicenter, Open-Label, Parallel-Group, Randomized, Flexible Dose Study To Evaluate the Safety and Tolerability of Switching From Existing Atypical Antipsychotics to Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder [NCT00347425]Phase 3286 participants (Actual)Interventional2006-12-31Completed
An Open-Label Study of Aripiprazole to Evaluate the Safety and Tolerability in Patients With Psychosis Associated With Parkinson's Disease [NCT00095810]Phase 450 participants Interventional2003-07-31Completed
Olanzapine Versus Aripiprazole in the Treatment of Acutely Ill Patients With Schizophrenia [NCT00103571]Phase 4600 participants Interventional2004-07-31Completed
Phase 3 Study of Aripriprazole in the Treatment of Post-Traumatic Stress Disorder Symptoms [NCT00440713]Phase 340 participants Interventional2004-01-31Completed
Switch Risperidone to Aripiprazole in Early Stage of Pharmacotherapy of Schizophrenia [NCT00352339]Phase 490 participants (Anticipated)Interventional2006-08-31Recruiting
Aripiprazole in Children and Adolescents With Bipolar Disorder and ADHD: A Randomized Double Blind Placebo Controlled Trial [NCT00116259]50 participants (Anticipated)Interventional2005-03-31Completed
Pilot Study of the Effect of Aripiprazole Treatment in Autism Spectrum Disorders on Functional Magnetic Resonance Imaging (fMRI) Activation Patterns and Symptoms [NCT01028820]Phase 413 participants (Actual)Interventional2009-08-31Completed
Abilify Prolonged Release Aqueous Suspension for Intramuscular Injection Specified Drug-use Results Survey (Prevention of Recurrence/Relapse of Mood Episodes in Bipolar I Disorder) [NCT04812379]535 participants (Actual)Observational2021-04-07Active, not recruiting
Augmentation Versus Switch: Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With Treatment Resistant Depression (ASCERTAIN-TRD) [NCT02977299]Phase 4278 participants (Actual)Interventional2017-05-01Completed
Open-Label Study of Aripiprazole in Individuals at Risk for Chronic Mental Illness [NCT00169949]30 participants Interventional2004-01-31Terminated(stopped due to The study was terminated due to low enrollment.)
Open Label Pilot Study of Aripiprazole Treatment of Difficult to Treat Bipolar Depression [NCT00198198]Phase 410 participants Interventional2005-08-31Completed
Efficacy and Safety of Aripiprazole in Patients With Schizophrenia or Bipolar Disorder [NCT00216723]3,000 participants (Anticipated)Observational2004-04-30Completed
Impulsivity and Drinking/Craving: Effect of a Dopamine Stabilizer Medication [NCT01292057]Phase 399 participants (Actual)Interventional2011-02-28Completed
A Long-term, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Flexible-Dose Oral Aripiprazole (OPC-14597) as Maintenance Treatment in Adolescent Patients With Schizophrenia or Child and Adolescent Patients With Bipolar I Disorder, [NCT01122927]Phase 3524 participants (Actual)Interventional2010-07-31Terminated(stopped due to The trial was terminated early as the objective of the Aripiprazole Pediatric Investigational Plan was met and provided 2 years of safety data.)
Low-Dose Adjunctive Aripiprazole in the Treatment of Bipolar Depression: Double-Blind Placebo-Controlled Pilot Study [NCT01520350]Phase 32 participants (Actual)Interventional2012-02-29Terminated(stopped due to recruitment issues)
Aripiprazole Oral Acceptability Trial [NCT00101569]Phase 359 participants Interventional2004-03-31Completed
Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients [NCT03839251]Phase 482 participants (Actual)Interventional2018-06-01Completed
[NCT00046384]Phase 30 participants Interventional2002-06-30Completed
A Phase 1, Open-label, Single Ascending Dose, Parallel Arm Trial to Determine the Pharmacokinetics, Safety, and Tolerability of Aripiprazole 2 Month Intramuscular Depot Administered Gluteally in Adult Subjects With Schizophrenia [NCT03150771]Phase 136 participants (Actual)Interventional2017-06-14Completed
Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders Having Drug-induced Weight Gain [NCT00845988]Phase 428 participants (Actual)Interventional2008-12-31Completed
Aripiprazole Augmentation Therapy in Treatment-resistant Depression [NCT00276978]Phase 30 participants (Actual)Interventional2005-06-30Withdrawn(stopped due to Initiation of study was stopped due to administrative reasons before first subject was enrolled.)
"Aripiprazole in the Treatment of Patients With Schizophrenia and Symptoms of Obsessive Compulsive Disorder (OCD)." [NCT00374348]10 participants (Actual)Interventional2005-03-31Completed
[NCT00036114]Phase 30 participants Interventional2000-03-31Completed
Randomized Evaluation of the Effectiveness of Clozapine and Aripiprazole Versus Clozapine and Haloperidol in the Treatment of Schizophrenia. An Independent, Pragmatic, Multicentre, Parallel-Group, Superiority Trial. [NCT00395915]Phase 4106 participants (Actual)Interventional2006-09-30Active, not recruiting
[NCT00036101]Phase 30 participants Interventional2002-02-28Completed
[NCT00041678]Phase 30 participants Interventional2000-01-31Completed
Effectiveness of Aripiprazole to Reduce Craving for Alcohol and Drinking Under Natural Observation, During Cue Induced Brain Imaging, and During a Motivated Free Choice Drinking Procedure Compared to Placebo [NCT00183235]Phase 230 participants Interventional2005-06-30Completed
Aripiprazole in Late Life Bipolar Disorder [NCT00194038]Phase 420 participants (Actual)Interventional2004-04-30Completed
An Open-Label Study of Aripiprazole in Children and Adolescents With Autistic Disorder [NCT00198055]Phase 225 participants (Actual)Interventional2005-01-31Completed
An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder [NCT00221416]Phase 330 participants (Anticipated)Interventional2005-06-30Completed
A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder [NCT00095511]Phase 3615 participants Interventional2004-06-30Completed
A Multicenter, Long-Term, Open-label, Study to Assess the Safety and Tolerability of Aripiprazole as an Adjunctive Therapy in the Treatment of Outpatients With Major Depressive Disorder [NCT00095745]Phase 31,002 participants (Actual)Interventional2004-09-30Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Aripiprazole as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder. [NCT00095823]Phase 31,200 participants Interventional2004-06-30Completed
Preventing Relapse: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE) [NCT00330863]Phase 4357 participants (Actual)Interventional2006-05-31Completed
Preventing Morbidity in First Episode Schizophrenia, Part II [NCT00320671]Phase 4198 participants (Actual)Interventional2005-12-31Completed
CSP #576 - VA Augmentation and Switching Treatments for Improving Depression Outcomes (VAST-D) [NCT01421342]Phase 31,522 participants (Actual)Interventional2012-12-31Completed
CONSTATRE: Risperdal Consta Trial Of Relapse Prevention And Effectiveness [NCT00216476]Phase 3753 participants (Actual)Interventional2004-10-31Completed
A Randomized, Double-blind, Dose-adjustment, Placebo-controlled Study to Evaluate the Efficacy and Safety of Aripiprazole in Children and Adolescents With Chronic Tic Disorders or Tourette's Disorder [NCT00706589]Phase 361 participants (Actual)Interventional2008-10-31Completed
A Cluster Randomized, Multi-center, Parallel-group, Rater-blind Study Comparing Treatment With Aripiprazole Once Monthly and Treatment as Usual on Effectiveness in First Episode and Early Phase Illness in Schizophrenia [NCT02360319]Phase 4489 participants (Actual)Interventional2014-12-11Completed
Acute Impact of Antipsychotics on Insulin Sensitivity: A Novel Human Model [NCT00895921]Phase 430 participants (Actual)Interventional2008-11-30Completed
Aripiprazole in Children With Symptoms of Mania [NCT00194077]Phase 360 participants (Actual)Interventional2004-08-31Completed
Efficacy and Safety of Aripiprazole in the Treatment of Acutely Relapsed Patients With Schizophrenia or Schizoaffective Disorder With Risperidone as an Active Control [NCT00283179]Phase 383 participants (Actual)Interventional2004-03-31Completed
Efficacy of Aripiprazole in Combination With Valproate or Lithium in the Treatment of Mania in Patients With Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy [NCT00257972]Phase 3400 participants Interventional2004-10-31Completed
A Multicenter, Comparative, Randomized, Double-Blind, Placebo Controlled Study on the Effect on Weight of Adjunctive Treatment With Aripiprazole in Patients With Schizophrenia. [NCT00300846]Phase 4200 participants Interventional2005-12-31Completed
Estimating and Reducing the Cardiovascular Risk of Patients With Schizophrenia Drugs From Lipid Measures and Ischemic Electrocardiographic Changes [NCT00288353]Phase 3250 participants (Actual)Interventional2006-01-31Terminated(stopped due to unable to secure additional funding)
Effects of Aripiprazole on the Steady-State Pharmacokinetics of Lamotrigine in Subjects With Bipolar I Disorder [NCT00321516]Phase 120 participants Interventional2006-07-31Completed
Comprehensive Treatment of Early Course Schizophrenia: A Nonrandomized Study of Long Acting Injectable Antipsychotic Medication Combined With Cognitive and Functional Skills Training [NCT05662306]Phase 460 participants (Anticipated)Interventional2024-02-01Recruiting
A Prospective Open-Label Study of Aripiprazole in the Management of Patients With Schizophrenia in General Psychiatric Practices [NCT00292409]Phase 3400 participants (Anticipated)Interventional2005-03-31Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled, 16 Week Study of Aripiprazole Used as Dual Therapy in the Treatment of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder Demonstrating an Inadequate Response to Quetiapine o [NCT00325689]Phase 4323 participants (Actual)Interventional2006-07-31Completed
Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD: A Randomized Cross-Over Placebo Controlled Trial [NCT00305370]Phase 420 participants (Anticipated)Interventional2005-08-31Completed
A Multi-center, Randomized, Open, Treatment-switching Study From Orally Administered Antipsychotic Monotherapy in the Treatment of Chronic Schizophrenic and Schizoaffective Patients [NCT00304616]Phase 4500 participants Interventional2004-10-31Completed
Multicenter, Single Group Study of Aripiprazole Efficacy and Safety in the Acute Psychosis Treatment of Schizophrenia, Schizophreniform Disorder and Schizoaffective Disorder. [NCT00304655]Phase 4300 participants Interventional2004-07-31Completed
Integrated Biological Markers for the Prediction of Treatment Response in Depression [NCT01655706]Phase 3211 participants (Actual)Interventional2012-04-23Completed
Early Detection and Intervention for the Prevention of Psychosis Project [NCT00531518]292 participants (Actual)Interventional2007-10-31Completed
Aripiprazole Augmentation of Antidepressants in PTSD [NCT00489866]Phase 214 participants (Actual)Interventional2007-03-31Completed
Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder [NCT01696617]Phase 446 participants (Actual)Interventional2012-02-10Completed
Randomized Controlled Trial of The Safety and Efficacy of Aripiprazole VS Ziprasidone in Schizophrenic Patients With Metabolic Syndrome and Diabetes Mellitus. [NCT01714011]Phase 4175 participants (Actual)Interventional2009-05-31Completed
Open-label Study to Assess Hospitalization Rates in Adult Schizophrenic Patients Treated With Oral Antipsychotics for 6 Months and IM Depot Aripiprazole for 6 Months, Respectively, in a Naturalistic Community Setting [NCT01432444]Phase 3493 participants (Actual)Interventional2011-09-30Completed
A Longitudinal Comparison of Aripiprazole vs. Higher Metabolic Risk Antipsychotic Drugs on Adiposity Using MRI [NCT01739127]83 participants (Actual)Observational2012-11-30Completed
[NCT01742390]Phase 4120 participants (Anticipated)Interventional2013-02-28Recruiting
Randomized Multicentric Open-label Phase III Clinical Trial to Evaluate the Efficacy of Continual Treatment Versus Discontinuation Based in the Presence of Prodromes in a First Episode of Non-affective Psychosis. [NCT01765829]Phase 3104 participants (Anticipated)Interventional2012-11-30Recruiting
A Multiple-Center, Randomized, Double-Blind Study of Comparison of Risperidone and Aripiprazole for Treatment [NCT01813643]Phase 450 participants (Actual)Interventional2012-07-31Terminated(stopped due to Effects of aripiprazole was not obvious and showed adverse reaction obviously)
A Multiple-Center, Randomized, Double-Blind Study of Aripiprazole for Treatment of Methamphetamine Dependence [NCT01813656]Phase 410 participants (Actual)Interventional2012-09-30Terminated(stopped due to Aripiprazole arm had obvious adverse reactions,especially akathisia.)
Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building [NCT04446234]Phase 4350 participants (Anticipated)Interventional2021-05-31Not yet recruiting
A Double-Blind, Placebo Controlled Study of Aripiprazole in Body Focused Repetitive Behaviors [NCT05545891]Phase 2100 participants (Anticipated)Interventional2023-12-31Not yet recruiting
The Role of Antidepressants or Antipsychotics in Preventing Psychosis: Fluoxetine vs Aripiprazole Comparative Trial (FACT) [NCT02357849]Phase 49 participants (Actual)Interventional2014-07-31Terminated
Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction in Patients Undergoing High-dose Antipsychotic Therapy [NCT03019887]139 participants (Actual)Interventional2011-04-30Completed
A Multi-Center, Randomized, Double-Blind Study, Comparing With Risperidone, to Evaluate the Efficacy and Safety of Aripiprazole in the Treatment of Patients With Schizophrenia [NCT00202007]Phase 2240 participants Interventional2005-02-28Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-Dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder [NCT01727700]Phase 3133 participants (Actual)Interventional2012-11-30Completed
Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder [NCT02955654]0 participants (Actual)Interventional2017-09-01Withdrawn(stopped due to Loss of finacial support)
Bergen Psychosis Project 2 - The Bergen-Stavanger-Innsbruck-Trondheim Study [NCT01446328]Phase 4151 participants (Actual)Interventional2011-10-31Completed
Effects of Aripiprazole on the Steady-State Pharmacokinetics of Venlafaxine in Healthy Subjects [NCT00362271]Phase 138 participants Interventional2006-08-31Completed
A Pragmatic Trial of Pharmacotherapy Options Following Unsatisfactory Initial Treatment in OCD [NCT04539951]Phase 21,600 participants (Anticipated)Interventional2020-09-22Recruiting
MAintain the Efficacy and Safety in Treatment of Schizophrenia After Switching to Long-acTing Injectable aRipiprazole From Oral Atypical Antipsychotics [NCT03376763]Phase 4201 participants (Actual)Interventional2017-11-21Completed
A Multi-Center, Open-Label, Safety and Tolerability Study of Flexible-Dose Oral Aripiprazole (2 Mg-30 mg) in the Treatment of Adolescent Patients With Schizophrenia and Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or [NCT00102518]Phase 3325 participants (Actual)Interventional2004-09-30Completed
A Single-dose, Two-treatment, Two-sequence, Two-period, Two Way Crossover Bioequivalence Study of Bosiqing Aripiprazole Orally Disintegrating Tablets and ABILIFY Under Fasting/Fed Condition [NCT03232710]66 participants (Anticipated)Interventional2017-06-26Recruiting
A Phase III Trial to Test the Safety and Efficacy of Two Doses of Aripiprazole in Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features [NCT00110461]Phase 3296 participants (Actual)Interventional2005-03-31Completed
Efficacy of Biofeedback in the Treatment of Tic Disorder:A Randomized Controlled Trial [NCT05361993]Phase 440 participants (Anticipated)Interventional2024-06-01Not yet recruiting
An Open Label Study of Aripiprazole in Children and Adolescents With Autism Spectrum Disorders [NCT00619190]Phase 230 participants (Actual)Interventional2006-01-31Completed
"Observational Study on the Effect of Switch to Lurasidone or Other Antipsychothics on Metabolic and Weight Changes in Subjects With Schizophrenia" [NCT04312503]95 participants (Actual)Observational2020-07-13Completed
An Open-label, Prospective, Randomized and Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied Patients With Previous Antipsychotic Drug [NCT01592201]Phase 413 participants (Actual)Interventional2012-07-31Terminated(stopped due to This study was early terminated due to insufficient enrollment required for hypothesis testing.)
An Open-label, Multiple Dose, Safety and Tolerability Study of Aripiprazole IM Depot Administered in the Deltoid Muscle in Adult Subjects With Schizophrenia [NCT01909466]Phase 1141 participants (Actual)Interventional2013-07-31Completed
OSMITTER 316-13-206A Substudy: A Substudy to Measure the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1) System and Determine the Latency Period [NCT02091882]Phase 430 participants (Actual)Interventional2014-03-21Completed
Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome [NCT00288366]49 participants (Actual)Interventional2006-01-31Completed
Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder [NCT00241176]Phase 411 participants (Actual)Interventional2005-09-30Completed
A Placebo-Controlled, Cross-Over Trial of Aripiprazole Added to Obese Olanzapine-Treated Patients With Schizophrenia [NCT00351936]Phase 416 participants (Actual)Interventional2005-12-31Completed
"Developing More Efficacious Treatments for Children With ADHD Who Are Partial or Non-responders to Stimulants" [NCT00279409]Phase 210 participants (Actual)Interventional2006-07-31Terminated(stopped due to Recruitment Rate too slow)
A Sequential and Parallel Cohort Design to Test the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry [NCT02462473]Phase 29 participants (Actual)Interventional2015-05-31Terminated(stopped due to Due to poor enrollment sponsor terminated early after enrolling 9 in Cohort 1 and no enrollment in Cohorts 2 and 3.)
A Long-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder [NCT01617460]Phase 386 participants (Actual)Interventional2012-09-30Completed
An Open-label, Randomized, Parallel Arm, Bioavailability Trial of Aripiprazole IM Depot Administered in the Deltoid or Gluteal Muscle in Adult Subjects With Schizophrenia [NCT01646827]Phase 137 participants (Actual)Interventional2012-05-31Completed
A Multicenter, Double-blind, Randomized, Dose-comparison Study of Three Different Doses of Aripiprazole (2 mg/Day, 6-12 mg/Day, 24-30 mg/Day) Orally Administered Over 6 Weeks in Pediatric Patients (Aged 13-17 Years) With Schizophrenia [NCT01942161]Phase 2/Phase 3106 participants (Actual)Interventional2010-08-31Completed
A Short-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder [NCT01617447]Phase 392 participants (Actual)Interventional2012-07-31Completed
Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Famotidine on the Pharmacokinetics of Atazanavir/Ritonavir/Tenofovir in Healthy Subjects [NCT00365339]Phase 140 participants Interventional2006-04-30Completed
Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) a Multicentre Open-label Randomized Controlled Trial Protocol [NCT05814640]Phase 1/Phase 2520 participants (Anticipated)Interventional2023-02-20Recruiting
Effects on Aripiprazole on the Steady-State Pharmacokinetics of Escitalopram in Healthy Subjects [NCT00361790]Phase 125 participants Interventional2006-08-31Completed
[NCT00363337]Phase 431 participants (Actual)Interventional2006-08-31Completed
Open-label Study to Assess Hospitalization Rates in Adult Schizophrenic Patients Treated With Oral Antipsychotics for 6 Months and IM Depot Aripiprazole for 6 Months, Respectively, in a Naturalistic Community Setting, Europe, Canada and Asia [NCT01509053]Phase 330 participants (Actual)Interventional2012-01-31Terminated
Aripiprazole for Clozapine Associated Medical Morbidity [NCT00345033]Phase 438 participants (Actual)Interventional2005-03-31Completed
Pan European Collaboration on Antipsychotic Naïve Schizophrenia II [NCT02339844]Phase 4130 participants (Actual)Interventional2014-01-31Completed
A 52-Week, Open-Label, Multicenter Study of the Safety and Tolerability of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder [NCT00365859]Phase 3330 participants (Actual)Interventional2006-09-30Completed
Aripiprazole in Fragile X Syndrome [NCT00420459]Phase 212 participants (Actual)Interventional2007-04-30Completed
A Multicenter, 8-week, Open-label, Single-Arm Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System by Adult Subjects With Schizophrenia, Major Depressive Disorder, or Bipolar 1 Treated With Oral Aripip [NCT02722967]Phase 249 participants (Actual)Interventional2016-03-31Completed
A Single-center, Uncontrolled, Open-label Clinical Trial Evaluating the Pharmacokinetic Characteristics and Safety of Aripiprazole IM Depot in Chinese Patients With Schizophrenia After Multi-dose Administration [NCT03285503]Phase 112 participants (Actual)Interventional2018-08-17Completed
A Randomized Controlled Trial of Sertraline Combined With Fluvoxamine in the Treatment of Refractory Obsessive-compulsive Disorder [NCT04963257]Phase 4400 participants (Anticipated)Interventional2020-01-01Recruiting
A Multicenter, Randomized, Double-blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Aripiprazole Intramuscular Depot in the Acute Treatment of Adults With Schizophrenia [NCT03172871]Phase 3436 participants (Actual)Interventional2017-05-15Completed
Pharmacovigilance in Gerontopsychiatric Patients [NCT02374567]Phase 3407 participants (Actual)Interventional2015-01-31Terminated
Open Flexible-dose Randomized Study of the Effectiveness of Second Generation Antipsychotics in First Episode Psychosis Patients: A 3-year Follow-up [NCT03090503]Phase 4200 participants (Anticipated)Interventional2014-06-30Enrolling by invitation
A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-Dose Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder [NCT01418352]Phase 383 participants (Actual)Interventional2011-08-02Completed
An Open-label, Safety and Tolerability Trial of Aripiprazole IM Depot Treatment Initiation in Adult Subjects With Schizophrenia Stabilized on Atypical Oral Antipsychotics Other Than Aripiprazole [NCT01552772]Phase 160 participants (Actual)Interventional2012-01-31Completed
Aripiprazole Treatment for Methamphetamine Dependence Among High-risk Individuals [NCT00497055]Phase 290 participants (Actual)Interventional2009-03-31Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Flexible-Dose Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder [NCT01418339]Phase 3135 participants (Actual)Interventional2011-07-27Completed
The Role of Antidepressants or Antipsychotics in Preventing Psychosis [NCT01724372]0 participants (Actual)Interventional2012-10-31Withdrawn
A Randomized, Open Label, Parallel Group, Study of the Impact of Aripiprazole (Abilify®) Once Monthly Versus Standard of Care Oral Antipsychotic Medications on Changes in Brain Structure and Metabolism [NCT02237417]Phase 447 participants (Actual)Interventional2014-09-01Completed
52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder [NCT01567527]Phase 3731 participants (Actual)Interventional2012-08-31Completed
An Open-Label, Multicenter Study Evaluating the Safety and Tolerability of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder [NCT01416441]Phase 3170 participants (Actual)Interventional2011-10-19Completed
Open-label, Multicenter, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Aripiprazole vs Paliperidone/Risperidone Using Multi-omics Data in Patients With a First Episode Psychosis [NCT06060886]Phase 4244 participants (Anticipated)Interventional2023-11-01Not yet recruiting
Striatal Connectivity and Clinical Outcome in Psychosis [NCT02822092]170 participants (Anticipated)Observational2016-07-31Recruiting
An Open-label Parallel Arm Multiple Dose Tolerability, Pharmacokinetics and Safety Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot Formulation Once Every Four Weeks [NCT01870999]Phase 141 participants (Actual)Interventional2007-11-30Completed
An Open-Label, Multicenter Study Evaluating the Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder [NCT01727713]Phase 3110 participants (Actual)Interventional2013-01-31Completed
Interventional, Open-label, Flexible-dose Extension Study of Aripiprazole Once-monthly in Patients With Schizophrenia [NCT01959035]Phase 388 participants (Actual)Interventional2013-10-31Completed
A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder [NCT01710709]Phase 3748 participants (Actual)Interventional2012-11-30Completed
Locus Coeruleus Neuroimaging of Antipsychotic/Modafinil Interactions on Cognition in Schizophrenia [NCT01913327]Phase 44 participants (Actual)Interventional2013-04-30Terminated(stopped due to Insufficient Funds and Inadequate Subject Recruitment)
A Multicenter, Open-label Study to Evaluate the Effectiveness and Safety of Aripiprazole in Patients With Acute Episode of Schizophrenia [NCT03289026]Phase 4770 participants (Actual)Interventional2017-09-01Completed
A Double Blind, Randomized, Placebo Controlled Trial of Aripiprazole Plus Valproate in the Short-Term and Long-Term Treatment of Bipolar Disorder [NCT00484471]Phase 4127 participants (Actual)Interventional2007-10-31Completed
1/2-MC4R Genotype and Pediatric Antipsychotic Drug- Induced Weight Gain [NCT01844700]Phase 414 participants (Actual)Interventional2013-07-31Terminated(stopped due to very slow recruitment, no sufficient results)
Metabolic Signatures and Biomarkers in First Episode and Recurrent Patients With Schizophrenia in Comparison to Healthy Controls [NCT00466310]Phase 171 participants (Actual)Interventional2007-02-28Completed
Clinical Management of Metabolic Problems in Patients With Schizophrenia [NCT00423878]Phase 4215 participants (Actual)Interventional2007-01-31Completed
Study on the Optimal Diagnosis and Treatment Strategy of Major Depressive Disorder Based on Anhedonia [NCT05389046]252 participants (Anticipated)Interventional2022-10-31Not yet recruiting
A Double-Blind, Placebo-Controlled Study of Aripiprazole Adjunctive to Antidepressant Therapy (ADT) Among Outpatients With Major Depressive Disorder Who Have Responded Inadequately to Prior ADT [NCT00683852]Phase 3225 participants (Actual)Interventional2008-09-30Completed
Comparison of Optimal Antipsychotic Treatments for Schizophrenia Pilot Study [NCT00802100]Phase 421 participants (Actual)Interventional2008-12-31Completed
Improving Metabolic Parameters of Antipsychotic Child Treatment (IMPACT) [NCT00806234]Phase 4127 participants (Actual)Interventional2009-01-31Completed
A Multicenter, Randomized, Double-Blind, Placebo Controlled Flexible Dose Study of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type [NCT01438060]Phase 3232 participants (Actual)Interventional2000-08-31Completed
A Multicenter, Open-label, Long-term Safety Study of Aripiprazole (Initial Dose 2 mg/Day, Maintenance Dose 6-24 mg/Day, Maximum Dose 30 mg/Day) Orally Administered Over 52 Weeks in Patients Who Complete a Short-term Treatment Study of Aripiprazole in Pedi [NCT01942148]Phase 368 participants (Actual)Interventional2010-08-31Completed
A 28-week, Randomised, Open-label Study Evaluating the Effectiveness of Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia [NCT01795547]Phase 3295 participants (Actual)Interventional2013-02-28Completed
Aripiprazole, Abilify Maintena Collaborative Clinical Protocol [NCT02717130]9 participants (Actual)Interventional2016-06-08Terminated(stopped due to The study was terminated due to lack of enrollment.)
Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole [NCT04903353]Phase 4350 participants (Anticipated)Interventional2022-02-01Recruiting
Proof of Concept Study to Treat Negative Affect in Chronic Low Back Pain [NCT04747314]Phase 2/Phase 3300 participants (Anticipated)Interventional2021-03-31Recruiting
Clinical Psychopharmacology Division Institute of Mental Health, Peking University [NCT03148509]Phase 4300 participants (Anticipated)Interventional2017-06-01Not yet recruiting
Estimating the Optimal Dynamic Antipsychotic Treatment Regime: Sequential Multiple-assignment Randomized Clinical Antipsychotic Trials in Chinese Patients With First-episode Psychosis. [NCT03510325]Phase 41,260 participants (Anticipated)Interventional2018-10-01Not yet recruiting
A Multicenter, Randomized, Double-Blind, Flexible-Dosed, Placebo-Controlled, Parallel-Group Clinical Trial Evaluating the Efficacy and Safety of Aripiprazole Oral Solution in Children and Adolescents With Tourette's Syndrome [NCT03487783]Phase 3121 participants (Actual)Interventional2018-05-02Completed
Phase IV Study of the Effectiveness of Aripiprazole, Quetiapine, and Ziprasidone in the Treatment of First Episode of Non-affective Psychosis Individuals Included in the First Episode Psychosis Clinical Program II (PAFIP II) [NCT02305823]Phase 4203 participants (Actual)Interventional2005-10-31Completed
[NCT02220712]Phase 117 participants (Actual)Interventional2014-07-31Completed
A Phase 3, Multicenter, Double-Blind Comparison of LY2140023 and Aripiprazole in Patients With DSM-IV-TR Schizophrenia Followed by Open-Label Treatment With LY2140023 [NCT01328093]Phase 3678 participants (Actual)Interventional2011-04-30Terminated(stopped due to The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.)
A Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder [NCT01111565]Phase 3137 participants (Actual)Interventional2010-10-04Terminated(stopped due to The study was terminated early due to Sponsor decision, closure of this combination therapy program is unrelated to any safety issues, no signals of concern.)
A Phase III, Multicenter, Randomized, Double-blind, Active-Controlled Study (Aripiprazole Tablets) to Evaluate the Efficacy and Safety of Brexpiprazole in the Treatment of Adults With Acute Schizophrenia [NCT03874494]Phase 3371 participants (Actual)Interventional2019-11-27Completed
A Multicenter, 8-week, Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adult Subjects With Schizophrenia Who Are Treated With Oral Aripiprazole [NCT02219009]Phase 267 participants (Actual)Interventional2014-08-31Completed
REFRESH : Randomized Double-blind, Placebo-controlled, Multicenter Trial to Assess the Safety and Efficacy of RP5063 in Subjects With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder [NCT01490086]Phase 2234 participants (Actual)Interventional2011-12-31Completed
Protocol 331-13-008: An Exploratory, Multicenter, Open-label, Flexible-dose Brexpiprazole (OPC-34712) Trial in Adults With Acute Schizophrenia [NCT02054702]Phase 397 participants (Actual)Interventional2014-02-28Completed
Effectiveness of Switching Antipsychotic Medications [NCT00044655]Phase 4219 participants (Actual)Interventional2001-07-31Completed
A 26-week, Multicenter, Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia [NCT01683058]Phase 374 participants (Actual)Interventional2013-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00044655 (1) [back to overview]Number Who Discontinued Medication Within First 6 Study Months
NCT00102063 (8) [back to overview]Clinical Global Impression (CGI) Improvement Score
NCT00102063 (8) [back to overview]Patients Achieving Remission
NCT00102063 (8) [back to overview]Change in Children's Global Assessment Scale (CGAS) Score
NCT00102063 (8) [back to overview]Change in Clinical Global Impression (CGI) Severity Score
NCT00102063 (8) [back to overview]Change in Pediatric Quality of Life Enjoyment and Satisfaction (PQLES) Questionnaire Total Score
NCT00102063 (8) [back to overview]Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score
NCT00102063 (8) [back to overview]Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score
NCT00102063 (8) [back to overview]Change in Positive and Negative Syndrome Scale (PANSS) Total Score
NCT00102518 (3) [back to overview]Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score
NCT00102518 (3) [back to overview]Change in Young Mania Rating Scale (Y-MRS) Total Score
NCT00102518 (3) [back to overview]Percentage of Subjects Experiencing SAEs
NCT00105196 (8) [back to overview]Mean Change in SDS Item Score (Social Life)
NCT00105196 (8) [back to overview]Mean Change in SDS Item Score (Family Life)
NCT00105196 (8) [back to overview]MADRS Response
NCT00105196 (8) [back to overview]MADRS Remission
NCT00105196 (8) [back to overview]Clinical Global Impression (CGI)-Improvement Response
NCT00105196 (8) [back to overview]Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)
NCT00105196 (8) [back to overview]Mean Change in Sheehan Disability Scale (SDS) Mean Score
NCT00105196 (8) [back to overview]Mean Change in SDS Item Score (Work/School)
NCT00110461 (30) [back to overview]Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4
NCT00110461 (30) [back to overview]Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30
NCT00110461 (30) [back to overview]Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4
NCT00110461 (30) [back to overview]Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30
NCT00110461 (30) [back to overview]Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4
NCT00110461 (30) [back to overview]Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30
NCT00110461 (30) [back to overview]Subject Response to Treatment at Week 4
NCT00110461 (30) [back to overview]Subject Response to Treatment at Week 30
NCT00110461 (30) [back to overview]Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4
NCT00110461 (30) [back to overview]Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 30
NCT00110461 (30) [back to overview]Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 4
NCT00110461 (30) [back to overview]Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 30
NCT00110461 (30) [back to overview]Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 4
NCT00110461 (30) [back to overview]Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 30
NCT00110461 (30) [back to overview]Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 4
NCT00110461 (30) [back to overview]Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 30
NCT00110461 (30) [back to overview]Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 4
NCT00110461 (30) [back to overview]Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 30
NCT00110461 (30) [back to overview]Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4
NCT00110461 (30) [back to overview]Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30
NCT00110461 (30) [back to overview]Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4
NCT00110461 (30) [back to overview]Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30
NCT00110461 (30) [back to overview]Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4
NCT00110461 (30) [back to overview]Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30
NCT00110461 (30) [back to overview]Change in Children's Global Assessment Scale (CGAS) Total Score at Week 4
NCT00110461 (30) [back to overview]Change in Children's Global Assessment (CGAS) Total Score at Week 30
NCT00110461 (30) [back to overview]Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 4
NCT00110461 (30) [back to overview]Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 30
NCT00110461 (30) [back to overview]Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 4
NCT00110461 (30) [back to overview]Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 30
NCT00177164 (4) [back to overview]Evaluate the Number of Clinical Events (Pooled) Occurring Between 3-15 Months Following a Switch/Stabilization of the Antipsychotic Agents Among Patients Who Receive Either Risperidal Consta or One of the 4 Marketed 2nd Generation Antipsychotic Agents.
NCT00177164 (4) [back to overview]Number of Participants With Treatment - Emergent Hyperglycemia
NCT00177164 (4) [back to overview]Number of Participants With Treatment Emergent Hyperlipidemia
NCT00177164 (4) [back to overview]BMI
NCT00194012 (15) [back to overview]Clinical Global Impressions Scale (CGI-Severity)
NCT00194012 (15) [back to overview]CDRS-R Children's Depression Rating Scale-Revised
NCT00194012 (15) [back to overview]Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)
NCT00194012 (15) [back to overview]Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)
NCT00194012 (15) [back to overview]Young Mania Rating Scale (YMRS)
NCT00194012 (15) [back to overview]Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)
NCT00194012 (15) [back to overview]Young Mania Rating Scale (YMRS)
NCT00194012 (15) [back to overview]CDRS-R Children's Depression Rating Scale-Revised
NCT00194012 (15) [back to overview]Young Mania Rating Scale (YMRS)
NCT00194012 (15) [back to overview]Children's Depression Rating Scale-Revised (CDRS-R )
NCT00194012 (15) [back to overview]Children's Global Assessment Scale (CGAS)
NCT00194012 (15) [back to overview]Children's Global Assessment Scale (CGAS)
NCT00194012 (15) [back to overview]Children's Global Assessment Scale (CGAS)
NCT00194012 (15) [back to overview]Clinical Global Impressions Scale (CGI-Severity)
NCT00194012 (15) [back to overview]Clinical Global Impressions Scale (CGI-Severity)
NCT00194077 (1) [back to overview]Time in Weeks to Discontinuation
NCT00198107 (10) [back to overview]Mean Post-baseline Score on a Modified Version of the Compulsion Subscale of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
NCT00198107 (10) [back to overview]Mean Social Reciprocity Scale (SRS) Total Score, Week 8
NCT00198107 (10) [back to overview]Mean Vineland Maladaptive Behavior Subscales Total Score, Week 8
NCT00198107 (10) [back to overview]Odds of Improvement as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2)
NCT00198107 (10) [back to overview]Mean Post-baseline Aberrant Behavior Checklist Social Withdrawal Score, Parent Report, Double-blind Phase
NCT00198107 (10) [back to overview]Mean Post-baseline Aberrant Behavior Checklist Inappropriate Speech Score, Parent Report, Double-blind Phase
NCT00198107 (10) [back to overview]Mean Autism Diagnostic Observation Schedule (ADOS) Social Affect and Restricted and Repetitive Behaviors Total Score, Week 8
NCT00198107 (10) [back to overview]Mean Post-baseline Aberrant Behavior Checklist Irritability Score, Parent Report, Double-blind Phase
NCT00198107 (10) [back to overview]Mean Post-baseline Aberrant Behavior Checklist Hyperactivity Score, Parent Report, Double-blind Phase
NCT00198107 (10) [back to overview]Mean Post-baseline Aberrant Behavior Checklist Stereotypy Score, Parent Report, Double-blind Phase
NCT00205699 (6) [back to overview]Change in MRI-measured Visceral Abdominal Fat
NCT00205699 (6) [back to overview]Change in MRI-measured Subcutaneous Abdominal Fat
NCT00205699 (6) [back to overview]Change in Insulin-stimulated Glycerol Rate of Appearance (Glycerol Ra)
NCT00205699 (6) [back to overview]Change in Insulin-stimulated Glucose Rate of Disappearance (Glucose Rd)
NCT00205699 (6) [back to overview]Change in DEXA % Body Fat
NCT00205699 (6) [back to overview]Change in Insulin-stimulated Glucose Rate of Appearance (Glucose Ra)
NCT00216476 (5) [back to overview]Change From Baseline to Endpoint in Short-Form Health Survey 12 (SF-12) Scores
NCT00216476 (5) [back to overview]Mean Relapse Free Period(Risperidone LAI Versus Quetiapine)
NCT00216476 (5) [back to overview]Mean Relapse Free Period (Exploratory/Aripiprazole)
NCT00216476 (5) [back to overview]Change From Baseline to Endpoint in Total Positive and Negative Syndrome Scale (PANSS) Score
NCT00216476 (5) [back to overview]Change From Baseline to Endpoint in Clinical Global Impression Scale (CGI) Score
NCT00220636 (4) [back to overview]Change in Global Assessment of Functioning Scale (GAFS)
NCT00220636 (4) [back to overview]Change in Beck Depression Inventory (BDI) Score
NCT00220636 (4) [back to overview]Hamilton Depression Rating Scale (HDRS)
NCT00220636 (4) [back to overview]Clinical Global Impressions Improvement Scale (CGI)
NCT00223496 (1) [back to overview]Primary Measure:Reduction in Depression Symptoms
NCT00239356 (7) [back to overview]Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population
NCT00239356 (7) [back to overview]Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population
NCT00239356 (7) [back to overview]Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population
NCT00239356 (7) [back to overview]Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population
NCT00239356 (7) [back to overview]Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population
NCT00239356 (7) [back to overview]Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population
NCT00239356 (7) [back to overview]Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population.
NCT00241176 (2) [back to overview]Clinical Global Impression Severity Scores
NCT00241176 (2) [back to overview]Calculating Difference Between Means (Baseline and Endpoint Scores on the Yale Global Tic Severity Scale Subscales)
NCT00250705 (5) [back to overview]Children's Aggression Scale-Parent Version
NCT00250705 (5) [back to overview]The Primary Outcome Efficacy Measure: Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993)
NCT00250705 (5) [back to overview]Overt Aggression Scale-Modified (OAS-M)
NCT00250705 (5) [back to overview]Secondary Outcome Measures Were the Clinical Global Impression--Improvement (CGI-I) Scales (NIMH, 1985a).
NCT00250705 (5) [back to overview]Secondary Outcome Measures Were the Clinical Global Impression-Severity (CGI-S) Scale (NIMH, 1985a).
NCT00261443 (124) [back to overview]Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2
NCT00261443 (124) [back to overview]Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3
NCT00261443 (124) [back to overview]Extension Phase: Adverse Events (AEs), by Maximum Intensity
NCT00261443 (124) [back to overview]Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations
NCT00261443 (124) [back to overview]Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania)
NCT00261443 (124) [back to overview]Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase
NCT00261443 (124) [back to overview]Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase
NCT00261443 (124) [back to overview]Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities
NCT00261443 (124) [back to overview]Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities
NCT00261443 (124) [back to overview]Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase
NCT00261443 (124) [back to overview]Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities
NCT00261443 (124) [back to overview]Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3
NCT00261443 (124) [back to overview]Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3
NCT00261443 (124) [back to overview]Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint
NCT00261443 (124) [back to overview]Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2
NCT00261443 (124) [back to overview]Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2
NCT00261443 (124) [back to overview]Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3
NCT00261443 (124) [back to overview]Median Baseline and Change From Baseline in Body Mass Index (BMI) Vital Sign Measurements at Phase 2 Endpoint
NCT00261443 (124) [back to overview]Median Baseline and Change From Baseline in ECG Measurements During Phase 2
NCT00261443 (124) [back to overview]Median Baseline and Change From Baseline in Heart Rate Measurements During Phase 2
NCT00261443 (124) [back to overview]Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2
NCT00261443 (124) [back to overview]Median Baseline and Change From Baseline in Weight Vital Sign Measurements At Phase 2 Endpoint
NCT00261443 (124) [back to overview]Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid
NCT00261443 (124) [back to overview]Median Baseline Eosinophils (Relative) and Neutrophils (Relative)
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Change Value in LDL Cholesterol (Fasting), Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in Alkaline Phosphatase (ALP), Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in ALT, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in AST, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in BUN, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in Creatine Kinase, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in Creatinine, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in Glucose (Fasting), Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in Lactate Dehydrogenase, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in Neutrophils (Relative), Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in PR, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in Prolactin, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in QRS, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in QT Interval Corrected for Heart Rate (QTc) Bazett, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in QTc (0.33), Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in Total Cholesterol (Fasting), Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in Triglycerides (Fasting), Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest Value of Change in Uric Acid, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Lowest Value of Change in HDL Cholesterol (Fasting), Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Lowest Value of Change in Hematocrit, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Lowest Value of Change in Hemoglobin, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2
NCT00261443 (124) [back to overview]Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2
NCT00261443 (124) [back to overview]Median Change From Baseline in Eosinophils (Relative) and Neutrophils (Relative)
NCT00261443 (124) [back to overview]Number of Participants Maintaining Remission During Phase 3
NCT00261443 (124) [back to overview]Number of Participants Showing Relevant Weight Gain During Phase 3
NCT00261443 (124) [back to overview]Number of Participants Showing Relevant Weight Loss During Phase 3
NCT00261443 (124) [back to overview]Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3
NCT00261443 (124) [back to overview]Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2
NCT00261443 (124) [back to overview]Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3
NCT00261443 (124) [back to overview]Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2
NCT00261443 (124) [back to overview]Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3
NCT00261443 (124) [back to overview]Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2
NCT00261443 (124) [back to overview]Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3
NCT00261443 (124) [back to overview]Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3
NCT00261443 (124) [back to overview]Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3
NCT00261443 (124) [back to overview]Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3
NCT00261443 (124) [back to overview]Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2
NCT00261443 (124) [back to overview]Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity
NCT00261443 (124) [back to overview]Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2
NCT00261443 (124) [back to overview]Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2
NCT00261443 (124) [back to overview]Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2
NCT00261443 (124) [back to overview]Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2
NCT00261443 (124) [back to overview]Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2
NCT00261443 (124) [back to overview]Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2
NCT00261443 (124) [back to overview]Baseline Abnormal Involuntary Movement Scale (AIMS)
NCT00261443 (124) [back to overview]Baseline in Barnes Akathisia Global Clinical Assessment
NCT00261443 (124) [back to overview]Baseline in Simpson-Angus Scale (SAS) Total Score
NCT00261443 (124) [back to overview]Extension Phase: Mean Change From Baseline in CGI-BP (Mania) Severity of Illness at Extension Phase Endpoint
NCT00261443 (124) [back to overview]Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Depression) at Extension Phase Endpoint
NCT00261443 (124) [back to overview]Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Overall) at Extension Phase Endpoint
NCT00261443 (124) [back to overview]Median Baseline Hematocrit
NCT00261443 (124) [back to overview]Median Baseline Hemoglobin
NCT00261443 (124) [back to overview]Median Baseline Homeostasis Model Assessment 2 (HOMA2)-Percent Beta
NCT00261443 (124) [back to overview]Median Baseline Homeostasis Model Assessment 2 HOMA2-Insulin Resistance (IR)
NCT00261443 (124) [back to overview]Median Baseline Leukocytes
NCT00261443 (124) [back to overview]Median Baseline Platelet Count
NCT00261443 (124) [back to overview]Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample
NCT00261443 (124) [back to overview]Median Baseline Prolactin
NCT00261443 (124) [back to overview]Median Change From Baseline in Hematocrit
NCT00261443 (124) [back to overview]Median Change From Baseline in Hemoglobin
NCT00261443 (124) [back to overview]Median Change From Baseline in HOMA2 Model Assesses Insulin Resistance (HOMA2-IR) at Phase 2 Endpoint
NCT00261443 (124) [back to overview]Median Change From Baseline in Homeostasis Model Assessment 2(HOMA2)-Percent Beta at Phase 2 Endpoint
NCT00261443 (124) [back to overview]Median Change From Baseline in Leukocytes at Phase 2 Endpoint
NCT00261443 (124) [back to overview]Median Change From Baseline in Platelet Count at Phase 2 Endpoint
NCT00261443 (124) [back to overview]Median Change From Baseline in Prolactin at Phase 2 Endpoint
NCT00261443 (124) [back to overview]Proportion of Participants Discontinuing For Any Reason Through Week 52 (During Phase 3)
NCT00261443 (124) [back to overview]Unadjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) at Phase 2 Endpoint
NCT00261443 (124) [back to overview]Unadjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Phase 2 Endpoint
NCT00261443 (124) [back to overview]Unadjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score at Phase 2 Endpoint
NCT00261443 (124) [back to overview]Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3
NCT00261443 (124) [back to overview]Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3
NCT00261443 (124) [back to overview]Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3
NCT00261443 (124) [back to overview]Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3
NCT00261443 (124) [back to overview]Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3
NCT00261443 (124) [back to overview]Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3
NCT00261443 (124) [back to overview]Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3
NCT00261443 (124) [back to overview]Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3
NCT00261443 (124) [back to overview]Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3
NCT00261443 (124) [back to overview]Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3
NCT00261443 (124) [back to overview]Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3
NCT00261443 (124) [back to overview]Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3
NCT00261443 (124) [back to overview]Baseline and Adjusted Mean Change From Baseline in Weight
NCT00277212 (17) [back to overview]Number of Participants Showing Clinically Relevant Weight Loss by Study Week
NCT00277212 (17) [back to overview]Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities Occurring During Double-Blind Treatment (Phase 2)
NCT00277212 (17) [back to overview]Number of Participants Showing Clinically Relevant Weight Gain by Study Week
NCT00277212 (17) [back to overview]Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment
NCT00277212 (17) [back to overview]Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2)
NCT00277212 (17) [back to overview]Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2
NCT00277212 (17) [back to overview]Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2)
NCT00277212 (17) [back to overview]Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2)
NCT00277212 (17) [back to overview]Summary of Concomitant Medications, Phase 1
NCT00277212 (17) [back to overview]Summary of Concomitant Medications, Phase 2
NCT00277212 (17) [back to overview]Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities Occurring During Double-Blind Treatment
NCT00277212 (17) [back to overview]Adjusted Mean Change From Baseline in Body Weight, Phase 2
NCT00277212 (17) [back to overview]Adjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
NCT00277212 (17) [back to overview]Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment,
NCT00277212 (17) [back to overview]Adjusted Mean Change From Baseline in BMI by Study Week
NCT00277212 (17) [back to overview]Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score
NCT00277212 (17) [back to overview]Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Medication, Treatment-Emergent AEs and Treatment-Emergent Extrapyramidal Syndrome (EPS)-Related AEs
NCT00288366 (1) [back to overview]HDL Ratio
NCT00299702 (2) [back to overview]Time in Remission
NCT00299702 (2) [back to overview]Time to Relapse
NCT00308074 (4) [back to overview]Clinical Global Impressions-Improvement
NCT00308074 (4) [back to overview]Brief Psychiatric Rating Scale for Children (BPRS-C)
NCT00308074 (4) [back to overview]Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
NCT00308074 (4) [back to overview]Aberrant Behavior Checklist-Irritability Subscale
NCT00320671 (1) [back to overview]Percentage of Participants That Responded to Treatment
NCT00330863 (3) [back to overview]Side Effects and Metabolic Measures
NCT00330863 (3) [back to overview]Substantial Clinical Deterioration Measured by Psychotic Symptoms
NCT00330863 (3) [back to overview]Number of Patients Discontinuing From the Study
NCT00332241 (8) [back to overview]Mean Clinical Global Impressions Improvement Scale (CGI-I) Score
NCT00332241 (8) [back to overview]Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)
NCT00332241 (8) [back to overview]Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score
NCT00332241 (8) [back to overview]Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)
NCT00332241 (8) [back to overview]Change From Baseline in Body Weight
NCT00332241 (8) [back to overview]Summary of Safety
NCT00332241 (8) [back to overview]Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores
NCT00332241 (8) [back to overview]Number of Participants With Response at Week 8
NCT00337571 (8) [back to overview]Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)
NCT00337571 (8) [back to overview]Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score
NCT00337571 (8) [back to overview]Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)
NCT00337571 (8) [back to overview]Mean Clinical Global Impressions Improvement Scale (CGI-I) Score
NCT00337571 (8) [back to overview]Number of Participants With Response at Week 8
NCT00337571 (8) [back to overview]Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores
NCT00337571 (8) [back to overview]Summary of Safety
NCT00337571 (8) [back to overview]Change From Baseline in Body Weight
NCT00345033 (6) [back to overview]Change in Triglycerides
NCT00345033 (6) [back to overview]Change in Body Mass Index (BMI)
NCT00345033 (6) [back to overview]Change in Weight
NCT00345033 (6) [back to overview]Change in Total Cholesterol
NCT00345033 (6) [back to overview]Change in Insulin Resistance
NCT00345033 (6) [back to overview]Change in Glucose Metabolism
NCT00351936 (7) [back to overview]Change From Baseline in Triglycerides
NCT00351936 (7) [back to overview]Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
NCT00351936 (7) [back to overview]Change From Baseline in Fasting Total Cholesterol
NCT00351936 (7) [back to overview]Change From Baseline in Body Mass Index (BMI)
NCT00351936 (7) [back to overview]Change From Baseline in Low-density Lipoprotein (LDL)
NCT00351936 (7) [back to overview]Change From Baseline in Waist-hip Ratio (WHR)
NCT00351936 (7) [back to overview]Change From Baseline in Weight (Lbs)
NCT00365859 (21) [back to overview]Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities
NCT00365859 (21) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs
NCT00365859 (21) [back to overview]Number of Potentially Clinically Relevant Vital Sign Abnormalities
NCT00365859 (21) [back to overview]CGI-Improvement Score at Week 52 (Endpoint, LOCF)
NCT00365859 (21) [back to overview]Change From Baseline in ABC Stereotypy Subscale Score at Week 52 (Endpoint, LOCF)
NCT00365859 (21) [back to overview]Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Score at Week 52 (Endpoint, LOCF)
NCT00365859 (21) [back to overview]Mean Change From Baseline By Time Period in BMI Z-Score
NCT00365859 (21) [back to overview]Mean Change From Baseline in Patient Body Mass Index (BMI)
NCT00365859 (21) [back to overview]Mean Change From Baseline by Time Period in Body Weight Z-Score
NCT00365859 (21) [back to overview]Mean Change From Baseline in ABC Hyperactivity Subscale Score at Week 52 (Endpoint, LOCF)
NCT00365859 (21) [back to overview]Mean Change From Baseline in ABC Inappropriate Speech Subscale Score at Week 52 (Endpoint, LOCF)
NCT00365859 (21) [back to overview]Mean Change From Baseline in ABC Social Withdrawal Scale At Week 52 (Endpoint, LOCF)
NCT00365859 (21) [back to overview]Mean Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Score at Week 52 (Endpoint, LOCF)
NCT00365859 (21) [back to overview]Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) At Week 8, Week 26, and Week 52
NCT00365859 (21) [back to overview]Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Week 8, Week 26, Week 52, and Endpoint
NCT00365859 (21) [back to overview]Mean Change From Baseline in Clinical Global Impression (CGI)-Severity Score at Week 52 (Endpoint, LOCF)
NCT00365859 (21) [back to overview]Mean Change From Baseline in Patient Weight
NCT00365859 (21) [back to overview]Mean Change From Baseline in Total Simpson-Angus Scale (SAS) At Week 8, Week 26, and Week 52
NCT00365859 (21) [back to overview]Number of Participants With Potentially Clinically Relevant Eletrocardiograph (ECG) Abnormalities
NCT00365859 (21) [back to overview]Number of Participants With Potentially Clinically Relevant Laboratory Chemistry Abnormalities
NCT00365859 (21) [back to overview]Number of Participants With Potentially Clinically Relevant Laboratory Hematology Abnormalities
NCT00373880 (3) [back to overview]Plasma Cocaine
NCT00373880 (3) [back to overview]Subjective Effects of Cocaine
NCT00373880 (3) [back to overview]Cocaine Self-administration
NCT00392197 (2) [back to overview]HbA1c
NCT00392197 (2) [back to overview]Fasting Blood Glucose (FBS) Level (if Fasting Blood Glucose Level Was Not Available, Non-fasting Blood Glucose (Non-FBS) Level)
NCT00420459 (4) [back to overview]Aberrant Behavior Checklist
NCT00420459 (4) [back to overview]The Children's Yale-Brown Obsessive Compulsive Scale
NCT00420459 (4) [back to overview]Clinical Global Impressions- Severity
NCT00420459 (4) [back to overview]Social Responsiveness Scale
NCT00423878 (2) [back to overview]Efficacy Failure, Defined as Psychiatric Hospitalization, a 25 Percent Increase From Baseline on the Positive and Negative Syndrome Scale or Substantial Clinical Deterioration on the Clinical Global Impressions-Change (CGI-C)
NCT00423878 (2) [back to overview]Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks
NCT00466310 (1) [back to overview]Total Plasmalogen Levels in the Lipid Profile
NCT00468130 (2) [back to overview]Clinical Global Impression Improvement (CGI-AD)
NCT00468130 (2) [back to overview]Aberrant Behavior Checklist
NCT00489866 (5) [back to overview]Beck Depression Inventory, Second Edition (BDI-II)
NCT00489866 (5) [back to overview]Clinician Administered PTSD Scale (CAPS)
NCT00489866 (5) [back to overview]Connor-Davidson Resilience Scale (CD-RISC)
NCT00489866 (5) [back to overview]Brief Assessment of Cognition in Affective Disorders (BAC-A)
NCT00489866 (5) [back to overview]Positive and Negative Symptoms Scale (PANSS)
NCT00497055 (3) [back to overview]To Measure the Safety and Tolerability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, as Determined by the Number of Adverse Clinical Events in the Aripiprazole and Placebo Arms.
NCT00497055 (3) [back to overview]To Measure the Acceptability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, by Determining (Via Electronic Pill Caps [MEMS or Medication Event Monitoring System]) Medication Adherence to Aripiprazole and Placebo.
NCT00497055 (3) [back to overview]To Test the Hypothesis That Aripiprazole 20 mg Daily Will Reduce Methamphetamine Use Significantly More Than Placebo Among Methamphetamine-dependent Individuals.
NCT00508157 (2) [back to overview]Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16
NCT00508157 (2) [back to overview]Number of Participants Remaining on Metabolic Syndrome at Week 16
NCT00509067 (3) [back to overview]MATRICS Verbal Learning and Memory
NCT00509067 (3) [back to overview]Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS)
NCT00509067 (3) [back to overview]Clinical Global Impression
NCT00531518 (1) [back to overview]Psychotic Symptoms
NCT00556140 (2) [back to overview]Depression and Psychosis Response Rate
NCT00556140 (2) [back to overview]Depression and Psychosis Remission Rate
NCT00592683 (2) [back to overview]Change in Bipolar Symptoms as Assessed by Young-Mania Rating Scale (YMRS)
NCT00592683 (2) [back to overview]DSM-IV Mania Symptom Checklist
NCT00606177 (2) [back to overview]Young Mania Rating Scale (YMRS)
NCT00606177 (2) [back to overview]Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)
NCT00606229 (2) [back to overview]Young Mania Rating Scale (YMRS)
NCT00606229 (2) [back to overview]Clinical Global Impression - Bipolar Version (CGI-BP) Sevirity of Illness Score (Mania)
NCT00606281 (2) [back to overview]Clinical Global Impression - Bipolar Version (CGI-BP), Severity of Illness Score (Mania)
NCT00606281 (2) [back to overview]Young Mania Rating Scale (YMRS)
NCT00606320 (2) [back to overview]Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)
NCT00606320 (2) [back to overview]Young Mania Rating Scale (YMRS)
NCT00608543 (6) [back to overview]Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems
NCT00608543 (6) [back to overview]Spatial Working Memory (SWM) Between Errors for 6-move Problems
NCT00608543 (6) [back to overview]Change in Hamilton Rating Scale for Depression (HRSD - 17-item)
NCT00608543 (6) [back to overview]Spatial Working Memory (SWM) Strategy Score
NCT00608543 (6) [back to overview]Quality of Life Enjoyment and Satisfaction Questionnaire
NCT00608543 (6) [back to overview]Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems
NCT00619190 (3) [back to overview]Clinical Global Impressions Scale - Severity Score (CGI-S)
NCT00619190 (3) [back to overview]Change From Baseline in the Aberrant Behavior Checklist -Lethargy/Social Withdrawal Subscale at 12 Weeks
NCT00619190 (3) [back to overview]Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks
NCT00665366 (12) [back to overview]Percentage of Participants With Relevant Weight Gain or Weight Loss From Baseline at Week 12 (LOCF Data Set)
NCT00665366 (12) [back to overview]Percentage of Participants Showing Remission in the Young Mania Rating Scale (YMRS) Score From Baseline (LOCF Data Set)
NCT00665366 (12) [back to overview]Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Overall) Scale at Week 12 (LOCF Data Set)
NCT00665366 (12) [back to overview]Change From Baseline in Total and Subscale Scores on the Functional Assessment Short Test (FAST)(LOCF Data Set)
NCT00665366 (12) [back to overview]Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set)
NCT00665366 (12) [back to overview]Change From Baseline to Week 12 in Body Mass Index (BMI) (LOCF Data Set)
NCT00665366 (12) [back to overview]Change From Baseline in Participant Weight (OC Data Set and Week 12 LOCF Data Set)
NCT00665366 (12) [back to overview]Percentage of Participants Showing A Response From Baseline on the Young Mania Rating Scale (YMRS)(OC Data Set)
NCT00665366 (12) [back to overview]Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Depression) Scale (LOCF Data Set)
NCT00665366 (12) [back to overview]Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set)
NCT00665366 (12) [back to overview]Participant Scores on Patient Global Impression Improvement (PGI-I) Scale (OC Data Set)
NCT00665366 (12) [back to overview]Change From Baseline in Total Score on the Longitudinal Interval Follow-up Evaluation-Rating Impaired Functioning Tool (LIFE-RIFT)(OC Data Set and Week 12 LOCF Data Set)
NCT00667875 (4) [back to overview]Percent Riboflavin Positive Urine Samples as a Measure of Medication Compliance
NCT00667875 (4) [back to overview]Percent Heavy Drinking Days
NCT00667875 (4) [back to overview]Pill Counts During Treatment
NCT00667875 (4) [back to overview]Drinks Per Drinking Day
NCT00683852 (8) [back to overview]Number of Patients With Treatment Emergent AEs in Two Treatment Groups - People Exclusively on Drug or Placebo Throughout the Study
NCT00683852 (8) [back to overview]Number of Patients With Treatment Emergent AEs in Two Treatment Groups - Placebo Non-Responders
NCT00683852 (8) [back to overview]Treatment Emergent AEs in Two Treatment Groups - Safety Sample
NCT00683852 (8) [back to overview]Mean Change in Symptom Questionnaire (SQ)
NCT00683852 (8) [back to overview]MADRS (Montgomery-Asberg Depression Rating Scale) Readmission Rate
NCT00683852 (8) [back to overview]MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate
NCT00683852 (8) [back to overview]Mean Change in Clinical Global Impression of Severity (CGI-S)
NCT00683852 (8) [back to overview]Mean Change in MADRS (Montgomery-Asberg Depression Rating Scale) Score From Baseline to the End of Follow-up
NCT00685334 (2) [back to overview]Change From Baseline in Weight (Lbs.) at 12 Weeks
NCT00685334 (2) [back to overview]Tolerability
NCT00705783 (10) [back to overview]Mean Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score
NCT00705783 (10) [back to overview]Mean Change From Baseline in the PANSS Negative Subscale Score
NCT00705783 (10) [back to overview]Mean Change From Baseline in the PANSS Positive Subscale Score
NCT00705783 (10) [back to overview]Mean Change From Baseline in the PANSS Total Score
NCT00705783 (10) [back to overview]Mean Clinical Global Impression-Improvement (CGI-I) Score
NCT00705783 (10) [back to overview]Percentage of Patients Achieving Remission
NCT00705783 (10) [back to overview]Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria
NCT00705783 (10) [back to overview]Percentage of Responders
NCT00705783 (10) [back to overview]Time to Discontinuation
NCT00705783 (10) [back to overview]Time to Exacerbation of Psychotic Symptoms/Impending Relapse
NCT00706589 (1) [back to overview]Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7)
NCT00706654 (4) [back to overview]Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26
NCT00706654 (4) [back to overview]Percentage of Patients Achieving Remission
NCT00706654 (4) [back to overview]Percentage of Responders up to Week 38
NCT00706654 (4) [back to overview]Time to Exacerbation of Psychotic Symptoms/Impending Relapse
NCT00712270 (1) [back to overview]QTc Measurement
NCT00731549 (10) [back to overview]Percentage of Participants With Time to First Exacerbation of Psychotic Symptoms/Impending Relapse.
NCT00731549 (10) [back to overview]Percentage of Participants Who Discontinued Due to All Causes.
NCT00731549 (10) [back to overview]Percentage of Participants Achieving Remission.
NCT00731549 (10) [back to overview]Mean Change From Baseline to Endpoint in PANSS Positive and Negative Subscales.
NCT00731549 (10) [back to overview]Mean Change From Baseline to Endpoint (Last Visit) in Positive and Negative Syndrome Scale (PANSS) Total Score.
NCT00731549 (10) [back to overview]Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score.
NCT00731549 (10) [back to overview]Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.
NCT00731549 (10) [back to overview]Mean Clinical Global Impression of Improvement (CGI-I) Score.
NCT00731549 (10) [back to overview]Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit).
NCT00731549 (10) [back to overview]Percentage of Participants Stable at Baseline and Remaining Stable at Week 28.
NCT00746252 (1) [back to overview]Weight Gain
NCT00802100 (2) [back to overview]Feasibility of Randomizing a Cohort of Participants Meeting the Inclusion and Exclusion Criteria of the Study
NCT00802100 (2) [back to overview]Antipsychotic Efficacy, Defined as Completion of the Trial Without Psychiatric Hospitalization, Clinician Decision to Discontinue Treatment, or Patient Decision to Discontinue Treatment
NCT00806234 (4) [back to overview]Change in Low Density Lipoprotein (LDL) Cholesterol Level
NCT00806234 (4) [back to overview]Body Mass Index (BMI) Z-score Change
NCT00806234 (4) [back to overview]Triglyceride Levels
NCT00806234 (4) [back to overview]Change in Whole Body Insulin Sensitivity Index
NCT00845026 (26) [back to overview]Percentage of Participants With Remission (Rate of Remission) at Week 24 Endpoint
NCT00845026 (26) [back to overview]Number of Participants With Treatment-Emergent Change in Neurological Examination
NCT00845026 (26) [back to overview]Number of Participants With Suicidal Behaviors and Ideations Baseline Through 52 Weeks
NCT00845026 (26) [back to overview]Change From Baseline in Simpson-Angus Scale (SAS) Total Score at 52 Weeks Endpoint
NCT00845026 (26) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at 52 Weeks Endpoint
NCT00845026 (26) [back to overview]Change From Baseline in Personal and Social Performance (PSP) at 52 Weeks Endpoint
NCT00845026 (26) [back to overview]Change From Baseline in Number of Psychiatric Visits at 24 Weeks Endpoint
NCT00845026 (26) [back to overview]Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 52 Weeks Endpoint
NCT00845026 (26) [back to overview]Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB): Overall Composite T-Score at 52 Weeks Endpoint
NCT00845026 (26) [back to overview]Change From Baseline in Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) Total Score at 52 Weeks Endpoint
NCT00845026 (26) [back to overview]Number of Participants With Potentially Clinical Significant Change in Lipids Level
NCT00845026 (26) [back to overview]Number of Participants With Shift From Baseline to Maximum Post-Baseline Grading in Electroencephalograms (EEGs)
NCT00845026 (26) [back to overview]Change From Baseline in University of California-San Diego (UCSD) Performance-Based Skills Assessment-B (UPSA-B) Total Score at 52 Weeks Endpoint
NCT00845026 (26) [back to overview]Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at 52 Weeks Endpoint
NCT00845026 (26) [back to overview]Percentage of Participants With Response (Rate of Response) at 6 and 24 Weeks Endpoints
NCT00845026 (26) [back to overview]Change From Baseline in EuroQoL Questionnaire-5 Dimension (EQ-5D) at 52 Weeks Endpoint
NCT00845026 (26) [back to overview]Change From Baseline in Blood Pressure (BP) at 52 Weeks Endpoint
NCT00845026 (26) [back to overview]Change From Baseline in 16-Item Negative Symptoms Assessment (NSA-16) Total Score at 52 Weeks Endpoint
NCT00845026 (26) [back to overview]Time to Discontinuation Due to Adverse Event (AE)
NCT00845026 (26) [back to overview]Change From Baseline in Pulse Rate at 52 Weeks Endpoint
NCT00845026 (26) [back to overview]Change From Baseline in Barnes Akathisia Scale (BAS) Global Score at 52 Weeks Endpoint
NCT00845026 (26) [back to overview]Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at 52 Weeks Endpoint
NCT00845026 (26) [back to overview]Percentage of Participants With Relapse (Rate of Relapse)
NCT00845026 (26) [back to overview]Number of Participants With Potentially Clinically Significant Changes in QT Intervals Electrocardiograms (ECGs)
NCT00845026 (26) [back to overview]Number of Participants With Potentially Clinical Significant Change in Fasting Glucose Level
NCT00845026 (26) [back to overview]Change From Baseline in Weight at 52 Weeks Endpoint
NCT00857818 (3) [back to overview]Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs
NCT00857818 (3) [back to overview]Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels
NCT00857818 (3) [back to overview]Mean Baseline Fasting Non-HDL Levels
NCT00870727 (6) [back to overview]Mean Post-baseline Aberrant Behavior Checklist Social Withdrawal Subscale Score, Parent Report, Double-blind Phase
NCT00870727 (6) [back to overview]Number of Participants Improved as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2)
NCT00870727 (6) [back to overview]Mean Post-baseline Aberrant Behavior Checklist Hyperactivity Subscale Score, Parent Report, Double-blind Phase
NCT00870727 (6) [back to overview]Mean Post-baseline Aberrant Behavior Checklist Inappropriate Speech Subscale Score, Parent Report, Double-blind Phase
NCT00870727 (6) [back to overview]Mean Post-baseline Aberrant Behavior Checklist Stereotypy Subscale Score, Parent Report, Double-blind Phase
NCT00870727 (6) [back to overview]Mean Post-baseline Aberrant Behavior Checklist Irritability Subscale Score, Parent Report, Double-blind Phase
NCT00876343 (3) [back to overview]Mean Change in Sheehan Disability Scale (SDISS)
NCT00876343 (3) [back to overview]MADRS Response Rate
NCT00876343 (3) [back to overview]Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
NCT00882362 (1) [back to overview]Montgomery-Asberg Depression Rating Scale (MADRS)
NCT00892047 (6) [back to overview]Akathisia
NCT00892047 (6) [back to overview]Weight
NCT00892047 (6) [back to overview]QTc Prolongation on EKG (to Greater or Equal to 480 Msec)
NCT00892047 (6) [back to overview]Percentage of Subjects Who Met Criteria for Remission Based on the Montgomery-Asberg Depression Rating Scale (MADRS)
NCT00892047 (6) [back to overview]Parkinsonism
NCT00892047 (6) [back to overview]Emergent Suicidal Ideation in Those With no Ideation at the Start of Treatment
NCT00895921 (3) [back to overview]Akathisia
NCT00895921 (3) [back to overview]Change in Glucose Disposition
NCT00895921 (3) [back to overview]Change in Percent of Insulin Suppression of Endogenous Glucose Production
NCT00905307 (8) [back to overview]Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score (Double Blind Phase)
NCT00905307 (8) [back to overview]Change From Baseline to Week 6 in PANSS Positive Subscale Score (Double Blind Phase)
NCT00905307 (8) [back to overview]Response Rate at Week 6
NCT00905307 (8) [back to overview]Mean Clinical Global Impression - Improvement (CGI-I) at Week 6
NCT00905307 (8) [back to overview]Discontinuation Rate for Lack of Efficacy or Receipt of Open Label OPC-34712
NCT00905307 (8) [back to overview]Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (Double Blind Phase)
NCT00905307 (8) [back to overview]Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP) (Double Blind Phase)
NCT00905307 (8) [back to overview]Change From Baseline to Week 6 in PANSS Negative Subscale Score (Double Blind Phase)
NCT00947154 (4) [back to overview]Mass General Hair Pulling Scale, Actual Pulling Subscale
NCT00947154 (4) [back to overview]Mass General Hair Pulling Scale
NCT00947154 (4) [back to overview]Clinical Global Impressions Improvement (CGI-I)
NCT00947154 (4) [back to overview]CGI-I Score of 1 or 2 (Very Much or Much Improved)
NCT00953745 (2) [back to overview]Fluorodopa Uptake Values in Brain Images of Aripiprazole Augmentation Responders
NCT00953745 (2) [back to overview]Depression Symptom Change on The Montgomery-Åsberg Depression Rating (MADRS) Scale Between ARP Responders and Non-responders.
NCT01001702 (8) [back to overview]Number of Participants With Clinically Significant Heart Rate
NCT01001702 (8) [back to overview]Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths
NCT01001702 (8) [back to overview]Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score
NCT01001702 (8) [back to overview]Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
NCT01001702 (8) [back to overview]Number of Participants Showing Significant Weight Gain or Loss
NCT01001702 (8) [back to overview]Number of Participants With Clinical Significant Laboratory Tests
NCT01001702 (8) [back to overview]Number of Participants With Clinically Abnormal Changes in Electrocardiograms (ECGs) Evaluations
NCT01001702 (8) [back to overview]Number of Participants With Clinically Significant Blood Pressure
NCT01009047 (9) [back to overview]Number of Participants With PANSS Response
NCT01009047 (9) [back to overview]Number of Participants With Clinical Stability
NCT01009047 (9) [back to overview]Change From Baseline in PANSS Total Score at Day 182
NCT01009047 (9) [back to overview]Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182
NCT01009047 (9) [back to overview]Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56
NCT01009047 (9) [back to overview]Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182
NCT01009047 (9) [back to overview]Change From Baseline in Other Marder Factors Scores at Day 56 and 182
NCT01009047 (9) [back to overview]Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182
NCT01009047 (9) [back to overview]Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182
NCT01028820 (2) [back to overview]Baseline and Week 8scores on Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version
NCT01028820 (2) [back to overview]Total Repetitive Behavior Scale - Revised (RBS_R)
NCT01104766 (2) [back to overview]Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.
NCT01104766 (2) [back to overview]Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S)
NCT01111539 (3) [back to overview]Phase C: Mean Clinical Global Impression - Improvement (CGI-I) Scale Score at the End of Phase C (Week 14)
NCT01111539 (3) [back to overview]Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14)
NCT01111539 (3) [back to overview]Phase C: Mean Change From End of Phase B (Week 8) in the Sheehan Disability Scale (SDS) Mean Score to End of Phase C (Week 14)
NCT01111552 (3) [back to overview]Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14)
NCT01111552 (3) [back to overview]Phase C: Clinical Global Impression - Improvement Scale (CGI-I) Score at The End of Phase C (Week 14)
NCT01111552 (3) [back to overview]Phase C: Mean Change From End of Phase B (Week 8) in the Sheehan Disability Scale (SDS) Mean Score to End of Phase C (Week 14)
NCT01111565 (3) [back to overview]Phase C: Clinical Global Impression - Improvement Scale (CGI-I) Score at the End of Phase C
NCT01111565 (3) [back to overview]Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14)
NCT01111565 (3) [back to overview]Phase C: Mean Change From End of Phase B (Week 8) in the Sheehan Disability Scale (SDS) Mean Score to End of Phase C (Week 14)
NCT01122927 (23) [back to overview]Number of Participants With Cognitive Impairment for Each New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT)
NCT01122927 (23) [back to overview]Mean Change From Baseline by Week in Simpson-Angus Scale (SAS) Total Score
NCT01122927 (23) [back to overview]Mean Change From Baseline by Week in Abnormal Involuntary Movement Scale (AIMS)
NCT01122927 (23) [back to overview]Incidence of Vital Signs of Potential Clinical Relevance
NCT01122927 (23) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01122927 (23) [back to overview]Incidence of Laboratory Values of Potential Clinical Relevance
NCT01122927 (23) [back to overview]Mean Change From Baseline in Children's Global Assessment Scale (CGAS) in Bipolar (de Novo Participants)
NCT01122927 (23) [back to overview]Mean Change From Baseline for Columbia-Suicide Severity Rating Scale (C-SSRS) in Suicidal Ideation Intensity Total Score
NCT01122927 (23) [back to overview]Incidence of Suicidality, Suicidal Behavior and Suicidal Ideation
NCT01122927 (23) [back to overview]Mean Change From Baseline in PANSS Negative Subscale Score
NCT01122927 (23) [back to overview]Baseline and Post-Baseline Tanner Staging
NCT01122927 (23) [back to overview]Incidence of Physical Examination Findings of Potential Clinical Relevance
NCT01122927 (23) [back to overview]Mean Change From Baseline in Clinical Global Impression Scale - Bipolar (CGI-BP) Version Severity Score
NCT01122927 (23) [back to overview]Mean Change From Baseline in Clinical Global Impression Scale - Bipolar Version Improvement Score
NCT01122927 (23) [back to overview]Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score
NCT01122927 (23) [back to overview]Mean Change From Baseline in General Behavior Inventory (GBI) Scale Total Score for Mania and Depression in Both Parent/Guardian and Subject Version of the Scale
NCT01122927 (23) [back to overview]Mean Change From Baseline in PANSS Positive Subscale Score
NCT01122927 (23) [back to overview]Mean Change From Baseline in Positive and Negative Symptoms Score (PANSS) Total Score
NCT01122927 (23) [back to overview]Mean Change From Baseline in the Attention Deficit Hyperactive Disorders Rating (ADHD-RS-IV) Scale Score
NCT01122927 (23) [back to overview]Mean Change From Baseline in Young Mania Rating Scale (YMRS) Score
NCT01122927 (23) [back to overview]Mean Change in Clinical Global Impression-Improvement (CGI-I) Score
NCT01122927 (23) [back to overview]Percentage of Participants Who Discontinued Due to All Adverse Events
NCT01122927 (23) [back to overview]Mean Change From Baseline by Week in Barnes Akathisia Rating Scale (BARS) Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Overall General Subscore
NCT01123707 (29) [back to overview]Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Total Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
NCT01123707 (29) [back to overview]Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
NCT01123707 (29) [back to overview]Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
NCT01123707 (29) [back to overview]Number of Participants With Potentially Clinically Significant Physical Examination Findings
NCT01123707 (29) [back to overview]Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment of Akathisia (Item 4) Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment of Akathisia (Item 4) Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Body Mass Index (BMI)
NCT01123707 (29) [back to overview]Mean Change From Baseline in Body Mass Index (BMI)
NCT01123707 (29) [back to overview]Mean Change From Baseline in Body Weight
NCT01123707 (29) [back to overview]Mean Change From Baseline in Body Weight
NCT01123707 (29) [back to overview]Mean Change From Baseline in Body Weight
NCT01123707 (29) [back to overview]Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Each Item as Measured by Massachusetts General Hospital Sexual Functioning Inventory (MGH SFI) Subscale Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Laboratory Test Results: Hemoglobin A1c (HbA1c)
NCT01123707 (29) [back to overview]Mean Change From Baseline in Laboratory Test Results: Hemoglobin A1c (HbA1c)
NCT01123707 (29) [back to overview]Mean Change From Baseline in Laboratory Test Results: Prolactin
NCT01123707 (29) [back to overview]Mean Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) Total Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Patient Global Impression - Severity of Depression Scale (PGI-S) Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Patient Global Impression - Severity of Depression Scale (PGI-S) Score
NCT01123707 (29) [back to overview]Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs), Severe (Grade 3 or Higher) TEAEs, and Discontinuations From the Trial Due to TEAEs
NCT01123707 (29) [back to overview]Percentage of Participants With Suicidal Ideation in Each Item as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
NCT01123707 (29) [back to overview]Mean Change From Baseline in Laboratory Test Results: Prolactin
NCT01123707 (29) [back to overview]Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities
NCT01129882 (2) [back to overview]Mean Change In Clinical Global Impression-Severity (CGI-S) of Illness Scale Score From Baseline To Last Visit
NCT01129882 (2) [back to overview]Number Of Participants Reporting Severe Treatment-Emergent Adverse Events (TEAE)
NCT01149655 (11) [back to overview]Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
NCT01149655 (11) [back to overview]Mean Change From Baseline to Endpoint in PANSS Total Score.
NCT01149655 (11) [back to overview]Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.
NCT01149655 (11) [back to overview]Percentage of Participants Who Discontinued Due to All Reasons Other Than Sponsor Discontinued Study.
NCT01149655 (11) [back to overview]Overall Relapse Rate (in Percent) From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse.
NCT01149655 (11) [back to overview]Mean Change From Baseline to Endpoint in CGI-S Score.
NCT01149655 (11) [back to overview]Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
NCT01149655 (11) [back to overview]Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
NCT01149655 (11) [back to overview]Percentage of Responders in Each Treatment Group.
NCT01149655 (11) [back to overview]Percentage of Participants Who Had Achieved Remission.
NCT01149655 (11) [back to overview]Mean CGI-I Score at Endpoint.
NCT01157351 (6) [back to overview]Time to First Treatment Failure
NCT01157351 (6) [back to overview]Time to First Psychiatric Hospitalization or Arrest/Incarceration
NCT01157351 (6) [back to overview]Time to First Psychiatric Hospitalization
NCT01157351 (6) [back to overview]Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration
NCT01157351 (6) [back to overview]Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration
NCT01157351 (6) [back to overview]Percentage of Participants in Each Event Category of First Treatment Failure
NCT01188668 (12) [back to overview]Aripiprazole Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR
NCT01188668 (12) [back to overview]Aripiprazole Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR
NCT01188668 (12) [back to overview]Aripiprazole Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR
NCT01188668 (12) [back to overview]Dehydro-aripiprazole (Metabolite) Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR
NCT01188668 (12) [back to overview]Plasma Aripiprazole Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg + Aripiprazole 5 mg
NCT01188668 (12) [back to overview]Dehydro-aripiprazole (Metabolite) Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR
NCT01188668 (12) [back to overview]Dehydro-aripiprazole (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR
NCT01188668 (12) [back to overview]Aripiprazole Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR
NCT01188668 (12) [back to overview]Dehydro-aripiprazole (Metabolite) Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR
NCT01188668 (12) [back to overview]Aripiprazole Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR
NCT01188668 (12) [back to overview]Plasma Dehydro-aripiprazole (Metabolite) Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg, Aripiprazole 5 mg
NCT01188668 (12) [back to overview]Aripiprazole Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR
NCT01227668 (5) [back to overview]Percentage of Patients Relapsing by Week 16
NCT01227668 (5) [back to overview]Adjusted Mean Change From Baseline to Week 16 on the Aberrant Behavior Checklist Irritability (ABC-I) Subscale Score (Last Observation Carried Forward [LOCF])
NCT01227668 (5) [back to overview]Change From Baseline in Mean Clinical Global Impression Improvement (CGI-I) Scale Score at Week 16 (Last Observation Carried Forward [LOCF])
NCT01227668 (5) [back to overview]Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation During Phase 1
NCT01227668 (5) [back to overview]Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment-related AEs During Phase 2
NCT01292057 (2) [back to overview]Total Number of Drinks Per Day During Natural (Usual Environment) Conditions
NCT01292057 (2) [back to overview]Total Number of Drinks Consumed in Bar Lab
NCT01328093 (16) [back to overview]Change From Baseline to 24 Weeks in Body Weight
NCT01328093 (16) [back to overview]Change From Baseline up to 24 Weeks in 16-Item Negative Symptom Assessment (NSA-16)
NCT01328093 (16) [back to overview]Change From Baseline up to 24 Weeks in Abnormal Involuntary Movement Scale (AIMS)
NCT01328093 (16) [back to overview]Change From Baseline up to 24 Weeks in Barnes Akathisia Scale (BAS)
NCT01328093 (16) [back to overview]Change From Baseline up to 24 Weeks in Clinical Global Impression-Severity Scale (CGI-S)
NCT01328093 (16) [back to overview]Change From Baseline up to 24 Weeks in Personal and Social Performance (PSP) Score
NCT01328093 (16) [back to overview]Change From Baseline up to 24 Weeks in Simpson-Angus Scale (SAS)
NCT01328093 (16) [back to overview]Change From Baseline up to 24 Weeks in Subjective Well-Being Under Neuroleptic Treatment Scale- Short Form (SWN-SF) Total Score
NCT01328093 (16) [back to overview]Number of Participants With 30% or Greater Decrease in Positive and Negative Syndrome Scale (PANSS) Total Score
NCT01328093 (16) [back to overview]Schizophrenia Resource Use Module (S-RUM) - Number of Sessions With a Psychiatrist
NCT01328093 (16) [back to overview]Time to Discontinuation
NCT01328093 (16) [back to overview]Change From Baseline up to 24 Weeks in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores
NCT01328093 (16) [back to overview]Number of Participants With Suicidal Behaviors and Ideations Measured by Columbia Suicide Severity Rating Scale (C-SSRS)
NCT01328093 (16) [back to overview]Percentage of Participants With Clinically Significant Weight Change
NCT01328093 (16) [back to overview]Schizophrenia Resource Utilization Module (S-RUM) - Number of Emergency Room (ER) or Equivalent Facility Visits and Outpatient Medical Visits
NCT01328093 (16) [back to overview]Change From Baseline up to 24 Weeks in EuroQol-5 Dimensions Questionnaire (EQ-5D) Visual Analog Scale (VAS) Health State Score
NCT01333072 (1) [back to overview]Changes in the Irritability Subscale of the Larger ABC (Abberent Behavior Checklist) That Occur From Baseline to 10 Weeks
NCT01338298 (2) [back to overview]To Determine if Adjunct Aripiprazole Will Resolve or Improve Prolactin Related Hormonal Side Effects (Amenorrhea, Oligomenorrhea, Galactorrhea).
NCT01338298 (2) [back to overview]To Test Whether Adjunctive Aripiprazole Will Improve Quality/Perceived Quality of Life.
NCT01354353 (8) [back to overview]Percentage of Participants With Worsening Severity From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)
NCT01354353 (8) [back to overview]Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests)
NCT01354353 (8) [back to overview]Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Scale (BAS)
NCT01354353 (8) [back to overview]Part A: Pharmacokinetics, Area Under the Concentration - Time Curve (AUC)
NCT01354353 (8) [back to overview]Percentage of Participants With Increasing Impairment From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Simpson-Angus Scale (SAS)
NCT01354353 (8) [back to overview]Part A: Pharmacokinetics, Maximum Concentration (Cmax)
NCT01354353 (8) [back to overview]Percentage of Participants With Increased Severity From Baseline to Day 17 in Clinical Global Impression- Severity Scale (CGI-S)
NCT01354353 (8) [back to overview]Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Brief Psychiatric Rating Scale (BPRS)
NCT01416441 (21) [back to overview]Number of Participants With Emergence of Suicidal Ideation, TEAEs Related to Suicide and Suicidality and Suicide Ideation From the Potential Suicide Events Recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS)
NCT01416441 (21) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation
NCT01416441 (21) [back to overview]Response Rates
NCT01416441 (21) [back to overview]Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score
NCT01416441 (21) [back to overview]Mean Change From Baseline in Body Weight
NCT01416441 (21) [back to overview]Mean Change From Baseline in Body Mass Index (BMI)
NCT01416441 (21) [back to overview]Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score
NCT01416441 (21) [back to overview]Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV)
NCT01416441 (21) [back to overview]Treatment Discontinuation Rates
NCT01416441 (21) [back to overview]Mean Change From Baseline in Children's Depression Rating Scale Revised (CDRS-R) Total Score
NCT01416441 (21) [back to overview]Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score
NCT01416441 (21) [back to overview]Mean Change From Baseline in Clinical Global Impression for Tourette's Syndrome (CGI-TS) Severity of Illness Score
NCT01416441 (21) [back to overview]Mean Change From Baseline in Gilles de la Tourette Quality of Life (GTS-QOL) Overall Score
NCT01416441 (21) [back to overview]Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Total Severity Score
NCT01416441 (21) [back to overview]Mean Change From Baseline in Simpson Angus Scale (SAS) Score
NCT01416441 (21) [back to overview]Mean Change From Baseline in Total YGTSS Score
NCT01416441 (21) [back to overview]Mean Change From Baseline in Waist Circumference
NCT01416441 (21) [back to overview]Mean Change From Baseline in Yale Global Tic Severity Scale (YGTSS) Total Tic Score
NCT01416441 (21) [back to overview]Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
NCT01416441 (21) [back to overview]Number of Participants With Clinically Significant Changes in Laboratory Parameter Values
NCT01416441 (21) [back to overview]Number of Participants With Clinically Significant Changes in Vital Signs
NCT01418339 (3) [back to overview]Change From Baseline in Clinical Global Impressions Scale for Tourette's Syndrome (CGI-TS) Score
NCT01418339 (3) [back to overview]Change From Baseline in Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) Total Score
NCT01418339 (3) [back to overview]Change From Baseline in Yale Global Tic Severity Scale (YGTSS) - Total Tic Score (TTS)
NCT01418352 (3) [back to overview]Mean Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score
NCT01418352 (3) [back to overview]Mean Change From Baseline in Clinical Global Impressions Scale for Tourette's Syndrome (CGI-TS) Score
NCT01418352 (3) [back to overview]Mean Change From Baseline in Gilles de la Tourette Quality of Life (GTS-QOL) Overall Score at Week 8
NCT01421342 (4) [back to overview]Rate of Protocol Relapse of Symptoms of Major Depression After Achieving Remission in the Acute Phase
NCT01421342 (4) [back to overview]Rate of Protocol Remission of Symptoms of Major Depressive Disorder
NCT01421342 (4) [back to overview]Rate of Protocol Response as Reduction in Symptoms of Major Depression (>= 50% Reduction in QIDS-C)
NCT01421342 (4) [back to overview]Rate of Protocol Response Measured as a Change in Clinical Global Impression (CGI) - Improvement Scale
NCT01432444 (6) [back to overview]Mean Clinical Global Impression-Improvement Score (CGI-I) by Week.
NCT01432444 (6) [back to overview]Change From Baseline in PANSS Positive Subscale Score.
NCT01432444 (6) [back to overview]Change From Baseline in PANSS Negative Subscale Score.
NCT01432444 (6) [back to overview]Change From Baseline in PANSS (Positive and Negative Syndrome Scale) Total Score.
NCT01432444 (6) [back to overview]Change From Baseline in Clinical Global Impression-Severity Score (CGI-S).
NCT01432444 (6) [back to overview]Number of Inpatient Psychiatric Hospitalization for Retrospective Period (Months 4-6) and Prospective Period (Months 4-6).
NCT01438060 (42) [back to overview]Change in Simpson-Angus Scale (SAS) Total Score During Extension Phase
NCT01438060 (42) [back to overview]Clinical Global Impression (CGI) Improvement Score During Extension Phase
NCT01438060 (42) [back to overview]Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase
NCT01438060 (42) [back to overview]Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase
NCT01438060 (42) [back to overview]Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Extension Phase
NCT01438060 (42) [back to overview]Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Treatment Beyond 140 Weeks
NCT01438060 (42) [back to overview]Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs in Acute Phase
NCT01438060 (42) [back to overview]Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase
NCT01438060 (42) [back to overview]Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase
NCT01438060 (42) [back to overview]Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events in Acute Phase
NCT01438060 (42) [back to overview]Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase
NCT01438060 (42) [back to overview]Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase
NCT01438060 (42) [back to overview]Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase
NCT01438060 (42) [back to overview]Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase
NCT01438060 (42) [back to overview]Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase
NCT01438060 (42) [back to overview]Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase
NCT01438060 (42) [back to overview]Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior
NCT01438060 (42) [back to overview]CGI Improvement Score in Acute Phase
NCT01438060 (42) [back to overview]Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score in Acute Phase
NCT01438060 (42) [back to overview]Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase
NCT01438060 (42) [back to overview]Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase
NCT01438060 (42) [back to overview]Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase
NCT01438060 (42) [back to overview]Change From Baseline in Mini Mental State Examination (MMSE) Total Score in Acute Phase
NCT01438060 (42) [back to overview]Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase
NCT01438060 (42) [back to overview]Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression
NCT01438060 (42) [back to overview]Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety
NCT01438060 (42) [back to overview]Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference
NCT01438060 (42) [back to overview]Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors
NCT01438060 (42) [back to overview]Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions
NCT01438060 (42) [back to overview]Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria
NCT01438060 (42) [back to overview]Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition
NCT01438060 (42) [back to overview]Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria
NCT01438060 (42) [back to overview]Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations
NCT01438060 (42) [back to overview]Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability
NCT01438060 (42) [back to overview]Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep
NCT01438060 (42) [back to overview]Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase
NCT01438060 (42) [back to overview]Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase
NCT01438060 (42) [back to overview]Change From Baseline in NPI Total Score in Acute Phase
NCT01438060 (42) [back to overview]Change From Baseline in Simpson-Angus Scale (SAS) Total Score in Acute Phase
NCT01438060 (42) [back to overview]Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase
NCT01438060 (42) [back to overview]Change in Barnes Global Clinical Assessment of Akathisia Score During Extension Phase
NCT01438060 (42) [back to overview]Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase
NCT01490086 (5) [back to overview]Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score
NCT01490086 (5) [back to overview]Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale
NCT01490086 (5) [back to overview]Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale
NCT01490086 (5) [back to overview]Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale
NCT01490086 (5) [back to overview]Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S)
NCT01552772 (11) [back to overview]Change From Baseline in PANSS Positive Sub-scale Score for LOCF Data.
NCT01552772 (11) [back to overview]CGI-I Scale Score in LOCF Data.
NCT01552772 (11) [back to overview]Change From Baseline in PANSS Negative Sub-scale Score for LOCF Data.
NCT01552772 (11) [back to overview]Change From Baseline in Clinical Global Impression Severity (CGI-S) Score in OC Data.
NCT01552772 (11) [back to overview]Change From Baseline in CGI-S Score in LOCF Data.
NCT01552772 (11) [back to overview]Change From Baseline in PANSS Positive Sub-scale Score for OC Data.
NCT01552772 (11) [back to overview]Change From Baseline in Total Score of PANSS for Last Observation Carried Forward (LOCF) Data.
NCT01552772 (11) [back to overview]Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Observed Cases (OC) Data.
NCT01552772 (11) [back to overview]Clinical Global Impression Improvement (CGI-I) Scale Score in OC Data.
NCT01552772 (11) [back to overview]Number of Participants With Adverse Events (AE).
NCT01552772 (11) [back to overview]Change From Baseline in PANSS Negative Sub-scale Score for OC Data.
NCT01567527 (4) [back to overview]Mean Change From Randomization to Endpoint in the CGI-BP-S (Mania) Score.
NCT01567527 (4) [back to overview]Time From Randomization to Recurrence Defined by Hospitalization for a Mood Episode.
NCT01567527 (4) [back to overview]Time From Randomization to Recurrence of Any Mood Episode During Double-bind Placebo-controlled Phase.
NCT01567527 (4) [back to overview]Number of Subjects Meeting Criteria for Recurrence of Any Mood Episode.
NCT01617447 (1) [back to overview]Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score
NCT01617460 (1) [back to overview]Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score
NCT01646827 (12) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Aripriprazole
NCT01646827 (12) [back to overview]Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
NCT01646827 (12) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Dehydro-Aripiprazole
NCT01646827 (12) [back to overview]Number of Participants With Vital Signs of Potential Clinical Relevance-Temperature
NCT01646827 (12) [back to overview]Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Aripiprazole
NCT01646827 (12) [back to overview]Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Dehydro-Aripiprazole
NCT01646827 (12) [back to overview]Number of Participants Reporting Treatment Emergent Adverse Events (TEAE).
NCT01646827 (12) [back to overview]Number of Participants With Electrocardiogram (ECG) Measurements of Potential Clinical Relevance
NCT01646827 (12) [back to overview]Number of Participants With Laboratory Values of Potential Clinical Relevance.
NCT01646827 (12) [back to overview]Number of Participants With Vital Signs of Potential Clinical Relevance-Blood Pressure
NCT01646827 (12) [back to overview]Number of Participants With Vital Signs of Potential Clinical Relevance-Heart Rate
NCT01646827 (12) [back to overview]Visual Analog Scale (VAS) Score at Day 1, Day 14, Day 28 and Last Visit.
NCT01663532 (7) [back to overview]Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.
NCT01663532 (7) [back to overview]Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Score.
NCT01663532 (7) [back to overview]Mean Clinical Global Impression-Improvement Scale (CGI-I) Score at Endpoint.
NCT01663532 (7) [back to overview]Responder Rate Based on PANSS Total Score.
NCT01663532 (7) [back to overview]Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.
NCT01663532 (7) [back to overview]Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.
NCT01663532 (7) [back to overview]Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.
NCT01683058 (25) [back to overview]Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Discontinued Investigational Medicinal Product (IMP) Due to AEs, Serious TEAEs and Outcome of Death
NCT01683058 (25) [back to overview]Number of Participants With Clinically Relevant Laboratory Values.
NCT01683058 (25) [back to overview]Number of Participants With Clinically Relevant Physical Examination.
NCT01683058 (25) [back to overview]Mean Change From Baseline by Week by EPS Evaluated Using Barnes Akathisia Rating Scale (BARS)
NCT01683058 (25) [back to overview]Mean Change From Baseline by Week by EPS Evaluated Using the Abnormal Involuntary Movement Scale (AIMS)
NCT01683058 (25) [back to overview]Mean Change From Baseline by Week by Extrapyramidal Symptoms (EPS) Evaluated Using the Simpson-Angus Scale (SAS)
NCT01683058 (25) [back to overview]Mean Change From Baseline in Suicidal Ideation Intensity Total Score by the Columbia Suicide Severity Rating Scale (C-SSRS)
NCT01683058 (25) [back to overview]Mean Change in Body Temperature From Baseline in All Participants.
NCT01683058 (25) [back to overview]Mean Change in Clinically Relevant Body Mass Index From Baseline in All Participants.
NCT01683058 (25) [back to overview]Mean Change in Clinically Relevant Body Weight Changes From Baseline in All Participants.
NCT01683058 (25) [back to overview]Mean Change in Clinically Relevant Waist Circumference From Baseline in All Participants.
NCT01683058 (25) [back to overview]Mean Change in Diastolic BP From Baseline in All Participants.
NCT01683058 (25) [back to overview]Mean Change in Diastolic Supine BP From Baseline in All Participants.
NCT01683058 (25) [back to overview]Mean Change in Heart Rate From Baseline in All Participants.
NCT01683058 (25) [back to overview]Mean Change in Heart Rate Supine From Baseline in All Participants.
NCT01683058 (25) [back to overview]Mean Change in PR Interval From Baseline in All Participants.
NCT01683058 (25) [back to overview]Mean Change in QRS Interval From Baseline in All Participants.
NCT01683058 (25) [back to overview]Mean Change in QT Interval From Baseline in All Participants.
NCT01683058 (25) [back to overview]Mean Change in QTcB Interval From Baseline in All Participants.
NCT01683058 (25) [back to overview]Mean Change in QTcF Interval From Baseline in All Participants.
NCT01683058 (25) [back to overview]Mean Change in QTcN Interval From Baseline in All Participants.
NCT01683058 (25) [back to overview]Mean Change in RR Interval From Baseline in All Participants.
NCT01683058 (25) [back to overview]Mean Change in Systolic BP From Baseline in All Participants.
NCT01683058 (25) [back to overview]Mean Change in Systolic Supine Blood Pressure (BP) From Baseline in All Participants.
NCT01683058 (25) [back to overview]Mean Change in Ventricular Rate From Baseline in All Participants.
NCT01710709 (9) [back to overview]Number of Participants With Adverse Events
NCT01710709 (9) [back to overview]Number of Participants Experiencing Suicidal Events and Their Classification According to the Completion of Columbia Suicide Severity Rating Scale (C-SSRS)
NCT01710709 (9) [back to overview]Injection Site Pain Measured by the Visual Analog Scale (VAS)
NCT01710709 (9) [back to overview]Number of Participants With Clinically Significant Abnormal Laboratory Test Results
NCT01710709 (9) [back to overview]Number of Participants With Clinically Significant Abnormal Vital Signs
NCT01710709 (9) [back to overview]Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating
NCT01710709 (9) [back to overview]Extrapyramidal Symptoms Will be Assessed by Mean Change From Baseline on Abnormal Involuntary Movement Scale(AIMS), Simpson-Angus Scale (SAS), Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS Only Used in Japan) and Barnes Akathisia Rating Scale (BARS)
NCT01710709 (9) [back to overview]Percentage of Participants Who Remained Stable at End of Treatment in Phase C
NCT01710709 (9) [back to overview]Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECGs)
NCT01727700 (6) [back to overview]Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS).
NCT01727700 (6) [back to overview]Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8.
NCT01727700 (6) [back to overview]Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score
NCT01727700 (6) [back to overview]Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score
NCT01727700 (6) [back to overview]Response Rate
NCT01727700 (6) [back to overview]Treatment Discontinuation Rate
NCT01727713 (21) [back to overview]Change From Baseline to Endpoint on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS).
NCT01727713 (21) [back to overview]Mean Change From Baseline in Body Mass Index (BMI).
NCT01727713 (21) [back to overview]Mean Change From Baseline in Body Weight.
NCT01727713 (21) [back to overview]Mean Change From Baseline in Waist Circumference.
NCT01727713 (21) [back to overview]Mean Change From Baseline to Endpoint in Total YGTSS Score.
NCT01727713 (21) [back to overview]Mean Clinical Global Impressions for Tourette's Syndrome (CGI-TS) Change Score at Endpoint.
NCT01727713 (21) [back to overview]Percentage of Participants With Adverse Events.
NCT01727713 (21) [back to overview]Percentage of Participants With Clinically Significant Abnormal Electrocardiogram (ECG).
NCT01727713 (21) [back to overview]Percentage of Participants With Clinically Significant Abnormal Laboratory Test Results.
NCT01727713 (21) [back to overview]Percentage of Participants With Clinically Significant Abnormal Vital Signs.
NCT01727713 (21) [back to overview]Percentage of Participants With Response (Response Rate).
NCT01727713 (21) [back to overview]Percentage of Participants With Treatment Discontinuation (Treatment Discontinuation Rate).
NCT01727713 (21) [back to overview]Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score.
NCT01727713 (21) [back to overview]Change From Baseline in Average Score of Attention Deficit Disorder/Attention-deficit Hyperactivity Disorder (ADD/ADHD) of Swanson, Nolan, and Pelham-IV Rating Scale (SNAP-IV).
NCT01727713 (21) [back to overview]Change From Baseline in Barnes Akathisia Rating Scale (BARS) Total Score.
NCT01727713 (21) [back to overview]Change From Baseline in Children's Depression Rating Scale - Revised (CDRS-R).
NCT01727713 (21) [back to overview]Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS).
NCT01727713 (21) [back to overview]Change From Baseline in Pediatric Anxiety Rating Scale (PARS).
NCT01727713 (21) [back to overview]Change From Baseline in Simpson-Angus Scale (SAS) Total Score.
NCT01727713 (21) [back to overview]Change From Baseline in Suicidal Ideation Intensity Total Score Based on Columbia-Suicide Severity Rating Scale (C-SSRS).
NCT01727713 (21) [back to overview]Change From Baseline to Endpoint in CGI-TS Severity of Illness Score.
NCT01795547 (9) [back to overview]Change From Baseline to Week 28 in the TooL Total Score
NCT01795547 (9) [back to overview]Investigator's Assessment Questionnaire (IAQ) Total Score at Week 28
NCT01795547 (9) [back to overview]Change From Baseline to Week 28 in the 'Instrumental Role' QLS Domain Score
NCT01795547 (9) [back to overview]Change From Baseline to Week 28 in CGI-S Score
NCT01795547 (9) [back to overview]Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score
NCT01795547 (9) [back to overview]Change From Baseline to Week 28 in the 'Common Objects and Activities' QLS Domain Score
NCT01795547 (9) [back to overview]Change From Baseline to Week 28 in SWN-S Total Score
NCT01795547 (9) [back to overview]Change From Baseline to Week 28 in the 'Interpersonal Relations' QLS Domain Score
NCT01795547 (9) [back to overview]Change From Baseline to Week 28 in the 'Intrapsychic Foundations' QLS Domain Score
NCT01844700 (4) [back to overview]Percent Weight Change Compared to Baseline Weight
NCT01844700 (4) [back to overview]BMI Z-scores
NCT01844700 (4) [back to overview]Weight Change
NCT01844700 (4) [back to overview]BMI Percentile
NCT01870999 (17) [back to overview]"Number of Participants Hospitalized for Adverse Event Worsening Schizophrenia"
NCT01870999 (17) [back to overview]Aripiprazole Area Under the Concentration-time Curve at Steady-state (AUCτ)
NCT01870999 (17) [back to overview]Aripiprazole Maximum (Peak) Plasma Concentration (Tmax)
NCT01870999 (17) [back to overview]Aripiprazole Maximum Steady State Plasma Concentration (Css,Max)
NCT01870999 (17) [back to overview]Aripiprazole Minimum Steady State Plasma Concentration (Css,Min)
NCT01870999 (17) [back to overview]Aripiprazole Steady-state Plasma Concentration (Css,Avg)
NCT01870999 (17) [back to overview]Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 and Week 24
NCT01870999 (17) [back to overview]Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Positive Subscale Scores at Week 12 and Week 24
NCT01870999 (17) [back to overview]Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Subscale Scores at Week 12 and Week 24
NCT01870999 (17) [back to overview]Change From Baseline in the Clinical Global Impression- Severity of Illness Score (CGI-S) at Week 12 and Week 24
NCT01870999 (17) [back to overview]Number of Participants With Adverse Events as a Measure of Safety
NCT01870999 (17) [back to overview]Dehydro-aripiprazole Maximum Steady State Plasma Concentration (Css,Max)
NCT01870999 (17) [back to overview]Dehydro-aripiprazole Maximum (Peak) Plasma Concentration (Tmax)
NCT01870999 (17) [back to overview]Dehydro-aripiprazole Area Under the Concentration-Time Curve at Steady-State (AUCτ)
NCT01870999 (17) [back to overview]Aripiprazole Terminal-phase Elimination Half-life (t1/2,z)
NCT01870999 (17) [back to overview]Dehydro-aripiprazole Minimum Steady State Plasma Concentration (Css,Min)
NCT01870999 (17) [back to overview]Clinical Global Impression-Improvement Scale (CGI-I) at Week 12 and Week 24
NCT01909466 (17) [back to overview]Number of Participants With Adverse Events (AEs).
NCT01909466 (17) [back to overview]Mean Visual Analog Scale (VAS) Score for Rating of Pain at the Injection Site.
NCT01909466 (17) [back to overview]Mean Change From Baseline Measured by EPS by Barnes Akathisia Rating Scale (BARS).
NCT01909466 (17) [back to overview]Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score.
NCT01909466 (17) [back to overview]Mean Change From Baseline in Emotional Regulation Score of SWN-S.
NCT01909466 (17) [back to overview]Mean Change From Baseline in Mental Functioning Score of SWN-S.
NCT01909466 (17) [back to overview]Mean Change From Baseline in Suicidal Ideation Intensity Total Score Via Columbia-suicide Severity Rating Scale (C-SSRS).
NCT01909466 (17) [back to overview]Mean Change From Baseline in PANSS Negative Sub-scale Score.
NCT01909466 (17) [back to overview]Mean Change From Baseline Measured by Extrapyramidal Symptoms (EPS) by Simpson-Angus Scale (SAS).
NCT01909466 (17) [back to overview]Clinical Global Impression-Improvement (CGI-I) Score.
NCT01909466 (17) [back to overview]Mean Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS).
NCT01909466 (17) [back to overview]Mean Change From Baseline in Total Score of Subject Well-being Under Neuroleptic Treatment-Short Form (SWN-S).
NCT01909466 (17) [back to overview]Mean Change From Baseline in Physical Functioning Score of SWN-S.
NCT01909466 (17) [back to overview]Mean Change From Baseline Measured by EPS by Abnormal Involuntary Movement Scale (AIMS).
NCT01909466 (17) [back to overview]Mean Change From Baseline in PANSS Positive Sub-scale Score.
NCT01909466 (17) [back to overview]Mean Change From Baseline in Self Control Score of SWN-S.
NCT01909466 (17) [back to overview]Mean Change From Baseline in Social Integration Score of SWN-S.
NCT01942148 (3) [back to overview]Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score
NCT01942148 (3) [back to overview]Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS)
NCT01942148 (3) [back to overview]Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score
NCT01942161 (5) [back to overview]Mean Change From Baseline at Final Assessment in Children's Global Assessment Scale (C-GAS) Score
NCT01942161 (5) [back to overview]Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score
NCT01942161 (5) [back to overview]Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Total Score
NCT01942161 (5) [back to overview]Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score
NCT01942161 (5) [back to overview]Mean Change From Baseline at Final Assessment in Clinical Global Impression-Improvement (CGI-I) Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 12 in the 'Instrumental Role' QLS Domain Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 12 in the 'Interpersonal Relations' QLS Domain Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 12 in the 'Intrapsychic Foundations' QLS Domain Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 12 in the TooL Total Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 12 in the WoRQ Total Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 24 in ASEX Total Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 24 in CGI-S Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 24 in QLS Total Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 24 in SWN-S Total Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 24 in the 'Common Objects and Activities' QLS Domain Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 24 in the 'Instrumental Role' QLS Domain Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 24 in the 'Interpersonal Relations' QLS Domain Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 24 in the 'Intrapsychic Foundations' QLS Domain Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 24 in the TooL Total Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 24 in the WoRQ Total Score
NCT01959035 (23) [back to overview]Patients Categorised As Sexually Dysfunctional Measured at Week 12 on the ASEX Scale
NCT01959035 (23) [back to overview]Patients Categorised As Sexually Dysfunctional Measured at Week 24 on the ASEX Scale
NCT01959035 (23) [back to overview]Safety and Tolerability
NCT01959035 (23) [back to overview]Change From Baseline to Week 12 in ASEX Total Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 12 in CGI-S Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 12 in QLS Total Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 12 in SWN-S Total Score
NCT01959035 (23) [back to overview]Change From Baseline to Week 12 in the 'Common Objects and Activities' QLS Domain Score
NCT02054702 (12) [back to overview]Change From Baseline in Cognitive Test Battery Composite Score
NCT02054702 (12) [back to overview]Change From Baseline in Cognitive Test Battery of Early Phase Battery Score
NCT02054702 (12) [back to overview]Change From Baseline in Cognitive Test Battery Scores of Detection Task
NCT02054702 (12) [back to overview]Change From Baseline in Cognitive Test Battery Scores of Groton Maze Learning (GML)
NCT02054702 (12) [back to overview]Response Rate by Study Week
NCT02054702 (12) [back to overview]Change From Baseline in Cognitive Test Battery Scores of Identification Task
NCT02054702 (12) [back to overview]Change From Baseline in Cognitive Test Battery Scores of One Card Learning Task
NCT02054702 (12) [back to overview]Change From Baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11 Item) Total Score
NCT02054702 (12) [back to overview]Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
NCT02054702 (12) [back to overview]Change From Baseline to Week 6 in Specific Levels of Functioning Scale (SLOF) Total Score
NCT02054702 (12) [back to overview]Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score
NCT02054702 (12) [back to overview]Mean Change in Clinical Global Impression-Improvement (CGI-I) Score at Week 6
NCT02091882 (2) [back to overview]Latency Period From Ingestion to Detection of IEM
NCT02091882 (2) [back to overview]Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection
NCT02219009 (3) [back to overview]Proportion of Participants Who Are Able to Pair & Apply a Patch Independently & Successfully by the End of the Week 8 Study Visit as Defined by a Score of 91 to 100 on the Subject Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP)
NCT02219009 (3) [back to overview]Proportion of Participants Able to Pair & Apply a Patch Successfully, Independently, or With Minimum Assistance, by the End of the Week 8 Study Visit, as Defined by a SAUSS-HCP Score of 71 to 100.
NCT02219009 (3) [back to overview]Proportion of Time During the Study Period When Participants Wear Their Patches
NCT02220712 (1) [back to overview]OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections
NCT02237417 (1) [back to overview]Number of Participants With Changes in Fractional Anisotropy (FA)
NCT02360319 (5) [back to overview]Total Number of Psychiatric Hospitalizations Per Treatment Arm
NCT02360319 (5) [back to overview]Brief Psychotic Rating Scale (BPRS) Total Score
NCT02360319 (5) [back to overview]Quality of Life (QLS) Total Score
NCT02360319 (5) [back to overview]Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Sum of Scores
NCT02360319 (5) [back to overview]Time to First Hospitalization
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Clinical Global Impression Severity (CGI-S) Score
NCT02431702 (31) [back to overview]Part-2 (Disease Progression): Time to First Treatment Failure
NCT02431702 (31) [back to overview]Part 3 (Extended Disease Progression [EDP]): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score
NCT02431702 (31) [back to overview]Part 3 (EDP): Time to First Treatment Failure
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Working Memory Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Verbal Learning Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Medication Satisfaction Questionnaire (MSQ) Score
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Speed of Processing Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Social Cognition Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Number of Participants With Change From Baseline in Severity of Psychotic Symptoms, as Measured by Clinician-Rated Dimensions of Psychosis Symptom Severity Scale (CRDPSS)
NCT02431702 (31) [back to overview]Part 3 (Disease Modification): Change From Baseline in Adjusted Intracortical Myelin Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (SE MRI)
NCT02431702 (31) [back to overview]Part 3 (Disease Modification): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score
NCT02431702 (31) [back to overview]Part 3 (Disease Modification): Personal and Social Performance (PSP) Total Observed Score
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Adjusted Intracortical Myelin Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (MRI)
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Attention/Vigilance Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Adjusted Intracortical Myelin (ICM) Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (MRI)
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Reasoning and Problem Solving: MCCB Domain
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Attention/Vigilance Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Clinical Global Impression Severity (CGI-S) Score
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Medication Satisfaction Questionnaire (MSQ) Total Score
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Reasoning and Problem Solving: MCCB Domain
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Social Cognition Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Speed of Processing Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Verbal Learning Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Working Memory Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Visual Learning Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Visual Learning Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 3 (EDP): Number of Participants With Change From Baseline in Severity of Psychotic Symptoms, as Measured by CRDPSS
NCT02435836 (13) [back to overview]Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score
NCT02435836 (13) [back to overview]Mean Change From Baseline in PANSS Negative Sub-scale Score by Week
NCT02435836 (13) [back to overview]Mean Change From Baseline in PANSS Positive Sub-scale Score by Week
NCT02435836 (13) [back to overview]Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week
NCT02435836 (13) [back to overview]Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week
NCT02435836 (13) [back to overview]Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week
NCT02435836 (13) [back to overview]Mean Clinical Global Impression of Improvement (CGI-I) by Week
NCT02435836 (13) [back to overview]Number of Participants With Adverse Events (AEs)
NCT02435836 (13) [back to overview]Percentage of Participants With ECG Measurements of Potential Clinical Relevance
NCT02435836 (13) [back to overview]Percentage of Participants With Vital Signs of Potential Clinical Relevance
NCT02435836 (13) [back to overview]Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week
NCT02435836 (13) [back to overview]Percentage of Participants With Laboratory Values of Potential Clinical Relevance
NCT02435836 (13) [back to overview]Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week
NCT02462473 (8) [back to overview]Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
NCT02462473 (8) [back to overview]Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP)
NCT02462473 (8) [back to overview]Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
NCT02462473 (8) [back to overview]Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
NCT02462473 (8) [back to overview]Number of Participants With Medication Treatment Modifications (MTM)
NCT02462473 (8) [back to overview]Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
NCT02462473 (8) [back to overview]Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
NCT02462473 (8) [back to overview]Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
NCT02472652 (2) [back to overview]Change in Arizona Sexual Experiences Scale (ASEX) Score
NCT02472652 (2) [back to overview]Prolactin Concentrations ng/ml (Normal Range 4.0 - 15.2ng/ml)
NCT02634320 (6) [back to overview]Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)
NCT02634320 (6) [back to overview]Number of Participants With Adverse Events
NCT02634320 (6) [back to overview]Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores
NCT02634320 (6) [back to overview]Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores
NCT02634320 (6) [back to overview]Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS)
NCT02634320 (6) [back to overview]Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS)
NCT02722967 (1) [back to overview]Assessment of the Functionality of an Integrated Call Center for DMS by Adult Subjects With SCH, MDD, or BP1 Who Were Treated With Oral Aripiprazole.
NCT02960763 (3) [back to overview]Number of Participants With Remission From Depression
NCT02960763 (3) [back to overview]Psychological Well-Being
NCT02960763 (3) [back to overview]Serious Adverse Events
NCT03019887 (1) [back to overview]Number of Participants With Relapse
NCT03179787 (1) [back to overview]Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline.
NCT03198078 (22) [back to overview]Percentage of Participants Achieving Response
NCT03198078 (22) [back to overview]Percentage of Participants Achieving Remission
NCT03198078 (22) [back to overview]Number of Participants With At Least One Occurrence of Suicidal Behavior or Suicidal Ideation as Recorded on Columbia-Suicide Severity Rating Scale (C-SSRS)
NCT03198078 (22) [back to overview]Change From Baseline to Week 6 in PANSS Positive and Negative Sub-Scales Scores
NCT03198078 (22) [back to overview]Mean Clinical Global Impression Improvement (CGI-I) Scale Score at Week 6
NCT03198078 (22) [back to overview]Mean Change From Baseline in Weight
NCT03198078 (22) [back to overview]Mean Change From Baseline in Waist Circumference
NCT03198078 (22) [back to overview]Mean Change From Baseline in Height
NCT03198078 (22) [back to overview]Mean Change From Baseline in Body Mass Index (BMI)
NCT03198078 (22) [back to overview]Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
NCT03198078 (22) [back to overview]Change From Baseline to Week 6 in Clinical Global Impression Severity (CGI-S) Scale Score
NCT03198078 (22) [back to overview]Number of Participants With Potentially Clinically Relevant Laboratory Test Values
NCT03198078 (22) [back to overview]Number of Participants With Treatment-emergent AEs (TEAEs), Serious TEAEs, and TEAEs Graded by Severity
NCT03198078 (22) [back to overview]Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters
NCT03198078 (22) [back to overview]Number of Participants With Severe Psychotropic Side Effects as Assessed by Udvalg for Kliniske Undersogelser (UKU) Rating Scale
NCT03198078 (22) [back to overview]Number of Participants With Adverse Events (AEs) and Trial Discontinuation Due to AEs
NCT03198078 (22) [back to overview]Number of Participants With Cognitive Adverse Effects Assessed by New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT)
NCT03198078 (22) [back to overview]Number of Participants With Potentially Clinically Relevant Abnormalities in Vital Signs
NCT03198078 (22) [back to overview]Change From Baseline to Week 6 in Children's Global Assessment Scale (CGAS) Total Score
NCT03198078 (22) [back to overview]Change From Baseline in Simpson Angus Scale (SAS) Total Score
NCT03198078 (22) [back to overview]Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score
NCT03198078 (22) [back to overview]Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
NCT03342963 (4) [back to overview]Area Under the Plasma Concentration Versus Time Curve 168h (AUC168h) of Aripiprazole in Cohort 1
NCT03342963 (4) [back to overview]Cmax of Aripiprazole and Sertraline in Cohort 2
NCT03342963 (4) [back to overview]AUC168h of Aripiprazole and Sertraline in Cohort 2
NCT03342963 (4) [back to overview]Peak Plasma Concentration (Cmax) of Aripiprazole in Cohort 1
NCT03345979 (7) [back to overview]Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
NCT03345979 (7) [back to overview]Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
NCT03345979 (7) [back to overview]Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9
NCT03345979 (7) [back to overview]Number of Participants With Serious and Non-serious Adverse Events (AEs)
NCT03345979 (7) [back to overview]Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9
NCT03345979 (7) [back to overview]Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25
NCT03345979 (7) [back to overview]Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25
NCT03408873 (15) [back to overview]Change in Social and Occupational Functioning Assessment Scale (SOFAS) Score
NCT03408873 (15) [back to overview]Change in Communication Styles Scale Score
NCT03408873 (15) [back to overview]Change in Drug Attitude Inventory (DAI) Score
NCT03408873 (15) [back to overview]Change in the Brief Psychiatric Rating Scale (BPRS) Score
NCT03408873 (15) [back to overview]Change in Global Assessment of Functioning (GAF) Score
NCT03408873 (15) [back to overview]Change in Montgomery Asberg Rating Scale (MADRS) Score
NCT03408873 (15) [back to overview]Change in Oxford Bipolar Knowledge Questionnaires (OBQ) Score
NCT03408873 (15) [back to overview]Change in Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8A) Score
NCT03408873 (15) [back to overview]Change in Tablets Routine Questionnaire (TRQ, Past Month)
NCT03408873 (15) [back to overview]Change in Tablets Routine Questionnaire (TRQ, Past Week)
NCT03408873 (15) [back to overview]Change in The Self-Report Habit Index (SRHI) Score
NCT03408873 (15) [back to overview]Change in Young Mania Rating Scale (YMRS) Score
NCT03408873 (15) [back to overview]Change in Clinical Global Impressions (CGI) Score
NCT03408873 (15) [back to overview]LAI Injection Adherence
NCT03408873 (15) [back to overview]Change in Attitude Towards Medication Questionnaire (AMSQ) Score
NCT03557931 (8) [back to overview]Number of Participants With Clinically Significant Differences in Barnes Akathisia Rating Scale (BARS) Values
NCT03557931 (8) [back to overview]Number of Participants With Clinically Significant Differences in Simpson Angus Scale (SAS) Values
NCT03557931 (8) [back to overview]Number of Participants With Clinically Significant Differences in Abnormal Involuntary Movement Scale (AIMS) Values
NCT03557931 (8) [back to overview]Number of Participants With Adverse Event (AE)
NCT03557931 (8) [back to overview]Concentration at Trough Level (Ctrough) for ASP4345
NCT03557931 (8) [back to overview]Number of Participants With Clinically Significant Differences in Columbia-Suicide Severity Rating Scale (C-SSRS) Values
NCT03557931 (8) [back to overview]Change From Baseline to Week 12/EoT in University of California San Diego Performance-based Skills Assessment-2 Extended Range (UPSA-2-ER) Total Score
NCT03557931 (8) [back to overview]Change From Baseline to Week 12/End of Treatment (EoT) in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score
NCT03568500 (2) [back to overview]Participant Adherence
NCT03568500 (2) [back to overview]Percentage Of Days With Good Patch Coverage
NCT03661983 (1) [back to overview]Percentage of Participants With Relapse During the Double-blind Randomized Withdrawal Phase
NCT03892889 (2) [back to overview]Percentage of Participants With Inpatient Psychiatric Hospitalization
NCT03892889 (2) [back to overview]Percentage of Days With Improved Adherence
NCT04030143 (37) [back to overview]Plasma Concentration of Aripiprazole 7 Days Post First Dose (C7) of Aripiprazole 2M LAI 960 mg
NCT04030143 (37) [back to overview]Plasma Concentration of Aripiprazole 56 Days Postdose (C56) of Aripiprazole 2M LAI 960 mg After the Fourth Dose
NCT04030143 (37) [back to overview]Plasma Concentration of Aripiprazole 28 Days Postdose (C28) of Aripiprazole IM Depot 400 mg After the Eighth Dose
NCT04030143 (37) [back to overview]Plasma Concentration of Aripiprazole 28 Days (C28) After the First Dose of Aripiprazole IM Depot 400 mg
NCT04030143 (37) [back to overview]Peak-to-Trough Percent Fluctuation (PTF%) After the Fourth Dose of Aripiprazole 2M LAI 960 mg
NCT04030143 (37) [back to overview]Number of Participants With Suicidality as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
NCT04030143 (37) [back to overview]VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg
NCT04030143 (37) [back to overview]Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg
NCT04030143 (37) [back to overview]Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities
NCT04030143 (37) [back to overview]Time to Reach the Maximum Plasma Concentration (Tmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg
NCT04030143 (37) [back to overview]Area Under the Plasma Concentration-Time Curve From Time 0 to 56 Days (AUC0-56) of Aripiprazole After the Fourth Dose of Aripiprazole 2M LAI 960 mg
NCT04030143 (37) [back to overview]AUC0-28 After the First Dose of Aripiprazole IM Depot 400 mg
NCT04030143 (37) [back to overview]AUC0-28 After the Fourth Dose of Aripiprazole 2M LAI 960 mg
NCT04030143 (37) [back to overview]Area Under the Plasma Concentration-Time Curve From Time 29 to 56 Days (AUC29-56) After the Fourth Dose of Aripiprazole 2M LAI 960 mg
NCT04030143 (37) [back to overview]Tmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg
NCT04030143 (37) [back to overview]Mean Change From Baseline in Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness Score
NCT04030143 (37) [back to overview]AUC0-56 After the First Dose of Aripiprazole 2M LAI 960 mg
NCT04030143 (37) [back to overview]Plasma Concentration of Aripiprazole 56 Days (C56) After the First Dose of Aripiprazole 2M LAI 960 mg
NCT04030143 (37) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg
NCT04030143 (37) [back to overview]Cmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg
NCT04030143 (37) [back to overview]PTF% After the Eighth Dose of Aripiprazole IM Depot 400 mg
NCT04030143 (37) [back to overview]Mean Change From Baseline in Clinical Global Impression - Improvement Scale (CGI-I) Score
NCT04030143 (37) [back to overview]Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities
NCT04030143 (37) [back to overview]Area Under the Plasma Concentration-Time Curve From Time 0 to 28 Days (AUC0-28) of Aripiprazole After the Seventh and Eighth Doses of Aripiprazole IM Depot 400 mg
NCT04030143 (37) [back to overview]Plasma Concentration of Aripiprazole Post First Dose (C14) of Aripiprazole IM Depot 400 mg
NCT04030143 (37) [back to overview]Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection
NCT04030143 (37) [back to overview]Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole 2M LAI 960 mg Injection
NCT04030143 (37) [back to overview]Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Score
NCT04030143 (37) [back to overview]Mean Change From Baseline in Simpson-Angus Neurologic Rating Scale (SAS) Total Score
NCT04030143 (37) [back to overview]Mean Change From Baseline in Barnes Akathisia Rating Score (BARS) Global Score
NCT04030143 (37) [back to overview]Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities
NCT04030143 (37) [back to overview]Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
NCT04030143 (37) [back to overview]Mean Change From Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Total Score
NCT04030143 (37) [back to overview]Mean Change From Baseline in Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) Total Score
NCT04030143 (37) [back to overview]Mean Change From Baseline in Young Mania Rating Scale (YMRS) Total Score
NCT04030143 (37) [back to overview]Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)
NCT04030143 (37) [back to overview]Mean Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score
NCT04203056 (3) [back to overview]Change in Role Ratings on the Global Functioning Scale From Baseline to 12 Months
NCT04203056 (3) [back to overview]Exacerbation or Relapse of Psychotic Symptoms
NCT04203056 (3) [back to overview]"Change From Baseline to One-Year in the MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T-Score."

Number Who Discontinued Medication Within First 6 Study Months

(NCT00044655)
Timeframe: Measured at Six Months

Interventionparticipants (Number)
Stay11
Switch23

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Clinical Global Impression (CGI) Improvement Score

"Last observed post-baseline value in CGI improvement score, using the last observation carried forward.~Scale refers to the global impression of the subject with respect to improvement of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe)." (NCT00102063)
Timeframe: Baseline and Day 42

Interventionpoints (Mean)
Aripiprazole 10 mg/Day Group2.7
Aripiprazole 30 mg/Day Group2.5
Placebo Group3.1

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Patients Achieving Remission

The number of subjects achieving remission. Remission was defined as a score of mild or less (≤ 3) for items P1, P2, P3, N1, N4, N6, G5, and G9 in the PANSS score. (NCT00102063)
Timeframe: Baseline and Day 42

Interventionparticipants (Number)
Aripiprazole 10 mg/Day Group53
Aripiprazole 30 mg/Day Group56
Placebo Group35

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Change in Children's Global Assessment Scale (CGAS) Score

"Change from baseline to last observed post-baseline value in CGAS score, using the last observation carried forward.~Scale is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome)." (NCT00102063)
Timeframe: Baseline and Day 42

Interventionpoints (Mean)
Aripiprazole 10 mg/Day Group14.7
Aripiprazole 30 mg/Day Group14.8
Placebo Group9.8

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Change in Clinical Global Impression (CGI) Severity Score

"Change from baseline to last observed post-baseline value in CGI severity score, using the last observation carried forward.~Scale refers to the global impression of the subject with respect to severity of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe)." (NCT00102063)
Timeframe: Baseline and Day 42

Interventionpoints (Mean)
Aripiprazole 10 mg/Day Group-1.2
Aripiprazole 30 mg/Day Group-1.3
Placebo Group-0.9

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Change in Pediatric Quality of Life Enjoyment and Satisfaction (PQLES) Questionnaire Total Score

"Change from baseline to last observed post-baseline value in PQLES total score, using the last observation carried forward.~Scale consists of 14 items pertaining to daily life activities and satisfaction, and an overall assessment item. Each item will be rated on a five-point scale (1=very poor, 2=poor, 3=fair, 4=good, 5=very good) with a minimum score of 14 (better outcome) and a maximum score of 70 (worse outcome)." (NCT00102063)
Timeframe: Baseline and Day 42

Interventionpoints (Mean)
Aripiprazole 10 mg/Day Group5.2
Aripiprazole 30 mg/Day Group5.9
Placebo Group4.5

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Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score

"Change from baseline to last observed post-baseline value in PANSS Negative Subscale score, using the last observation carried forward.~Scale consists of 7 negative symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome." (NCT00102063)
Timeframe: Baseline and Day 42

Interventionpoints (Mean)
Aripiprazole 10 mg/Day Group-6.9
Aripiprazole 30 mg/Day Group-6.6
Placebo Group-5.4

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Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score

"Change from baseline to last observed post-baseline value in PANSS positive subscale score, using the last observation carried forward.~Scale consists of 7 positive symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome." (NCT00102063)
Timeframe: Baseline and Day 42

Interventionpoints (Mean)
Aripiprazole 10 mg/Day Group-7.6
Aripiprazole 30 mg/Day Group-8.1
Placebo Group-5.6

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Change in Positive and Negative Syndrome Scale (PANSS) Total Score

"Change from baseline to last observed post-baseline value in PANSS total score, using the last observation carried forward.~This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome." (NCT00102063)
Timeframe: Baseline and Day 42

Interventionpoints (Mean)
Aripiprazole 10 mg/Day Group-26.7
Aripiprazole 30 mg/Day Group-28.6
Placebo Group-21.2

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Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score

"Change from baseline to the last scheduled post-baseline evaluation in PANSS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).~This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome." (NCT00102518)
Timeframe: Baseline and Week 26

Interventionpoints (Mean)
NCT00102063 and NCT00110461 Subjects-7.5

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Change in Young Mania Rating Scale (Y-MRS) Total Score

"Change from baseline to last scheduled post-baseline evaluation in YMRS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)." (NCT00102518)
Timeframe: Baseline and Week 26

Interventionpoints (Mean)
NCT00102063 and NCT00110461 Subjects-7.74

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Percentage of Subjects Experiencing SAEs

Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity. (NCT00102518)
Timeframe: Baseline and Week 23

Interventionpercentage of participants (Number)
NCT00102063 and NCT00110461 Subjects6.2

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Mean Change in SDS Item Score (Social Life)

Mean change from Week 8 (baseline) to Week 14 in SDS Social Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement. (NCT00105196)
Timeframe: Baseline (Week 8) and Week 14

Interventionunits on a scale (Mean)
Aripiprazole + ADT-1.18
Placebo + ADT-0.65

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Mean Change in SDS Item Score (Family Life)

Mean change from Week 8 (Baseline) to Week 14 in SDS Family Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement. (NCT00105196)
Timeframe: Baseline (Week 8) and Week 14

Interventionunits on a scale (Mean)
Aripiprazole + ADT-1.39
Placebo + ADT-0.82

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MADRS Response

Number of subjects with a ≥50 percent reduction from Week 8 (baseline) in MADRS Total Score, a 10-item, ordinal rating scale to assess the severity of depressive symptoms (0=no symptoms; 60=most severe symptoms). (NCT00105196)
Timeframe: Baseline (Week 8) and Week 14

,
Interventionparticipants (Number)
RespondersNonresponders
Aripiprazole + ADT8193
Placebo + ADT45124

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MADRS Remission

Number of subjects in remission. Remission defined as as MADRS Total Score of <10 at 14 weeks, and a reduction of ≥50 percent from Week 8 (baseline) in MADRS, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). (NCT00105196)
Timeframe: Baseline (Week 8) and Week 14

,
Interventionparticipants (Number)
RemissionNo remission
Aripiprazole + ADT64110
Placebo + ADT32137

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Clinical Global Impression (CGI)-Improvement Response

Number of subjects with response relative to Week 8 (baseline). Response defined as score of 1 (very much improved) or 2 (much improved) on a 7-point, ordinal scale (1=very much improved; 7=very much worse). (NCT00105196)
Timeframe: Baseline (Week 8) and Week 14

,
InterventionParticipants (Number)
RespondersNonresponders
Aripiprazole + ADT10965
Placebo + ADT7495

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Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)

Mean change from Week 8 (baseline) to Week 14 in MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement. (NCT00105196)
Timeframe: Baseline (Week 8) and Week 14

Interventionunits on a scale (Mean)
Aripiprazole + ADT-10.12
Placebo + ADT-6.39

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Mean Change in Sheehan Disability Scale (SDS) Mean Score

Mean change from Week 8 (baseline) to Week 14 in SDS Mean Score, a 3-item, ordinal scale (0=unimpaired; 30=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement. (NCT00105196)
Timeframe: Baseline (Week 8) and Week 14

Interventionunits on a scale (Mean)
Aripiprazole + ADT-1.22
Placebo + ADT-0.80

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Mean Change in SDS Item Score (Work/School)

Mean change from Week 8 (baseline) to Week 14 in SDS Work/School Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement. (NCT00105196)
Timeframe: Baseline (Week 8) and Week 14

Interventionunits on a scale (Mean)
Aripiprazole + ADT-0.75
Placebo + ADT-0.67

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Subject Response to Treatment at Week 4

"Percentage of Subjects with a 50% or higher reduction from baseline in Young Mania Rating Scale (Y-MRS) total score at Week 4.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)." (NCT00110461)
Timeframe: Baseline and Week 4

Interventionpercentage of participants (Number)
Aripiprazole 10 mg/Day44.79
Aripiprazole 30 mg/Day63.64
Placebo26.09

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Subject Response to Treatment at Week 30

"Percentage of Subjects with a 50% or higher reduction from baseline in Y-MRS total score at Week 30.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)." (NCT00110461)
Timeframe: Baseline and Week 30

Interventionpercentage of participants (Number)
Aripiprazole 10 mg/Day50.00
Aripiprazole 30 mg/Day55.56
Placebo26.60

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Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4

"Change from Baseline to Week 4 in Y-MRS total score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through the continuation phase.)~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)." (NCT00110461)
Timeframe: Baseline and Week 4

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-14.04
Aripiprazole 30 mg/Day-16.16
Placebo-8.67

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Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 30

"Change from baseline to Week 30 in Y-MRS total score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)." (NCT00110461)
Timeframe: Baseline and Week 30

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-13.91
Aripiprazole 30 mg/Day-14.6
Placebo-8.69

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Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 4

Change from baseline to Week 4 in GBI Total Subject Version Mania score, using the LOCF. Assessments performed at baseline and weekly through acute phase (Week 4). (Also performed Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome. (NCT00110461)
Timeframe: Baseline and Week 4

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-6.51
Aripiprazole 30 mg/Day-6.52
Placebo-4.57

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Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 30

Change from baseline to Week 30 in GBI Total Subject Version Mania score, using LOCF. Assessments performed at baseline and weekly through acute phase (Week 4) and Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score of 0=better outcome, maximum score of 60=worse outcome. (NCT00110461)
Timeframe: Baseline and Week 30

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-6.82
Aripiprazole 30 mg/Day-7.84
Placebo-5.23

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Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 4

Change from Baseline to Week 4 in GBI Total Subject Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by subject. Symptoms wrated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome. (NCT00110461)
Timeframe: Baseline and Week 4

Interventionpoints (Mean)
Aripiprazole 10 mg/Day0
Aripiprazole 30 mg/Day-3.24
Placebo-3.11

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Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 30

Change from baseline to Week 30 in GBI Total Subject Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome. (NCT00110461)
Timeframe: Baseline and Week 30

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-4.45
Aripiprazole 30 mg/Day-4.38
Placebo-2.7

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Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 4

Change from baseline to Week 4 in GBI Total Parent/Guardian Version Mania score, using LOCF. Assessments performed baseline and weekly through acute phase (Week 4). (Also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) GBI is self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome. (NCT00110461)
Timeframe: Baseline and Week 4

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-9.66
Aripiprazole 30 mg/Day-9.1
Placebo-4.63

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Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 30

Change from baseline to Week 30 in GBI Total Parent/Guardian Version Mania score, using LOCF. Assessments performed at baseline and weekly through acute phase(Week 4) and Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome. (NCT00110461)
Timeframe: Baseline and Week 30

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-8.76
Aripiprazole 30 mg/Day-8.48
Placebo-5

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Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 4

Change from baseline to Week 4 in GBI Total Parent/Guardian Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome. (NCT00110461)
Timeframe: Baseline and Week 4

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-6.12
Aripiprazole 30 mg/Day-3.71
Placebo-3.92

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Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 30

Change from Baseline to Week 30 in GBI Total Parent/Guardian Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome. (NCT00110461)
Timeframe: Baseline and Week 30

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-5.17
Aripiprazole 30 mg/Day-3.71
Placebo-3.03

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Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4

"Change from baseline to Week 4 in CGI-BP severity overall illness score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)." (NCT00110461)
Timeframe: Baseline and Week 4

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-1.6
Aripiprazole 30 mg/Day-1.91
Placebo-0.84

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Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30

"Change from baseline to Week 30 in CGI-BP severity overall illness score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)." (NCT00110461)
Timeframe: Baseline and Week 30

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-1.59
Aripiprazole 30 mg/Day-1.75
Placebo-0.91

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Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4

"Change from baseline to Week 4 in CGI-BP mania score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)." (NCT00110461)
Timeframe: Baseline and Week 4

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-1.6
Aripiprazole 30 mg/Day-2.02
Placebo-0.89

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Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30

"Change from baseline to Week 30 in CGI-BP mania score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)." (NCT00110461)
Timeframe: Baseline and Week 30

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-1.63
Aripiprazole 30 mg/Day-1.93
Placebo-1.03

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Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4

"Change from baseline to Week 4 in CGI-BP severity depression score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4. (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)." (NCT00110461)
Timeframe: Baseline and Week 4

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-0.86
Aripiprazole 30 mg/Day-0.9
Placebo-0.57

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Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30

"Change from baseline to Week 30 in CGI-BP severity depression score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)." (NCT00110461)
Timeframe: Baseline and Week 30

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-0.71
Aripiprazole 30 mg/Day-0.94
Placebo-0.47

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Change in Children's Global Assessment Scale (CGAS) Total Score at Week 4

"Change from baseline to Week 4 in CGAS total score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGAS is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome)." (NCT00110461)
Timeframe: Baseline and Week 4

Interventionpoints (Mean)
Aripiprazole 10 mg/Day14.97
Aripiprazole 30 mg/Day16.96
Placebo6.21

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Change in Children's Global Assessment (CGAS) Total Score at Week 30

"Change from baseline to Week 30 in CGAS total score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGAS is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome)." (NCT00110461)
Timeframe: Baseline and Week 30

Interventionpoints (Mean)
Aripiprazole 10 mg/Day15.81
Aripiprazole 30 mg/Day16.28
Placebo7.45

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Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 4

Change from baseline to Week 4 in CDRS-R score, using last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Minimum score on the scale is 17 (better outcome). Maximum score on the scale is 113 (worse outcome or more severe symptoms). (NCT00110461)
Timeframe: Baseline and Week 4

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-7.65
Aripiprazole 30 mg/Day-5.97
Placebo-4.66

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Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 30

Change from baseline to Week 30 in CDRS-R score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Minimum score on the scale is 17 (better outcome). Maximum score on the scale is 113 (worse outcome or more severe symptoms). (NCT00110461)
Timeframe: Baseline and Week 30

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-6.47
Aripiprazole 30 mg/Day-4.39
Placebo-3.81

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Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 4

Change from baseline to Week 4 in ADHD-RS-IV Total score, using last observation carried forward. Assessments performed at baseline and weekly through acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) ADHD-RS-IV is an instrument for diagnosing ADHD in children/adolescents and for assessing treatment response. The scale contains 18 items linked directly to DSM-IV diagnostic criteria for ADHD. Parent questionnaire on home behaviors (Eng.) used in this study. Minimum score of 0 is a better outcome, maximum score of 54 is a worse outcome. (NCT00110461)
Timeframe: Baseline and Week 4

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-12.03
Aripiprazole 30 mg/Day-11.61
Placebo-4.57

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Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 30

"Change from baseline to Week 30 in ADHD-RS-IV Total score, using the LOCF.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The ADHD-RS-IV is an instrument both for diagnosing ADHD in children and adolescents and for assessing treatment response. The scale contains 18 items and is linked directly to DSM-IV diagnostic criteria for ADHD. The parent questionnaire on home behaviors (English) was used in this study. Minimum score of 0 = better outcome, maximum score of 54 = worse outcome." (NCT00110461)
Timeframe: Baseline and Week 30

Interventionpoints (Mean)
Aripiprazole 10 mg/Day-11.04
Aripiprazole 30 mg/Day-9.76
Placebo-5.58

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Evaluate the Number of Clinical Events (Pooled) Occurring Between 3-15 Months Following a Switch/Stabilization of the Antipsychotic Agents Among Patients Who Receive Either Risperidal Consta or One of the 4 Marketed 2nd Generation Antipsychotic Agents.

(NCT00177164)
Timeframe: Upto 15 months

InterventionNumber of clinical events (Mean)
Risperidone LAI0.86
Oral AAP1.61

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Number of Participants With Treatment - Emergent Hyperglycemia

Number of participants with hyperglycemia based on safety labs (NCT00177164)
Timeframe: from baseline to end of 15 months

Interventionparticipants (Number)
Risperidone LAI0
Oral AAP0

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Number of Participants With Treatment Emergent Hyperlipidemia

Number of participants with Hyperlipidemia as determined by safety labs (NCT00177164)
Timeframe: from baseline to end of 15 months

Interventionparticipants (Number)
Risperidone LAI0
Oral AAP0

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BMI

BMI at baseline and at end of 15 months for Risperidone LAI and oral AAP groups (NCT00177164)
Timeframe: baseline to end of 15 months

,
Interventionkg / m^2 (Mean)
BaselineFinal
Oral AAP29.8632.0
Risperidone LAI31.0532.27

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Clinical Global Impressions Scale (CGI-Severity)

Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). (NCT00194012)
Timeframe: Open-Label Extension - 6 weeks

InterventionScores on a scale (Mean)
Open-Label Extension (Abilify)1.85
Open-Label Extension (Placebo)1.89

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CDRS-R Children's Depression Rating Scale-Revised

The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms. (NCT00194012)
Timeframe: 12 weeks

InterventionScores on a scale (Mean)
Aripiprazole Randomized Phase24.4
Placebo Randomized Phase25.9

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Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)

The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54. (NCT00194012)
Timeframe: Open-Label Extension - 6 weeks

InterventionScores on a scale (Mean)
Open-Label Extension (Abilify)18.1
Open-Label Extension (Placebo)28.1

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Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)

The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54. (NCT00194012)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Aripiprazole Randomized Phase32.4
Placebo Randomized Phase36.8

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Young Mania Rating Scale (YMRS)

The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania. (NCT00194012)
Timeframe: 12 weeks

InterventionScores on a scale (Mean)
Abilify Randomized Phase9.7
Placebo Randomized Phase16.2

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Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)

The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54. (NCT00194012)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Aripiprazole Randomized Phase21.0
Placebo Randomized Phase32.1

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Young Mania Rating Scale (YMRS)

The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania. (NCT00194012)
Timeframe: Open-Label Extension - 6 weeks

InterventionScores on a scale (Mean)
Open-Label Extension (Abilify)5.73
Open-Label Extension (Placebo)7.57

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CDRS-R Children's Depression Rating Scale-Revised

The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms. (NCT00194012)
Timeframe: Open-Label Extension - 6 weeks

InterventionScores on a scale (Mean)
Open-Label Extension (Abilify)21.5
Open-Label Extension (Placebo)21.7

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Young Mania Rating Scale (YMRS)

The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania. (NCT00194012)
Timeframe: Baseline

InterventionScores on a scale (Mean)
Abilify Randomized Phase24.8
Placebo Randomized Phase21.6

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Children's Depression Rating Scale-Revised (CDRS-R )

The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms. (NCT00194012)
Timeframe: Baseline

InterventionScores on a scale (Mean)
Aripiprazole Randomized Phase33.7
Placebo Randomized Phase30.3

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Children's Global Assessment Scale (CGAS)

"Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 Doing very well to 1-10 Extremely impaired.~The score should be calculated separate from diagnosis, treatment or prognosis." (NCT00194012)
Timeframe: 12 weeks

InterventionScores on a scale (Mean)
Aripiprazole Randomized Phase67.1
Placebo Randomized Phase61.4

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Children's Global Assessment Scale (CGAS)

"Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 Doing very well to 1-10 Extremely impaired.~The score should be calculated separate from diagnosis, treatment or prognosis." (NCT00194012)
Timeframe: Baseline

InterventionScores on a scale (Mean)
Aripiprazole Randomized Phase56.1
Placebo Randomized Phase57.5

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Children's Global Assessment Scale (CGAS)

"Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 Doing very well to 1-10 Extremely impaired.~The score should be calculated separate from diagnosis, treatment or prognosis." (NCT00194012)
Timeframe: Open-Label Extension - 6 weeks

InterventionScores on a scale (Mean)
Open-Label Extension (Abilify)71.47
Open-Label Extension (Placebo)69.72

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Clinical Global Impressions Scale (CGI-Severity)

Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). (NCT00194012)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Aripiprazole Randomized Phase2.3
Placebo Randomized Phase3.0

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Clinical Global Impressions Scale (CGI-Severity)

Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). (NCT00194012)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Aripiprazole Randomized Phase4.2
Placebo Randomized Phase3.8

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Time in Weeks to Discontinuation

Time in weeks to discontinuation due to any reason, including mood event, adverse event, or other. (NCT00194077)
Timeframe: up to 72 weeks

Interventiontime in weeks to discontinuation (Mean)
Aripiprazole25.93
Placebo3.00

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Mean Post-baseline Score on a Modified Version of the Compulsion Subscale of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

The CYBOCS- PDD is a semi-structured clinician-rated scale designed to rate the current severity of repetitive behavior in children with idiopathic autism spectrum disorders. Once the current repetitive behaviors are identified, they are rated on: Time Spent, Interference, Distress, Resistance, and Control. Each of these items is scored from 0 (least symptomatic) to 4 (most symptomatic), yielding a Total score from 0 to 20. Higher scores indicate higher severity. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints. (NCT00198107)
Timeframe: Weeks 2, 4, 6 and 8

Interventionunits on a scale (Mean)
1 Placebo14.4
2 Aripiprazole12.5

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Mean Social Reciprocity Scale (SRS) Total Score, Week 8

The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total score results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment. Means were estimated using a repeated measures linear regression model with treatment group, study week (in categories, baseline or 8 weeks), and sex x Tanner stage stratum as covariates. (NCT00198107)
Timeframe: Week 8

Interventionunits on a scale (Mean)
1 Placebo127.6
2 Aripiprazole112.6

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Mean Vineland Maladaptive Behavior Subscales Total Score, Week 8

The Vineland Adaptive Behavior Scales, (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults. It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. An increase in standard scores from Baseline to the Final Visit indicates improvement. Means were estimated using a repeated measures linear regression model with treatment group, study week (in categories, baseline or 8 weeks), and sex x Tanner stage stratum as covariates. (NCT00198107)
Timeframe: Week 8

Interventionunits on a scale (Mean)
1 Placebo33.1
2 Aripiprazole23.1

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Odds of Improvement as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2)

Clinical Global Impressions (Guy, 1976) global improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7, with lower scores indicating greater improvement (1=very much improved and 2=much improved). Participants with a CGI-I score of 1 or 2 were classified as improved. Odds were estimated using a repeated measures logistic regression model with treatment group, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average log odds across study timepoints. Confidence intervals reflect a Bonferroni multiple testing correction accounting for the selection of two primary outcomes. (NCT00198107)
Timeframe: Weeks 1, 2, 3, 4, 6 and 8

Interventionodds (Number)
1 Placebo0.10
2 Aripiprazole0.50

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Mean Post-baseline Aberrant Behavior Checklist Social Withdrawal Score, Parent Report, Double-blind Phase

The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item Parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its subscales is that higher scores, indicates greater severity. Sixteen item scores with values ranging from 0 (not a problem) to 3 (problem is severe) are summed to arrive at the total social withdrawal scale score ranging from 0 to 48. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints. (NCT00198107)
Timeframe: Weeks 1, 2, 3, 4, 6, and 8

Interventionunits on a scale (Mean)
1 Placebo15.4
2 Aripiprazole11.7

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Mean Post-baseline Aberrant Behavior Checklist Inappropriate Speech Score, Parent Report, Double-blind Phase

The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item Parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its subscales is that higher scores, indicate greater severity. Four item scores with values ranging from 0 (not a problem) to 3 (problem is severe) are summed to arrive at the total inappropriate speech scale score ranging from 0 to 12. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints. (NCT00198107)
Timeframe: Weeks 1, 2, 3, 4, 6, and 8

Interventionunits on a scale (Mean)
1 Placebo7.4
2 Aripiprazole5.0

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Mean Autism Diagnostic Observation Schedule (ADOS) Social Affect and Restricted and Repetitive Behaviors Total Score, Week 8

Autism Diagnostic Observation Scale (ADOS) (Lord), Modules 1-3 yields scores in 2 scales: Social Affect and Restricted and Repetitive Behavior. The ADOS has been repeatedly evaluated as a diagnostic measure, it has also been used as an outcome measure of autism severity (Aldred et al., 2004; Gutstein, 2007; Owly et al, 2001, Green et al, 2010). For modules 1-3, scores ranging from 0-2 on 14 items are summed to arrive at the Social Affect and Restricted and Repetitive Behavior Total Score, which ranges from 0 to 28. Higher scores indicate greater autism severity. Means were estimated using a repeated measures linear regression model with treatment group, study week (in categories, baseline or 8 weeks), and sex x Tanner stage stratum as covariates (NCT00198107)
Timeframe: Week 8

Interventionunits on a scale (Mean)
1 Placebo19.0
2 Aripiprazole18.3

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Mean Post-baseline Aberrant Behavior Checklist Irritability Score, Parent Report, Double-blind Phase

The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its subscales is that higher scores, indicate greater severity. Fifteen item scores with values ranging from 0 (not a problem) to 3 (problem is severe) are summed to arrive at the total irritability scale store ranging from 0 to 45. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints. Confidence intervals reflect a Bonferroni multiple testing correction accounting (NCT00198107)
Timeframe: Weeks 1, 2, 3, 4, 6, and 8

Interventionunits on a scale (Mean)
1 Placebo25.5
2 Aripiprazole18.6

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Mean Post-baseline Aberrant Behavior Checklist Hyperactivity Score, Parent Report, Double-blind Phase

The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item Parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers overactivity, impulsiveness, inattention and noncompliance. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its subscale is that higher scores, indicate greater severity. Sixteen item scores with values ranging from 0 (not a problem) to 3 (problem is severe) are summed to arrive at the total score ranging from 0 to 48. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints. (NCT00198107)
Timeframe: Weeks 1, 2, 3, 4, 6 and 8

Interventionunits on a scale (Mean)
1 Placebo29.7
2 Aripiprazole22.5

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Mean Post-baseline Aberrant Behavior Checklist Stereotypy Score, Parent Report, Double-blind Phase

The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item Parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its subscales is that higher scores, indicates greater severity. Seven item scores with values ranging from 0 (not a problem) to 3 (problem is severe) are summed to arrive at the total stereotypy scale score ranging from 0 to 21. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints. (NCT00198107)
Timeframe: Weeks 1, 2, 3, 4, 6, and 8

Interventionunits on a scale (Mean)
1 Placebo10.0
2 Aripiprazole7.2

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Change in MRI-measured Visceral Abdominal Fat

This study hypothesized that antipsychotic treatment would increase visceral abdominal fat, as measured by abdominal magnetic resonance imaging (MRI), with larger adverse effects for olanzapine. (NCT00205699)
Timeframe: 12 weeks

InterventionChange in cm-squared (Mean)
Risperidone6.85
Olanzapine10.73
Aripiprazole12.04

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Change in MRI-measured Subcutaneous Abdominal Fat

This study hypothesized that antipsychotic treatment would increase subcutaneous abdominal fat, as measured by abdominal magnetic resonance imaging (MRI), with larger adverse effects for olanzapine. (NCT00205699)
Timeframe: 12 weeks

InterventionChange in cm-squared (Mean)
Risperidone18.21
Olanzapine34.27
Aripiprazole15.84

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Change in Insulin-stimulated Glycerol Rate of Appearance (Glycerol Ra)

This study hypothesized that antipsychotic treatment would decrease insulin sensitivity at adipose tissue, as measured by the insulin-stimulated rate of disappearance of glycerol (glycerol Ra), with larger adverse effects for olanzapine. (NCT00205699)
Timeframe: 12 weeks

Interventionpercentage of % change (Mean)
Risperidone-3.65
Olanzapine-8.29
Aripiprazole1.70

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Change in Insulin-stimulated Glucose Rate of Disappearance (Glucose Rd)

This study hypothesized that antipsychotic treatment would decrease insulin sensitivity at muscle, as measured by the insulin-stimulated rate of disappearance of glucose (glucose Rd), with larger adverse effects for olanzapine. (NCT00205699)
Timeframe: 12 weeks

Interventionpercentage of % change (Mean)
Risperidone2.30
Olanzapine-29.34
Aripiprazole-30.26

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Change in DEXA % Body Fat

This study hypothesized that antipsychotic treatment would increase percent total body fat, as measured by whole body dual energy x-ray absorptiometry (DEXA), with larger adverse effects for olanzapine. (NCT00205699)
Timeframe: 12 weeks

Interventionpercent body fat (Mean)
Risperidone1.81
Olanzapine4.12
Aripiprazole1.66

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Change in Insulin-stimulated Glucose Rate of Appearance (Glucose Ra)

This study hypothesized that antipsychotic treatment would decrease hepatic insulin sensitivity, as measured by the rate of appearance of glucose (glucose Ra), with larger adverse effects for olanzapine. (NCT00205699)
Timeframe: 12 weeks

Interventionpercentage of % change (Mean)
Risperidone-2.50
Olanzapine-6.57
Aripiprazole-3.27

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Change From Baseline to Endpoint in Short-Form Health Survey 12 (SF-12) Scores

Quality of life was assessed by means of the 12-item SF-12® survey. Two parameters, i.e., PCS (physical component summary) and MCS (mental component summary) were calculated. Both components scores range from 0 to 100 with higher scores indicating better QOL. (NCT00216476)
Timeframe: Assessed at the moment the subject was randomized to a treatment arm (baseline visit) and after 1, 3, 6, 12, 18, and 24 months of treatment

,,
Interventionunits on a scale (Mean)
PCS scoreMCS score
Aripiprazole2.44.9
Quetiapine1.02.7
Risperidone LAI2.13.2

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Mean Relapse Free Period(Risperidone LAI Versus Quetiapine)

Relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. The relapse rate in each treatment arm was estimated using the Kaplan-Meier method. (NCT00216476)
Timeframe: Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)

Interventiondays (Mean)
Risperidone LAI607
Quetiapine533

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Mean Relapse Free Period (Exploratory/Aripiprazole)

As for risperidone and quetiapine, relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. Since aripiprazole was new on the market at the time the study was conducted, this aripiprazole analysis was exploratory. (NCT00216476)
Timeframe: Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)

Interventiondays (Mean)
Aripiprazole314

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Change From Baseline to Endpoint in Total Positive and Negative Syndrome Scale (PANSS) Score

"The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item PANSS scale. The PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, i.e., the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items).~Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme)." (NCT00216476)
Timeframe: Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)

Interventionunits on a scale (Mean)
Risperidone LAI-9.3
Quetiapine-1.1
Aripiprazole-7.7

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Change From Baseline to Endpoint in Clinical Global Impression Scale (CGI) Score

The 7-point CGI scale of Severity (CGI-S) was used to assess the severity of a subject's psychotic condition (0= normal, not at all ill, 1= borderline, etc. and 6= among the most extremely ill subjects). (NCT00216476)
Timeframe: Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Month 24 or earlier)

Interventionunits on a scale (Mean)
Risperidone LAI-0.3
Quetiapine0.1
Aripiprazole-0.1

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Change in Global Assessment of Functioning Scale (GAFS)

Ranging from 0 to 100, with higher score indicating better global functioning. Outcome is the post-treatment GAFS score compared to the pre-treatment GAFS score. (NCT00220636)
Timeframe: baseline and 12 weeks

Interventionpoints on GAFS scale (Mean)
Aripiprazole7.3

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Change in Beck Depression Inventory (BDI) Score

"21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.~Outcome is the subject's total BDI score post-treatment compared to the subject's total BDI score pre-treatment." (NCT00220636)
Timeframe: baseline and 12 weeks

Interventionpoints on BDI scale (Mean)
Aripiprazole4.2

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Hamilton Depression Rating Scale (HDRS)

"Clinician rated measure of depression, mean score; this study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7) Outcome is the number of these subjects whose depression responded after treatment with aripiprazole, which means a 50% or greater decrease in Hamilton Depression Rating Scale scores at week 12." (NCT00220636)
Timeframe: 12 weeks

Interventionparticipants (Number)
Aripiprazole7

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Clinical Global Impressions Improvement Scale (CGI)

clinician rated improvement, score on CGI scale ranging from 1 (very much improved) to 7 (very much worse) (NCT00220636)
Timeframe: 12 weeks

Interventionunits on CGI scale (Mean)
Aripiprazole2.8

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Primary Measure:Reduction in Depression Symptoms

Primary efficacy will be assessed by the proportion of patients achieving a 50% reduction (range 0- 60, higher the number the more depressed) on the Montgomery Asberg Depression Rating Scale (MADRS) (defined as response) concomitant with a Clinical Global Impression Scale(CGI-S) improvement of 1 or 2 (range 0-7, higher the number the more severe the overall bipolar symptoms). (NCT00223496)
Timeframe: up to 12 weeks

Interventionparticipants (Number)
Aripiprazole Plus Divalalproex ER16

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Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population

Mean exposure is mean number of milligrams per day (mg/day) of aripiprazole administered to the participants. (NCT00239356)
Timeframe: Day 1 to Day 1170

,
Interventionmg/day (Mean)
Days 541 to 630 (N=57, 17)Days 721 to 810 (N=44, 15)Days 1081 to 1170 (N=27, 12)
Aripiprazole 10 - 30 mg Once Daily (QD)20.2520.5523.20
Aripiprazole 5 - 30 mg QD13.5313.6714.7

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Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. (NCT00239356)
Timeframe: Baseline to Week 348

,
Interventionparticipants (Number)
DeathSerious Adverse EventsAdverse EventsDiscontinuations due to AEs
Aripiprazole 10 - 30 mg Once Daily (QD)013476
Aripiprazole 5 - 30 mg QD00140

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Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population

Clinically relevant abnormalities: greater than, equal to (>=); less than, equal to (<=). Upper limits of normal (ULN). milligram per deciliter (mg/dL); milliequivalent per liter (mEq/L); nanograms per milliliter (ng/mL);outside of normal range inclusive (): alanine transaminase (ALT>= 3*ULN; aspartate aminotransferase (AST >=3*ULN; alkaline phosphatase >=3*ULN; total bilirubin >= 2.0 mg/dL; blood urea nitrogen >= 30mg/dL; calcium (8.40 - 9.90 mg/dL); chloride (85.00 - 108.00 mEq/L); total cholesterol (140.0 - 200.0 mg/dL); cholesterol high density (HDL) and low density (LDL) lipoprotein (39.0 - 116.0 mg/dL); creatine kinase (15.0 - 170.0 U/L); creatinine >=2.0 mg/dL; prolactin (3.00 - 29.00 ng/mL); sodium (136.0 - 144.0 mEq/L); Glucose fasting (70.0 - 110.0 mg/dL); triglycerides (58.0 - 164.0 mg/dL; uric acid male >= 10.5, female >= 8.5mg/dL. Baseline is Day 1 of the study, prior to study drug administration. (NCT00239356)
Timeframe: Baseline to end of study (Week 348)

,
Interventionparticipants (Number)
Total Bilirubin (N=78, 18)Blood urea nitrogen (N=37, 18)Total Calcium (N=76, 18)Serum chloride (N=62, 17)Cholesterol HDL Fasting (N=44, 13)Cholesterol LDL Fasting (N=47, 13)Total Cholesterol Fasting (N=55, 16)Creatine Kinase (N=64, 18)Creatinine (N=81, 18)Glucose, Fasting serum (N=61, 15)Glucose, serum (N=37, 2)Prolactin (N=63, 18)Sodium, serum (N=76, 17)Triglycerides Fasting (N=59, 16)Uric Acid (N=71, 17)
Aripiprazole 10 - 30 mg Once Daily (QD)41111713152112281171
Aripiprazole 5 - 30 mg QD000090000801020

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Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population

Potentially clinically relevant abnormality or change relative to baseline: sinus tachycardia: >= 120 beats per minute (bpm) and increased >= 15 bpm; sinus bradycardia: <= 50 bpm and decrease >= 15 bpm; supraventricular tachycardia, ventricular tachycardia, atrial fibrillation, atrial flutter: not present to present. First degree atrioventricular (A-V) block: PR interval(beginner of P wave to beginning of complex of Q, R, and S waves) >= 0.20 seconds (sec) and increase >= 0.05 sec; second and third degree A-V block, right bundle branch block (RBB) block, left bundle branch block (LBB) block: not present to present; other intraventricular block: QRS (complex of Q, R and S waves) >= 0.12 sec and increase >= 0.02 sec. Myocardial ischemia not present to present. QT interval with Bazett's correction (QTcB) or Fridericia's correction (QTcF) >= 450 milliseconds (msec) and elevation of 10% over baseline. (NCT00239356)
Timeframe: Baseline to end of study (Week 348

,
Interventionparticipants (Number)
Tachycardia (N=85, 16)Bradycardia (N=85, 16)Sinus Tachycardia (N=85, 16)Sinus Bradycardia (N=85, 16)First degree A-V Block (N=85, 16)RBB Block (N=85, 16)Pre-excitation syndrome (N=85, 16)Other intraventricular Block (N=85, 16)Myocardial Ischemia (N=85, 16)QTcB (N=83, 16)QTcF (N=83, 16)
Aripiprazole 10 - 30 mg Once Daily (QD)0101101171116
Aripiprazole 5 - 30 mg QD11110002040

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Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population

Clinically relevant laboratory abnormality: Hemoglobin male <= 11.5 g/dL; female <= 9.5 g/dL. Hematocrit male <= 37 and 3 point decrease from baseline (BL); female <=32 and 3 point decrease from BL. Leukocytes <= 2800 mm^3 or >= 16000 mm^3; eosinophils >=10%. Baseline is Day 1 of the study, prior to study drug administration. (NCT00239356)
Timeframe: Baseline to end of study (Week 348)

,
Interventionparticipants (Number)
Eosinophils, relative (N=80, 18)Hematocrit (N=80, 16)Hemoglobin (N=81, 18)Leukocytes (N=81, 18)
Aripiprazole 10 - 30 mg Once Daily (QD)1121
Aripiprazole 5 - 30 mg QD3111

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Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population

Vital signs include standing, sitting and supine systolic and diastolic blood pressure, measured in millimeters of mercury (mmHg) and standing, sitting and supine heart rate, measured in beats per minute. Baseline (BL) is Day 1 of the study, prior to study drug administration. Criteria for identifying vital sign values as clinically relevant: Systolic blood pressure (criterion value=90-180 mmHg) change relative to baseline: increase of greater than, equal to (>=) 20; decrease of >= 20 mmHg. Diastolic blood pressure (criterion value=50 - 105 mmHg) change relative to baseline: increase of >= 15; decrease of >= 15 mmHg. Heart rate (criterion value=50-120bpm) change relative to baseline: increase >=15; decreased >= 15 mmHg. To be clinically significantly abnormal: value must meet the criterion value and also represent a change from the participant's pre-treatment value of at least the magnitude shown in the change relative to baseline. (NCT00239356)
Timeframe: Baseline to end of study (Week 348)

,
Interventionparticipants (Number)
Standing Systolic decrease (N=87,18)Standing Diastolic increase (N=87,18)Supine Diastolic increase (N=79,20)Sitting Diastolic increase (N=61,5)Standing Heart Rate increase (N=87,18)Orthostatic Hypotension (N=78, 18)
Aripiprazole 10 - 30 mg Once Daily (QD)311231
Aripiprazole 5 - 30 mg QD000000

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Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population.

Baseline is Day 1 of the study, prior to first dose. CGI-S is a questionnaire completed by the clinician which evaluates the severity of mental illness of a participant at a specific point in time. It consists of 7 categories with the lower categories indicating less illness and the higher numbered categories indicating greater severity of illness: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3= mildly ill; 4=moderately ill; 5= markedly ill; 6=severely ill; 7=among the most extremely ill. (NCT00239356)
Timeframe: Baseline to Week 348

,
Interventionunits on a scale (Mean)
BaselineWeek 52 (N=67, 15)Week 108 (N=46,15)Week 156 (N=26,12)Week 212 (N=21,0)Week 260 (N=8,0)Week 316 (N=5,0)Week 348 (N=5,0)
Aripiprazole 10 - 30 mg Once Daily (QD)2.62.32.32.42.11.92.42.4
Aripiprazole 5 - 30 mg QD1.01.11.11.1NANANANA

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Clinical Global Impression Severity Scores

The Clinical Global Impression scale (CGI) is a classic instrument for making global assessments. This scale yields three different measures: 1. Severity of illness (7-point scale, with 7 being the most impaired; assessment of patient's current symptom severity, referred to here as CGIs), 2. Global improvement (7-point scale, with 7 being the most impaired; comparison of patient's baseline condition with his/her current condition, referred to here as CGIi), 3. Efficacy index (4 point x 4 point rating scale, comparison of patient's baseline condition with a ratio of current therapeutic benefit to severity of side effects) (NCT00241176)
Timeframe: 24 Months

Interventionunits on a scale (Mean)
Group 1 - Baseline4.45
Group 1 - Endpoint3.18

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Calculating Difference Between Means (Baseline and Endpoint Scores on the Yale Global Tic Severity Scale Subscales)

The Yale Global Tic Severity Scale (YGTSS) is a clinical rating instrument that was designed for use in studies of Tourette's syndrome and other tic disorders. The YGTSS provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic symptoms. The maximum YGTSS Global score is 100, while the maximum motor score is 25, the maximum vocal score is 25, and the maximum impairment score is 50. Higher scores indicate more severe tics. (NCT00241176)
Timeframe: 8 Weeks

,
Interventionunits on a scale (Mean)
YGTSS Motor TicYGTSS Vocal TicYGTSS Total TicYGTSS Global Severity
Group 1 - Baseline15.8212.3628.1861.82
Group 1 - Endpoint9.737.0016.7333.73

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Children's Aggression Scale-Parent Version

"CAS-P is a 33 item scale representing 5 domains of aggression: Items in a domain were computed based on two reference points. The first was based on a 5 point frequency range with 0 being best (never) and 4 (> 10 times being) worst. These same items were then adjusted such that more severe acts would be weighted more heavily compared to less severe aggressive behaviors. Within a domain, 0 was the best score. Worst score for the various aggression domains were: Verbal 26.16, Against Objects and Animals 11.8, Provoked 15.84, Initiated 17.84, and Use of Weapons 13.16." (NCT00250705)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Verbal AggressionAggression Against Objects and AnimalsProvoked AggressionInitiated AggressionAggression with Use of Weapons
Adolescent Conduct Disorder Males2.70.41.60.60.1

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The Primary Outcome Efficacy Measure: Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993)

Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993) is a global rating scale of aggression completed by clinicians. Score given based on following severity scale with subject assigned 1 number: Intolerable behavior-frequently physically attacks others and destroys property (5); Severe-occasionally physically attacks people and destroys property (4); Moderately 21); and No aggressiveness reported (1). A minimum score of 1 is best and a maximum score of 5 is worst. There are no subscale scores. (NCT00250705)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Aripiprazole Treatment of Conduct Disorder1.7

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Overt Aggression Scale-Modified (OAS-M)

"OAS-M divides aggressions into 4 subtypes: 1) verbal aggression, 2) property aggression, 3) self aggression (autoaggression), and 4) physical aggression. Each subtype has an initial score ranging from 0 (least aggressive) to 4 (most aggressive). The score for each subscale is further weighed (multiplied) by a constant: verbal scale's constant is 1 (max adjusted score of 4); property scale's constant is 2 (max adjusted score 8); self scale's constant is 3 (max adjusted score 12); and physical scale's constant is 4 (max adjusted score of 16). Within a given scale, 0 is the best score and maximum adjusted scale score is worst." (NCT00250705)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
verbal aggressionproperty aggressionself aggressionphysical aggression
Adolescent Conduct Disorder Males1.00.60.61.6

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Secondary Outcome Measures Were the Clinical Global Impression--Improvement (CGI-I) Scales (NIMH, 1985a).

The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1. Very much improved; 2. Much improved; 3. Minimally improved; 4. No change; 5. Minimally worse; 6. Much worse; or 7. Much worse) (NCT00250705)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Aripiprazole Treatment of Conduct Disorder2.1

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Secondary Outcome Measures Were the Clinical Global Impression-Severity (CGI-S) Scale (NIMH, 1985a).

The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 1. Normal, not at all ill; 2. Borderline mentally ill, 3. Mildly ill; 4. Moderately ill; 5. Markedly ill; 6. Severely ill; or 7. Among the most extremely ill patients. (NCT00250705)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Aripiprazole Treatment of Conduct Disorder3.0

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Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2

Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. (NCT00261443)
Timeframe: During Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

,
InterventionParticipants (Number)
DeathsSAEsDiscontinuations due to AEsAny AETreatment-related AEs in >=2% of ParticipantsAny Extrapyramidal Syndrome-Related AE
Lithium0538226188108
Valproate01050287233113

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Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3

Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. (NCT00261443)
Timeframe: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
InterventionParticipants (Number)
DeathsTreatment-Emergent SAEsTreatment-Emergent AEsTreatment-Emergent AEs in >=2% of ParticipantsTreatment-Emergent AEs Leading to Discontinuation
Aripiprazole1111056219
Placebo181054915

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Extension Phase: Adverse Events (AEs), by Maximum Intensity

AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death). (NCT00261443)
Timeframe: From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
InterventionParticipants (Number)
Mild / Grade 1Moderate / Grade 2Severe / Grade 3Very Severe / Grade 4
Aripiprazole7200
Placebo4100

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Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations

Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. (NCT00261443)
Timeframe: From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
InterventionParticipants (Number)
DeathsSAEsAEsDiscontinuations due to AEsTreatment-related AEs
Aripiprazole00801
Placebo00512

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Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania)

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. (NCT00261443)
Timeframe: Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 of LTE Phase. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
Interventionunits on a scale (Mean)
Mean Baseline (N=19, 23)Mean Change at Week 8 (n=19, 23)Mean Change at Week 16 (n=18, 23)Mean Change at Week 24 (n=17, 20)Mean Change at Week 32 (n=15, 15)Mean Change at Week 40 (n=9, 12)Mean Change at Week 48 (n=9, 9)Mean Change at Week 56 (n=5, 9)Mean Change at Week 64 (n=5, 4)Mean Change at Week 72 (n=1, 2)
Aripiprazole1.35-0.30-0.30-0.40-0.33-0.33-0.22-0.220.00-0.50
Placebo1.26-0.26-0.28-0.290.00-0.11-0.110.000.000.00

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Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. (NCT00261443)
Timeframe: Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
Interventionunits on a scale (Mean)
Mean Baseline (N=19, 23)Mean Change at Week 8 (n=19, 23)Mean Change at Week 16 (n=18, 23)Mean Change at Week 24 (n=17, 20)Mean Change at Week 32 (n=15, 15)Mean Change at Week 40 (n=9, 12)Mean Change at Week 48 (n=9, 9)Mean Change at Week 56 (n=5, 9)Mean Change at Week 64 (n=5, 4)Mean Change at Week 72 (n=1, 2)
Aripiprazole1.000.000.000.000.000.000.000.000.000.00
Placebo1.21-0.11-0.11-0.12-0.20-0.11-0.11-0.20-0.200.00

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Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. (NCT00261443)
Timeframe: Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
Interventionunits on a scale (Mean)
Mean Baseline (N=19, 23)Mean Change at Week 8 (n=19, 23)Mean Change at Week 16 (n=18, 23)Mean Change at Week 24 (n=17, 20)Mean Change at Week 32 (n=15, 15)Mean Change at Week 40 (n=9, 12)Mean Change at Week 48 (n=9, 9)Mean Change at Week 56 (n=5, 9)Mean Change at Week 64 (n=5, 4)Mean Change at Week 72 (n=1, 2)
Aripiprazole1.35-0.30-0.30-0.40-0.33-0.33-0.22-0.220.00-0.50
Placebo1.37-0.26-0.28-0.29-0.07-0.22-0.22-0.20-0.200.00

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Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities

ECG abnormalities considered by the investigator as clinically relevant.Left Bundle Branch Block: Not present at Baseline--> present post-baseline. (NCT00261443)
Timeframe: From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
InterventionParticipants (Number)
Left Bundle Branch Block (see description)QTcB > 450 msecQTcF > 450 msecQTcB Change from Baseline > 30 msecQTcF Change from Baseline > 30 msecQTcB Change from Baseline > 60 msecQTcF Change from Baseline > 60 msec
Aripiprazole1315300
Placebo4113411

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Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities

Chemistry, hematology, and urinalysis abnormalities considered by the investigator as clinically relevant. Hematocrit: ≤37%(M)/≤32%(F)+3 percentage pts↓from baseline. (NCT00261443)
Timeframe: From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
InterventionParticipants (Number)
Creatine Kinase >= 3 x ULNHematocrit (see description)Hemoglobin ≤11.5 g/dL(M)/≤9.5 g/dL(F)Eosinophils relative (calculated) ≥10%Urine Glucose (any glucose in the urine)
Aripiprazole00022
Placebo12220

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Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase

Metabolic abnormalities considered by the investigator as clinically relevant. (Need normal values for each.) (NCT00261443)
Timeframe: From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
InterventionParticipants (Number)
Glucose, non-fasting (n=3,1)Glucose, fasting (n=17, 22)HDL Cholesterol, combined (n=18, 22)HDL Cholesterol, fasting (n=17, 22)HDL Cholesterol, non-fasting (n=2, 1)Total Cholesterol, combined (n=18, 22)Total Cholesterol, fasting (n=17, 22)Total Cholesterol, non-fasting (n=2, 1)LDL Cholesterol, combined (n=18, 22)LDL Cholesterol, fasting (n=17, 22)LDL Cholesterol, non-fasting (n=2, 1)Triglycerides, combined (n=18, 22)Triglycerides, fasting (n=17, 22)Triglycerides, non-fasting (n=2, 1)
Aripiprazole0311110110330000
Placebo0212120000110440

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Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities

Vital sign abnormalities considered by the investigator as clinically relevant. (NCT00261443)
Timeframe: From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
InterventionParticipants (Number)
Systolic Blood Pressure IncreaseSystolic Blood Pressure DecreaseDiastolic Blood Pressure IncreaseDiastolic Blood Pressure DecreaseHeart Rate IncreaseHeart Rate DecreaseWeight IncreaseWeight Decrease
Aripiprazole00000071
Placebo00000012

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Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3

The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement. (NCT00261443)
Timeframe: Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
Interventionunits on a scale (Mean)
Mean Baseline (n=164, 162)Mean Change from Baseline at Week 4 (n=160, 162)Mean Change from Baseline at Week 8 (n=164, 162)Mean Change from Baseline at Week 12 (n=164, 162)Mean Change from Baseline at Week 16 (n=164, 162)Mean Change from Baseline at Week 20 (n=164, 162)Mean Change from Baseline at Week 24 (n=164, 162)Mean Change from Baseline at Week 28 (n=164, 162)Mean Change from Baseline at Week 32 (n=164, 162)Mean Change from Baseline at Week 36 (n=164, 162)Mean Change from Baseline at Week 40 (n=164, 162)Mean Change from Baseline at Week 44 (n=164, 162)Mean Change from Baseline at Week 48 (n=164, 162)Mean Change from Baseline at Week 52 (n=164, 162)
Aripiprazole4.621.421.231.421.271.471.491.641.701.891.651.531.481.46
Placebo4.411.922.272.422.122.612.923.143.323.033.183.103.573.47

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Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3

"The Y-MRS consists of 11 items: 1) Elevated Mood, 2) Increased Motor Activity -Energy, 3) Sexual Interest, 4) Sleep, 5) Irritability, 6) Speech (Rate and Amount), 7) Language -Thought Disorder, 8) Content, 9) Disruptive-Aggressive Behavior, 10) Appearance, 11) Insight. 7 items are rated on a 0 to 4 scale, while 4 items (items 5, 6, 8 and 9) are rated on a 0 to 8 scale (twice the weight of the other items.) For all items, 0 is the best rating and 4 or 8 is the worst rating. Total Score is the sum of the ratings for all 11 items. The possible Total Scores are from 0 (best) to 60 (worst)." (NCT00261443)
Timeframe: Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
Interventionunits on a scale (Mean)
Baseline (n=164, 162)Change at Week 4 (n=160, 162)Change at Week 8 (n=164, 162)Change at Week 12 (n=164, 162)Change at Week 16 (n=164, 162)Change at Week 20 (n=164, 162)Change at Week 24 (n=164, 162)Change at Week 28 (n=164, 162)Change at Week 32 (n=164, 162)Change at Week 36 (n=164, 162)Change at Week 40 (n=164, 162)Change at Week 44 (n=164, 162)Change at Week 48 (n=164, 162)Change at Week 52 (n=164, 162)
Aripiprazole4.060.530.230.430.350.380.240.400.390.260.110.270.07-0.11
Placebo4.030.470.911.531.742.292.423.022.723.042.823.193.152.93

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Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint

The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement. (NCT00261443)
Timeframe: Baseline (end of Ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 (Ph2) Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

,
Interventionunits on a scale (Mean)
Mean Baseline (n=289, 383)Change from Baseline at Week 1 (n=277, 371)Change from Baseline at Week 2 (n=267, 355)Change from Baseline at Week 4 (n=245, 326)Change from Baseline at Week 6 (n=221, 305)Change from Baseline at Week 8 (n=201, 287)Change from Baseline at Week 12 (n=179, 253)Change from Baseline at Week 16 (n=138, 193)Change from Baseline at Week 20 (n=59, 99)Change from Baseline at Week 24 (n=22, 39)Change from Baseline at Ph2 Endpoint (n=289, 383)
Lithium10.97-1.48-2.23-2.94-2.92-3.07-2.82-2.88-4.68-3.77-2.13
Valproate11.56-1.51-2.70-3.16-3.69-3.64-3.91-4.28-4.49-5.15-2.54

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Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2

"The Y-MRS consists of 11 items: 1) Elevated Mood, 2) Increased Motor Activity -Energy, 3) Sexual Interest, 4) Sleep, 5) Irritability, 6) Speech (Rate and Amount), 7) Language -Thought Disorder, 8) Content, 9) Disruptive-Aggressive Behavior, 10) Appearance, 11) Insight. Seven items are rated on a 0 to 4 scale, while 4 items (items 5, 6, 8 and 9) are rated on a 0 to 8 scale (twice the weight of the other items.) For all items, 0 is the best rating and 4 or 8 is the worst rating. Total Score is the sum of the ratings for all 11 items. The possible Total Scores are from 0 (best) to 60 (worst)." (NCT00261443)
Timeframe: Baseline (end of ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 (Ph2) Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, + Confirmation of Partial Nonresponse Phase)

,
Interventionunits on a scale (Mean)
Baseline (n=289, 383)Change from Baseline at Week 1 (n=277, 371)Change from Baseline at Week 2 (n=266, 355)Change from Baseline at Week 4 (n=245, 326)Change from Baseline at Week 6 (n=221, 305)Change from Baseline at Week 8 (n=201, 287)Change from Baseline at Week 12 (n=179, 253)Change from Baseline at Week 16 (n=138, 193)Change from Baseline at Week 20 (n=59, 99)Change from Baseline at Week 24 (n=22, 39)Change from Baseline at Ph2 endpoint (n=289, 383)
Lithium23.15-4.50-7.90-12.11-13.92-16.18-17.74-18.88-20.37-20.82-14.78
Valproate22.32-4.86-7.82-10.75-13.28-14.84-16.28-17.55-17.64-19.77-14.32

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Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample

(NCT00261443)
Timeframe: Baseline

,
InterventionU/L (Median)
ALP (n=265, 347)ALT (n=266, 346)AST (n=266, 346)CK (n=266, 347)LD (n=262, 342)
Lithium72.020.019.079.0168.0
Valproate64.017.020.091.0173.0

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Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2

(NCT00261443)
Timeframe: Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

,
InterventionmmHg (Median)
Supine Systolic BP (SBP) at Baseline (n=286, 372)Supine SBP Change at Phase 2 Endpoint (n=286, 372)Supine Diastolic BP (DBP) at Baseline(n=286, 372)Supine DBP Change at Phase 2 Endpoint (n=286, 372)Sitting SBP at Baseline (n=51, 67)Sitting SBP Change at Phase 2 Endpoint (n=51, 67)Sitting DBP at Baseline (n=51, 67)Sitting DBP Change at Phase 2 Endpoint (n=51, 67)Standing SBP at Baseline (n=260, 333)Standing SBP Change at Phase 2 Endpoint(n=260,333)Standing DBP at Baseline (n=260, 333)Standing DBP Change at Phase 2 Endpoint(n=260,333)
Lithium120.00.076.00.0120.00.078.00.0120.00.078.50.0
Valproate120.00.077.50.0120.00.080.00.0120.00.078.00.0

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Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3

(NCT00261443)
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 52, Week 52 (LOCF), During Phase 3 (for lowest/highest values)

,
Interventionkg/m^2 (Median)
Baseline (n=161, 160)Change at Week 12 (n=129, 121)Change at Week 24 (n=111, 118)Change at Week 36 (n=89, 98)Change at Week 52 (n=85, 95)Change at Week 52 (LOCF) (n=161, 160)Highest Value During Phase 3 (n=161, 160)Lowest Value During Phase 3 (n=161, 160)
Aripiprazole27.90.20.20.40.70.50.7-0.1
Placebo27.00.00.10.10.50.20.4-0.4

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Median Baseline and Change From Baseline in Body Mass Index (BMI) Vital Sign Measurements at Phase 2 Endpoint

(NCT00261443)
Timeframe: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

,
Interventionkg/m^2 (Median)
BMI at BaselineBMI Change at Phase 2 Endpoint
Lithium26.90.3
Valproate27.20.5

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Median Baseline and Change From Baseline in ECG Measurements During Phase 2

(NCT00261443)
Timeframe: Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

,
Interventionmsecs (Median)
QTcBazett (QTcB) at Baseline (n=223, 285)QTcB Change at Phase 2 Endpoint (n=223, 285)QTcB (0.33) at Baseline (n=223, 284)QTcB(0.33) Change at Phase 2 Endpoint (n=223, 284)PR at Baseline (n=222, 284)PR Change at Phase 2 Endpoint (n=222, 284)RR at Baseline (n=223, 284)RR Change at Phase 2 Endpoint (n=223, 284)QRS at Baseline (n=223, 284)QRS Change at Phase 2 Endpoint (n=223, 284)
Lithium415.04.0403.04.0154.02.0845.00.090.00.0
Valproate412.0-8.0400.0-6.0150.0-2.0870.00.090.0-1.0

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Median Baseline and Change From Baseline in Heart Rate Measurements During Phase 2

(NCT00261443)
Timeframe: Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

,
Interventionmsecs (Median)
Heart Rate at Baseline (n=223, 284)Heart Rate Change at Phase 2 Endpoint (n=223, 284)
Lithium71.00.0
Valproate69.00

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Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2

(NCT00261443)
Timeframe: Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

,
Interventionbeats per minute (Median)
Supine Heart Rate (HR) at Baseline (n=286, 372)Supine HR Change at Phase 2 Endpoint (n=286, 372)Sitting Heart Rate (HR) at Baseline (n=51, 67)Sitting HR Change at Phase 2 Endpoint (n=51, 67)Standing HR at Baseline (n=260, 333)Standing HR Change at Phase 2 Endpoint(n=260, 333)
Lithium76.00.078.02.078.00.0
Valproate74.00.082.0-2.078.00.0

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Median Baseline and Change From Baseline in Weight Vital Sign Measurements At Phase 2 Endpoint

(NCT00261443)
Timeframe: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

,
Interventionkg (Median)
Weight at BaselineWeight Change at Phase 2 Endpoint
Lithium76.20.9
Valproate76.41.5

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Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid

(NCT00261443)
Timeframe: Baseline

,
InterventionU/L (Median)
BUN (n=223, 302)TC (n=245, 318)Creatine (n=263, 343)Glucose (n=242, 312)HDL-C (n=245, 318)LDL-C (n=245, 318)Bilirubin (n=265, 347)Triglycerides (n=245, 318)Uric Acid (n=266, 347)
Lithium11.0182.00.90092.047.0105.00.40112.05.55
Valproate13.0174.00.90089.045.0101.00.40114.05.10

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Median Baseline Eosinophils (Relative) and Neutrophils (Relative)

(NCT00261443)
Timeframe: Baseline

,
Interventionpercent of total white blood cell count (Median)
Eosinophils, relative (n=266, 347)Neutrophils, relative (n=266, 346)
Lithium2.5067.60
Valproate2.2058.10

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Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest/lowest value)

,
Interventionx 10^3 c/uL (Median)
BaselineChange from Baseline at Week 52 LOCFHighest Value of Change During Phase 3Lowest Value of Change During Phase 3
Aripiprazole7.650-0.1001.100-1.000
Placebo6.9000.1501.100-0.900

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Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3

(NCT00261443)
Timeframe: Baseline, During Phase 3 (for highest/lowest values), Week 52

,
Interventionmm Hg (Median)
BaselineChange from Baseline at Week 52 (LOCF)Highest Change Value During Phase 3Lowest Change Value During Phase 3
Aripiprazole80.0-2.00.0-4.0
Placebo80.00.04.0-4.0

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Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3

(NCT00261443)
Timeframe: Baseline, During Phase 3 (for highest/lowest values), Week 52

,
Interventionbeats per minute ? (Median)
BaselineChange from Baseline at Week 52 (LOCF)Highest Change Value During Phase 3Lowest Change Value During Phase 3
Aripiprazole76.0-2.04.0-2.0
Placebo78.0-4.03.0-4.0

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Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3

(NCT00261443)
Timeframe: Baseline, During Phase 3 (for highest/lowest values), Week 52

,
Interventionmm Hg (Median)
BaselineChange from Baseline at Week 52 (LOCF)Highest Change Value During Phase 3Lowest Change Value During Phase 3
Aripiprazole120.00.04.0-6.0
Placebo120.02.08.0-3.0

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Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3

(NCT00261443)
Timeframe: Baseline, During Phase 3 (for highest/lowest values), Week 52

,
Interventionmm Hg (Median)
BaselineChange from Baseline at Week 52 (LOCF)Highest Change Value During Phase 3Lowest Change Value During Phase 3
Aripiprazole78.00.06.0-6.0
Placebo78.00.06.0-6.0

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Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3

(NCT00261443)
Timeframe: Baseline, During Phase 3 (for highest/lowest values), Week 52

,
Interventionbeats per minute (Median)
BaselineChange from Baseline at Week 52 (LOCF)Highest Change Value During Phase 3Lowest Change Value During Phase 3
Aripiprazole78.01.07.0-6.0
Placebo78.00.06.0-7.0

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Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3

(NCT00261443)
Timeframe: Baseline, During Phase 3 (for highest/lowest values), Week 52

,
Interventionmm Hg (Median)
BaselineChange from Baseline at Week 52 (LOCF)Highest Change Value During Phase 3Lowest Change Value During Phase 3
Aripiprazole120.00.06.0-8.0
Placebo120.00.08.0-7.0

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Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3

(NCT00261443)
Timeframe: Baseline, During Phase 3 (for highest/lowest values), Week 52

,
Interventionmm Hg (Median)
BaselineChange from Baseline at Week 52 (LOCF)Highest Change Value During Phase 3Lowest Change Value During Phase 3
Aripiprazole79.00.06.0-6.0
Placebo78.00.05.5-6.0

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Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3

(NCT00261443)
Timeframe: Baseline, During Phase 3 (for highest/lowest values), Week 52

,
Interventionbeats per minute (bpm) (Median)
BaselineChange from Baseline at Week 52 (LOCF)Highest Change Value During Phase 3Lowest Change Value During Phase 3
Aripiprazole74.01.08.0-5.0
Placebo74.00.07.5-5.5

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Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3

(NCT00261443)
Timeframe: Baseline, During Phase 3 (for highest/lowest values), Week 52

,
Interventionmm Hg (Median)
BaselineChange from Baseline at Week 52 (LOCF)Highest Change Value During Phase 3Lowest Change Value During Phase 3
Aripiprazole120.00.06.0-8.0
Placebo120.00.08.0-6.0

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Median Baseline, Change From Baseline, and Highest Change Value in LDL Cholesterol (Fasting), Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
Interventionmg/dL (Median)
BaselineChange from Baseline in Week 52 LOCFHighest Value of Change During Phase 3
Aripiprazole100.00.016.5
Placebo104.53.516.0

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Median Baseline, Change From Baseline, and Highest Value of Change in Alkaline Phosphatase (ALP), Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
InterventionU/L (Median)
BaselineChange at Week 52 LOCFHighest Value of Change in Phase 3
Aripiprazole62.50.07.0
Placebo60.51.08.0

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Median Baseline, Change From Baseline, and Highest Value of Change in ALT, Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
InterventionU/L (Median)
BaselineChange at Week 52 LOCFHighest Value of Change in Phase 3
Aripiprazole20.00.05.0
Placebo19.5-1.06.0

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Median Baseline, Change From Baseline, and Highest Value of Change in AST, Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
InterventionU/L (Median)
BaselineChange at Week 52 LOCFHighest Value of Change in Phase 3
Aripiprazole22.0-1.06.0
Placebo20.01.05.0

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Median Baseline, Change From Baseline, and Highest Value of Change in BUN, Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
Interventionmg/dL (Median)
BaselineChange at Week 52 LOCFHighest Value of Change in Phase 3
Aripiprazole12.00.02.0
Placebo11.00.03.0

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Median Baseline, Change From Baseline, and Highest Value of Change in Creatine Kinase, Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
InterventionU/L (Median)
BaselineChange at Week 52 LOCFHighest Value of Change in Phase 3
Aripiprazole91.5-2.028.0
Placebo82.05.033.0

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Median Baseline, Change From Baseline, and Highest Value of Change in Creatinine, Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
Interventionmg/dL (Median)
BaselineChange at Week 52 LOCFHighest Value of Change in Phase 3
Aripiprazole0.9000.0000.100
Placebo0.9000.0000.100

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Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample

The change values reported are the median of (post baseline percentage (of white blood cell count) minus baseline percentage (of white blood cell count). (NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
Interventionpercent of total white blood cell count (Median)
BaselineChange at Week 52 LOCFHighest Value of Change in Phase 3
Aripiprazole2.20-0.100.90
Placebo2.300.000.80

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Median Baseline, Change From Baseline, and Highest Value of Change in Glucose (Fasting), Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
Interventionmg/dL (Median)
BaselineChange at Week 52 LOCFHighest Value of Change in Phase 3
Aripiprazole90.00.07.0
Placebo90.00.06.0

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Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
Interventionbpm (Median)
BaselineChange from Baseline at Week 52 LOCFHighest Value of Change in Heart RateLowest Value of Change in Heart Rate
Aripiprazole69.00.03.0-2.0
Placebo70.00.01.0-3.0

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Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample

HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of 'normal function.' (NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value

,
Interventionproportion of 'normal function' (Median)
BaselineChange from Baseline at Week 52 LOCFHighest Value of Change During Phase 3
Aripiprazole1.06-0.130.37
Placebo1.24-0.130.20

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Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample

HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of 'normal function.' (NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value

,
Interventionpercentage of 'normal function' (Median)
BaselineChange at Week 52 LOCFHighest Value of Change in Phase 3
Aripiprazole106.908.505.30
Placebo120.0-6.35-10.85

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Median Baseline, Change From Baseline, and Highest Value of Change in Lactate Dehydrogenase, Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
InterventionU/L (Median)
BaselineChange at Week 52 LOCFHighest Value of Change During Phase 3
Aripiprazole171.00.019.0
Placebo161.04.025.0

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Median Baseline, Change From Baseline, and Highest Value of Change in Neutrophils (Relative), Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
Interventionpercent of total white blood cell count (Median)
BaselineChange from Week 52 LOCFHighest Value of Change During Phase 3
Aripiprazole62.60-0.55-6.20
Placebo61.55-1.30-6.45

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Median Baseline, Change From Baseline, and Highest Value of Change in PR, Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
Interventionmsecs (Median)
BaselineChange from Baseline at Week 52 LOCFHighest Value of Change in PR
Aripiprazole150.00.04.0
Placebo155.0-2.02.0

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Median Baseline, Change From Baseline, and Highest Value of Change in Prolactin, Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
Interventionng/mL (Median)
BaselineChange from Baseline in Week 52 LOCFHighest Value of Change During Phase 3
Aripiprazole6.00.01.0
Placebo7.02.03.0

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Median Baseline, Change From Baseline, and Highest Value of Change in QRS, Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
Interventionmsecs (Median)
BaselineChange from Baseline at Week 52 LOCFHighest Value of Change in QRS
Aripiprazole90.00.02.0
Placebo89.00.02.0

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Median Baseline, Change From Baseline, and Highest Value of Change in QT Interval Corrected for Heart Rate (QTc) Bazett, Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
Interventionmsecs (Median)
BaselineChange from Baseline at Week 52 LOCFHighest Value of Change in QTc Bazett
Aripiprazole410.03.012.0
Placebo415.03.06.0

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Median Baseline, Change From Baseline, and Highest Value of Change in QTc (0.33), Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
Interventionmsecs (Median)
BaselineChange from Baseline at Week 52 LOCFHighest Value of Change in QTc (0.33)
Aripiprazole400.02.010.0
Placebo404.01.03.0

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Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
Interventionmsecs (Median)
BaselineChange from Baseline at Week 52 LOCFHighest Value of Change in RRLowest Value of Change in RR
Aripiprazole870.0-4.020.0-42.0
Placebo857.03.038.0-15.0

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Median Baseline, Change From Baseline, and Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
Interventionmg/dL (Median)
BaselineChange from Baseline at Week 52 LOCFHighest Value of Change in Phase 3
Aripiprazole0.400.000.10
Placebo0.400.000.10

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Median Baseline, Change From Baseline, and Highest Value of Change in Total Cholesterol (Fasting), Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
Interventionmg/dL (Median)
BaselineChange at Week 52 LOCFHighest Value of Change in Phase 3
Aripiprazole181.0-0.520.5
Placebo180.05.018.5

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Median Baseline, Change From Baseline, and Highest Value of Change in Triglycerides (Fasting), Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
Interventionmg/dL (Median)
BaselineChange from Baseline at Week 52 LOCFHighest Value of Change During Phase 3
Aripiprazole134.50.042.0
Placebo130.04.037.0

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Median Baseline, Change From Baseline, and Highest Value of Change in Uric Acid, Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

,
Interventionmg/dL (Median)
BaselineChange from Baseline at Week 52 LOCFHighest Value of Change in Uric Acid
Aripiprazole5.750.000.50
Placebo5.50-0.100.65

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Median Baseline, Change From Baseline, and Lowest Value of Change in HDL Cholesterol (Fasting), Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value

,
Interventionmg/dL (Median)
BaselineChange at Week 52 LOCFLowest Value of Change in Phase 3
Aripiprazole45.0-1.0-5.0
Placebo46.0-1.0-5.0

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Median Baseline, Change From Baseline, and Lowest Value of Change in Hematocrit, Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value)

,
Interventionpercentage of total blood volume (Median)
BaselineChange at Week 52 LOCFLowest Value of Change in Phase 3
Aripiprazole42.15-0.30-1.90
Placebo41.40-0.40-1.60

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Median Baseline, Change From Baseline, and Lowest Value of Change in Hemoglobin, Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value)

,
Interventiong/dL (Median)
BaselineChange at Week 52 LOCFLowest Value of Change in Phase 3
Aripiprazole14.00-0.10-0.60
Placebo13.80-0.10-0.50

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Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2

(NCT00261443)
Timeframe: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

,
InterventionU/L (Median)
ALP (n=265, 347)ALT (n=266, 346)AST (n=266, 346)CK (n=266, 347)LD (n=262, 342)
Lithium-2.00.00.0-1.0-3.0
Valproate-2.02.01.0-2.0-1.0

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Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2

(NCT00261443)
Timeframe: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

,
InterventionU/L (Median)
BUN (n=223, 302)TC (n=245, 318)Creatine (n=263, 343)Glucose (n=242, 312)HDL-C (n=245, 318)LDL-C (n=245, 318)Bilirubin (n=265, 347)Triglycerides (n=245, 318)Uric Acid (n=266, 347)
Lithium0.0-1.00.02.0-1.0-4.00.02.0-0.10
Valproate0.04.50.01.01.02.00.03.00.10

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Median Change From Baseline in Eosinophils (Relative) and Neutrophils (Relative)

(NCT00261443)
Timeframe: Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

,
Interventionpercent of total white blood cell count (Median)
Eosinophils, relative (n=266, 347)Neutrophils, relative (n=266, 346)
Lithium-0.400.25
Valproate-0.200.60

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Number of Participants Maintaining Remission During Phase 3

Remission is defined as Y-MRS Total Score <=12 and MADRS Total Score <=12. (NCT00261443)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
Interventionparticipants (Number)
Week 4 (n=160, 162)Week 8 (n=152, 145)Week 12 (n=144, 136)Week 16 (n=138, 131)Week 20 (n=131, 127)Week 24 (n=115, 122)Week 28 (n=114, 122)Week 32 (n=104, 119)Week 36 (n=99, 108)Week 40 (n=100, 110)Week 44 (n=91, 109)Week 48 (n=92, 102)Week 52 (n=89, 97)
Aripiprazole14213612612611711911511210410910210195
Placebo142138133122115107100999193818582

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Number of Participants Showing Relevant Weight Gain During Phase 3

Relevant weight gain: >=7% increase from baseline (NCT00261443)
Timeframe: Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment)

,
InterventionParticipants (Number)
Weight Gain at Week 12 (n=129, 121)Weight Gain at Week 24 (n=111, 118)Weight Gain at Week 36 (n=89, 98)Weight Gain at Week 52 (n=85, 95)Weight Gain at Week 52 (LOCF) (n=161, 160)Weight Gain at Any Time (n=163, 164)
Aripiprazole61112182229
Placebo3616161923

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Number of Participants Showing Relevant Weight Loss During Phase 3

Relevant weight loss: >=7% decrease from baseline (NCT00261443)
Timeframe: Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment)

,
InterventionParticipants (Number)
Weight Gain at Week 12 (n=129, 121)Weight Gain at Week 24 (n=111, 118)Weight Gain at Week 36 (n=89, 98)Weight Gain at Week 52 (n=85, 95)Weight Gain at Week 52 (LOCF) (n=161, 160)Weight Gain at Any Time (n=163, 164)
Aripiprazole68851018
Placebo57771318

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Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3

(NCT00261443)
Timeframe: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
Interventionparticipants (Number)
Any EPS MedicationsCardiovascular System-PropanololNervous System-BenztropineNervous System-BiperidenNervous System-Trihexyphenidyl
Aripiprazole402119210
Placebo361810411

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Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2

Sinus Tachycardia: ≥120bpm+↑≥15bpm+no current diagnosis of supraventricular (SV) or ventricular tachycardia or atrial fibrillation (AF) or flutter or other rhythm abnormality (RA). Sinus Bradycardia:≥50bpm+↓≥15bpm+no current diagnosis of AF or flutter or other RA. AF:not present→present or present at rate <100bpm pretreatment to present with rate ≥100bpm+increase of ≥15bpm. AV=atrioventricular; PR=PR interval. Other Intraventricular Block: QRS wave ≥0.12 sec+↑≥0.02 sec+no current diagnosis of left or right bundle branch block. Old Infarction not present→present at ≥12 weeks post study entry. (NCT00261443)
Timeframe: Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

,
InterventionParticipants (Number)
Tachycardia ≥ 120 bpm and ↑ ≥ 15 bpmBradycardia ≤ 50 bpm and ↓ 15 bpmSinus Tachycardia (see description)Sinus Bradycardia (see description)SV Premature Beat - not present → presentVentricular Premature Beat - not present → presentSV Tachycardia not present → presentVentricular Tachycardia not present → presentAtrial Fibrillation (see description)Atrial Flutter not present → present1st Degree AV Block PR ≥0.20 sec and ↑ ≥0.05 sec2nd Degree AV Block not present → present3rd Degree AV Block not present → presentLeft Bundle Branch Block not present → presentRight Bundle Branch Block not present → presentPre-excitation Syndrome not present → presentOther Intraventricular Block (see description)Acute Infarction not present → presentSubacute (Recent) Infarction not present → presentOld Infarction not present → present at >=12 weeksMyocardial Ischemia not present → presentSymmetrical T-Wave Inversion not present → presentQTc Bazett (QTcB) > 450 msecQTc Frederica (QTcF) > 450 msecQTcB > 500 msecQTcF > 500 msecQTcB Change from Baseline > 30 msecQTcF Change from Baseline > 30 msecQTcB Change from Baseline > 60 msecQTcF Change from Baseline > 60 msec
Lithium0000220000000115001100115520282121
Valproate24242100000007200010008200171140

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Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3

Sinus Tachycardia: ≥120bpm+↑≥15bpm+no current diagnosis of supraventricular (SV) or ventricular tachycardia or atrial fibrillation (AF) or flutter or other rhythm abnormality (RA). Sinus Bradycardia:≥50bpm+↓≥15bpm+no current diagnosis of AF or flutter or other RA. AF:not present→present or present at rate <100bpm pretreatment to present with rate ≥100bpm+increase of ≥15bpm. AV=atrioventricular; PR=PR interval. Other Intraventricular Block: QRS wave ≥0.12 sec+↑≥0.02 sec+no current diagnosis of left or right bundle branch block. Old Infarction not present→present at ≥12 weeks post study entry. (NCT00261443)
Timeframe: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
InterventionParticipants (Number)
Tachycardia ≥ 120 bpm and ↑ ≥ 15 bpmBradycardia ≤ 50 bpm and ↓ 15 bpmSinus Tachycardia (see description)Sinus Bradycardia (see description)SV Premature Beat - not present → presentVentricular Premature Beat - not present → presentSV Tachycardia not present → presentVentricular Tachycardia not present → presentAtrial Fibrillation (see description)Atrial Flutter not present → present1st Degree AV Block PR ≥0.20 sec and ↑ ≥0.05 sec2nd Degree AV Block not present → present3rd Degree AV Block not present → presentLeft Bundle Branch Block not present → presentRight Bundle Branch Block not present → presentPre-excitation Syndrome not present → presentOther Intraventricular Block (see description)Acute Infarction not present → presentSubacute (Recent) Infarction not present → presentOld Infarction (see description)Myocardial Ischemia not present → presentSymmetrical T-Wave Inversion not present → presentQTc Bazett (QTcB) > 450 msecQTc Frederica (QTcF) > 450 msecQTcB > 500 msecQTcF > 500 msecQTcB Change from Baseline > 30 msecQTcF Change from Baseline > 30 msecQTcB Change from Baseline > 60 msecQTcF Change from Baseline > 60 msec
Lithium1111110000000126010101012500201032
Valproate010110000000093000202115411252043

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Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2

ULN=upper limit of normal; HDL=high density lipoprotein; LDL=low density lipoprotein. Values for ULN are provided by the lab in the database and could be different for each individual patient based on characteristics such as age, gender, or other patient attributes. (NCT00261443)
Timeframe: Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

,
InterventionParticipants (Number)
Alkaline Phosphatase ≥ 3 x ULN (n=272, 360)Alanine Aminotransferase ≥ 3 x ULN (n=273, 359)Aspartate Aminotransferase ≥ 3 x ULN (n=273, 359)Blood Urea Nitrogen ≥ 30 mg/dL (n=225, 312)Creatine Kinase >= 3 x ULN (n=273, 360)Creatinine ≥ 2.0 mg/dL (n=271, 359)Lactate Dehydrogenase >= 3 x ULN (n=270, 358)Prolactin > ULN (n=231, 306)Bilirubin Total ≥ 2.0 mg/dL (n=n=272, 360)Uric Acid ≥10.5mg/dL(M)/≥8.5mg/dL(F) (n=273, 360)Total Calcium ≤8.2 mg/dL or ≥12 mg/dL (n=273, 360)Chloride Serum ≤90 mEq/L or ≥118 mEq/L(n=273, 360)Potassium Serum ≤2.5 mEq/L/≥6.5 mEq/L(n=271, 358)Sodium Serum ≤126 mEq/L/≥156 mEq/L (n=273, 360)Hematocrit ≤37(M)/≤32(F)+3 pts↓from BL(n=272, 358)Hemoglobin ≤11.5 g/dL(M)/≤9.5 g/dL(F) (n=272, 359)Leukocytes <=2800 mm^3 or >=16000 mm^3(n=272, 358)Eosinophils Relative (Calculated) ≥10%(n=272, 358)Neutrophils Relative (Calculated) ≤15%(n=272, 358)Platelets ≤75,000 mm^3/≥700,000 mm^3 (n=268, 357)Urine Glucose-any glucose in the urine(n=269,357)Urine Protein Increase of ≥ 2 units (n=269, 357)Glucose (Non-fasting) ≥200 mg/dL (n=78, 89)Glucose (Fasting) ≥ 126 mg/dL (n=251, 332)HDL Cholesterol (combined) <40 mg/dL (n=273, 360)HDL Cholesterol (Fasting) <40 mg/dL (n=252, 332)HDL Cholesterol (Non-fasting) <40 mg/dL (n=79, 91)Total Cholesterol (Combined) ≥240 mg/dL(n=273,360)Total Cholesterol (Fasting) ≥240 mg/dL (n=252,332)Total Cholesterol (Non-fasting) ≥240mg/dL(n=79,92)LDL Cholesterol (Combined) ≥160 mg/dL (n=273, 360)LDL Cholesterol (Fasting) ≥160 mg/dL (n=252, 332)LDL Cholesterol (Non-fasting) ≥160 mg/dL (n=79,91)Triglycerides (Combined) ≥ 200 mg/dL (n=273, 360)Triglycerides (Non-Fasting) ≥ 200 mg/dL (n=79, 93)Triglycerides (Fasting) ≥ 200 mg/dL (n=252, 332)
Lithium03006101021021005899017102429485203732730284882573
Valproate0637201091713412432121013632813111731534911474481083385

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Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3

ULN=upper limit of normal; Hb=hemoglobin (NCT00261443)
Timeframe: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
Interventionparticipants (Number)
Alkaline Phosphatase ≥ 3 x ULN (n=166,165)Alanine Aminotransferase ≥ 3 x ULN (n=166,165)Aspartate Aminotransferase ≥ 3 x ULN (n=166,165)Blood Urea Nitrogen ≥ 30 mg/dL (n=139, 138)Creatine Kinase (n=166,165)Creatinine ≥ 2.0 mg/dL (n=166,164)Lactate Dehydrogenase (n=166,164)Prolactin > ULN (n=163, 158)Bilirubin Total ≥ 2.0 mg/dL (n=166, 165)Uric Acid≥10.5 mg/dL(M)/≥ 8.5 mg/dL(F)(n=166, 165)Total Calcium ≤8.2 mg/dL or ≥12 mg/dL (n=166, 165)Chloride Serum ≤90 mEq/L or ≥118 mEq/L(n=166, 165)Potassium Serum ≤2.5 or ≥6.5 mEq/L (n=166, 164)Sodium Serum ≤126 or ≥156 mEq/L (n=166, 165)Hematocrit ≤37(M) or ≤32(F)3 poi (n=166, 164)Hb ≤11.5 g/dl (M) / ≤9.5 g/dL (F) (n=166, 164)Leukocytes (n=166, 164)Eosinophils Relative (Calculated) ≥10 (n=166, 164)Neutrophils Relative (Calculated) ≤15 (n=166, 164)Platelet Count (n=165, 162)Urine Glucose (n=166, 165)Urine Protein (n=166, 165)Glucose (non-fasting) (n=38, 28)Glucose (fasting) (n=159, 158)HDL Cholesterol (combined) (n=166, 165)HDL Cholesterol (fasting) (n=160, 159)HDL Cholesterol (non-fasting) (n=38, 27)Total Cholesterol (combined) (n=166, 165)Total Cholesterol (fasting) (n=160, 159)Total Cholesterol (non-fasting) (n=38, 27)LDL Cholesterol (combined) (n=166, 165)LDL Cholesterol (fasting) (n=160, 159)LDL Cholesterol (non-fasting) (n=38, 27)Triglycerides (combined) (n=166, 165)Triglycerides (non-fasting) (n=38, 28)Triglycerides (fasting) (n=160,159)
Aripiprazole0301610143771318431100840279188113835723223671563
Placebo230380014244101725600851268176202827324241591648

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Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2

Heart Rate: increase, ≥120 beats per minute (bpm) and ≥15 relative to baseline (RBL); decrease, ≤50 bpm and ≥15 RBL. Systolic BP: increase, ≥180 mmHg and ≥20 RBL; decrease, ≤90 mmHg and ≥20 RBL. Diastolic BP: increase, ≥105 mmHg and ≥15 RBL; decrease, ≤50 mmHg and ≥15 RBL. For patients missing a baseline value, an on-treatment value was considered potentially clinically relevant if the value meets the criterion value. (NCT00261443)
Timeframe: Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

,
InterventionParticipants (Number)
Systolic Blood Pressure (SBP) - Standing IncreaseSBP - Standing DecreaseSBP - Supine IncreaseSBP - Supine DecreaseSBP - Sitting IncreaseSBP - Sitting DecreaseDiastolic Blood Pressure (DBP) - Standing IncreaseDBP - Standing DecreaseDBP - Supine IncreaseDBP - Supine DecreaseDBP - Sitting IncreaseDBP - Sitting DecreaseHeart Rate - Standing IncreaseHeart Rate - Standing DecreaseHeart Rate - Supine IncreaseHeart Rate - Supine DecreaseHeart Rate - Sitting IncreaseHeart Rate - Sitting DecreaseWeight - IncreaseWeight - Decrease
Lithium2012014021000101002615
Valproate446400735330201110466

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Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3

Heart Rate: increase, ≥120 beats per minute (bpm) and ≥15 relative to baseline (RBL); decrease, ≤50 bpm and ≥15 RBL. Systolic BP: increase, ≥180 mmHg and ≥20 RBL; decrease, ≤90 mmHg and ≥20 RBL. Diastolic BP: increase, ≥105 mmHg and ≥15 RBL; decrease, ≤50 mmHg and ≥15 RBL. For patients missing a baseline value, an on-treatment value was considered potentially clinically relevant if the value meets the criterion value. (NCT00261443)
Timeframe: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
InterventionParticipants (Number)
SBP- Standing Increase (n=145, 147)SBP- Standing Decrease (n=145, 147)SBP- Supine Increase (n=165, 164)SBP- Supine Decrease (n=165, 164)SBP- Sitting Increase (n=41, 47)SBP- Sitting Decrease (n=41, 47)DBP- Standing Increase (n=145, 147)DBP- Standing Decrease (n=145, 147)DBP- Supine Increase (n=165, 164)DBP- Supine Decrease (n=165, 164)DBP- Sitting Increase (n=41, 47)DBP- Sitting Decrease (n=41, 47)HR- Standing Increase (n=145, 147)HR- Standing Decrease (n=145, 147)HR- Supine Increase (n=165, 164)HR- Supine Decrease (n=165, 164)HR- Sitting Increase (n=41, 47)HR- Sitting Decrease (n=41, 47)
Aripiprazole010201123200100101
Placebo020200504110120100

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Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3

Kaplan Meier estimated survival rate. Relapse is defined as any of the following events accompanied by a YMRS > 16 and/or a MADRS > 16; serious adverse event of worsening disease, or discontinuation by the investigator for lack of efficacy. A hospitalization for a manic, mixed, or depressive episode does meet the criteria for relapse, however does not require an accompanying Y-MRS and/or MADRS score > 16. (NCT00261443)
Timeframe: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3

,
Interventionproportion of participants (Number)
Proportion at Week 0 (n=169, 168)Proportion at Week 4 (n=153, 148)Proportion at Week 8 (n=148, 139)Proportion at Week 12 (n=142, 133)Proportion at Week 16 (n=132, 130)Proportion at Week 20 (n=123, 128)Proportion at Week 24 (n=115, 125)Proportion at Week 28 (n=107, 121)Proportion at Week 32 (n=104, 114)Proportion at Week 36 (n=101, 111)Proportion at Week 40 (n=98, 110)Proportion at Week 44 (n=94, 107)Proportion at Week 48 (n=91, 98)Proportion at Week 52 (n=6, 8)
Aripiprazole1.000.980.970.970.960.960.950.950.910.910.910.910.900.90
Placebo1.000.960.940.940.930.920.920.890.890.890.880.880.870.87

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Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3

Kaplan-Meier estimated survival rate. Criteria for relapse include one or more of the following: relapse is defined as any of the following events accompanied by a Young-Mania Rating Scale (Y-MRS) >16 and/or a Montgomery Åsberg Depression Rating Scale (MADRS) >16; serious adverse event of worsening disease, or discontinuation by the investigator for lack of efficacy. A hospitalization for a manic, mixed, or depressive episode does meet the criteria for relapse, however does not require an accompanying Y-MRS and/or MADRS score >16. (NCT00261443)
Timeframe: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3

,
Interventionproportion of participants (Number)
Proportion at Week 0 (n=169,168)Proportion at Week 4 (n=153,148)Proportion at Week 8 (n=148,139)Proportion at Week 12 (n=142,133)Proportion at Week 16 (n=132,130)Proportion at Week 20 (n=122,128)Proportion at Week 24 (n=113,125)Proportion at Week 28 (n=105,121)Proportion at Week 32 (n=102,115)Proportion at Week 36 (n=99, 111)Proportion at Week 40 (n=95,110)Proportion at Week 44 (n=91,107)Proportion at Week 48 (n=88, 98)Proportion at Week 52 (n=5, 8)
Aripiprazole1.000.990.980.970.970.970.970.970.950.950.950.950.950.95
Placebo1.000.990.990.970.950.930.910.900.890.880.870.860.850.85

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Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3

Kaplan-Meier estimated survival rate. Criteria for relapse include one or more of the following: hospitalization for a manic, mixed or depressive episode; serious adverse event of worsening disease under study accompanied by a Y-MRS > 16 and/or a MADRS > 16; discontinuation due to lack of efficacy as determined by the investigator accompanied by a Y-MRS > 16 and/or a MADRS > 16. (NCT00261443)
Timeframe: Week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
Interventionproportion of participants (Number)
Proportion at Week 0 (n=169, 168)Proportion at Week 4 (n=153, 148)Proportion at Week 8 (n=148, 139)Proportion at Week 12 (n=142, 133)Proportion at Week 16 (n=131, 130)Proportion at Week 20 (n=122, 128)Proportion at Week 24 (n=113, 125)Proportion at Week 28 (n=105, 121)Proportion at Week 32 (n=102, 114)Proportion at Week 36 (n=99, 111)Proportion at Week 40 (n=95, 110)Proportion at Week 44 (n=91,107)Proportion at Week 48 (n=88, 98)Proportion at Week 52 (n=5, 8)
Aripiprazole1.000.960.940.930.920.910.890.890.840.840.840.840.830.83
Placebo1.000.950.930.900.870.830.810.770.760.750.730.730.710.71

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Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2

AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death). (NCT00261443)
Timeframe: During Phase 2. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

,
InterventionParticipants (Number)
Any Adverse EventMild/Grade 1Moderate/Grade 2Severe/Grade 3Very Severe/Grade 4
Lithium226172109202
Valproate287219165311

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Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity

AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death). (NCT00261443)
Timeframe: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
InterventionParticipants (Number)
Participants <= 50 Years (n=132, 131)Participants >50 Years (n=34, 36)Male Participants (n=70, 81)Female Participants (n=96, 86)White Participants (n=63, 74)Non-White Participants (n=42, 31)Participants with Mild/Grade 1 AEParticipants with Moderate/Grade 2 AEParticipants with Severe/Grade 3 AEParticipants with Very Severe/Grade 4 AE
Aripiprazole842147587431755592
Placebo8124456063427553111

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Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from baseline (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. (NCT00261443)
Timeframe: Baseline (end of Ph 1), Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

,
Interventionunits on a scale (Mean)
Mean Baseline (BL) (n=289, 383)Mean Change from BL to Week 1 (n=275, 370)Mean Change from BL to Week 2 (n=267, 354)Mean Change from BL to Week 4 (n=245, 326)Mean Change from BL to Week 6 (n=219, 305)Mean Change from BL to Week 8 (n=200, 287)Mean Change from BL to Week 12 (n=179, 252)Mean Change from BL to Week 16 (n=138, 193)Mean Change from BL to Week 20 (n=59, 99)Mean Change from BL to Week 24 (n=22, 39)Mean Change from BL to Phase 2 Endpoint(n=289,383)
Lithium4.22-0.58-1.15-1.73-2.04-2.40-2.60-2.83-2.93-2.91-2.21
Valproate4.06-0.58-1.06-1.45-1.82-2.06-2.27-2.40-2.32-2.56-2.01

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Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from baseline (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. (NCT00261443)
Timeframe: Baseline (end of Ph 1), Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

,
Interventionunits on a scale (Mean)
Mean Baseline (BL) (n=289, 383)Mean Change from BL to Week 1 (n=275, 370)Mean Change from BL to Week 2 (n=267, 354)Mean Change from BL to Week 4 (n=245, 326)Mean Change from BL to Week 6 (n=219, 305)Mean Change from BL to Week 8 (n=200, 287)Mean Change from BL to Week 12 (n=179, 252)Mean Change from BL to Week 16 (n=138, 193)Mean Change from BL to Week 20 (n=59, 99)Mean Change from BL to Week 24 (n=22, 39)Mean Change from BL to Phase 2 Endpoint(n=289,383)
Lithium2.16-0.16-0.22-0.29-0.31-0.30-0.17-0.21-0.27-0.23-0.16
Valproate2.33-0.19-0.33-0.39-0.43-0.37-0.35-0.36-0.37-0.46-0.26

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Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. (NCT00261443)
Timeframe: Baseline (end of Ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

,
Interventionunits on a scale (Mean)
Mean Baseline (BL) (n=289, 383)Mean Change from BL to Week 1 (n=275, 370)Mean Change from BL to Week 2 (n=267, 354)Mean Change from BL to Week 4 (n=245, 326)Mean Change from BL to Week 6 (n=219, 305)Mean Change from BL to Week 8 (n=200, 287)Mean Change from BL to Week 12 (n=179, 252)Mean Change from BL to Week 16 (n=138, 193)Mean Change from BL to Week 20 (n=59, 99)Mean Change from BL to Week 24 (n=22, 39)Mean Change from BL to Phase 2 Endpoint(n=289,383)
Lithium4.25-0.52-1.05-1.56-1.86-2.17-2.31-2.57-2.71-2.73-1.90
Valproate4.08-0.53-0.97-1.31-1.62-1.80-1.99-2.17-2.14-2.38-1.66

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Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse). (NCT00261443)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

,
Interventionunits on a scale (Mean)
Mean Change from BL to Week 1 (n=274, 368)Mean Change from BL to Week 2 (n=265, 353)Mean Change from BL to Week 4 (n=245, 325)Mean Change from BL to Week 6 (n=219, 305)Mean Change from BL to Week 8 (n=200, 287)Mean Change from BL to Week 12 (n=179, 250)Mean Change from BL to Week 16 (n=138, 193)Mean Change from BL to Week 20 (n=59, 99)Mean Change from BL to Week 24 (n=22, 39)Mean Change from BL to Phase 2 Endpoint(n=289,382)
Lithium3.563.423.353.223.133.283.303.242.913.30
Valproate3.403.253.193.133.113.062.993.183.153.26

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Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall change from preceding phase items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse). (NCT00261443)
Timeframe: Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

,
Interventionunits on a scale (Mean)
Mean Change from BL to Week 1 (n=274, 369)Mean Change from BL to Week 2 (n=265, 353)Mean Change from BL to Week 4 (n=245, 325)Mean Change from BL to Week 6 (n=219, 305)Mean Change from BL to Week 8 (n=200, 287)Mean Change from BL to Week 12 (n=179, 252)Mean Change from BL to Week 16 (n=138, 193)Mean Change from BL to Week 20 (n=59, 99)Mean Change from BL to Week 24 (n=22, 39)Mean Change from BL to Phase 2 Endpoint(n=289,382)
Lithium3.152.612.141.951.731.661.541.691.641.95
Valproate3.092.582.241.971.801.651.611.681.671.94

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Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse). (NCT00261443)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

,
Interventionunits on a scale (Mean)
Mean Change from BL to Week 1 (n=274, 369)Mean Change from BL to Week 2 (n=265, 353)Mean Change from BL to Week 4 (n=245, 325)Mean Change from BL to Week 6 (n=219, 305)Mean Change from BL to Week 8 (n=200, 287)Mean Change from BL to Week 12 (n=179, 252)Mean Change from BL to Week 16 (n=138, 193)Mean Change from BL to Week 20 (n=59, 99)Mean Change from BL to Week 24 (n=22, 39)Mean Change from BL to Phase 2 Endpoint(n=289,382)
Lithium3.202.702.272.111.941.871.741.811.682.26
Valproate3.132.692.402.192.081.941.801.901.822.37

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Baseline Abnormal Involuntary Movement Scale (AIMS)

The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction. (NCT00261443)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Lithium0.10
Valproate0.08

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Baseline in Barnes Akathisia Global Clinical Assessment

The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia. (NCT00261443)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Lithium0.09
Valproate0.14

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Baseline in Simpson-Angus Scale (SAS) Total Score

The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50.(lower score=less severe). Negative change scores indicate improvement. (NCT00261443)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Lithium10.28
Valproate10.30

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Extension Phase: Mean Change From Baseline in CGI-BP (Mania) Severity of Illness at Extension Phase Endpoint

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. (NCT00261443)
Timeframe: Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Interventionunits on a scale (Mean)
Placebo-0.05
Aripiprazole-0.35

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Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Depression) at Extension Phase Endpoint

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. (NCT00261443)
Timeframe: Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Interventionunits on a scale (Mean)
Placebo-0.16
Aripiprazole0.00

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Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Overall) at Extension Phase Endpoint

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. (NCT00261443)
Timeframe: Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Interventionunits on a scale (Mean)
Placebo-0.11
Aripiprazole-0.35

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Median Baseline Hematocrit

(NCT00261443)
Timeframe: Baseline

Interventionpercentage of total blood volume (Median)
Lithium41.30
Valproate41.10

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Median Baseline Hemoglobin

(NCT00261443)
Timeframe: Baseline

Interventiong/dL (Median)
Lithium13.75
Valproate13.80

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Median Baseline Homeostasis Model Assessment 2 (HOMA2)-Percent Beta

HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of 'normal function.' (NCT00261443)
Timeframe: Baseline

Interventionpercentage of 'normal function' (Median)
Lithium99.95
Valproate118.70

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Median Baseline Homeostasis Model Assessment 2 HOMA2-Insulin Resistance (IR)

HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of 'normal function.' (NCT00261443)
Timeframe: Baseline

Interventionproportion of 'normal function' (Median)
Lithium1.14
Valproate1.42

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Median Baseline Leukocytes

(NCT00261443)
Timeframe: Baseline

Interventionx10^3 c/L (Median)
Lithium8.350
Valproate6.800

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Median Baseline Platelet Count

(NCT00261443)
Timeframe: Baseline

Interventionx10^9 c/L (Median)
Lithium297.0
Valproate226.0

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Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample

(NCT00261443)
Timeframe: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest/lowest value)

,
Interventionx10^9 c/L (Median)
BaselineChange from Baseline at Week 52 LOCFHighest Value of Change During Phase 3Lowest Value of Change During Phase 3
Aripiprazole254.0-3.517.5-22.0
Placebo252.0-1.026.0-27.0

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Median Baseline Prolactin

(NCT00261443)
Timeframe: Baseline

Interventionng/dL (Median)
Lithium10.0
Valproate9.5

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Median Change From Baseline in Hematocrit

(NCT00261443)
Timeframe: Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Interventionpercentage of total blood volume (Median)
Lithium0.30
Valproate0.20

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Median Change From Baseline in Hemoglobin

(NCT00261443)
Timeframe: Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Interventiong/dL (Median)
Lithium0.05
Valproate0.10

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Median Change From Baseline in HOMA2 Model Assesses Insulin Resistance (HOMA2-IR) at Phase 2 Endpoint

HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of 'normal function.' (NCT00261443)
Timeframe: Baseline (end of Ph 1), Phase 2 Endpoint (endpoint of a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

Interventionproportion of 'normal function' (Median)
Lithium0.09
Valproate0.15

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Median Change From Baseline in Homeostasis Model Assessment 2(HOMA2)-Percent Beta at Phase 2 Endpoint

HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of 'normal function.' (NCT00261443)
Timeframe: Baseline (end of Ph 1), Phase 2 Endpoint (endpoint of a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

Interventionpercentage of 'normal function' (Median)
Lithium7.70
Valproate17.05

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Median Change From Baseline in Leukocytes at Phase 2 Endpoint

(NCT00261443)
Timeframe: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Interventionx10^3 c/L (Median)
Lithium-0.100
Valproate-0.200

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Median Change From Baseline in Platelet Count at Phase 2 Endpoint

(NCT00261443)
Timeframe: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Interventionx10^9 c/L (Median)
Lithium-4.0
Valproate-2.0

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Median Change From Baseline in Prolactin at Phase 2 Endpoint

(NCT00261443)
Timeframe: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Interventionng/dL (Median)
Lithium-2.5
Valproate-3.0

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Proportion of Participants Discontinuing For Any Reason Through Week 52 (During Phase 3)

(NCT00261443)
Timeframe: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

InterventionProportion of Participants (Number)
Placebo0.473
Aripiprazole0.387

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Unadjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) at Phase 2 Endpoint

The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction. (NCT00261443)
Timeframe: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Interventionunits on a scale (Mean)
Lithium0.05
Valproate0.04

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Unadjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Phase 2 Endpoint

The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia. (NCT00261443)
Timeframe: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Interventionunits on a scale (Mean)
Lithium0.14
Valproate0.07

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Unadjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score at Phase 2 Endpoint

The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50(lower score=less severe). Negative change scores indicate improvement. (NCT00261443)
Timeframe: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Interventionunits on a scale (Mean)
Lithium0.44
Valproate0.15

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Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3

The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 10 Score range from 0 to 4. A negative score signifies improvement. (NCT00261443)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)

,
Interventionunits on a scale (Mean)
Baseline (n=164, 162)Change at Week 4 (n=160, 162)Change at Week 8 (n=151, 145)Change at Week 12 (n=144, 136)Change at Week 24 (n=113, 120)Change at Week 36 (n=97, 105)Change at Week 52 (n=85, 96)Change at Week 52 LOCF (n=164, 162)Highest Value in Change During Phase 3 (n=164,162)
Aripiprazole0.040.030.010.00-0.01-0.02-0.03-0.010.06
Placebo0.02-0.000.020.020.050.020.010.000.04

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Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3

The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 8 Score range from 0 to 4. A negative score signifies improvement. (NCT00261443)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)

,
Interventionunits on a scale (Mean)
Baseline (n=164, 162)Change at Week 4 (n=160, 162)Change at Week 8 (n=151, 145)Change at Week 12 (n=144, 136)Change at Week 24 (n=113, 120)Change at Week 36 (n=97, 105)Change at Week 52 (n=85, 96)Change at Week 52 LOCF (n=164, 162)Highest Value in Change During Phase 3 (n=164,162)
Aripiprazole0.030.030.020.010.00-0.00-0.010.010.07
Placebo0.04-0.010.010.020.020.01-0.000.010.03

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Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3

The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 9 Score range from 0 to 4. A negative score signifies improvement. (NCT00261443)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)

,
Interventionunits on a scale (Mean)
Baseline (n=164, 162)Change at Week 4 (n=160, 162)Change at Week 8 (n=151, 145)Change at Week 12 (n=144, 136)Change at Week 24 (n=113, 120)Change at Week 36 (n=97, 105)Change at Week 52 (n=85, 96)Change at Week 52 LOCF (n=164, 162)Highest Value in Change During Phase 3 (n=164,162)
Aripiprazole0.010.010.020.010.01-0.00-0.000.010.05
Placebo0.01-0.010.030.030.030.030.020.010.04

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Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3

The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction. (NCT00261443)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)

,
Interventionunits on a scale (Mean)
Baseline (n=164, 162)Change at Week 4 (n=160, 162)Change at Week 8 (n=151, 145)Change at Week 12 (n=144, 136)Change at Week 24 (n=113, 120)Change at Week 36 (n=97, 105)Change at Week 52 (n=85, 96)Change at Week 52 LOCF (n=164, 162)Highest Value in Change During Phase 3 (n=164,162)
Aripiprazole0.140.050.11-0.01-0.03-0.07-0.020.060.28
Placebo0.11-0.010.110.100.130.080.060.010.16

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Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3

The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia. (NCT00261443)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)

,
Interventionunits on a scale (Mean)
Baseline (n=164, 162)Change at Week 4 (n=160, 162)Change at Week 8 (n=151, 144)Change at Week 12 (n=144, 136)Change at Week 24 (n=113, 120)Change at Week 36 (n=97, 104)Change at Week 52 (n=85, 96)Change at Week 52 LOCF (n=164, 162)Highest Value in Change During Phase 3 (n=164,162)
Aripiprazole0.160.01-0.04-0.03-0.04-0.05-0.07-0.050.11
Placebo0.10-0.01-0.06-0.07-0.06-0.09-0.10-0.060.07

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Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3

The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50(lower scores=less severe). Negative change scores indicate improvement. (NCT00261443)
Timeframe: Baseline, Weeks 4,8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)

,
Interventionunits on a scale (Mean)
Baseline (n=164, 162)Change at Week 4 (n=160, 161)Change at Week 8 (n=151, 145)Change at Week 12 (n=144, 136)Change at Week 24 (n=113, 120)Change at Week 36 (n=97, 104)Change at Week 52 (n=85, 95)Change at Week 52 LOCF (n=164, 162)Highest Value in Change During Phase 3 (n=164,162)
Aripiprazole10.500.04-0.03-0.10-0.020.01-0.07-0.100.53
Placebo10.48-0.02-0.13-0.20-0.24-0.26-0.24-0.200.17

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Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse). (NCT00261443)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
Interventionunits on a scale (Mean)
Mean Change at Week 4 (n=160, 162)Mean Change at Week 8Mean Change at Week 12Mean Change at Week 16Mean Change at Week 20Mean Change at Week 24Mean Change at Week 28Mean Change at Week 32Mean Change at Week 36Mean Change at Week 40Mean Change at Week 44Mean Change at Week 48Mean Change at Week 52
Aripiprazole3.563.523.453.453.533.543.523.493.523.473.493.443.44
Placebo3.463.553.513.523.583.633.653.693.623.553.523.583.56

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Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. (NCT00261443)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
Interventionunits on a scale (Mean)
Mean Change at Week 4 (n=160, 162)Mean Change at Week 8Mean Change at Week 12Mean Change at Week 16Mean Change at Week 20Mean Change at Week 24Mean Change at Week 28Mean Change at Week 32Mean Change at Week 36Mean Change at Week 40Mean Change at Week 44Mean Change at Week 48Mean Change at Week 52
Aripiprazole3.002.983.032.983.032.963.013.002.942.942.962.962.89
Placebo2.963.173.143.273.293.263.373.313.373.323.333.353.29

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Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse). (NCT00261443)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
Interventionunits on a scale (Mean)
Mean Change at Week 4 (n=160, 162)Mean Change at Week 8Mean Change at Week 12Mean Change at Week 16Mean Change at Week 20Mean Change at Week 24Mean Change at Week 28Mean Change at Week 32Mean Change at Week 36Mean Change at Week 40Mean Change at Week 44Mean Change at Week 48Mean Change at Week 52
Aripiprazole3.273.223.273.223.313.313.313.293.283.243.283.263.25
Placebo3.173.363.343.453.533.603.653.633.613.543.573.633.58

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Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. (NCT00261443)
Timeframe: Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
Interventionunits on a scale (Mean)
Baseline MeanMean Change from Baseline at Week 4 (n=160, 162)Mean Change from Baseline at Week 8Mean Change from Baseline at Week 12Mean Change from Baseline at Week 16Mean Change from Baseline at Week 20Mean Change from Baseline at Week 24Mean Change from Baseline at Week 28Mean Change from Baseline at Week 32Mean Change from Baseline at Week 36Mean Change from Baseline at Week 40Mean Change from Baseline at Week 44Mean Change from Baseline at Week 48Mean Change from Baseline at Week 52
Aripiprazole1.470.290.240.230.240.280.270.280.270.320.280.280.270.30
Placebo1.430.300.350.370.350.410.440.500.530.490.470.460.500.51

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Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. (NCT00261443)
Timeframe: Baseline (end of Phase 2), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,
Interventionunits on a scale (Mean)
Mean Baseline (n=164, 162)Mean Change from Baseline to Week 4 (n=160, 162)Mean Change from Baseline to Week 8 (n=164, 162)Mean Change from Baseline to Week 12 (n=164, 162)Mean Change from Baseline to Week 16 (n=164, 162)Mean Change from Baseline to Week 20 (n=164, 162)Mean Change from Baseline to Week 24 (n=164, 162)Mean Change from Baseline to Week 28 (n=164, 162)Mean Change from Baseline to Week 32 (n=164, 162)Mean Change from Baseline to Week 36 (n=164, 162)Mean Change from Baseline to Week 40 (n=164, 162)Mean Change from Baseline to Week 44 (n=164, 162)Mean Change from Baseline to Week 48 (n=164, 162)Mean Change from Baseline to Week 52 (n=164, 162)
Aripiprazole1.540.050.010.070.070.070.050.100.080.050.050.060.050.04
Placebo1.540.010.050.120.190.230.250.310.270.300.270.330.330.32

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Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. (NCT00261443)
Timeframe: Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

,
Interventionunits on a scale (Mean)
Mean BaselineMean Change from Baseline At Week 4 (n=160, 162)Mean Change from Baseline At Week 8Mean Change from Baseline At Week 12Mean Change from Baseline At Week 16Mean Change from Baseline At Week 20Mean Change from Baseline At Week 24Mean Change from Baseline At Week 28Mean Change from Baseline At Week 32Mean Change from Baseline At Week 36Mean Change from Baseline At Week 40Mean Change from Baseline At Week 44Mean Change from Baseline At Week 48Mean Change from Baseline At Week 52
Aripiprazole1.700.270.210.260.260.290.250.320.300.330.280.300.280.31
Placebo1.650.250.320.400.440.510.560.620.610.620.570.640.680.66

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Baseline and Adjusted Mean Change From Baseline in Weight

(NCT00261443)
Timeframe: Baseline, Weeks 12, 24, 36, 52, During Phase 3 (for highest value)

,
Interventionkg (Mean)
Baseline (n=161, 160)Change at Week 12 (n=129, 121)Change at Week 24 (n=111, 118)Change at Week 36 (n=89, 98)Change at Week 52 (n=85, 95)Change at Week 52 (LOCF) (n=161, 160)Highest Change Value (n=161, 160)
Aripiprazole80.220.280.130.591.611.072.35
Placebo81.33-1.000.350.641.660.602.39

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Number of Participants Showing Clinically Relevant Weight Loss by Study Week

Weight Loss of at least a 7% decrease from Baseline. (NCT00277212)
Timeframe: Weeks 12, 24, 36, 52

,
InterventionParticipants (Number)
Week 12 (n=105, 107)Week 24 (n=84, 87)Week 36 (n=54, 67)Week 52 (n=49, 56)Week 52 LOCF (n=143, 151)At Any Time (n=147, 154)
Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole99661319
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo7810102226

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Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities Occurring During Double-Blind Treatment (Phase 2)

Chemistry, hematology, and urinalysis abnormalities.Abbreviations used: alanine aminotransferase (ALT), institutional upper limit of normal (ULN), aspartate aminotransferase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), baseline (BL) (NCT00277212)
Timeframe: Throughout Phase 2 of the study, up to Week 52

,
Interventionparticiapnts (Number)
ALT ≥3 x ULN (n=151,157)AST ≥3 x ULN (n=151, 157)ALP ≥3 x ULN (n=151, 157)LDH ≥3 x ULN (n=151, 158)BUN ≥30 mg/dL (n=151, 158)Creatine kinase (n=3, 1)Creatinine ≥2.0 mg/dL (n=151, 157)Uric acid (n=151, 157)Bilirubin (total) ≥ 2.0 mg/dL (n=152, 157)Prolactin (n=152, 158)Cholesterol Total (n=151, 157)Cholesterol Total (fasting) (n=126, 124)Cholesterol Total (non-fasting) (n=68, 75)Glucose Fasting Serum (n=126, 125)HDL-C (n=151, 158)HDL-C (fasting) (n=126, 125)HDL-C (non-fasting) (n=68, 75)LDL-C (n=151, 157)LDL-C (fasting) (n=126, 124)LDL-C (non-fasting) (n=68, 75)Triglycerides (n=151, 157)Triglycerides (fasting) (n=126, 124)Triglycerides (non-fasting) (n=68, 75)Sodium serum (n=152, 158)Potassium serum (n=152, 158)Chloride serum (n=152, 158)Calcium (n=151, 157)Hemoglobin ≤11.5 g/dL(m)/≤9.5 g/dL(f) (n=152, 156)Hematocrit ≤37(m)/≤32(f) & 3 ↓from BL (n=152,156)Leukocytes ≤2800 mm^3 or ≥16000 mm^3 (n=152, 156)Eosinophils relative (calculated)≥10% (n=152, 156)Neutrophils relative (calculated)≤15% (n=152, 156)Platelets ≤75,000 mm3 or ≥700,000 mm3 (n=152,155)Protein urine increase of ≥2 units (n=145, 152)Glucose urine (n=149, 155)
Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole0100200201828257133825192622502920000003220000
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo3200000003222179155344231714702619100011020000

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Number of Participants Showing Clinically Relevant Weight Gain by Study Week

Weight gain of at least a 7% increase from Baseline. (NCT00277212)
Timeframe: Weeks 12, 24, 36, 52

,
InterventionParticipants (Number)
Week 12 (n=105, 107)Week 24 (n=84, 87)Week 36 (n=54, 67)Week 52 (n=49, 56)Week 52 LOCF (n=143, 151)At Any Time (n=147, 154)
Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole4101471827
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo235258

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Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment

Abbreviations and further description used in table: Sinus tachycardia, ≥120 beats per minute (bpm) and ↑ ≥15 bpm & no current diagnosis of supraventricular or ventricular tachycardia/atrial fibrillation (AF)/atrial flutter/ other rhythm abnormality. Sinus bradycardia, ≤ 50 bpm and ↓ 15 bpm & no current diagnosis of AF/atrial flutter/other rhythm abnormality. Supraventricular premature beat (SPB), Ventricular premature beat (VPB), Atroventricular (A-V). Other intraventricular block, QRS ≥0.12 sec and ↑ ≥0.02 sec & no current diagnosis of left or right bundle branch block. (NCT00277212)
Timeframe: Throughout the study, up to Week 52

,
Interventionparticiapnts (Number)
Tachycardia: ≥ 120 bpm and ↑ ≥ 15 bpmBradycardia: ≤ 50 bpm and ↓ 15 bpmSinus Tachycardia: ≥ 120 bpm and ↑ ≥ 15 bpmSinus Bradycardia: ≤ 50 bpm and ↓ 15 bpmSPB: not present → present (see description)VPB: not present → present (see description)Supraventricular Tachycardia: not present→ presentVentricular Tachycardia: not present → presentAtrial Fibrillation (AF): not present → presentAF With Rapid Ventricular ResponseAtrial Flutter: not present → present1st Degree A-V Block: PR ≥0.20 sec and ↑ ≥0.05 sec2nd Degree A-V Block: not present → present3rd Degree A-V Block: not present → presentLeft Bundle Branch Block: not present → presentRight Bundle Branch Block: not present → presentPre-excitation Syndrome: not present → presentOther Intraventricular Conduction: see descriptionAcute Infarction: not present → presentSubacute (recent) Infarction: not present→ presentOld Infarction: not present → presentMyocardial Ischemia: not present → presentSymmetrical T-Wave Inversions: not present→presentQTc Bazett: > 450 msecQTc (.37): > 450 msecQTc (.33): > 450 msec
Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole10000100001000040000000601
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo12120200000000060000100500

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Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2)

Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate). (NCT00277212)
Timeframe: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,
InterventionProportion of Participants (Number)
Week 0 (n=173, n=178)Week 2 (n=163, n=175)Week 4 (n=151, n=160)Week 6 (n=145, n=149)Week 8 (n=132, n=136)Week 12 (n=119, n=123)Week 16 (n=102, n=113)Week 20 (n=102, n=111)Week 24 (n=91, n=95)Week 28 (n=79, n=85)Week 32 (n=74, n=82)Week 36 (n=74, n=76)Week 40 (n=74, n=70)Week 44 (n=74, n=70)Week 48 (n=74, n=70)Week 52 (n=19, n=70)
Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole1.000.980.950.940.930.900.890.890.870.850.840.830.820.820.820.82
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo1.000.980.940.910.890.850.840.840.820.790.790.790.790.790.790.76

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Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2

Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate). (NCT00277212)
Timeframe: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,
InterventionProportion of Participants (Number)
Week 0 (n=173, n=178)Week 2 (n=163, n=175)Week 4 (n=154, n=160)Week 6 (n=145, n=149)Week 8 (n=135, n=136)Week 12 (n=121, n=123)Week 16 (n=102, n=113)Week 20 (n=94, n=111)Week 24 (n=91, n=95)Week 28 (n=78, n=85)Week 32 (n=69, n=83)Week 36 (n=67, n=76)Week 40 (n=62, n=70)Week 44 (n=62, n=70)Week 48 (n=62, n=70)Week 52 (n=19, n=70)
Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole1.000.950.910.880.840.820.800.800.780.770.750.740.730.730.730.73
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo1.000.960.910.870.830.760.750.740.690.650.620.620.610.610.610.58

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Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2)

Time from randomization to relapse to a manic or mixed episode in the Double-Blind Relapse Assessment Phase as measured by the Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate). (NCT00277212)
Timeframe: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,
InterventionProportion of Participants (Number)
Week 0 (n=173, n=178)Week 2 (n=162, n=172)Week 4 (n=154, n=159)Week 6 (n=142, n=147)Week 8 (n=135, n=135)Week 12 (n=121, n=127)Week 16 (n=101, n=127)Week 20 (n=94, n=127)Week 24 (n=86, n=127)Week 28 (n=79, n=127)Week 32 (n=69, n=83)Week 36 (n=67, n=83)Week 40 (n=62, n=83)Week 44 (n=62, n=83)Week 48 (n=62, n=83)Week 52 (n=62, n=83)
Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole1.000.980.960.930.900.900.900.900.900.900.890.890.890.890.890.89
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo1.000.980.970.950.930.890.880.880.840.810.780.780.770.770.770.77

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Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2)

Proportion of Participants without Discontinuation Through Week 52(Kaplan-Meier's estimated survival rate). (NCT00277212)
Timeframe: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,
InterventionProportion of Participants (Number)
Week 0 (n=173, n=178)Week 2 (n=164, n=175)Week 4 (n=155, n=161)Week 6 (n=145, n=149)Week 8 (n=135, n=138)Week 12 (n=122, n=124)Week 16 (n=103, n=115)Week 20 (n=95, n=110)Week 24 (n=90, n=104)Week 28 (n=78, n=89)Week 32 (n=70, n=83)Week 36 (n=64, n=77)Week 40 (n=61, n=72)Week 44 (n=57, n=69)Week 48 (n=56, n=66)Week 52 (n=19, n=65)
Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole0.990.910.840.780.700.650.620.590.510.470.440.410.390.380.370.37
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo0.950.900.840.790.710.610.550.530.460.410.380.360.340.330.320.25

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Summary of Concomitant Medications, Phase 1

(NCT00277212)
Timeframe: Phase 1 (9 to 24 Week Single-blind Stabilization Phase)

Interventionparticipants (Number)
Any central nervous system MedicationAnalgesicAnesthetic, generalAnesthetic, localAnticholinergicAntidepressantAntiepilepticAntimigraine prepAntipsychoticAnxiolyticHypnotic & SedativeOpiodOther Analgesic & AntipyreticOther Nervous System DrugPsychostimulantAny extrapyramidal syndrome MedicationBenztropine
Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole550213981248122026720678253129898

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Summary of Concomitant Medications, Phase 2

(NCT00277212)
Timeframe: Phase 2 (52 Week Double-blind Relapse Assessment Phase)

,
Interventionparticipants (Number)
Any central nervous system MedicationAnesthetic, localAnticholinergicAntidepressantAntiepilepticAntimigraine prepAntipsychoticAnxiolyticHypnotic & SedativeOpiodOther Analgesic & AntipyreticPsychostimulantAny extrapyramidal syndrome MedicationBenztropineTrihexyphenidyl
Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole1320251113362411466135351
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo120121381563502053025251

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Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities Occurring During Double-Blind Treatment

In order to be identified as clinically relevant abnormal, an on-drug value must meet the Criterion Value (CV) and also represent a change from the patient's pretreatment value of at least the Change Relative to Baseline (CRB) magnitude. Heart Rate CV: 120 beats per minute (bpm), CRB: increase of ≥15 / CV: 50 bpm, CRB: decrease of ≥15. Systolic BP CV: 180 mmHg, CRB: increase of ≥20 / CV: 90 mmHg, CRB: decrease of ≥20. Diastolic BP CV: 105 mmHg, CRB: increase of ≥15 / CV: 50 mmHg, CRB: decrease of ≥15. (NCT00277212)
Timeframe: Up to 52 Weeks

,
Interventionparticipants (Number)
Systolic BP, supine-Increase (n=160,168)Systolic BP, supine-Decrease (n=160,168)Systolic BP, standing-Increase (n=153, 157)Systolic BP, standing-Decrease (n=153,157)Diastolic BP, supine-Increase (n=160,168)Diastolic BP, supine-Decrease (n=160,168)Diastolic BP, standing-Increase (n=153,157)Diastolic BP, standing-Decrease (n=153,157)Heart Rate, supine-Increase (n=160,168)Heart Rate, supine-Decrease (n=160,168)Heart Rate, standing-Increase (n=153, 157)Heart Rate, standing-Decrease (n=153, 157)
Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole150403110020
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo373220600341

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Adjusted Mean Change From Baseline in Body Weight, Phase 2

Adjusted for index mood episode and baseline assessment (NCT00277212)
Timeframe: Baseline, Week 52

Interventionkg (Mean)
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo-1.81
Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole0.43

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Adjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score

The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction. (NCT00277212)
Timeframe: Baseline, Weeks 8, 24, 36, 52

,
Interventionunits on a scale (Mean)
Baseline (n=125, 128)Change from Baseline at Week 8 (n=124, 124)Change from Baseline at Week 24 (n=85, 89)Change from Baseline at Week 36 (n=54, 67)Change from Baseline at Week 52 (n=50, 56)Change from Baseline at Week 52 LOCF (n=153, 161)Highest Change from Baseline (n=153, 161)
Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole0.140.060.040.13-0.05-0.010.14
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo0.21-0.05-0.01-0.09-0.110.050.10

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Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment,

The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia. (NCT00277212)
Timeframe: Baseline, Weeks 8, 24, 36, 52

,
Interventionunits on a scale (Mean)
Baseline (n=125, 128)Change from Baseline at Week 8 (n=125, 124)Change from Baseline at Week 24 (n=85, 89)Change from Baseline at Week 36 (n=54, 67)Change from Baseline at Week 52 (n=50, 56)Change from Baseline at Week 52 LOCF (n=153, 161)Highest Change from Baseline (n=153, 161)
Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole0.270.04-0.06-0.18-0.17-0.050.15
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo0.22-0.12-0.09-0.18-0.20-0.11-0.02

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Adjusted Mean Change From Baseline in BMI by Study Week

Adjusted for index mood episode and baseline assessment. (NCT00277212)
Timeframe: Baseline, Weeks 12, 24, 36, 52

,
Interventionkg/m2 (Mean)
Baseline (n=143, 150)Change from Baseline Week 12 (n=105, 107)Change from Baseline Week 24 (n=84, 87)Change from Baseline Week 36 (n=54, 67)Change from Baseline Week 52 (n=49, 56)Change from Baseline Week 52 LOCF (n=143, 150)Highest Change from Baseline (n=143, 150)
Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole30.13-0.030.140.340.190.170.61
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo30.77-0.39-0.60-0.63-0.73-0.62-0.02

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Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score

The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement. (NCT00277212)
Timeframe: Baseline, Weeks 8, 24, 36, 52

,
Interventionunits on a scale (Mean)
Baseline (n=125, 128)Change from Baseline at Week 8 (n=125, 124)Change from Baseline at Week 24 (n=85, 89)Change from Baseline at Week 36 (n=54, 67)Change from Baseline at Week 52 (n=50, 56)Change from Baseline at Week 52 LOCF (n=152, 161)Highest Change from Baseline (n=152, 161)
Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole10.580.050.03-0.14-0.050.020.34
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo10.59-0.20-0.21-0.38-0.35-0.220.03

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HDL Ratio

change in HDL ratio after medication switch (NCT00288366)
Timeframe: 24 weeks from Baseline

,
Interventionunit of Measure ''g/dL'' (Mean)
Baseline24 weeks
Aripiprazole39.743.5
Ziprasidone38.442.3

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Time in Remission

Time in remission for an individual subject was defined as the length of time (in days) that the remission criteria were maintained during the trial. Remission was defined as the simultaneous attainment of a score of 3 (mild), 2 (minimal), or 1 (absent) for all the following individual items from Positive and Negative Syndrome Scale (PANSS): delusions (P1), concept disorganization (P2), hallucinatory behavior (P3), unusual thought content (G9), mannerisms and posturing (G5), blunted affect (N1), passive/apathetic social withdrawal (N4), and lack of spontaneity and flow of conversation (N6). (NCT00299702)
Timeframe: Day 1 to last PANSS measurement

Interventiondays (Mean)
Risperdal Consta373.5
Abilify356.7

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Time to Relapse

Time to relapse was defined as the number of days from the date of first dose to the date of relapse, as determined by the Relapse Monitoring Board. (NCT00299702)
Timeframe: Day 1 to relapse

Interventiondays (Median)
Risperdal Consta131
Abilify113

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Clinical Global Impressions-Improvement

The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to evaluate how much the patient's illness has improved or worsened compared to their baseline condition at the beginning of the intervention. The ratings are evaluated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. (NCT00308074)
Timeframe: Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.

Interventionunits on a scale (Mean)
Aripiprazole1.8

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Brief Psychiatric Rating Scale for Children (BPRS-C)

"The Brief Psychiatric Rating Scale for Children is a 21-item rating scale to evaluate psychiatric problems based on the clinician' s interview with the child/adolescent and parents. It has 7 scales: behavioral problems, depression, thought disorders, psychomotor excitation, withdrawal-retardation, anxiety, organicity. Ratings are based on a 7 point scale, from Not Present (scores 0) to Extremely Severe (scores 6 points). Total is the sum of the 21 items. The range of possible totals is 0 (no symptoms) to 126 (extremely severe).A decrease in score indicates improvement." (NCT00308074)
Timeframe: Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.

Interventionunits on a scale (Mean)
Baseline scoreEndpoint score
Aripiprazole69.036.1

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Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

10-item assessment of obsessive-compulsive symptoms in patients less than 18 years of age. There are 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale ( from 0=no symptoms/minimum severity, to 4=extreme symptoms/maximum severity). Total is the sum of 10 items. The range of possible totals is 0 (no symptoms) to 40 (severe). A decrease in value indicates improvement. (NCT00308074)
Timeframe: Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.

Interventionunits on a scale (Mean)
Baseline scoreEndpoint score
Aripiprazole15.99.9

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Aberrant Behavior Checklist-Irritability Subscale

"Aberrant Behavior Checklist (ABC) The ABC is a 58 item symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. Items are rated on a 4-point scale (0=no problem to 3=severe problem). A decrease in score indicates improvement.~There are five subscales: a) Irritability and Agitation b) Lethargy and Social Withdrawal c) Stereotypic Behavior d) Hyperactivity and Noncompliance and e) Inappropriate Speech.This study uses the Irritability subscale for its outcome. The Irritability subscale is the sum of 15 items. Each item is rated using the scale: 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The Irritability subscale total score ranges from 0 to 45. A decrease in score over time indicates improvement." (NCT00308074)
Timeframe: Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.

Interventionunits on a scale (Mean)
Baseline irritability scoreEndpoint irritability score
Aripiprazole24.58

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Percentage of Participants That Responded to Treatment

Brief Psychiatric Rating Scale-Anchored (BPRS-A) 4 items on this scale were examined to determine subjects responder status: Items 4. Conceptual Disorganization 8. Grandiosity 12. Hallucinations and 15. Unusual Thought Content. Scores range from-7 (not assessed) to 7 (very severe) Subjects with scores of 3 or less on all 4 items for 2 consecutive visits are deemed responders, subjects with 4 or greater and any of the aforementioned items for 2 consecutive study visits are non responders. Additionally, the subjects response on the Clinical Global Impressions Scale. A Clinical Global Improvement CGI) rating of much or very much improved on 2 consecutive ratings were deemed a responder. Percentages and confidence intervals were used to report response outcome. Response status was assessed throughout the duration of the study; a participant can be deemed a responder any time between weeks 1-week 12. The possible range for this outcome is a score of 4 to 28 (NCT00320671)
Timeframe: this outcome was assessed throughout the study.

Interventionpercentage of response (Number)
Percentage of Participants That Reposonded to Aripiprazole62.8
Percentage of Participants That Reposonded to Risperidone56.8

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Side Effects and Metabolic Measures

The highest severity of each of 24 adverse event (AE) that was assessed.over the 30 month study period. The mean severity on a scale of 1 (none) to 4 very severe symptom was recorded at each biweekly visit. Results for each variable are summarized over time so that each subject has a single mean severity rating for each AE. There is no named scale. Each of the side effects measured is named in ways that are clear to medical readers e.g anorexia. The range is 1 none to 4 very severe. Therefore, a higher scale score is worse. (NCT00330863)
Timeframe: Measured throughout study up to 30 months

,
Interventionunits on a scale (Mean)
Bruising easilyRashUrticaria (hives, itching)Blurred visionsedation/drowsinessRestlessnessInsomniaMalaise (weakness, fatigue)StiffnessTremorDizzinessHeadacheFeverSore ThroatDry MouthHypersalivationEnuresisConstipationDiarrheaAnorexia (loss of appetite)NauseaVomitingMenstrual IrregularityBreast tenderness/galactorrhea
Injectable1.431.531.601.762.342.482.382.222.011.771.821.991.271.642.361.761.631.751.651.891.781.481.621.39
Oral1.481.441.711.912.532.432.362.141.971.751.781.891.241.572.251.841.561.641.681.691.721.511.551.32

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Substantial Clinical Deterioration Measured by Psychotic Symptoms

Brief Psychiatric Rating Scale (BPRS) psychosis cluster. Score range is based on the score range for individual items rather than the factor total because is factors have different numbers of items. Score range is 1 -7 where 1 + no symptomatology and 7 = very severe symptoms. (NCT00330863)
Timeframe: Measured throughout study up to 30 months

Interventionunits on a scale (Least Squares Mean)
Injectable1.8
Oral2.0

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Number of Patients Discontinuing From the Study

(NCT00330863)
Timeframe: Measured throughout study up to 30 months

Interventionparticipants (Number)
Injectable81
Oral80

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Mean Clinical Global Impressions Improvement Scale (CGI-I) Score

The CGI scale is a clinician-rated global assessment of a patient's improvement over time. Baseline assessment rated a patient's condition on a 7-point scale (1=no symptoms, 7=very severe symptoms). Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse). (NCT00332241)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Placebo3.6
Aripiprazole2.2

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Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)

CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients <18 years. 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity). A decrease in value indicates improvement. (NCT00332241)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Placebo-0.8
Aripiprazole-3.8

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Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score

The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement. (NCT00332241)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Placebo-5.0
Aripiprazole-12.9

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Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)

A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms). The patient's improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse). A decrease in value indicates improvement. (NCT00332241)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Placebo-0.4
Aripiprazole-1.2

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Change From Baseline in Body Weight

Adjusted mean change (Week 8 - baseline) in body weight (NCT00332241)
Timeframe: Week 8

Interventionkilograms (Mean)
Placebo0.8
Aripiprazole2.0

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Summary of Safety

Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation (NCT00332241)
Timeframe: continuous throughout the study

,
Interventionparticipants (Number)
DeathsTreatment-emergent SAEsAEs leading to discontinuationTreatment-emergent AEs overallTreatment-emergent AEs realted to study drugTreatment-emergent extrapyramidal symptom AEs
Aripiprazole00543397
Placebo00336254

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Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores

Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech). A decrease in value indicates improvement (NCT00332241)
Timeframe: Week 8

,
Interventionunits of a scale (Mean)
ABC Hyperactivity Subscale ScoreABC Stereotypy Subscale ScoreABC Inappropriate Speech Subscale ScoreABC Social Withdrawal Subscale Score
Aripiprazole-12.7-4.8-2.5-7.9
Placebo-2.8-2.0-0.4-6.2

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Number of Participants With Response at Week 8

Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint (NCT00332241)
Timeframe: Week 8

Interventionparticipant (Number)
Placebo7
Aripiprazole24

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Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)

A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms). The patient's improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse). A decrease in value indicates improvement. (NCT00337571)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Placebo-0.6
Aripiprazole 5 mg-0.9
Aripiprazole 10 mg-1.0
Aripiprazole 15 mg-1.1

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Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score

The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement. (NCT00337571)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Placebo-8.4
Aripiprazole 5 mg-12.4
Aripiprazole 10 mg-13.2
Aripiprazole 15 mg-14.4

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Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)

CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients <18 years. 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity). A decreased in value indicates improvement. (NCT00337571)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Placebo-1.7
Aripiprazole 5 mg-2.6
Aripiprazole 10 mg-2.4
Aripiprazole 15 mg-3.2

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Mean Clinical Global Impressions Improvement Scale (CGI-I) Score

The CGI scale is a clinician-rated global assessment of a patient's improvement over time. Baseline assessment rated a patient's condition on a 7-point scale (1=no symptoms, 7=very severe symptoms). Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse). (NCT00337571)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Placebo3.3
Aripiprazole 5 mg2.6
Aripiprazole 10 mg2.5
Aripiprazole 15 mg2.5

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Number of Participants With Response at Week 8

Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint. (NCT00337571)
Timeframe: Week 8

InterventionParticipants (Number)
Placebo17
Aripiprazole 5 mg29
Aripiprazole 10 mg29
Aripiprazole 15 mg28

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Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores

Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech). A decrease in value indicates improvement. (NCT00337571)
Timeframe: Week 8

,,,
Interventionunits on a scale (Mean)
ABC Hyperactivity Subscale ScoreABC Stereotypy Subscale ScoreABC Inappropriate Speech Subscale ScoreABC Social Withdrawal Subscale Score
Aripiprazole 10 mg-13.3-4.2-1.8-4.9
Aripiprazole 15 mg-16.3-4.5-2.3-7.9
Aripiprazole 5 mg-14.0-4.5-2.0-5.8
Placebo-7.7-1.8-1.1-5.2

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Summary of Safety

Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation (NCT00337571)
Timeframe: continuously throughout the study

,,,
Interventionparticipants (Number)
DeathsTreatment-emergent SAEsAEs leading to discontinuation of study medicationTreatment-emergent AEs overallTreatment-emergent AEs related to study medicationTreatment-emergent extrapyramidal symptom AEs
Aripiprazole 10 mg018535013
Aripiprazole 15 mg004463912
Aripiprazole 5 mg015463712
Placebo00437226

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Change From Baseline in Body Weight

Adjusted mean change (Week 8 - baseline) in body weight (NCT00337571)
Timeframe: Week 8

Interventionkilograms (Mean)
Placebo0.3
Aripiprazole 5 mg1.3
Aripiprazole 10 mg1.3
Aripiprazole 15 mg1.5

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Change in Triglycerides

(NCT00345033)
Timeframe: Measured at Baseline and Week 8

Interventionmg/dL (Mean)
Aripiprazole-5.9
Placebo-7.3

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Change in Body Mass Index (BMI)

A comparison between aripiprazole group and placebo group of change in Body Mass Index (BMI) measured at Baseline and Week 8. (NCT00345033)
Timeframe: Measured at Baseline and Week 8

Interventionkg/m^2 (Mean)
Aripiprazole-0.52
Placebo0.03

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Change in Weight

A comparison between aripiprazole group and placebo group in change in weight measured at Baseline and Week 8. (NCT00345033)
Timeframe: Measured at Baseline and Week 8

Interventionkg (Mean)
Aripiprazole-1.5
Placebo0.3

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Change in Total Cholesterol

A comparison of aripiprazole group and placebo group in change in total cholesterol measured at Baseline and Week 8. (NCT00345033)
Timeframe: Measured at Baseline and Week 8

Interventionmg/dL (Mean)
Aripiprazole-15.3
Placebo5.6

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Change in Insulin Resistance

A comparison between aripiprazole group and placebo group of change in insulin resistance measured at Baseline and Week 8. (NCT00345033)
Timeframe: Measured at Baseline and Week 8

InterventionHOMA score (Mean)
Aripiprazole0.6
Placebo0.65

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Change in Glucose Metabolism

A comparison between the aripiprazole group and placebo group in change in glucose metabolism measured at Baseline and Week 8. (NCT00345033)
Timeframe: Measured at Baseline and Week 8

Interventionmin^-1 (Mean)
Aripiprazole0.003
Placebo-0.005

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Change From Baseline in Triglycerides

Evaluating change in triglyceride levels between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks. (NCT00351936)
Timeframe: baseline, week 4

Interventionmg/dL (Mean)
Aripiprazole-51.7
Placebo47.6

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Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)

Evaluating change in high-density lipoprotein cholesterol (HDL-C) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks. (NCT00351936)
Timeframe: baseline, week 4

Interventionmg/dL (Mean)
Aripiprazole0.4
Placebo0.6

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Change From Baseline in Fasting Total Cholesterol

Evaluating change in fasting total cholesterol between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks. (NCT00351936)
Timeframe: baseline, week 4

Interventionmg/dL (Mean)
Aripiprazole-3
Placebo9

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Change From Baseline in Body Mass Index (BMI)

Evaluating change in Body Mass Index (BMI) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks. (NCT00351936)
Timeframe: baseline, week 4

Interventionkg/m^2 (Mean)
Aripiprazole-0.4
Placebo0.3

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Change From Baseline in Low-density Lipoprotein (LDL)

Evaluating change in low-density lipoprotein (LDL) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks. (NCT00351936)
Timeframe: baseline, week 4

Interventionmg/dL (Mean)
Aripiprazole-0.2
Placebo3.1

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Change From Baseline in Waist-hip Ratio (WHR)

Evaluating change in waist-hip ratio (WHR) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks. (NCT00351936)
Timeframe: baseline, week 4

Interventioncm (Mean)
Aripiprazole0.0
Placebo0.0

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Change From Baseline in Weight (Lbs)

Evaluating change in weight (lbs) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks. (NCT00351936)
Timeframe: baseline, week 4

Interventionlbs (Mean)
Aripiprazole-2.9
Placebo2.1

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Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities

Abnormal metabolic criterion values include the following: fasting serum glucose ≥115 mg/dL; non-fasting serum glucose ≥ 200 mg/dL; total cholesterol ≥240 mg/dL; LDL cholesterol ≥160 mg/dL; HDL cholesterol ≤30 mg/dL; triglycerides ≥120 mg/dL (females), ≥160 mg/dL (males) (NCT00365859)
Timeframe: At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52

,,,
InterventionParticipants (Number)
Glucose, Fasting SerumGlucose, SerumCholesterol, HDL FastingCholesterol, HDL Non-FastingCholesterol, HDL RandomCholesterol, LDL FastingCholesterol, LDL Non-FastingCholesterol, LDL RandomCholesterol, Total FastingCholesterol, Total Non-FastingCholesterol, Total RandomTriglycerides, FastingTriglycerides, Non-FastingTriglycerides, Random
De Novo10447000101101522
Rollover Aripiprazole5071016202112203347
Rollover Placebo1033600000081220
Total70141729202213386089

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Number of Potentially Clinically Relevant Vital Sign Abnormalities

Clinically significantly abnormal vital signs met age-appropriate (heart rate cohorts: ages 5-14 & ages 15+; blood pressure cohorts: ages 6-12 & ages 13-17) criterion AND represented change from pretreatment value of at least the following magnitudes: systolic blood pressure (≥130 mmHg & ≥144 mmHg w/ increase of ≥20 mmHg) or (≤117 mmHg & ≤120 mmHg w/ decrease of ≥20 mmHg); diastolic blood pressure (≥86 mmHg & ≥92 mmHg w/ increase of ≥15 mmHg) or (≤75 mm Hg & ≤80 mmHg w/ decrease of ≥15 mmHg); heart rate (140 bpm and 120 bpm w/ increase of ≥15 bpm) or (50 bpm and 50 bpm w/ decrease of ≥15 bpm). (NCT00365859)
Timeframe: At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)

,,,
InterventionParticipants (Number)
Supine Systolic Blood Pressure IncreaseSupine Systolic Blood Pressure DecreaseStanding Systolic Blood Pressure IncreaseStanding Systolic Blood Pressure DecreaseSitting Systolic Blood Pressure IncreaseSitting Systolic Blood Pressure DecreaseSupine Diastolic Blood Pressure IncreaseSupine Diastolic Blood Pressure DecreaseStanding Diastolic Blood Pressure IncreaseStanding Diastolic Blood Pressure DecreaseSitting Diastolic Blood Pressure IncreaseSitting Diastolic Blood Pressure DecreaseSupine Heart Rate IncreaseSupine Heart Rate DecreaseStanding Heart Rate IncreaseStanding Heart Rate DecreaseSitting Heart Rate IncreaseSitting Heart Rate Decrease
De Novo514616311615322214105010
Rollover Aripiprazole182713256131138173619204110
Rollover Placebo2157221851982028103000
Total255626631032227228785314012120

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CGI-Improvement Score at Week 52 (Endpoint, LOCF)

CGI scale is a global evaluation of improvement over time. CGI-Improvement (CGI-I) is a clinician rated assessment that evaluates improvement relative to symptoms at baseline on a a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). CGI-I Score is from 1 to 7. A lower score signifies larger improvement. (NCT00365859)
Timeframe: Week 52 (Endpoint, LOCF)

Interventionunits on a scale (Mean)
De Novo2.7
Rollover Placebo2.4
Rollover Aripiprazole2.5
Total2.5

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Change From Baseline in ABC Stereotypy Subscale Score at Week 52 (Endpoint, LOCF)

The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Stereotypy Subscale Score is from 0 to 21. A negative change score signifies improvement. (NCT00365859)
Timeframe: Week 0 (Baseline), Week 52 (Endpoint, LOCF)

,,,
Interventionunits on a scale (Mean)
BaselineChange at Endpoint (LOCF)
De Novo8.1-2.5
Rollover Aripiprazole6.40.1
Rollover Placebo8.1-1.9
Total7.2-1.0

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Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Score at Week 52 (Endpoint, LOCF)

CY-BOCS is a 10-item, clinician-rated scale designed to measure the severity of obsessive-compulsive symptoms in patients below the age of 18. The scale contains 5 items pertaining to obsessions (which were not used in this trial) and 5 items pertaining to compulsions, which rated each symptom domain in terms of time spent, interference with functioning, distress, resistance, and control. Each item was rated on a 5-point scale, from 0 (no symptoms or minimum severity) to 4 (extreme symptoms or maximum severity). CY-BOCS Score is from 0 to 20. A negative change score signifies improvement. (NCT00365859)
Timeframe: Week 0 (Baseline), Week 52 (Endpoint, LOCF)

,,,
Interventionunits on a scale (Mean)
BaselineChange at Endpoint (LOCF)
De Novo12.6-2.0
Rollover Aripiprazole10.40.2
Rollover Placebo12.1-2.4
Total11.4-0.9

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Mean Change From Baseline By Time Period in BMI Z-Score

The Z-Score indicates how many standard deviations a person is from the population norm values. The BMI z-scores are designed to take into account the BMI that would be expected due to normal growth in children and adolescents. The BMI z-scores are by age and gender standardized values (corresponding to a normal distribution with mean 0 and a standard deviation of 1) of the actual BMI measurements, based on the Growth Charts provided by the Centers for Disease Control (CDC; see Links section of this record). (NCT00365859)
Timeframe: At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)

,,,
InterventionStandard Deviations away from Population (Mean)
Baseline (n=84, 70, 169, 323)<=3 Months (n=84, 70, 169, 323)3-6 Months (n=73, 56, 145, 274)6-9 Months (n=62, 49, 129, 240)>9 Months (n=59, 44, 115, 218)
De Novo0.440.170.290.360.33
Rollover Aripiprazole1.010.090.180.180.14
Rollover Placebo0.980.120.280.240.15
Total0.860.120.230.240.19

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Mean Change From Baseline in Patient Body Mass Index (BMI)

The body mass index (BMI) is a statistical measurement which compares a person's weight and height. Though it does not actually measure the percentage of body fat, it is used to estimate a healthy body weight based on subject height. (NCT00365859)
Timeframe: At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)

,,,
Interventionkg/m2 (Mean)
Baseline (n=84, 69, 169, 322)Change at Endpoint (LOCF) (n=84, 69, 169, 322)
De Novo20.11.7
Rollover Aripiprazole21.61.8
Rollover Placebo21.01.4
Total21.11.7

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Mean Change From Baseline by Time Period in Body Weight Z-Score

The Z-Score indicates how many standard deviations a person is from the population norm values. The body weight z-scores are designed to take into account the amount of weight gain that would be expected due to normal growth in children and adolescents. The body weight z-scores are by age and gender standardized values (corresponding to a normal distribution with mean 0 and a standard deviation of 1) of the actual weight measurements, based on the Growth Charts provided by the Centers for Disease Control (CDC; see Links section of this record). (NCT00365859)
Timeframe: At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)

,,,
InterventionStandard Deviations away from Population (Mean)
Baseline (n=84, 70, 169, 323)<= 3 Months (n=84, 70, 169, 323)3-6 Months (n=73, 56, 145, 274)6-9 Months (n=63, 49, 131, 243)>9 Months (n=59, 44, 115, 218)
De Novo0.470.130.240.310.33
Rollover Aripiprazole0.980.090.200.230.24
Rollover Placebo0.950.100.260.280.23
Total0.840.100.220.260.26

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Mean Change From Baseline in ABC Hyperactivity Subscale Score at Week 52 (Endpoint, LOCF)

The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Hyperactivity Subscale Score is from 0 to 48. A negative change score signifies improvement. (NCT00365859)
Timeframe: Week 0 (Baseline), Week 52 (Endpoint, LOCF)

,,,
Interventionunits on a scale (Mean)
BaselineChange at Endpoint (LOCF)
De Novo28.4-10.0
Rollover Aripiprazole18.40.3
Rollover Placebo25.8-8.3
Total22.5-4.2

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Mean Change From Baseline in ABC Inappropriate Speech Subscale Score at Week 52 (Endpoint, LOCF)

The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Inappropriate Speech Subscale score is from 1 to 12. A negative change score signifies improvement. (NCT00365859)
Timeframe: Week 0 (Baseline), Week 52 (Endpoint, LOCF)

,,,
Interventionunits on a scale (Mean)
BaselineChange at Endpoint (LOCF)
De Novo5.8-1.9
Rollover Aripiprazole4.2-0.3
Rollover Placebo5.7-1.8
Total4.9-1.0

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Mean Change From Baseline in ABC Social Withdrawal Scale At Week 52 (Endpoint, LOCF)

The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Social Withdrawal Subscale Score is from 0 to 48. A negative change score signifies improvement. (NCT00365859)
Timeframe: Week 0 (Baseline), Week 52 (Endpoint, LOCF)

,,,
Interventionunits on a scale (Mean)
BaselineChange at Endpoint (LOCF)
De Novo14.6-5.4
Rollover Aripiprazole10.4-1.8
Rollover Placebo11.3-3.0
Total11.7-3.0

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Mean Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Score at Week 52 (Endpoint, LOCF)

The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Irritability Subscale Score is from 0 to 45. A negative change signifies improvement (NCT00365859)
Timeframe: Week 0 (Baseline), Week 52 (Endpoint, LOCF)

,,,
Interventionunits on a scale (Mean)
BaselineChange at Endpoint (LOCF)
De Novo23.2-6.5
Rollover Aripiprazole15.00.7
Rollover Placebo21.5-6.1
Total18.5-2.6

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Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) At Week 8, Week 26, and Week 52

The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction. (NCT00365859)
Timeframe: Baseline, Week 8, Week 26, Week 52

,,,
Interventionunits on a scale (Mean)
Baseline (n=79, 67, 155, 301)Change at Week 8 (n=78, 64, 149, 291)Change at Week 26 (n=61, 49, 130, 240)Change at Week 52 (n=48, 36, 93, 177)Change at Endpoint (LOCF) (n=79, 67, 155, 301)
De Novo0.5-0.3-0.4-0.4-0.3
Rollover Aripiprazole0.3-0.1-0.2-0.1-0.1
Rollover Placebo0.5-0.1-0.0-0.00.0
Total0.4-0.2-0.2-0.2-0.1

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Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Week 8, Week 26, Week 52, and Endpoint

The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia. (NCT00365859)
Timeframe: Baseline, Week 8, Week 26, Week 52

,,,
Interventionunits on a scale (Mean)
Baseline (n=79, 64, 154, 297)Change at Week 8 (n=78, 60, 149, 287)Change at Week 26 (n=61, 47, 129, 237)Change at Week 52 (n=48, 35, 93, 176)Change at Endpoint (LOCF) (n=79, 64, 154, 297)
De Novo0.1-0.1-0.1-0.10.0
Rollover Aripiprazole0.10.00.00.10.1
Rollover Placebo0.2-0.1-0.10.00.0
Total0.10.00.00.00.0

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Mean Change From Baseline in Clinical Global Impression (CGI)-Severity Score at Week 52 (Endpoint, LOCF)

CGI scale is a global evaluation of improvement over time. CGI-Severity (CGI-S) is a clinician-rated assessment that evaluates the severity of a patient's condition on a 7-point scale ranging from 1 (no symptoms) to 7 (very severe symptoms). CGI-Severity score is from 1 to 7. A negative change score signifies improvement. (NCT00365859)
Timeframe: Week 0 (Baseline), Week 52 (Endpoint, LOCF)

,,,
Interventionunits on a scale (Mean)
BaselineChange at Endpoint (LOCF)
De Novo4.8-0.8
Rollover Aripiprazole3.9-0.0
Rollover Placebo4.2-0.4
Total4.2-0.3

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Mean Change From Baseline in Patient Weight

(NCT00365859)
Timeframe: At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)

,,,
Interventionkg (Mean)
Baseline (n=84, 69, 169, 322)Change at Week 1 (n=78, 58, 149, 285)Change at Week 2 (n=81, 67, 165, 313)Change at Week 4 (n=80, 67, 165, 312)Change at Week 8 (n=77, 65, 149, 291)Change at Week 14 (n=71, 55, 142, 268)Change at Week 20 (n=66, 50, 136, 252)Change at Week 26 (n=61, 49, 130, 240)Change at Week 34 (n=60, 46, 123, 229)Change at Week 42 (n=58, 43, 115, 216)Change at Week 52 (n=48, 36, 94, 178)Change at Endpoint (LOCF) (n=84, 69, 169, 322)
De Novo42.50.20.20.81.63.34.05.06.07.08.76.3
Rollover Aripiprazole45.40.40.81.21.93.14.24.96.17.17.96.6
Rollover Placebo45.1-0.10.00.51.52.83.34.75.86.47.75.5
Total44.60.30.51.01.83.14.04.96.06.98.16.3

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Mean Change From Baseline in Total Simpson-Angus Scale (SAS) At Week 8, Week 26, and Week 52

The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement. (NCT00365859)
Timeframe: Baseline, Week 8, Week 26, Week 52

,,,
Interventionunits on a scale (Mean)
Baseline (n=79, 63, 153, 295)Change at Week 8 (n=77, 60, 145, 282)Change at Week 26 (n=61, 47, 126, 234)Change at Week 52 (n=48, 36, 91, 175)Change at Endpoint (LOCF) (n=79, 63, 153, 295)
De Novo10.7-0.3-0.2-0.6-0.2
Rollover Aripiprazole11.0-0.4-0.6-0.5-0.3
Rollover Placebo10.60.10.20.30.3
Total10.8-0.2-0.3-0.3-0.1

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Number of Participants With Potentially Clinically Relevant Eletrocardiograph (ECG) Abnormalities

"These abbreviations are used in the table of ECG measurements: supraventricular (SV), baseline (BL), 1 degree (1°), atrioventricular (A-V), intraventricular (IVT), symmetrical (SYM), corrected QT interval (QTc). QRS complex is a recording of a single heartbeat on ECG corresponding to the depolarization of the right and left ventricles. PR interval is measured from beginning of P wave to beginning of QRS complex. QT interval is a measure of time between start of Q wave and end of T wave in the heart's electrical cycle. ↑ = increase from baseline, ↓ = decrease from baseline, → = to" (NCT00365859)
Timeframe: At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52

,,,
InterventionParticipants (Number)
Sinus Tachycardia (≥140 bpm & ↑ ≥15 bpm)Sinus Bradycardia (≤50 bpm and ↓ ≥15 bpm)SV Premature Beat (≥2per10sec & ↑ over BL)Ventricular Premature Beat(≥1per10sec & ↑ over BL)SV Tachycardia (not present → present)Ventricular Tachycardia (not present → present)Atrial Fibrillation (not present → present)Atrial Flutter (not present → present)1° A-V Block (PR ≥ 0.20 sec and ↑ ≥ 0.05 sec)2° A-V block (not present → present)3° A-V block (not present → present)Left Bundle Branch Block (not present → present)Right Bundle Branch Block (not present → present)Pre-Excitation Syndrome (not present → present)Other ITV Block (QRS ≥ 0.10 sec & ↑ 0.02 sec)Old Infarction (not present-present at ≥12 weeks)Acute/Subacute Infarction (not present → present)Myocardial Ischemia (not present → present)SYM T-Wave Inversion (not present → present)QTcB interval (>475 msec & elevation 10% over BL)QTcF interval (>475 msec & elevation 10% over BL)Other Abnormality
De Novo2000000000000000000113
Rollover Aripiprazole2000000010000030000206
Rollover Placebo0000000000000000000003
Total40000000100000300003112

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Number of Participants With Potentially Clinically Relevant Laboratory Chemistry Abnormalities

Abnormal chemistry criterion values include the following: aspartate aminotransferase ≥3x upper limit of normal (ULN); alanine aminotransferase ≥3x ULN; alkaline phosphatase ≥3x ULN; lactate dehydrogenase ≥3x ULN; creatinine ≥2.0 mg/dL; uric acid, ≥10.5 mg/dL (male), ≥8.5 mg/dL (female); bilirubin (Total) ≥2.0 mg/dL; serum prolactin >ULN; creatine kinase ≥3x ULN; blood urea nitrogen ≥30 mg/dL; sodium ≤126 mEq/L or ≥156 mEq/L; potassium ≤2.5 mEq/L or ≥ 6.5 mEq/L; chloride ≤90 mEq/L or ≥118 mEq/L; calcium ≤8.2 mg/dL or ≥12 mg/dL (NCT00365859)
Timeframe: At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52

,,,
InterventionParticipants (Number)
Alanine AminotransferaseAspartate AminotransferaseAlkaline PhosphataseProlactinLactate DehydrogenaseCreatinineUric AcidBilirubin, TotalCreatine KinaseBlood Urea NitrogenSodium, SerumPotassium, SerumChloride, SerumCalcium, Total
De Novo30020000200000
Rollover Aripiprazole52000000710000
Rollover Placebo20000000410000
Total1020200001320000

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Number of Participants With Potentially Clinically Relevant Laboratory Hematology Abnormalities

Abnormal hematology criterion values include the following: hematocrit (ages 6-17, males & females) ≤33%; hemoglobin (ages 6-17, males & females) <11.3 g/dL; leukocytes ≤2800 c/mm3 or ≥16000 c/mm3; eosinophils (ages 6-17, males & females) >17%; neutrophils <15%; platelet count ≤75,000 c/mm3 or ≥700,000 c/mm3 (NCT00365859)
Timeframe: At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52

,,,
InterventionParticipants (Number)
HematocritHemoglobinLeukocytesPlatelet CountEosinophils, relativeNeutrophils, relative
De Novo002001
Rollover Aripiprazole233030
Rollover Placebo020110
Total255141

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Plasma Cocaine

Mean plasma cocaine levels after a single administration of each cocaine dose as a function of aripiprazole and cocaine dose. (NCT00373880)
Timeframe: 8 minutes

Interventionng/mL (Mean)
Placebo + 0mg Cocaine32
Placebo + 12mg Cocaine60
Placebo + 25mg Cocaine67
Placebo + 50mg Cocaine119
Aripiprazole + 0 mg Cocaine18
Aripiprazole + 12mg Cocaine36
Aripiprazole + 25mg Cocaine75
Aripiprazole + 50mg Cocaine130

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Subjective Effects of Cocaine

"Mean Visual Analog Scale (VAS) ratings (items: Quality, Pay for Dose, Good Drug Effect, and Cocaine Craving) from 0-100mm as a function of cocaine dose and aripiprazole dose 4 min following a single administration of cocaine (the sample dose) at the start of the session.~For Quality item, the perceived quality of the drug is rated. The higher the rating, the better quality the drug was perceived to be.~For Pay for Dose item, the likelihood that the participant would pay for the drug is indicated. Higher ratings indicate a better likelihood that the person would pay for the dose received.~For Good Drug Effect, the likelihood of feeling a good drug effect is indicated. The higher the number, the more of a good drug effect the person reported.~For Cocaine Craving, the intensity of craving is reported. Higher scores indicate more craving for cocaine." (NCT00373880)
Timeframe: 5 days

,,,,,,,
InterventionScores on a scale of 0-100mm (Mean)
QualityPay for DoseGood Drug EffectCocaine Craving
Aripiprazole + 0 mg Cocaine00226
Aripiprazole + 12mg Cocaine101.61630
Aripiprazole + 25mg Cocaine252.930.536
Aripiprazole + 50mg Cocaine3763533.5
Placebo + 0mg Cocaine00120
Placebo + 12mg Cocaine8.51.41128
Placebo + 25mg Cocaine3252930
Placebo + 50mg Cocaine38.55.754238.5

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Cocaine Self-administration

"Mean number of cocaine choices as a function of cocaine dose and aripiprazole dose (n=8).~Participants sampled the dose of cocaine available for the session and then had five choices to respond for money ($5.00) or cocaine using a modified progressive-ratio schedule." (NCT00373880)
Timeframe: 5 days

InterventionNumber of Choices (Mean)
Placebo + 0mg Cocaine0
Placebo + 12mg Cocaine1.5
Placebo + 25mg Cocaine3
Placebo + 50mg Cocaine4
Aripiprazole + 0 mg Cocaine0.2
Aripiprazole + 12mg Cocaine2.8
Aripiprazole + 25mg Cocaine3.9
Aripiprazole + 50mg Cocaine3.7

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HbA1c

The number of subjects with an HbA1c value of 6.5% or higher were calculated. In addition, for 5.8% and above, the number of subjects were also calculated, in the same way (NCT00392197)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation

,
Interventionparticipants (Number)
6.5 % or more increase in HbA1c5.8 % or more increase in HbA1c
Antipsychotic-naïve Patients00
Patients Previously Treated With Antipsychotic Drugs00

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Fasting Blood Glucose (FBS) Level (if Fasting Blood Glucose Level Was Not Available, Non-fasting Blood Glucose (Non-FBS) Level)

The number of subjects whose FBS level reached or exceeded 126 mg/dL (200 mg/dL, non-FBS level) at least once during the test product administration period as well as the incidence were determined. Also, for 110 mg/dL and above (140 mg/dL, non-FBS level), the number of subjects were determined in the same way. (NCT00392197)
Timeframe: Prior to the start of administration (Baseline) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation

,
Interventionparticipants (Number)
FBS: 126 mg/dL or aboveFBS: 110 mg/dL or abovenon-FBS: 200 mg/dL or abovenon-FBS: 140 mg/dL or above
Antipsychotic-naïve Patients0100
Patients Previously Treated With Antipsychotic Drugs0401

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Aberrant Behavior Checklist

The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. The ABC has 5 subscales: Social Withdrawal (16 items) ranging from 0 (not at all) to 48 (severe), Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), and Stereotypy (7 items) ranging from 0 (not at all) to 21 (severe). Items are rated from 0 (not at all) to 3 (severe). (NCT00420459)
Timeframe: Obtained at Baseline and Week 12

Interventionunits on a scale (Mean)
ABC IrritablityABC HyperactivityABC Social WithdrawallABC StereotypyABC Inappropriate Speech
Open-label Aripiprazole7.115.69.67.64.0

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The Children's Yale-Brown Obsessive Compulsive Scale

The CY-BOCS PDD has been utilized in a largescale clinical treatment study of repetitive behavior in idiopathic ASDs. CYBOCS-PDD scores range from 0 to 20 and measure repetitive/compulsive behavior and not obsessions. Higher score indicate worse outcome. (NCT00420459)
Timeframe: Obtained at Baseline and Week 12

Interventionunits on a scale (Mean)
Open-label Aripiprazole10.6

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Clinical Global Impressions- Severity

The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. (NCT00420459)
Timeframe: Obtained at Baseline and Week 12

Interventionunits on a scale (Mean)
Open-label Aripiprazole3.5

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Social Responsiveness Scale

The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment (NCT00420459)
Timeframe: Obtained at Baseline and Week 12

Interventionunits on a scale (Mean)
Open-label Aripiprazole90.1

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Efficacy Failure, Defined as Psychiatric Hospitalization, a 25 Percent Increase From Baseline on the Positive and Negative Syndrome Scale or Substantial Clinical Deterioration on the Clinical Global Impressions-Change (CGI-C)

(NCT00423878)
Timeframe: Measured at Month 6

Interventionparticipants (Number)
Switch Group22
Stay Group18

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Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks

Change in non-HDL cholesterol measured at baseline and every 4 weeks for 24 weeks. The efficacy analysis corresponded to a comparison of change in non-HDL cholesterol from baseline to 24 weeks between treatment groups (stay versus switch). Repeated measurements mixed effects linear models were fit for the primary analysis. (NCT00423878)
Timeframe: 24 weeks

Interventionmg/dL non-HDL cholesterol (Least Squares Mean)
Switch Group-20.2
Stay Group-10.8

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Total Plasmalogen Levels in the Lipid Profile

Plasmalogens are a subclass of glycerophospholipids and ubiquitous constituents of cellular membranes and serum lipoproteins. Several neurological disorders show decreased level of plasmalogens. (NCT00466310)
Timeframe: Baseline

Interventionnmoles/gram (Mean)
First Episode Schizophrenics57.65
Recurrent Episode Schizophrenics59.57
Healthy Volunteers75

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Clinical Global Impression Improvement (CGI-AD)

Clinical Global Impression Improvement (CGI)-AD (Guy, 1976). This is a standard rating scale with 7-point global severity and change scales which has been modified for Autistic Disorder. A rating of 2 is given when there is a substantial reduction in symptoms so that a treating clinician would be unlikely to change treatment. A rating of 1 is reserved for patients who become virtually symptom-free. A rating of 3 (minimally improved) on the CGI is defined as slight symptomatic improvement that is not deemed clinically significant. Administration time is approximately 2 minutes. Minimum is 1 and maximum is 5. A lower score indicates improvement, whereas a higher score indicates worsening. (NCT00468130)
Timeframe: Administered weekly, initial and week 8 reported

,
Interventionscore on a scale (Mean)
Initial CGI scoreWeek 8 CGI score
Aripiprazole3.832.67
Placebo4.254.25

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Aberrant Behavior Checklist

Aberrant Behavior Checklist (ABC) (irritability section) (Aman et al, 1985). The Aberrant Behavior Checklist assesses drug and other treatment effects on mentally retarded individuals. It consists of a five-factor scale comprising 58 items. We will use the Irritability section to assess aggressive and agitated behavior. While the internal consistency, validity and test-retest reliability were reported to be very good, inter-rater reliability was moderate (Aman et al, 1985). The ABC will be filled out by an informant, and then reviewed by the psychiatrist. Administration time is approximately 10 minutes. Maximum is 36, minimum is 0, a lower score indicates improvement. (NCT00468130)
Timeframe: Administered biweekly, initial and week 8 reported

,
Interventionscore on a scale (Mean)
Initial, IrritabilityWeek 8, Irritability
Aripiprazole15.676.83
Placebo8.008.67

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Beck Depression Inventory, Second Edition (BDI-II)

The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression. Scores range from 0 to 63 (higher scores suggest higher levels of depression). Change scores were calculated from Week 2 and Week 6 scores (Week 2 minus Week 6). (NCT00489866)
Timeframe: Week 2 and Week 6

InterventionUnits on a Scale (Mean)
Depression Symptoms Aripiprazole Treated Group8.0
Depression Symptoms Placebo Treated Group2.28

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Clinician Administered PTSD Scale (CAPS)

"Mean change scores (Week 2 minus Week 6) in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).~A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms." (NCT00489866)
Timeframe: Week 2 and Week 6

InterventionUnits on a scale (Mean)
PTSD Symptoms Aripiprazole Treated Group18.6
PTSD Symptoms Placebo Treated Group9.58

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Connor-Davidson Resilience Scale (CD-RISC)

This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience. Change scores calculated at Week 2 and Week 6 (Week 2 minus Week 6). (NCT00489866)
Timeframe: Week 2 and Week 6

InterventionUnits on a scale (Mean)
Resilience Symptoms Aripiprazole Treated Group-3.00
Resilience Symptoms PlaceboTreated Group-2.03

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Brief Assessment of Cognition in Affective Disorders (BAC-A)

The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 6 (Week 2 minus Week 6). (NCT00489866)
Timeframe: Week 2 and Week 6

InterventionUnits on a Scale (Mean)
Cognitive Symptoms Aripiprazole Treated Group-0.41
Cognitive Symptoms PlaceboTreated Group-0.14

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Positive and Negative Symptoms Scale (PANSS)

The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.Mean change scores from Week 2 and Week 6 (Week 2 minus Week 6) (NCT00489866)
Timeframe: Week 2 and Week 6

InterventionUnits on a Scale (Mean)
Psychotic Symptoms Aripiprazole Treated Group2.57
Psychotic Symptoms Placebo Treated Group-5.1

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To Measure the Safety and Tolerability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, as Determined by the Number of Adverse Clinical Events in the Aripiprazole and Placebo Arms.

(NCT00497055)
Timeframe: Total reported adverse events (throughout study, up to 12 weeks)

Interventiontotal reported adverse events (Number)
Aripiprazole156
Placebo144

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To Measure the Acceptability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, by Determining (Via Electronic Pill Caps [MEMS or Medication Event Monitoring System]) Medication Adherence to Aripiprazole and Placebo.

To measure the acceptability of aripiprazole and placebo among methamphetamine-dependent individuals, by determining (via electronic pill caps [MEMS or Medication Event Monitoring System]) medication adherence to aripiprazole and placebo. (Percent adherence from MEMS is determined by 100* the number of days where MEMS registered an opening out of the number of days a dose was prescribed for each arm.) (NCT00497055)
Timeframe: Adherence as determined by MEMS (throughout study, up to 12 weeks)

Interventionpercent adherence from MEMS (Mean)
Aripiprazole46
Placebo39

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To Test the Hypothesis That Aripiprazole 20 mg Daily Will Reduce Methamphetamine Use Significantly More Than Placebo Among Methamphetamine-dependent Individuals.

To test the hypothesis that aripiprazole 20 mg daily will reduce methamphetamine use significantly more than placebo among methamphetamine-dependent individuals, as determined by the proportion of methamphetamine-positive urines in the aripiprazole versus placebo group. (NCT00497055)
Timeframe: Final study visit at week 12

Interventionperc of positive urines at final visit (Number)
Aripiprazole44
Placebo40

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Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16

Non-HDL cholesterol was calculated as fasting Total Cholesterol minus fasting HDL Cholesterol. (NCT00508157)
Timeframe: Baseline, Week 16

Interventionpercent change (Mean)
Control Group10.06
Aripiprazole-2.3

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Number of Participants Remaining on Metabolic Syndrome at Week 16

Metabolic syndrome is defined as the presence of at least 3 out of the following Adult Treatment Panel III-A (ATP III-A) criteria (all of which are to be assessed at the same visit): waist >102 cm in males, >88 cm in females; blood pressure (BP) systolic BP ≥130 or diastolic BP ≥85 mm Hg; fasting HDL <40 mg/dL in males, <50 mg/dL in females; fasting triglycerides ≥150 mg/dL; fasting glucose ≥100 mg/dL, and/or the start of a treatment for any of the parameters of metabolic syndrome during the course of the study. (NCT00508157)
Timeframe: Week 16

Interventionparticipants (Number)
Control Group22
Aripiprazole16

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MATRICS Verbal Learning and Memory

The measure of verbal learning and memory is the Hopkins Verbal Learning Test. The score for each subject is the sum of the total number of words recalled correctly for Trials 1, 2, and 3. The measure is the mean of these scores at baseline, Week 8, and Week 16. (NCT00509067)
Timeframe: Measured at Baseline and Weeks 8 and 16

,
Interventionraw scores (Mean)
BaselineWeek 8Week 16
Galantamine and CDP-choline Group20.521.823.0
Placebo Group20.621.220.4

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Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS)

The score for each subject was the sum of the ratings for five items on the negative-symptom subscale of the PANSS: 1) blunted affect, 2) emotional withdrawal, 3) poor rapport, 4) passive/apathetic social withdrawal, and 5) lack of spontaneity and flow of conversation. Each item (symptom) is rated on a scale from 1 = absence of negative symptom to 7 = extreme negative symptom. The sum of the ratings for the five items range from 5 to 35, with higher scores indicating more severe symptoms. The primary outcome measure is the mean of the sum of these ratings across subjects. (NCT00509067)
Timeframe: Measured at Baseline and Weeks 4, 8, 12, and 16

,
Interventionunits on a scale (Mean)
BaselineWeek 4Week 8Week 12Week 16
Galantamine/CDP Choline17.6317.0613.9314.9313.93
Placebos for Galantamine/CDP Choline18.2917.0817.2617.3216.05

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Clinical Global Impression

The score for each subject was the mean rating on the severity item. The score of the item ranged from 1 (normal) to 7 (among most severely ill). (NCT00509067)
Timeframe: Measured at Baseline and Weeks 4, 8, 12, and 16

,
Interventionunits on a scale (Mean)
BaselineWeek 4Week 8Week 12Week 16
Galantamine and CDP-choline Group4.3243.673.873.8
Placebo Group4.383.924.0443.68

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Psychotic Symptoms

Psychotic symptoms were assessed and scored using the Structured Interview for the Prodromal Syndrome (SIPS) and the Scale of Prodromal Symptoms (SOPS). The SOPS provides a measure of four domains of symptoms, including positive, negative, disorganized and general symptoms. The Positive Symptom sub-scale score reported is the sum of all five symptom items in the Positive Symptom sub-scale. The Positive Symptom sub-scale assesses psychotic symptoms, each item on a scale of 0-6. The sum scale score is 0-30, with 30 indicating severe psychotic symptoms, while 0 indicates no psychotic symptoms. (NCT00531518)
Timeframe: two years

Interventionunits on a scale (Mean)
Control9.2
Family-aided Assertive Community Treatment6.7

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Depression and Psychosis Response Rate

This response rate refers to the percentage of patients who experienced a 50 percent or greater reduction in symptoms. Specifically, this refers to a 50 percent reduction in Hamilton Depression Rating Scale 17 (HAM-D-17) scores from baseline and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed. (NCT00556140)
Timeframe: Baseline and 7 weeks

Interventionpercent of participants (Number)
Major Depression With Psychotic Features62.5

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Depression and Psychosis Remission Rate

This remission rate refers to a Hamilton Depression Rating Scale 17 (HAM-D-17) score of 7 or less and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed. (NCT00556140)
Timeframe: Baseline and 7 weeks

Interventionpercent of participants (Number)
Major Depression With Psychotic Features50

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Change in Bipolar Symptoms as Assessed by Young-Mania Rating Scale (YMRS)

The YMRS is used to evaluate symptoms of mania in children and adolescents. Items are rated from 0-4 or 0-8, with higher scores indicating greater severity. The minimum total score (least severe) is 0, and the maximum total score (most severe) is 60. (NCT00592683)
Timeframe: weekly for 1st 6 weeks then biweekly

InterventionUnits on a scale (Mean)
Aripiprazole + Fish Oil9.5
Aripiprazole + Placebo8.5

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DSM-IV Mania Symptom Checklist

The DSM-IV Mania Symptom Checklist is used to evaluate symptoms of mania. Item scores range from 0-3, with larger scores indicating greater severity. With 33 items, the maximum (most severe) score possible is 99, with the minimum (least severe) score possible being 0. (NCT00592683)
Timeframe: weekly for first 6 weeks then biweekly

Interventionunits on a scale (Mean)
Aripiprazole + Fish Oil5.25
Aripiprazole + Placebo5

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Young Mania Rating Scale (YMRS)

"Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated for each treatment group.~YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) levated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior.~YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome)." (NCT00606177)
Timeframe: Baseline (Day 1 of preceding study) , Day 154 or at discontinuation

Interventionscores on a scale (Mean)
Aripiprazole-22.6
Placebo-15.4

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Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)

"Using LOCF datasets, descriptive statistics of actual values for change of CGI-BP severity of illness score (mania) from baseline (Day 1 of preceding study) to endpoint (Day 154) were calculated for each treatment group.~CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components-mania, depression, and overall bipolar illness.~CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill)." (NCT00606177)
Timeframe: Baseline (Day 1 of preceding study), Day 154 or at discontinuation

Interventionscores on scale (Mean)
Aripiprazole-2.9
Placebo-1.9

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Young Mania Rating Scale (YMRS)

"Mean change from baseline (Day 1) to endpoint in the YMRS total score~YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) elevated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior.~Total score range is 0 to 60, and the higher value represents worsen." (NCT00606229)
Timeframe: Day 1 and Day 168 or time of discontinuation

Interventionscores on a scale (Mean)
Aripiprazole-18.8

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Clinical Global Impression - Bipolar Version (CGI-BP) Sevirity of Illness Score (Mania)

"Mean change from baseline (Day 1) to endpoint in Clinical Global Impression -Bipolar Version (CGI-BP) severity of illness score (mania)~The severity of manic symptoms on a scale of 1 (normal, not ill) to 7 (very severely ill)" (NCT00606229)
Timeframe: Day 1 and Daty 168 or time of discontinuation

Interventionscores on a scale (Mean)
Aripiprazole-2.6

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Clinical Global Impression - Bipolar Version (CGI-BP), Severity of Illness Score (Mania)

"CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components-mania, depression, and overall bipolar illness.~CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill).~Using LOCF datasets, change in CGI-BP severity of illness score (mania) from baseline (Day 1) to endpoint (Day 21) was evaluated through ANCOVA." (NCT00606281)
Timeframe: Day1, Day21

Interventionscores on a scale (Least Squares Mean)
Aripiprazole-1.4
Placebo-0.7

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Young Mania Rating Scale (YMRS)

"Using LOCF datasets, change in YMRS total score from baseline (Day 1) to endpoint (Day 21) was evaluated through analysis of covariance(ANCOVA).~YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) elevated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior.~YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome)." (NCT00606281)
Timeframe: Day1, Day21

Interventionscores on a scale (Least Squares Mean)
Aripiprazole-11.3
Placebo-5.3

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Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)

"CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components-mania, depression, and overall bipolar illness. CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill).~Using LOCF datasets, descriptive statistics of actual values for change of CGI-BP severity of illness score (mania) from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated for each treatment group." (NCT00606320)
Timeframe: Baseline (Day 1 of preceding study) , Day 154 or at discontinuation

Interventionscores on a scale (Mean)
Aripiprazple-2.4

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Young Mania Rating Scale (YMRS)

YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) levated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior. YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome). Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated. (NCT00606320)
Timeframe: baseline (Day 1 of preceding study), Day 154 or at discontinuation

Interventionscores on a scale (Mean)
Aripiprazple-18.3

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Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems

The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 5-move problems is the time (in milliseconds) taken to plan a problem solution for trials requiring 5 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment. (NCT00608543)
Timeframe: baseline and 6 weeks

Interventionmilliseconds (Mean)
Open Label Aripiprazole Augmentation-4676.10

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Spatial Working Memory (SWM) Between Errors for 6-move Problems

The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. Between errors are times the subject revisits a box in which a token was previously found; errors are calculated for 4-, 6-, and 8-box trials. Higher numbers indicate poorer performance. Errors reported are the difference between baseline and 6 weeks post-treatment. (NCT00608543)
Timeframe: baseline and 6 weeks

Interventionnumber of errors (Mean)
Spatial Working Memory Between Errors for 6-move Problems-4.00

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Change in Hamilton Rating Scale for Depression (HRSD - 17-item)

The HRSD 17-item scale is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression. Scores range from 0 to 52, with higher scores indicating higher levels of depression severity. (NCT00608543)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Open Label Aripiprazole Augmentation-11.42

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Spatial Working Memory (SWM) Strategy Score

The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. The Strategy score represents the number of times a participant begins a search with the same box for 6- and 8-box problems. Minimum score is 8 and maximum score is 56. Higher numbers indicate poorer performance. Score reported is the difference between baseline and 6 weeks post-treatment. (NCT00608543)
Timeframe: baseline and 6 weeks

Interventionunits on a scale (Mean)
Open Label Aripiprazole Augmentation-3.15

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Quality of Life Enjoyment and Satisfaction Questionnaire

The Q-LES-Q general activities is designed to measure subjective satisfaction and enjoyment, as opposed to function, in various domains including physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and range from 0 to 100. Higher scores indicate greater enjoyment and satisfaction. (NCT00608543)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Open Label Aripiprazole Augmentation0.81

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Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems

The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 3-move problems is the time (in milliseconds)taken to plan a problem solution for trials requiring 3 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment. (NCT00608543)
Timeframe: baseline and 6 weeks

Interventionmilliseconds (Mean)
Open Label Aripiprazole Augmentation-4485.50

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Clinical Global Impressions Scale - Severity Score (CGI-S)

"One of the most widely used of clinician assessment tools in psychiatry, the CGI is an observer-rated scale that measures illness severity (CGI-S).~The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (among the most severely ill patients)." (NCT00619190)
Timeframe: Baseline to 12 weeks

Interventionunits on a scale (Mean)
Open Aripipraprazole5.35
no Medication Control4.5

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Change From Baseline in the Aberrant Behavior Checklist -Lethargy/Social Withdrawal Subscale at 12 Weeks

The Aberrant Behavior Checklist lethargy/social withdrawal subscale (ABC-SW) is the sum of ratings from 0 - not a problem at all to 3 - problem is severe in degree on 16 items within the Aberrant Behavior checklist (also described in the primary outcome measure section above). Scores can range from 0 to 48, with higher scores indicating more severe problems. The period for the rating is one week and the reference group is typically developing children of the same age and gender as the participant. Both frequency of the behaviors and severity of the problems related to them are considered. High ratings on these items reflect lack of response and interaction with other people in the child's environment. (NCT00619190)
Timeframe: Baseline to 12 weeks

Interventionunits on a scale (Mean)
Open Aripipraprazole-4.5
no Medication Control-0.3

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Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks

The Aberrant Behavior Checklist (ABC) is a caregiver rated questionnaire for assessing problem behaviors of children over the past week relative to typically developing children of the same age. Problem behaviors are rated on a categorical scale between 0 not at all a problem and 3 problem is severe in degree. Raters are instructed to consider both the severity and the frequency of the behavior in determining how severe a problem the behavior is. Thus, if a given behavior occurs more often than in other children of the same age and sex, scores greater than or equal to 1 are warranted. The total score can range from a minimum of 0 (no problem behaviors) to a maximum of 174, higher the number the worse the symptoms.The irritability subscale consists of 15 items with a minimal score of 0 - no irritability problems to 45 - all irritability items rated as severe. A rating of 18 or more on the irritability subscale is considered clinically significant. (NCT00619190)
Timeframe: Baseline to 12 weeks

Interventionunits on a scale (Mean)
Open Aripipraprazole7.6
no Medication Control-0.6

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Percentage of Participants With Relevant Weight Gain or Weight Loss From Baseline at Week 12 (LOCF Data Set)

Relevant weight gain=7% or greater increase in weight; relevant weight loss=7% or greater decrease in weight. LOCF=last observation carried forward. (NCT00665366)
Timeframe: Baseline to Weeks 3, 6, 9, and12

,
InterventionPercentage of participants (Number)
Weight gain: Week 12 (n=184,174)Weight loss: Week 12 (n=184,174)
Aripiprazole + Valproate or Lithium5.24.0
Placebo + Valproate or Lithium4.32.7

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Percentage of Participants Showing Remission in the Young Mania Rating Scale (YMRS) Score From Baseline (LOCF Data Set)

Remission is defined as a YMRS total score of 12 or less. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward. (NCT00665366)
Timeframe: Baseline to Weeks 3,6, 9, and 12

,
InterventionPercentage of participants (Number)
Week 3 (n=183, 174)Week 6 (n=186, 176)Week 9 (n=186, 176)Week 12 (n=186, 176)
Aripiprazole + Valproate or Lithium31.051.765.969.9
Placebo + Valproate or Lithium30.648.957.064.0

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Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Overall) Scale at Week 12 (LOCF Data Set)

Adjusted mean change. The CGI-BP is scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward. (NCT00665366)
Timeframe: Baseline to Week 12

InterventionUnits on a scale (Mean)
Placebo + Valproate or Lithium-1.51
Aripiprazole + Valproate or Lithium-1.59

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Change From Baseline in Total and Subscale Scores on the Functional Assessment Short Test (FAST)(LOCF Data Set)

The FAST is an interview-administered instrument used to assess the main functioning problems that patients with bipolar disorder experience. Participants are rated at Baseline, Week 3, Week 6, Week 9, and Week 12/End of Study Visit. The FAST consists of 24 items that assess impairment or disability in 6 specific areas of functioning, categorized as the subscales: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal (IP) relationships, and leisure time. All items are rated using a 4-point scale, 0=no difficulty, 1=mild difficulty, 2=moderate difficulty, and 3=severe difficulty. The global score is the sum of the scores of all items and ranges from 0 (0*24)to 96 (4*24). The higher the global score, the higher the level of impairment. function=functioning. LOCF=last observation carried forward. (NCT00665366)
Timeframe: Baseline to Weeks 3, 6, 9, and 12

,
InterventionUnits on a scale (Mean)
Total score: Week 3 (n=179, 169)Total score: Week 6 (n=182, 171)Total score: Week 9 (n=182, 171)Total score: Week 12 (n=182, 171)Autonomy score: Week 3 (n=179, 169)Autonomy score: Week 6 (n=182, 171)Autonomy score: Week 9 (n=182, 171)Autonomy score: Week 12 (n=182, 171)Occupational function score: Week 3 (n=179, 169)Occupational function score: Week 6 (n=182, 171)Occupational function score: Week 9 (n=182, 171)Occupational function score: Week 12 (n=182, 171)Cognitive function score: Week 3 (n=179, 169)Cognitive function score: Week 6 (n=182, 171)Cognitive function score: Week 9 (n=182, 171)Cognitive function score: Week 12 (n=182, 171)IP relationships score: Week 3 (n=179,169)IP relationships score: Week 6 (n=182, 171)IP relationships score: Week 9 (n=182, 171)IP relationships score: Week 12 (n=182, 171)Leisure time score: Week 3 (n=179, 169)Leisure time score: Week 6 (n=182, 171)Leisure time score: Week 9 (n=182, 171)Leisure time score: Week 12 (n=182, 171)Financial issues score: Week 3 (n=179, 169)Financial issues score: Week 6 (n=182, 171)Financial issues score: Week 9 (n=182, 171)Financial issues score: Week 12 (n=182, 171)
Aripiprazole + Valproate or Lithium-5.00-6.93-7.71-8.51-0.93-1.11-1.20-1.45-1.00-1.40-1.22-1.24-0.99-1.46-1.68-1.91-1.33-1.91-2.14-2.31-0.28-0.34-0.52-0.59-0.48-0.76-0.99-1.07
Placebo + Valproate or Lithium-5.68-8.59-9.18-10.39-0.93-1.44-1.56-1.84-0.65-1.23-1.20-1.49-1.33-2.12-2.30-2.59-1.57-2.20-2.41-2.57-0.50-0.53-0.52-0.68-0.78-1.16-1.25-1.30

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Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set)

The YMRS is a clinician-administered scale, consisting of 11 multiple choice items, and used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-though disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward. (NCT00665366)
Timeframe: Baseline to Week 12

InterventionUnits on a scale (Mean)
Placebo + Valproate or Lithium-11.54
Aripiprazole + Valproate or Lithium-13.57

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Change From Baseline to Week 12 in Body Mass Index (BMI) (LOCF Data Set)

BMI=Weight in kilograms /(Height in meters^2). LOCF=last observation carried forward. (NCT00665366)
Timeframe: Baseline to Week 12

Interventionkg/m^2 (Median)
Placebo + Valproate or Lithium0.0
Aripiprazole + Valproate or Lithium0.0

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Change From Baseline in Participant Weight (OC Data Set and Week 12 LOCF Data Set)

Adjusted mean change.OC=observed cases; LOCF=last observation carried forward. (NCT00665366)
Timeframe: Baseline to Weeks 3, 6, 9, and 12

,
InterventionKilograms (Mean)
Week 3 (n=177, 171)Week 6 (n=152,144)Week 9 (n=142, 128)Week 12 (n=133, 123)Week 12 (LOCF) (n=183, 174)
Aripiprazole + Valproate or Lithium0.140.29-0.010.020.11
Placebo + Valproate or Lithium-0.06-0.020.070.220.11

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Percentage of Participants Showing A Response From Baseline on the Young Mania Rating Scale (YMRS)(OC Data Set)

Response on the YMRS is defined as a 50% or greater improvement from baseline in YMRS total score. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. OC=observed cases. (NCT00665366)
Timeframe: Baseline to Weeks 3, 6, 9, and 12

,
InterventionPercentage of participants (Number)
Week 3 (n=183, 174)Week 6 (n=186, 176)Week 9 (n=186, 176)Week 12 (n=186, 176)
Aripiprazole + Valproate or Lithium29.349.464.268.8
Placebo + Valproate or Lithium26.246.253.861.3

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Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Depression) Scale (LOCF Data Set)

Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward. (NCT00665366)
Timeframe: Baseline to Weeks 3, 6, 9, and 12

,
InterventionUnits on a scale (Mean)
Week 3 (n=183, 174)Week 6 (n=186, 176)Week 9 (n=186, 176)Week 12 (n=186, 176)
Aripiprazole + Valproate or Lithium-0.09-0.010.110.14
Placebo + Valproate or Lithium-0.01-0.02-0.04-0.03

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Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set)

Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward. (NCT00665366)
Timeframe: Baseline to Weeks 3, 6, 9, and 12

,
InterventionUnits on a scale (Mean)
Week 3 (n=183, 174)Week 6 (n=186, 176)Week 9 (n=186, 176)Week 12 (n=186, 176)
Aripiprazole + Valproate or Lithium-0.93-1.46-1.83-2.07
Placebo + Valproate or Lithium-0.97-1.35-1.55-1.78

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Participant Scores on Patient Global Impression Improvement (PGI-I) Scale (OC Data Set)

Adjusted Mean Scores. The PGI-I is a self-administered 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. OC=observed cases. (NCT00665366)
Timeframe: Baseline to Weeks 3, 6, 9, and 12

,
InterventionUnits on a scale (Mean)
Week 3 (n=178, 168)Week 6 (n=151, 140)Week 12 (n=127, 119)Week 12 (LOCF) (n=181, 173)
Aripiprazole + Valproate or Lithium2.992.642.242.88
Placebo + Valproate or Lithium2.942.392.022.60

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Change From Baseline in Total Score on the Longitudinal Interval Follow-up Evaluation-Rating Impaired Functioning Tool (LIFE-RIFT)(OC Data Set and Week 12 LOCF Data Set)

Adjusted mean change. The LIFE-RIFT total score ranges from 4 to 20 and is the sum of scores of 4 items: work, interpersonal relations, satisfaction, and recreation. A negative change score signifies improvement. OC=observed cases; LOCF=last observation carried forward. (NCT00665366)
Timeframe: Baseline to Weeks 6 and 12

,
InterventionUnits on a scale (Mean)
Week 6 (n=146, 135)Week 12 (n=123, 115)Week 12 (LOCF) (n=165, 150)
Aripiprazole + Valproate or Lithium-1.45-2.37-1.69
Placebo + Valproate or Lithium-2.13-3.20-2.30

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Percent Riboflavin Positive Urine Samples as a Measure of Medication Compliance

Riboflavin was added to each individual capsule of medication and measured as a proxy for compliance with the medication regime (NCT00667875)
Timeframe: 16 weeks treatment trial

InterventionPercent of riboflavin positive samples (Mean)
Placebo: Placebo74.9
Naltrexone: Placebo Aripiprazole85.1
Naltrexone:Aripiprazole62.1

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Percent Heavy Drinking Days

percent of total 112 day trial in which heavy drinking occurred (>=4 for females, >=5 male) (NCT00667875)
Timeframe: 16 weeks

Interventionpercent of days (Mean)
Placebo: Placebo10.54
Naltrexone: Placebo Aripiprazole16.7
Naltrexone:Aripiprazole7.34

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Pill Counts During Treatment

Compliance with medication as determined by pill counts (NCT00667875)
Timeframe: 16-week

,,
InterventionPercent of pills taken (Mean)
Percent aripiprazole or aripiprazole placebo takenPercent naltrexone or naltrexone placebo taken
1 Placebo96.496.8
2 Naltrexone97.096.9
3 Naltrexone Plus Aripiprazole84.286.4

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Drinks Per Drinking Day

Standard drinks per drinking day (NCT00667875)
Timeframe: 16-week treatment period

Interventiondrinks per drinking day (Mean)
Inactive Placebo7.2
Naltrexone and Inactive Placebo Aripiprazole7.8
Naltrexone + Aripiprazole5.2

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Number of Patients With Treatment Emergent AEs in Two Treatment Groups - People Exclusively on Drug or Placebo Throughout the Study

Differences in the incidence of treatment emergent AEs between the treatment groups were examined and evaluated using descriptive statistics. This analysis compared AEs between the arms that received exclusively drug throughout the study or placebo throughout the study. (NCT00683852)
Timeframe: 12 Weeks

InterventionPatients (Number)
ADAPT Drug/Drug Group39
ADAPT Placebo/Placebo Group60

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Number of Patients With Treatment Emergent AEs in Two Treatment Groups - Placebo Non-Responders

Differences in the incidence of treatment emergent AEs between the treatment groups were examined and evaluated using descriptive statistics. This analysis focused on placebo non-responders in phase 1 and presented them by their treatment assignment in phase 2. (NCT00683852)
Timeframe: 12 Weeks

InterventionPatients (Number)
Phase 1 Placebo Non-Responders on Drug in Phase 240
Phase 1 Placebo Non-Responders on Placebo in Phase 244

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Treatment Emergent AEs in Two Treatment Groups - Safety Sample

Differences in the incidence of treatment emergent AEs between the treatment groups were examined and evaluated using descriptive statistics. In this analysis, AEs were summarized according to person-phase of occurrence. Each AE was attributed to the person and then to phase 1 or phase 2, depending on the initial date of onset. (NCT00683852)
Timeframe: 12 Weeks

Interventionadverse events (Number)
ADAPT Drug Group58
ADAPT Placebo Group110

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Mean Change in Symptom Questionnaire (SQ)

The SQ, a 92-item (yes/no) self-rating questionnaire, includes 4 distress and 4 well-being subscales. There are 68 items for the distress subscales and 24 items for the well-being subscales. Each item has either a Yes/No or True/False answer. For the distress symptom score, add together the following items and score 1 when the answer is Yes/True: 1, 2, 3, 5, 6, 8, 11, 12, 15, 18, 20, 22, 24, 25, 26, 27, 28, 29, 30, 32, 33, 34, 36, 37, 39, 41, 42, 44, 45, 47, 48, 49, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 72, 73, 74, 75, 76, 77, 79, 80, 81, 82, 84, 85, 86, 87, 88, 90, 91, 92. Minimum score is 0 and maximum score is 68. A higher score indicates more distress symptoms. For the well-being subscale score, add together the following items and score 1 when the answer is No/False: 4, 7, 9, 10, 13, 14, 16, 17, 19, 21, 23, 29, 31, 35, 38, 40, 43, 46, 50, 51, 71, 78, 83, 89. Minimum score is 0 and maximum score is 24. A higher score indicates more well-being. (NCT00683852)
Timeframe: Baseline and 12 weeks

,,,
Interventionunits on a scale (Mean)
Sum of 4 subscaled distress scoresSum of 4 subscaled well-being scores
Phase 1 Drug-9.443.71
Phase 1 Placebo Non-Responders on Drug in Phase 2-6.783.34
Phase 1 Placebo Non-Responders on Placebo in Phase 2-4.521.98
Phase I Placebo-9.702.75

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MADRS (Montgomery-Asberg Depression Rating Scale) Readmission Rate

MADRS readmission rate is defined as MADRS score<11. The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression. (NCT00683852)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Phase 1 Drug4
Phase 1 Placebo Non-Responders on Drug in Phase 28
Phase I Placebo16
Phase 1 Placebo Non-Responders on Placebo in Phase 24

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MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate

The primary outcome was the difference in response rate (decrease in MADRS total score of at least 50%) using the SPCD (sequential parallel comparison design). The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression. (NCT00683852)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Phase 1 Drug10
Phase 1 Placebo Non-Responders on Drug in Phase 211
Phase I Placebo29
Phase 1 Placebo Non-Responders on Placebo in Phase 25

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Mean Change in Clinical Global Impression of Severity (CGI-S)

The CGI-S scale was administered by clinicians based on assessment of the patient's clinical status. They measured, based on history and scores on other instruments, depressive severity. It consists of one question scored on a seven-point scale (1 = normal to 7 = among the most severe), so a higher total score indicates greater depressive severity. The minimum score is 1, and the maximum score is 7. (NCT00683852)
Timeframe: Baseline and 12 weeks

Interventionunits on a scale (Mean)
Phase 1 Drug-0.81
Phase 1 Placebo Non-Responders on Drug in Phase 2-0.64
Phase I Placebo-0.84
Phase 1 Placebo Non-Responders on Placebo in Phase 2-0.43

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Mean Change in MADRS (Montgomery-Asberg Depression Rating Scale) Score From Baseline to the End of Follow-up

The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression. (NCT00683852)
Timeframe: Baseline and 12 Weeks

Interventionunits on a scale (Mean)
Phase 1 Drug-8.54
Phase 1 Placebo Non-Responders on Drug in Phase 2-5.80
Phase I Placebo-8.09
Phase 1 Placebo Non-Responders on Placebo in Phase 2-3.32

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Change From Baseline in Weight (Lbs.) at 12 Weeks

This study looked at change in weight before and after medication use. (NCT00685334)
Timeframe: baseline and 12 weeks

Interventionlbs (Mean)
Olanzapine2.2
Aripiprazole-1.2

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Tolerability

This study addressed the benefits, tolerability, acceptability, safety, and appropriate dosage of olanzapine and aripiprazole, as determined by clinical evaluation and self report. The outcome measure reported here is the number of patients who did not experience untoward side effects while taking the medication. (NCT00685334)
Timeframe: Measured at Week 12

InterventionParticipants (Number)
Olanzapine8
Aripiprazole9

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Mean Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score

"The severity of illness for each patient was rated using the CGI-S. To assess CGI-S, the rater or investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The CGI-S score ranged from 0-7 with a higher score indicating greater illness. A negative change score indicates improvement." (NCT00705783)
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)

InterventionUnits on a scale (Mean)
Aripiprazole Depot0.14
Placebo Depot0.66

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Mean Change From Baseline in the PANSS Negative Subscale Score

The PANSS Negative Subscale consists of 7 symptom constructs (blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Scores on each subscale ranged from 7-49 with a higher score indicating more severe symptoms. A negative change score indicates improvement. (NCT00705783)
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)

InterventionUnits on a scale (Least Squares Mean)
Aripiprazole Depot0.19
Placebo Depot1.55

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Mean Change From Baseline in the PANSS Positive Subscale Score

The PANSS Positive Subscale consists of 7 symptom constructs (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Scores on each subscale ranged from 7-49 with a higher score indicating more severe symptoms. A negative change score indicates improvement. (NCT00705783)
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)

InterventionUnits on a scale (Least Squares Mean)
Aripiprazole Depot0.44
Placebo Depot4.25

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Mean Change From Baseline in the PANSS Total Score

The PANSS consists of 3 subscales (Positive Subscale, 7 constructs, scores ranged from 7-49, Negative Subscale, 7 constructs, scores ranged from 7-49, General Psychopathology Subscale, 16 constructs, scores ranged from 16-112) containing a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30-210 with a higher score indicating more severe symptoms. A negative change score indicates improvement. (NCT00705783)
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)

InterventionUnits on a scale (Least Squares Mean)
Aripiprazole Depot1.43
Placebo Depot11.55

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Mean Clinical Global Impression-Improvement (CGI-I) Score

The efficacy of the study medication was rated for each patient using the CGI-I scale. The rater or investigator rated the patient's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the patient's condition at Baseline. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I score ranged from 0-7 with a higher score indicating less improvement/worsening. (NCT00705783)
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)

InterventionUnits on a scale (Mean)
Aripiprazole Depot3.70
Placebo Depot4.53

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Percentage of Patients Achieving Remission

A patient was considered to have achieved remission if they had a score of ≤ 3 on each of the following PANSS items, maintained for a period of 6 months: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6). (NCT00705783)
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)

InterventionPercentage of patients (Number)
Aripiprazole Depot52.9
Placebo Depot38.7

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Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria

This is the key secondary Outcome Measure. (NCT00705783)
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)

InterventionPercentage of patients (Number)
Aripiprazole Depot10.0
Placebo Depot39.6

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Percentage of Responders

A patient was considered to be a responder if all of the following criteria were met. 1) Outpatient status, 2) PANSS total score ≤ 80, 3) Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): Conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and 4) Clinical Global Impression of Severity of Illness (CGI-S) ≤ 4 (moderately ill) and 5) CGI-SS ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. (NCT00705783)
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)

InterventionPercentage of patients (Number)
Aripiprazole Depot87.6
Placebo Depot56.0

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Time to Discontinuation

Time to discontinuation was defined as the date of randomization to the date of study discontinuation. (NCT00705783)
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)

InterventionDays (Median)
Aripiprazole DepotNA
Placebo Depot162

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Time to Exacerbation of Psychotic Symptoms/Impending Relapse

A patient experienced an exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score > 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score > 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage. (NCT00705783)
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)

InterventionDays (Median)
Aripiprazole DepotNA
Placebo Depot209

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Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7)

The meaning of the total tic scores is a sum of the total motor tic score and total phonic tic score and the total tic score will be indicated from zero point to 50 points. And also, for the global tic severity scale is sum of the total tic scores and impairment score and it will be indicated from zero point to 100 points. Additionally, for the imparment score is also indicated from zero to 50 points same as total tic scores. And it is divided as 0 point, 10 point, 20 point and etc… Lastly, someone who gets a high score, it will be considered worse result. (NCT00706589)
Timeframe: 10 week

Interventionunits on a scale (Mean)
Aripiprazole-9.62
Placebo-14.97

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Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26

A patient had exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score > 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score > 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage. (NCT00706654)
Timeframe: Baseline to Week 26

InterventionPercentage of patients (Number)
Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase7.12
Aripiprazole 10-30 mg Orally - Depot Maintenance Phase7.76
Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase21.80

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Percentage of Patients Achieving Remission

A patient was considered to have achieved remission if they had a score of ≤ 3 on each of the following PANSS items, maintained for a period of 6 months: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6). (NCT00706654)
Timeframe: Baseline to the end of the study (Week 38)

InterventionPercentage of patients (Number)
Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase48.8
Aripiprazole 10-30 mg Orally - Depot Maintenance Phase53.2
Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase59.7

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Percentage of Responders up to Week 38

A patient was considered to be a responder if all of the following criteria were met. 1) Outpatient status, 2) PANSS total score ≤ 80, 3) Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): Conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and 4) Clinical Global Impression of Severity of Illness (CGI-S) ≤ 4 (moderately ill) and 5) CGI-SS ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. (NCT00706654)
Timeframe: Baseline to the end of the study (Week 38)

InterventionPercentage of patients (Number)
Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase89.8
Aripiprazole 10-30 mg Orally - Depot Maintenance Phase89.4
Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase75.2

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Time to Exacerbation of Psychotic Symptoms/Impending Relapse

(NCT00706654)
Timeframe: Baseline to the end of the study (Week 38)

InterventionDays (Median)
Aripiprazole Depot 300 or 400 mg - Depot Maintenance PhaseNA
Aripiprazole 10-30 mg Orally - Depot Maintenance PhaseNA
Aripiprazole Depot 25 or 50 mg - Depot Maintenance PhaseNA

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QTc Measurement

Information regarding the Outcome Measure being a Primary or Secondary, is unavailable. (NCT00712270)
Timeframe:

Interventionmilliseconds (Mean)
QTc Pre-treatment for Entire Study Population381
QTc Post-treat for Entire Study Population389

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Percentage of Participants With Time to First Exacerbation of Psychotic Symptoms/Impending Relapse.

Participants who first time meet relapse criteria were considered as having an event at date of exacerbation of psychotic symptoms/impending relapse. Time to first event was calculated as the earliest date of meeting one of relapse criteria. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy. (NCT00731549)
Timeframe: Baseline to Week 52

InterventionPercentage of participants (Number)
Aripiprazole 400/300 mg IM Depot8.2

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Percentage of Participants Who Discontinued Due to All Causes.

Participants who discontinued due to any cause were noted. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy. (NCT00731549)
Timeframe: Baseline to Week 52

InterventionPercentage of participants (Number)
Aripiprazole 400/300 mg IM Depot20.6

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Percentage of Participants Achieving Remission.

Remission is defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of six months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, and lack of spontaneity. (NCT00731549)
Timeframe: Overall remission from Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48 and 52

InterventionPercentage of participants (Number)
Aripiprazole 400/300 mg IM Depot51.7

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Mean Change From Baseline to Endpoint in PANSS Positive and Negative Subscales.

PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. Positive subscale consists of 7 positive symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. Negative subscale consists of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. (NCT00731549)
Timeframe: Baseline, Weeks 12, 24, 52 and last visit

InterventionUnits on a scale (Mean)
Week 12 positive subscale score (N=987)Week 24 positive subscale score (N=882)Week 52 positive subscale score (N=669)Last visit positive subscale score (N=1078)Week 12 negative subscale score (N=987)Week 24 negative subscale score (N=882)Week 52 negative subscale score (N=669)Last visit negative subscale score (N=1078)
Aripiprazole 400/300 mg IM Depot-0.42-0.68-1.04-0.49-0.40-0.53-0.80-0.46

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Mean Change From Baseline to Endpoint (Last Visit) in Positive and Negative Syndrome Scale (PANSS) Total Score.

PANSS total score (range 30-210) is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS scale. PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. (NCT00731549)
Timeframe: Baseline, Weeks 12, 24, 52 and last visit

InterventionUnits on a scale (Mean)
Week 12 (N=987)Week 24 (N=882)Week 52 (N=669)Last visit (N=1078)
Aripiprazole 400/300 mg IM Depot-1.69-2.55-3.55-1.72

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Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score.

"To assess CGI-S, the rater or physician will answer the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants." (NCT00731549)
Timeframe: Baseline, Weeks 12, 24, 52 and last visit

InterventionUnits on a scale (Mean)
Week 12 (N=987)Week 24 (N=883)Week 52 (N=668)Last visit (N=1079)
Aripiprazole 400/300 mg IM Depot-0.11-0.17-0.24-0.14

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Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.

"Impending relapse criteria was defined as meeting all the following criteria: 1) Clinical Global Impression of Improvement (CGI-I) ≥ 5 (minimally worse), AND an increase to score of >4 and absolute increase of ≥ 2 on the individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content); or an increase to score >4 and absolute increase of ≥ 4 on the combined 4 PANSS items on any of these PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) OR 2) Hospitalization due to worsening of psychotic symptoms, but excluding hospitalization for psychosocial reasons, OR 3) CGI-SS score of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2, OR 4) Violent behavior resulting in clinically relevant self-injury, injury to another person, or property damage." (NCT00731549)
Timeframe: Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48,52, and Last visit (upto 4 weeks ± 3 days after completion or withdrawal)

InterventionPercentage of participants (Number)
Week 2 (N=1028)Week 4 (N=1049)Week 8 (N=1011)Week 12 (N=988)Week 16 (N=948)Week 20 (N=920)Week 24 (N=883)Week 28 (N=857)Week 32 (N=838)Week 36 (N=814)Week 40 (N=808)Week 44 (N=783)Week 48 (N=750)Week 52 (N=668)Last visit (N=1079)Overall (N=1079)
Aripiprazole 400/300 mg IM Depot0.490.480.791.520.841.090.450.580.360.250.250.260.270.304.178.25

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Mean Clinical Global Impression of Improvement (CGI-I) Score.

To assess CGI-I the rater or physician will rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses will be compared to the participants condition at baseline. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. (NCT00731549)
Timeframe: Weeks 2, 4, 12, 24, 52 and last visit

InterventionUnits on a scale (Mean)
Baseline (N=1081)Week 2 (N=1026)Week 4 (N=1049)Week 12 (N=987)Week 24 (N=882)Week 52 (N=669)Last visit (N=1079)
Aripiprazole 400/300 mg IM Depot3.483.523.493.423.333.253.35

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Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit).

"Stable was defined as meeting all of the following criteria: Outpatient status; Positive and negative syndrome scale (PANSS) total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at endpoint (last visit) is described here." (NCT00731549)
Timeframe: Baseline to Week 52/Last visit

InterventionPercentage of participants (Number)
Baseline (N=1075)Week 2 (N=1023)Week 4 (N=1045)Week 8 (N=1009)Week 12 (N=988)Week 16 (N=951)Week 20 (N=919)Week 24 (N=880)Week 28 (N=854)Week 32 (N=838)Week 36 (N=814)Week 40 (N=807)Week 44 (N=784)Week 48 (N=751)Week 52 (N=671)Last visit (N=1072)
Aripiprazole 400/300 mg IM Depot10099.0299.1498.5197.4798.4298.1599.2098.9599.1699.2699.5099.1199.2098.9694.96

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Percentage of Participants Stable at Baseline and Remaining Stable at Week 28.

"Stable was defined as meeting all of the following criteria: Outpatient status; PANSS total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at Week 28 is described here." (NCT00731549)
Timeframe: Baseline to Week 28

InterventionPercentage of participants (Number)
Baseline (N=1075)Week 28 (N=854)
Aripiprazole 400/300 mg IM Depot10098.95

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Weight Gain

Weight gain from baseline to last observation up to 12 weeks. Last observation carried to 12 weeks. (NCT00746252)
Timeframe: These measurements are done biweekly from baseline up until 12 weeks

Interventionpounds (Mean)
Risperidone8.5
Aripiprazole6.65

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Feasibility of Randomizing a Cohort of Participants Meeting the Inclusion and Exclusion Criteria of the Study

Goal was to randomize 60 participants who met eligibility criteria. (NCT00802100)
Timeframe: Baseline

Interventionparticipants (Number)
Overall Study21

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Antipsychotic Efficacy, Defined as Completion of the Trial Without Psychiatric Hospitalization, Clinician Decision to Discontinue Treatment, or Patient Decision to Discontinue Treatment

(NCT00802100)
Timeframe: Measured over 28 weeks of study visits

,,
Interventionparticipants (Number)
InefficacyUnacceptable side effectsPatient refusalDrop-out, no information availableAdministrativeCompleted trial without discontinuing
Aripiprazole100032
Olanzapine003210
Perphenazine100152

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Change in Low Density Lipoprotein (LDL) Cholesterol Level

(NCT00806234)
Timeframe: From Baseline to Week 24

Interventionmg/dL (Least Squares Mean)
Healthy Lifestyle Information3.6
Switch Treatment + Healthy Lifestyle Instruction-8.1
Metformin Treatment + Healthy Lifestyle Instruction-4.1

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Body Mass Index (BMI) Z-score Change

(NCT00806234)
Timeframe: Change from baseline to 24 weeks

InterventionZ Score (Least Squares Mean)
Healthy Lifestyle Information0.040
Switch Treatment + Healthy Lifestyle Instruction-0.112
Metformin Treatment + Healthy Lifestyle Instruction-0.088

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Triglyceride Levels

(NCT00806234)
Timeframe: Change from baseline to 24 weeks

Interventionmg/dL (Least Squares Mean)
Healthy Lifestyle Information0.2
Switch Treatment + Healthy Lifestyle Instruction16.6
Metformin Treatment + Healthy Lifestyle Instruction14.7

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Change in Whole Body Insulin Sensitivity Index

(NCT00806234)
Timeframe: Change from baseline to 24 weeks

InterventionmU/L (Least Squares Mean)
Healthy Lifestyle Information0.74
Switch Treatment + Healthy Lifestyle Instruction0.42
Metformin Treatment + Healthy Lifestyle Instruction-0.34

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Percentage of Participants With Remission (Rate of Remission) at Week 24 Endpoint

Remission is defined as endpoint score of mild or better (≤3) for each of the following PANSS items: delusions, conceptual disorganization, hallucinatory behavior, social withdrawal, blunted affect, lack of spontaneity and flow of conversation, mannerisms and posturing, and unusual thought content. PANSS assesses the positive and negative symptoms and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated from 1 (symptom not present) to 7 (extremely severe). The sum of the 30 items is the PANSS total score and ranges 30 - 210. (Analysis for Study Period III only) (NCT00845026)
Timeframe: 24 weeks

Interventionpercentage of participants (Number)
LY214002315.0
Standard-of-Care (SOC)22.7

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Number of Participants With Treatment-Emergent Change in Neurological Examination

An increase in score from baseline was considered a treatment-emergent change, unless stated otherwise. Tremor: 0 (absent) - 3 (interferes with motor function); Nystagmus: 0 (absent) - 3 (present on forward gaze); Reflexes: 0 (absent) - 4 (clonic) with normal being a score 2, decrease or increase in score was considered change. Finger-nose and gait tests: 0 (normal) - 1(abnormal); Romberg's sign: (0) absent - (1) present; Muscular strength: 0 (no contraction)-5 (full/normal resistance), decrease in score was considered change; Myoclonic jerks: 0 (absent) - 3 (frequent). (NCT00845026)
Timeframe: Baseline through 52 weeks

,
Interventionparticipants (Number)
TremorNystagmusIncreased reflexesDecreased reflexesAbnormal finger-nose testRomberg's signAbnormal GaitDecreased muscle strengthMyoclonus
LY2140023161792020471
Standard-of-Care (SOC)2312628011110

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Number of Participants With Suicidal Behaviors and Ideations Baseline Through 52 Weeks

"Columbia Suicide Rating Scale (C-SSRS): scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. There are no scores on a scale reported, rather, number of patients who reported yes as described above." (NCT00845026)
Timeframe: Baseline through 52 weeks

,
Interventionparticipants (Number)
Suicidal ideationSuicidal behavior/acts
LY214002380
Standard-of-Care (SOC)162

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Change From Baseline in Simpson-Angus Scale (SAS) Total Score at 52 Weeks Endpoint

The SAS is used to measure Parkinsonian type symptoms in patients exposed to antipsychotics. The scale consists of 10 items each rated on a 5-point scale, with 0 meaning complete absence of the condition and 4 meaning the presence of the condition in extreme form. The range of possible total score is 0-40. LS Mean of change from baseline in the SAS total score is from a MMRM model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline and baseline-by-visit interaction. (NCT00845026)
Timeframe: Baseline, 52 weeks

Interventionunits on a scale (Least Squares Mean)
LY2140023-0.87
Standard-of-Care (SOC)-0.82

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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at 52 Weeks Endpoint

Assesses the positive and negative symptoms and general psychopathology associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. LS Mean of change from baseline is from a mixed model repeated measures (MMRM) model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline score and baseline-by-visit interaction. Higher PANSS scores mean worse symptoms. (NCT00845026)
Timeframe: Baseline, 52 weeks

Interventionunits on a scale (Least Squares Mean)
LY2140023-4.54
Standard-of-Care (SOC)-21.47

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Change From Baseline in Personal and Social Performance (PSP) at 52 Weeks Endpoint

The Personal and Social Performance (PSP) scale is a 100-point, single-item, clinician-rated scale to assess 4 domains of functioning, including personal and social relationships, socially useful activities, self care, and disturbing and aggressive behaviors. Score ranges from 1-100. The higher score indicates a better health state. LS Mean of changes from baseline is from a MMRM model which includes the effects of treatment, gender, investigator site, visit, treatment-by-visit interaction, baseline score and baseline score by-visit interaction. (NCT00845026)
Timeframe: Baseline, 52 weeks

Interventionunits on a scale (Least Squares Mean)
LY21400236.47
Standard-of-Care (SOC)10.71

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Change From Baseline in Number of Psychiatric Visits at 24 Weeks Endpoint

Change in number of psychiatric visits between the 6 months prior to the active treatment phase and psychiatric visits reported during the active treatment phase was summarized. Treatment groups were compared on change using the analysis of covariance (ANCOVA) model. The model has baseline as a covariate, and investigative site, gender, and treatment as fixed effects. (Analysis for Study Period III only) (NCT00845026)
Timeframe: Baseline, 24 weeks

Interventionvisits (Least Squares Mean)
LY2140023-2.60
Standard-of-Care (SOC)-2.95

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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 52 Weeks Endpoint

The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). LS Mean of changes from baseline is from a MMRM model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline score and baseline-by-visit interaction. Higher MADRS scores mean worse symptoms. (NCT00845026)
Timeframe: Baseline, 52 weeks

Interventionunits on a scale (Least Squares Mean)
LY21400232.72
Standard-of-Care (SOC)-2.82

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Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB): Overall Composite T-Score at 52 Weeks Endpoint

The MCCB assesses cognitive function in 7 domains important in schizophrenia. The MCCB overall composite score is calculated by summing age- and gender-corrected T-scores of all the domains and then standardizing the sum to a T-score, where the mean is 50 and a standard deviation is 10. A higher score indicates better performance. LS Mean of change from baseline is from a MMRM model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline score and baseline-by-visit interaction. (NCT00845026)
Timeframe: Baseline, 52 weeks

Interventionunits on a scale (Least Squares Mean)
LY21400235.29
Standard-of-Care (SOC)8.19

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Change From Baseline in Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) Total Score at 52 Weeks Endpoint

Measures subjective well-being for previous 7 days. 20 items covering 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Subscale scores range from 4 to 24. Total score ranges from 20 to 120. LS mean of change from baseline is from a MMRM model which includes the effects of treatment, gender, investigator site, visit, treatment-by-visit interaction, baseline score and baseline score by-visit interaction. (NCT00845026)
Timeframe: Baseline, 52 weeks

Interventionunits on a scale (Least Squares Mean)
LY21400231.11
Standard-of-Care (SOC)4.15

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Number of Participants With Potentially Clinical Significant Change in Lipids Level

Treatment-emergent changes in lab results on lipids level were analyzed using the American Diabetes Association (ADA 2001) and National Cholesterol Education Program (NCEP ATP III) guidelines. Total cholesterol Normal to High is <200 mg/dL at baseline and ≥240 mg/dL post-baseline. Low-density lipoprotein (LDL) cholesterol Normal to High is <100 mg/dL at baseline and ≥160 mg/dL post-baseline. High-density lipoprotein (HDL) cholesterol Normal to Low is ≥40 mg/dL at baseline and <40 mg/dL post-baseline. Triglycerides Normal to High is <150 mg/dL at baseline and ≥200 mg/dL post-baseline. (NCT00845026)
Timeframe: Baseline through 52 weeks

,
Interventionparticipants (Number)
Total cholesterol Normal to High (n=56, 59)LDL cholesterol Normal to High (n=20, 22)HDL cholesterol Normal to Low (n=74, 91)Triglycerides Normal to High (n=58, 77)
LY214002330167
Standard-of-Care (SOC)602321

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Number of Participants With Shift From Baseline to Maximum Post-Baseline Grading in Electroencephalograms (EEGs)

EEG scoring by a central neurologist is done by the following definitions: E0=Normal; E1(within normal)=fewer than 3 focal abnormalities or non-epileptiform abnormalities; E2(questionably epileptiform)=3-10 focal discharges and/or 1-10 multifocal or generalized discharges; E3=(clearly epileptiform)= Sharp/slow complex, runs of epileptiform abnormalities, greater than 10 total epileptiform discharges; and E4= seizure. Decreased= maximum (max) post-baseline (PB) EEG grading< baseline EEG grading; Increased= max PB EEG grading> baseline EEG grading; Same=no change from baseline to max PB result. (NCT00845026)
Timeframe: Baseline through 52 weeks

,
Interventionparticipants (Number)
DecreasedSameIncreased
LY2140023117418
Standard-of-Care (SOC)87733

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Change From Baseline in University of California-San Diego (UCSD) Performance-Based Skills Assessment-B (UPSA-B) Total Score at 52 Weeks Endpoint

The UPSA-B is a performance-based assessment of improvement in functional capacity. Patients are asked to role-play tasks in 2 areas of functioning: communication and finances. Scores are assigned for each of the 2 subscales and a provided formulae is used to calculated an UPSA-B Total Score (range = 0-100). The higher score indicates a better performance. LS mean of change from baseline is from a MMRM model which includes the effects of treatment, gender, investigator site, visit, treatment-by-visit interaction, baseline score and baseline score by-visit interaction. (NCT00845026)
Timeframe: Baseline, 52 weeks

Interventionunits on a scale (Least Squares Mean)
LY214002311.82
Standard-of-Care (SOC)12.84

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Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at 52 Weeks Endpoint

The AIMS is a 12-item scale designed to record the occurrence of dyskinetic movements. Items 1 to 10 are rated 0 - 4, with 0 being no dyskinetic movements and 4 being severe dyskinetic movements. Items 11 and 12 are yes/no questions regarding the dental condition of a subject. The total score is the sum of items 1-7 and ranges from 0-28. LS means of change from baseline in the AIMS total score is from a MMRM model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline and baseline-by-visit interaction. (NCT00845026)
Timeframe: Baseline, 52 weeks

Interventionunits on a scale (Least Squares Mean)
LY21400230.13
Standard-of-Care (SOC)-0.23

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Percentage of Participants With Response (Rate of Response) at 6 and 24 Weeks Endpoints

Response is defined as reduction ≥ 30% from baseline on PANSS Total Score (Each PANSS item transformed to a 0-6 scale first). PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on an original scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. Higher scores indicate greater severity of illness. (Analysis for Study Period III only) (NCT00845026)
Timeframe: 6 and 24 weeks

,
Interventionpercentage of participants (Number)
6 weeks24 weeks
LY214002335.026.7
Standard-of-Care (SOC)31.337.5

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Change From Baseline in EuroQoL Questionnaire-5 Dimension (EQ-5D) at 52 Weeks Endpoint

The EQ-5D is a quality-of-life (QoL) instrument with 2 parts: a health status profile and a visual analog scale (VAS). The profile rates patients' health state in 5 domains and each of them ranges 1-3. The outcomes on the 5 domains are mapped to an index with range 0-1. The higher score indicates a better health state. The VAS is used to indicate the patient's health status with range 0=worst and 100=best. LS means are from a MMRM model with the effects of treatment, gender, investigator site, visit, treatment-by-visit interaction, baseline score and baseline score by-visit interaction. (NCT00845026)
Timeframe: Baseline, 52 weeks

,
Interventionunits on a scale (Least Squares Mean)
Visual Analog Scale (n=107, 120)Index Score (n=107, 119)
LY21400234.830.03
Standard-of-Care (SOC)12.840.10

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Change From Baseline in Blood Pressure (BP) at 52 Weeks Endpoint

Least Square (LS) Mean of change from baseline in BP is from a mixed model repeated measures (MMRM) model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction. (NCT00845026)
Timeframe: Baseline, 52 weeks

,
Interventionmillimeters of mercury (mmHg) (Least Squares Mean)
Supine Diastolic BPStanding Diastolic BPSupine Systolic BPStanding Systolic BP
LY21400232.495.572.844.65
Standard-of-Care (SOC)0.871.103.471.93

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Change From Baseline in 16-Item Negative Symptoms Assessment (NSA-16) Total Score at 52 Weeks Endpoint

"The NSA-16 is used to rate behaviors (not psychopathology) associated with negative symptoms of schizophrenia and rates patients on 16 anchors, each of which is rated 1 to 6. The total score is their sum and ranges from 16 to 96. Higher scores indicate greater severity of illness. LS Mean of change from baseline is from a MMRM model which includes treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline score and baseline-by-visit interaction." (NCT00845026)
Timeframe: Baseline, 52 weeks

Interventionunits on a scale (Least Squares Mean)
LY2140023-2.86
Standard-of-Care (SOC)-7.81

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Time to Discontinuation Due to Adverse Event (AE)

(NCT00845026)
Timeframe: Baseline through 24 weeks

Interventiondays (Mean)
LY214002393.02
Standard-of-Care (SOC)116.86

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Change From Baseline in Pulse Rate at 52 Weeks Endpoint

LS Mean of change from baseline in pulse rate is from a MMRM model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction. (NCT00845026)
Timeframe: Baseline, 52 weeks

,
Interventionbeats per minute (bpm) (Least Squares Mean)
Supine PulseStanding Pulse
LY2140023-1.62-2.16
Standard-of-Care (SOC)-2.44-2.41

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Change From Baseline in Barnes Akathisia Scale (BAS) Global Score at 52 Weeks Endpoint

The BAS rates drug induced akathisia symptoms. Akathisia is rated on a 4-point scale, with 0 being no akathisia and 3 being severe akathisia. A global clinical assessment of akathisia is then scored on a 6-point scale, with 0 being no evidence of akathisia and 5 being severe akathisia. LS mean of change from baseline in BAS global score is from a MMRM model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline and baseline-by-visit interaction. (NCT00845026)
Timeframe: Baseline, 52 weeks

Interventionunits on a scale (Least Squares Mean)
LY2140023-0.06
Standard-of-Care (SOC)-0.08

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Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at 52 Weeks Endpoint

The CGI-S scale measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS Mean of change from baseline is from a MMRM model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline score and baseline-by-visit interaction. Higher CGI-S score means worse symptoms. (NCT00845026)
Timeframe: Baseline, 52 weeks

Interventionunits on a scale (Least Squares Mean)
LY2140023-0.27
Standard-of-Care (SOC)-0.81

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Percentage of Participants With Relapse (Rate of Relapse)

Relapse is defined as an increase in at least one PANSS positive item to a score>5 and an absolute increase of ≥2 points on that item post randomization , or hospitalization for any psychiatric condition, or active suicidal ideation or suicidal behavior as captured by the C-SSRS. PANSS assesses the positive and negative symptoms and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30-210. (NCT00845026)
Timeframe: Baseline through 52 weeks

Interventionpercentage of participants (Number)
LY214002326.2
Standard-of-Care (SOC)16.8

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Number of Participants With Potentially Clinically Significant Changes in QT Intervals Electrocardiograms (ECGs)

"A potentially clinically significant QT interval (high) is defined as a value meeting the criteria of (> 450 millisecond [ms]) at anytime during the active treatment phase, provided it does not meet the criteria at baseline.~(analysis for Study Period III only)" (NCT00845026)
Timeframe: Baseline through 24 weeks

Interventionparticipants (Number)
LY21400233
Standard-of-Care (SOC)4

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Number of Participants With Potentially Clinical Significant Change in Fasting Glucose Level

Treatment-emergent changes in lab results on fasting glucose were analyzed using the American Diabetes Association (ADA 2001) and National Cholesterol Education Program (NCEP ATP III) guidelines. Glucose Normal to High is <100 milligram/deciliter (mg/dL) at baseline and ≥126mg/dL post-baseline. (NCT00845026)
Timeframe: Baseline through 52 weeks

Interventionparticipants (Number)
LY21400238
Standard-of-Care (SOC)13

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Change From Baseline in Weight at 52 Weeks Endpoint

LS Mean of change from baseline in weight is from a MMRM model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline weight and baseline-by-visit interaction. (NCT00845026)
Timeframe: Baseline, 52 weeks

Interventionkilogram (kg) (Least Squares Mean)
LY2140023-4.76
Standard-of-Care (SOC)3.88

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Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs

AE=any new untoward medical event or worsening of a preexisting medical condition that may or may not be causally related to treatment. SAE=any untoward medical occurrence that at any dose results in death; is life-threatening, a congenital anomaly/birth defect, or an important medical event; requires or prolongs inpatient hospitalization, or results in persistent or significant incapacity or drug dependency or abuse. (NCT00857818)
Timeframe: Baseline to Week 16, continuously

,
InterventionParticipants (Number)
DeathsSAEsAEs leading to discontinuation1 or more AEs
Aripiprazole02311
Control Group (Olanzapine, Risperidone, or Quetiapine)0006

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Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels

Based on Last Observation Carried Forward data. Non-HDL cholesterol is defined as the difference between total cholesterol and high-density lipoprotein (HDL) cholesterol levels. Fasting non-HDL cholesterol is defined as the measured fasting HDL cholesterol level subtracted from the measured fasting total cholesterol level. (NCT00857818)
Timeframe: Baseline to Weeks 4, 8, and 16

,
InterventionPercentage of change (Mean)
Week 4Week 8Week 16
Aripiprazole-7.54-18.45-14.72
Control Group (Olanzapine, Risperidone, or Quetiapine)0.19-4.44-2.47

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Mean Baseline Fasting Non-HDL Levels

(NCT00857818)
Timeframe: At baseline (Day 1)

Interventionmg/dL (Mean)
Aripiprazole176.07
Control Group (Olanzapine, Risperidone, or Quetiapine)167.14

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Mean Post-baseline Aberrant Behavior Checklist Social Withdrawal Subscale Score, Parent Report, Double-blind Phase

The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item Parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Social Withdrawal subscale is 0 to 48. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints. (NCT00870727)
Timeframe: Weeks 1, 2, 3, 4, 6 and 8

Interventionunits on a scale (Mean)
Arm 1. Aripiprazole Oral Product6.1
Arm 2. Placebo Oral Capsule9.6

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Number of Participants Improved as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2)

Clinical Global Impressions (Guy, 1976) global improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7, with lower scores indicating greater improvement (1=very much improved and 2=much improved). Participants with a CGI-I score of 1 or 2 were classified as improved. Four participants assigned to placebo completed an exit interview prior to week 8. One participant assigned to placebo and one participant assigned to aripiprazole withdrew from the study without completing an exit interview. (NCT00870727)
Timeframe: Double-blind phase study exit - up to 8 weeks

Interventionparticipants (Number)
Arm 1. Aripiprazole Oral Product11
Arm 2. Placebo Oral Capsule3

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Mean Post-baseline Aberrant Behavior Checklist Hyperactivity Subscale Score, Parent Report, Double-blind Phase

The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers overactivity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores is 0 to 48 on the Hyperactivity subscale. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints. (NCT00870727)
Timeframe: Weeks 1, 2, 3, 4, 6 and 8

Interventionunits on a scale (Mean)
Arm 1. Aripiprazole Oral Product23.8
Arm 2. Placebo Oral Capsule29.4

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Mean Post-baseline Aberrant Behavior Checklist Inappropriate Speech Subscale Score, Parent Report, Double-blind Phase

The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Inappropriate Speech subscale is 0 to 12. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints. (NCT00870727)
Timeframe: Weeks 1, 2, 3, 4, 6 and 8

Interventionunits on a scale (Mean)
Arm 1. Aripiprazole Oral Product4.6
Arm 2. Placebo Oral Capsule6.0

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Mean Post-baseline Aberrant Behavior Checklist Stereotypy Subscale Score, Parent Report, Double-blind Phase

The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Stereotypy subscale is 0 to 21. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints. (NCT00870727)
Timeframe: Weeks 1, 2, 3, 4, 6 and 8

Interventionunits on a scale (Mean)
Arm 1. Aripiprazole Oral Product3.9
Arm 2. Placebo Oral Capsule5.3

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Mean Post-baseline Aberrant Behavior Checklist Irritability Subscale Score, Parent Report, Double-blind Phase

The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Irritability subscale is 0 to 45. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints. Confidence intervals reflect a Bonferroni multiple testing correction accounting for the selection of two primary outcomes. (NCT00870727)
Timeframe: Weeks 1, 2, 3, 4, 6 and 8

Interventionunits on a scale (Mean)
Arm 1. Aripiprazole Oral Product18.3
Arm 2. Placebo Oral Capsule26.4

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Mean Change in Sheehan Disability Scale (SDISS)

"The endpoint evaluated the change in SDISS from the end of the SSRI/SNRI treatment period to Week 6 of the placebo-controlled, double-blind treatment period.~The patient rates the extent to which his or her 1) work, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired)." (NCT00876343)
Timeframe: Baseline (the end of the SSRI/SNRI treatment period), at completion of administration

InterventionRating score (Mean)
Variable Dose Group of Aripiprazole-1.03
Fixed Dose Group of Aripiprazole-0.96
Placebo Group-0.46

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MADRS Response Rate

The percentage of subjects with a decrease in MADRS total score of 50% or more, from the end of the SSRI/SNRI treatment period to the end of the placebo-controlled, double-blind treatment period (or withdrawal). (NCT00876343)
Timeframe: Baseline (the end of the SSRI/SNRI treatment period), at completion of administration

Interventionpercentage of subjects (Number)
Variable Dose Group of Aripiprazole39.2
Fixed Dose Group of Aripiprazole42.1
Placebo Group28.2

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Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

"The change in MADRS total score from the end of the SSRI/SNRI treatment period to Week 6 of the placebo-controlled, double-blind treatment period by covariance analysis, and compared the aripiprazole variable dose group with the placebo group as well as the aripiprazole fixed dose group with the placebo group.~Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~The questionnaire includes questions on the following symptoms~1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts" (NCT00876343)
Timeframe: Baseline (the end of the SSRI/SNRI treatment period), at completion of administration

InterventionRating score (Mean)
Variable Dose Group of Aripiprazole-9.6
Fixed Dose Group of Aripiprazole-10.5
Placebo Group-7.4

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Montgomery-Asberg Depression Rating Scale (MADRS)

"Change from baseline to Last Observation Carried Forward (LOCF).~Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~The questionnaire includes questions on the following symptoms~1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts" (NCT00882362)
Timeframe: Baseline(Day 1), Week52 or at discontinuation

InterventionRating Score (Mean)
Continuing Subjects-4.60
Newly Entering Subjects-10.5

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Akathisia

Percentage of participants who developed clinically significant akathisia. (NCT00892047)
Timeframe: 12 weeks

Interventionpercentage of participants (Number)
1: Venlafaxine Plus Aripiprazole26.7
2: Placebo Comparator12.2

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Weight

Weight change in kilograms (NCT00892047)
Timeframe: Baseline through12 weeks

Interventionkilograms (Mean)
1: Venlafaxine Plus Aripiprazole1.93
2: Placebo Comparator0.01

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QTc Prolongation on EKG (to Greater or Equal to 480 Msec)

percentage of participants (NCT00892047)
Timeframe: 12 weeks

Interventionpercent of participants (Number)
1: Venlafaxine Plus Aripiprazole1.3
2: Placebo Comparator0

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Percentage of Subjects Who Met Criteria for Remission Based on the Montgomery-Asberg Depression Rating Scale (MADRS)

The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten item instrument assessing depression symptoms. Possible scores range from 0-60; higher scores indicate greater severity of depression. Remission defined as score of 10 or less based on the MADRS. (NCT00892047)
Timeframe: 12 weeks

Interventionpercentage of participants (Number)
1: Venlafaxine Plus Aripiprazole44
2: Placebo Comparator29

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Parkinsonism

Percentage of participants who develop signs of parkinsonism (NCT00892047)
Timeframe: 12weeks

Interventionpercentage of participants (Number)
1: Venlafaxine Plus Aripiprazole17.4
2: Placebo Comparator2.5

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Emergent Suicidal Ideation in Those With no Ideation at the Start of Treatment

percentage of participants who reported suicidal ideation during treatment but not at baseline (NCT00892047)
Timeframe: 12 weeks

Interventionpercent of participants (Number)
1: Venlafaxine Plus Aripiprazole21.3
2: Placebo Comparator29.2

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Akathisia

Number of subjects reporting mild or greater complaints of akathisia after antipsychotic administration (NCT00895921)
Timeframe: 6 hours

Interventionparticipants (Number)
Aripiprazole1
Olanzapine7

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Change in Glucose Disposition

Ratio of post-antipsychotic/pre-antipsychotic glucose disposition as measured using the hyperglycemic clamp technique. This method allows one to measure either how well an individual metabolizes glucose or how sensitive an individual is to insulin. (NCT00895921)
Timeframe: Measured over 6 hours

Interventionratio of post/pre values (Mean)
Aripiprazole1.18
Olanzapine1.42

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Change in Percent of Insulin Suppression of Endogenous Glucose Production

Ratio of Post-Antipsychotic/Pre-Antipsychotic Percent of Insulin Suppression of Endogenous Glucose Production (NCT00895921)
Timeframe: Measured over 6 hours

Interventionratio of post/pre values (Mean)
Aripiprazole1.0594
Olanzapine1.312

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Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score (Double Blind Phase)

"The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the rater or investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? Response choices include the following: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients" (NCT00905307)
Timeframe: Baseline to Week 6

InterventionUnits on a scale (Mean)
OPC-34712 0.25 mg-0.39
OPC-34712 Low-dose-0.99
OPC-34712 Mid-dose-0.87
OPC-34712 High-dose-1.10
Aripiprazole-1.00
Placebo-0.82

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Change From Baseline to Week 6 in PANSS Positive Subscale Score (Double Blind Phase)

The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. The positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS positive subscale score is the sum of the rating scores for the 7 positive scale items from the PANSS panel. The PANSS positive subscale score ranges from 7-49, with higher scores indicating more severe symptoms. (NCT00905307)
Timeframe: Baseline to Week 6

InterventionUnits on a scale (Mean)
OPC-34712 0.25 mg-3.22
OPC-34712 Low-dose-5.97
OPC-34712 Mid-dose-4.94
OPC-34712 High-dose-5.98
Aripiprazole-6.60
Placebo-4.82

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Response Rate at Week 6

Response rate was defined as a reduction of ≥ 30% from baseline in PANSS Total Score; or a CGI-I score of 1 (very much improved) or 2 (much improved) at Week 6 (NCT00905307)
Timeframe: Week 6

InterventionPercentage of participants (Number)
OPC-34712 0.25 mg40.5
OPC-34712 Low-dose57.3
OPC-34712 Mid-dose46.7
OPC-34712 High-dose51.6
Aripiprazole60.0
Placebo49.5

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Mean Clinical Global Impression - Improvement (CGI-I) at Week 6

The rater or investigator rated the particpant's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant's condition at baseline prior to the first dose of double-blind study medication. Response choices included the following: 0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. (NCT00905307)
Timeframe: Week 6

InterventionUnits on a scale (Mean)
OPC-34712 0.25 mg3.66
OPC-34712 Low-dose3.08
OPC-34712 Mid-dose3.17
OPC-34712 High-dose3.04
Aripiprazole3.04
Placebo3.34

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Discontinuation Rate for Lack of Efficacy or Receipt of Open Label OPC-34712

Efficacy-related discontinuation rate was assessed (NCT00905307)
Timeframe: Baseline to Week 6

InterventionPercentage of participants (Number)
OPC-34712 0.25 mg31
OPC-34712 Low-dose22.5
OPC-34712 Mid-dose17.8
OPC-34712 High-dose16.1
Aripiprazole16.0
Placebo24.2

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Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (Double Blind Phase)

The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. PANSS total score is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms. (NCT00905307)
Timeframe: Baseline to Week 6

InterventionUnits on a scale (Mean)
OPC-34712 0.25 mg-9.76
OPC-34712 Low-dose-18.73
OPC-34712 Mid-dose-16.19
OPC-34712 High-dose-18.25
Aripiprazole-17.98
Placebo-14.40

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Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP) (Double Blind Phase)

The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains. The rating is based on four main areas: (a) socially useful activities, including work and study; (b) personal and social relationships; (c) self-care; and (d) disturbing and aggressive behaviors. The ratings are converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment to determine the total score within the 10-point interval. Ratings from 71-100 reflect only mild difficulties. Ratings from 31-70 reflect manifest disabilities of various degrees. Ratings from 1-30 reflect functioning so poor that intensive support or supervision is needed. (NCT00905307)
Timeframe: Baseline to Week 6

InterventionUnits on a scale (Mean)
OPC-34712 0.25 mg4.54
OPC-34712 Low-dose11.36
OPC-34712 Mid-dose10.67
OPC-34712 High-dose12.17
Aripiprazole10.66
Placebo7.56

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Change From Baseline to Week 6 in PANSS Negative Subscale Score (Double Blind Phase)

The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. PANSS negative subscale score is the sum of the rating scores for the 7 negative scale items from the PANSS panel. The PANSS negative subscale score ranges from 7-49, with higher scores indicating more severe symptoms. (NCT00905307)
Timeframe: Baseline to Week 6

InterventionUnits on a scale (Mean)
OPC-34712 0.25 mg-1.93
OPC-34712 Low-dose-3.61
OPC-34712 Mid-dose-3.84
OPC-34712 High-dose-3.99
Aripiprazole-3.00
Placebo-3.17

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Mass General Hair Pulling Scale, Actual Pulling Subscale

Sum of scores for items 4, 5 and 6 from the Mass General Hair Pulling Scale (Frequency of Pulling, Attempts to Resist Pulling, Control Over Hair Pulling). Score can range from 0 to 12; higher scores indicate more severe hair pulling. (NCT00947154)
Timeframe: change from baseline to end of week 8

Interventionunits on a scale (Mean)
Open-label Aripiprazol-3.9

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Mass General Hair Pulling Scale

A brief, self-report instrument for assessing repetitive hairpulling. Seven individual items, rated for severity from 0 to 4, assess frequency and intensity of urges to pull, ability to control the urges, frequency of pulling, attempts to resist pulling, success in resisting, and associated distress. Statistical analyses indicate that the seven items form a homogenous scale for the measurement of severity in trichotillomania. Higher scores indicate greater severity of hair pulling. Total score can range from 0 to 28. (NCT00947154)
Timeframe: Change from baseline to week 8

Interventionunits on a scale (Mean)
Open-label Aripiprazol-7.8

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Clinical Global Impressions Improvement (CGI-I)

The CGI-I is a clinician rated scale ranging from 0 (not assessed) to 7 (very much worse), with intermediate scores of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse). The clinician is rating the overall change in the patient's clinical condition. (NCT00947154)
Timeframe: At week 8

Interventionpercentage completers with score 1 or 2 (Number)
Open-label Aripiprazol64

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CGI-I Score of 1 or 2 (Very Much or Much Improved)

CGI = Clinical Global Improvement 7-item scale, from very much worse to very much better. (NCT00947154)
Timeframe: At week 8

Interventionparticipants (Number)
Open-label Aripiprazol7

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Fluorodopa Uptake Values in Brain Images of Aripiprazole Augmentation Responders

A ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity specifically in a cluster within the right medial caudate (see data below). (NCT00953745)
Timeframe: Week 10 and Week 16 (6 weeks of combined therapy)

,
InterventionFDOPA ratio in the right medial caudate (Mean)
Week 10Week 16
ARP Non-Responders1.3631.350
ARP Responders1.2971.333

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Depression Symptom Change on The Montgomery-Åsberg Depression Rating (MADRS) Scale Between ARP Responders and Non-responders.

Montgomery-Åsberg Depression Rating (MADRS) Scale scores compared between the 6 week Aripiprazole augmentation groups (responds vs. non-responders). Total range of the MADRS is 0 to 60, with a score of greater than 34 indicating severe depression, 20-34 indicating moderate depression, 7-19 mild depression, and 0-6 normal or absent of symptoms. (NCT00953745)
Timeframe: Week 10 and Week 16 (6 weeks of combined therapy)

,
Interventionscore on the MADRS scale (Mean)
Week 10Week 16
ARP Non-Responders31.725.3
ARP Responders27.96.5

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Number of Participants With Clinically Significant Heart Rate

Heart rate was measured at Baseline and at each visit supine (lying on the back) and standing. A heart rate increase is an increase of ≥ 15 beats per minute (bpm) compared to Baseline. A heart rate decrease is a decrease of ≥ 15 bpm compared to Baseline. (NCT01001702)
Timeframe: Baseline, Up to 72 months

InterventionParticipants (Number)
Supine Heart Rate IncreaseSupine Heart Rate DecreaseStanding Heart Rate IncreaseStanding Heart Rate Decrease
Oral Aripiprazole0010

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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths

"An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject. Change in clinical relevance (severity increased) was entered as a new AE in the current trial. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (clinically significant) change from baseline for that individual subject.~An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention.~Additional information about Adverse Events can be found in the Adverse Event section." (NCT01001702)
Timeframe: Up to 72 months

InterventionParticipants (Number)
AEsSAEsDiscontinuation due to AEsDeath
Oral Aripiprazole611171

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Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score

"The rater or investigator answered the following question:~Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? Response choices included: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. A negative change from Baseline indicated improvement" (NCT01001702)
Timeframe: Baseline, Last Visit (Up to 72 Months)

InterventionScore on a scale (Mean)
Oral Aripiprazole-0.26

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Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)

The C-SSRS consisted of a baseline evaluation (completed at the first scheduled visit upon approval of protocol Amendment 3) that assessed the lifetime experience of the participant with suicide events and suicidal ideation and a post-baseline evaluation at each visit that focused on suicidality since the last trial visit. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). The number of participants experiencing suicidal ideation or suicidal behavior is reported. (NCT01001702)
Timeframe: Baseline, Up to 72 months

InterventionParticipants (Number)
Oral Aripiprazole0

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Number of Participants Showing Significant Weight Gain or Loss

Weight was measured at Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72. A clinically significant weight gain was defined as a ≥ 7 % increase from Baseline. A clinically significant Weight loss was defined as a ≥ 7% decrease from Baseline. (NCT01001702)
Timeframe: Baseline, Up to 72 months

InterventionParticipants (Number)
Weight GainWeight Loss
Oral Aripiprazole374

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Number of Participants With Clinical Significant Laboratory Tests

"Blood was collected for Fasting clinical laboratory tests (serum chemistry and hematology) at Baseline, Months 12, 24, 36, 48, 60, and 72 and were analyzed at a central laboratory.~Clinically significant values are defined as the following:~Bilirubin, total ≥ 2.0 mg/dL. Creatine phosphokinase > 500 U/L for participants 13-17 years or 3 times the upper limit of normal for participants ≥ 18 years [Reference Range (0 to 190 IU/L (females) and 0 to 235 IU/L (males)].~Eosinophils ≥ 10 %. Hematocrit < 30 % for participants 13-17 years old or ≥ 18 year old participants female ≤ 32 % and a 3 point decrease from baseline or male ≤ 37 % and a 3 point decrease from baseline.~Hemoglobin female ≤ 9.5 g/dL or male ≤ 11.5 g/dL. Prolactin > 1 times the upper limit of normal [Reference range: 2 to 18 ng/mL (males) and 3 to 30 ng/mL (females)]." (NCT01001702)
Timeframe: Baseline, Up to 72 Months

InterventionParticipants (Number)
Bilirubin, total (mg/dL)Creatine phosphokinase (CPK), total (IU/L)Eosinophils (%)Hematocrit (%)Hemoglobin (g/dL)Prolactin (ng/mL)
Oral Aripiprazole765533

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Number of Participants With Clinically Abnormal Changes in Electrocardiograms (ECGs) Evaluations

"A 12-lead ECG was recorded at Baseline, Months 6, 12, 24, 36, 48, 60 and 72. Three readings taken 5 minutes were read by a central ECG reading service and averaged.~Clinically significant ECGs were defined as:~Sinus Bradycardia: ≤ 50 beats per minute (bpm), decrease of ≥ 15 bpm from Baseline.~Supraventricular premature beat: ≥ 2 per 10 seconds, increase from Baseline. Ventricular premature beat: ≥ 1 per 10 seconds, increase from Baseline. Right bundle branch block: present. Other intraventricular block: QRS ≥ 0.10 seconds for age 13-17 years or QRS ≥ 0.11 seconds for age ≥ 18 years, an increase of ≥ 0.02 seconds from Baseline.~Symmetrical T-wave inversion: present. QTcB (QT interval corrected Bazett's formula), QTcF (QT interval corrected Fridericia's formula), QTcN (QT corrected FDA Neuropharmacology Division formula), QTcE (QT corrected fractional exponent correction method: ≥ 420 msec for age 13-17 years or ≥ 450 msec for age ≥ 18 years, ≥ 10 % increase from Baseline." (NCT01001702)
Timeframe: Baseline, Up to 72 months

InterventionParticipants (Number)
Sinus bradycardiaSupraventricular premature beatVentricular premature beatRight bundle branch blockOther intraventricular blockSymmetrical T-wave inversionQTcBQTcFQTcNQTcE
Oral Aripiprazole7611519465

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Number of Participants With Clinically Significant Blood Pressure

"Systolic and Diastolic blood pressure was measured at Baseline and at all visits supine (lying on the back) and standing.~Systolic increase was an increase of ≥ 20 mm Hg compared to Baseline and systolic decrease was a decrease of ≥ 20 mm Hg compared to Baseline.~A diastolic increase was an increase of ≥ 15 mm Hg compared to Baseline and a diastolic decrease was a decrease of ≥ 15 mm Hg compared to Baseline." (NCT01001702)
Timeframe: Baseline, Up to 72 months

InterventionParticipants (Number)
Supine Systolic Blood Pressure IncreaseSupine Systolic Blood Pressure DecreaseStanding Systolic Blood Pressure IncreaseStanding Systolic Blood Pressure DecreaseSupine Diastolic Blood Pressure IncreaseSupine Diastolic Blood Pressure DecreaseStanding Diastolic Blood Pressure IncreaseStanding Diastolic Blood Pressure Decrease
Oral Aripiprazole43525050

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Number of Participants With PANSS Response

The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Participants with PANSS response were defined as those who achieved greater than or equal to 20 percent or higher reduction from Baseline in the PANSS total score at Day 56 and 182. (NCT01009047)
Timeframe: Day 56 and 182

,
InterventionParticipants (Number)
Day 56Day 182
Aripiprazole8793
Paliperidone Extended Release (ER)7686

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Number of Participants With Clinical Stability

Clinical stability is defined as a decrease of 20 percent or more from Baseline in PANSS total score and CGI-S score less than or equal to 4 at Days 56 and 182, no hospitalizations due to psychiatric illness and no emergence of clinically significant suicidal or homicidal ideation during the maintenance phase. (NCT01009047)
Timeframe: Day 56 and 182

InterventionParticipants (Number)
Paliperidone Extended Release (ER)58
Aripiprazole68

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Change From Baseline in PANSS Total Score at Day 182

The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. (NCT01009047)
Timeframe: Baseline and Day 182

,
InterventionUnits on a scale (Mean)
BaselineChange at Day 182
Aripiprazole92.0-26.8
Paliperidone Extended Release (ER)89.6-25.6

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Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182

The PSP scale assesses degree of a participants' dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numerical score to rate degree of difficulty (1=absent to 6=very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score (total score ranges from 1 to 100, divided into 10 equal intervals). Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. (NCT01009047)
Timeframe: Baseline, Day 56 and Day 182

,
InterventionUnits on a Scale (Mean)
BaselineChange at Day 56Change at Day 182
Aripiprazole49.212.217.1
Paliperidone Extended Release (ER)49.812.217.1

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Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56

The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. (NCT01009047)
Timeframe: Baseline and Day 56

,
InterventionUnits on a scale (Mean)
BaselineChange at Day 56
Aripiprazole92.0-19.8
Paliperidone Extended Release (ER)89.6-19.3

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Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182

The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). (NCT01009047)
Timeframe: Baseline, Day 56 and 182

,
InterventionUnits on a scale (Mean)
Baseline: Positive SubscaleChange at Day 56: Positive SubscaleChange at Day 182: Positive SubscaleBaseline: Negative SubscaleChange at Day 56: Negative SubscaleChange at Day 182: Negative SubscaleBaseline: General PsychopathologyChange at Day 56: General PsychopathologyChange at Day 182: General Psychopathology
Aripiprazole22.5-6.2-8.324.24.5-6.145.3-9.1-12.4
Paliperidone Extended Release (ER)21.5-6.4-8.023.8-4.2-5.744.3-8.7-11.9

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Change From Baseline in Other Marder Factors Scores at Day 56 and 182

The subscales based on marder factors are: positive symptoms, disorganised thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for Uncontrolled hostility/excitement and anxiety/depression. Higher score indicate worsening. (NCT01009047)
Timeframe: Baseline, Day 56 and 182

,
InterventionUnits on a scale (Mean)
Baseline: Positive symptomsChange at Day 56: Positive symptomsChange at Day 182: Positive symptomsBaseline: Negative symptomsChange at Day 56: Negative symptomsChange at Day 182: Negative symptomsBaseline: Disorganized thoughtsChange at Day 56: Disorganized thoughtsChange at Day 182: Disorganized thoughtsBaseline: Uncontrolled hostilityChange at Day 56: Uncontrolled hostilityChange at Day 182: Uncontrolled hostilityBaseline: Anxiety/depressionChange at Day 56: Anxiety/depressionChange at Day 182: Anxiety/depression
Aripiprazole24.9-5.6-7.823.3-4.7-6.222.1-4.1-5.711.7-2.9-3.810.0-2.6-3.2
Paliperidone Extended Release (ER)24.6-6.1-7.823.2-4.3-6.021.4-4.0-5.510.7-2.5-3.29.7-2.4-3.0

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Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182

The PANSS negative subscale based on marder factor assesses 7 negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). (NCT01009047)
Timeframe: Baseline, Day 56 and Day 182

,
InterventionUnits on a scale (Mean)
BaselineChange at Day 56Change at Day 182
Aripiprazole23.3-4.7-6.2
Paliperidone Extended Release (ER)23.2-4.3-6.0

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Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182

"The CGI-S rating scale is a 7-point global assessment that measures the Clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening." (NCT01009047)
Timeframe: Baseline, Day 56 and 182

,
InterventionUnits on a scale (Median)
BaselineChange at Day 56Change at Day 182
Aripiprazole4.0-1-1.0
Paliperidone Extended Release (ER)4.0-1.0-1.0

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Baseline and Week 8scores on Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version

The Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version (CY-BOCS-PDD) is a clinician-rated interview designed to evaluate repetitive behavior in children with pervasive developmental disorders (PDDs). It is a modification of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), developed to assess typically-developing children with obsessive compulsive behavior. Because of language limitations in children with PDDs the CY-BOCS-PDD only includes the five compulsion items: Time Spent, Interference, Distress, Resistance of repetitive behavior, and Control of repetitive behavior. Each item is rated from 0 (none) through 4 (extreme), and scores can range from 0 to 20, with higher scores reflecting more severe symptoms. Usually a score > than 8 is considered clinically significant. (NCT01028820)
Timeframe: "Baseline (Pre-Dose) to 8 Weeks (Post-Dose)"

InterventionScores on a scale (Mean)
Open-Label, Flexible-Dose Aripiprazole: Baseline (Pre-Dose)12.7
Open-Label, Flexible-Dose Aripiprazole: 8 Weeks (Post-Dose)8.6

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Total Repetitive Behavior Scale - Revised (RBS_R)

"The RBS-R is an assessment that includes Sameness, Self-Injurious Behavior, Ritualistic, Compulsive, and Restrictive Behavior subscales. The assessments are completed by caregivers for the past week, with consideration of frequency,ease of redirecting and extent to which behavior interferes with functioning compared to a typically developing child of the same age and gender. Scores are rated from 0 - behavior does not occur to 3 - behavior occurs and is a serious problem. There are 43 items and 5 subscales. Higher scores indicate greater symptom severity. total score is the sum of all items in all subscales.~The subscales are stereotyped behaviors 6 items, self-injurious behaviors 8 items, Compulsive behaviors- 8 items, Ritualistic Behaviors 6 items, Sameness 11 items, restricted behaviors 4 items.Total score ranges from 0 to 129." (NCT01028820)
Timeframe: baseline week 0, 8 weeks

Interventionunits on a scale (Mean)
Open-Label, Flexible-Dose Aripiprazole: Baseline (Pre-Dose)42.2
Open-Label, Flexible-Dose Aripiprazole: 8 Weeks (Post-Dose)20.5

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Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.

The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement. (NCT01104766)
Timeframe: Baseline to Week 6

InterventionUnits on a Scale (Least Squares Mean)
Placebo-14.3
Cariprazine 3.0 mg-20.2
Cariprazine 6.0mg-23.0
Aripiprazole 10.0 mg-21.2

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Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S)

"The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a normal state and 7 indicating among the most extremely ill participants. A higher score indicates greater illness. A negative change from baseline score indicates improvement." (NCT01104766)
Timeframe: Baseline to Week 6

InterventionUnits on a Scale (Least Squares Mean)
Placebo-1.0
Cariprazine 3.0 mg-1.4
Cariprazine 6.0mg-1.5
Aripiprazole 10.0 mg-1.4

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Phase C: Mean Clinical Global Impression - Improvement (CGI-I) Scale Score at the End of Phase C (Week 14)

CGI-I is a 7-point clinician-rated scale ranging from 1 to 7, rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. A higher score indicates greater impairment. (NCT01111539)
Timeframe: Week 14

Interventionscore on a scale (Mean)
Phase C: Aripiprazole/Escitalopram Combination2.6
Phase C: Escitalopram Monotherapy2.9
Phase C: Aripiprazole Monotherapy3.0

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Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14)

The MADRS assessed severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms). Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). A negative change from Week 8 indicates improvement. (NCT01111539)
Timeframe: Week 8 to Week 14

Interventionscore on a scale (Least Squares Mean)
Phase C: Aripiprazole/Escitalopram Combination-8.0
Phase C: Escitalopram Monotherapy-7.0
Phase C: Aripiprazole Monotherapy-4.3

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Phase C: Mean Change From End of Phase B (Week 8) in the Sheehan Disability Scale (SDS) Mean Score to End of Phase C (Week 14)

SDS is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. The participant is asked to rate the degree to which their functioning is impaired on an 11-point scale, ranging from 0 (not at all) to 10 (extremely). The scores for the 3 domains are summed into a total score that ranges from 0 (unimpaired) to 30 (highly impaired). A higher score indicates greater impairment. A negative change from Week 8 indicates improvement. (NCT01111539)
Timeframe: Week 8 to Week 14

Interventionscore on a scale (Least Squares Mean)
Phase C: Aripiprazole/Escitalopram Combination-1.2
Phase C: Escitalopram Monotherapy-1.2
Phase C: Aripiprazole Monotherapy-0.2

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Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14)

The MADRS assessed severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms). Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). A negative change from Week 8 indicates improvement. Last observation carried forward (LOCF) method was used for analyses. (NCT01111552)
Timeframe: Week 8 to Week 14

Interventionscore on a scale (Least Squares Mean)
Phase C: Escitalopram Monotherapy-8.0
Phase C: Aripiprazole Monotherapy-9.6
Phase C: Aripiprazole/Escitalopram Combination Therapy-9.2

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Phase C: Clinical Global Impression - Improvement Scale (CGI-I) Score at The End of Phase C (Week 14)

The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Last observation carried forward (LOCF) method was used for analyses. (NCT01111552)
Timeframe: Week 14

Interventionscore on a scale (Mean)
Phase C: Escitalopram Monotherapy2.4
Phase C: Aripiprazole Monotherapy2.3
Phase C: Aripiprazole/Escitalopram Combination Therapy2.3

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Phase C: Mean Change From End of Phase B (Week 8) in the Sheehan Disability Scale (SDS) Mean Score to End of Phase C (Week 14)

The SDS is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0= no impairment to 10= most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe). A negative change from Week 8 indicates improvement. Last observation carried forward (LOCF) method was used for analyses. (NCT01111552)
Timeframe: Week 8 to Week 14

Interventionscore on a scale (Least Squares Mean)
Phase C: Escitalopram Monotherapy-0.9
Phase C: Aripiprazole Monotherapy-1.4
Phase C: Aripiprazole/Escitalopram Combination Therapy-1.2

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Phase C: Clinical Global Impression - Improvement Scale (CGI-I) Score at the End of Phase C

CGI-I is a 7-point clinician-rated scale ranging from 1 to 7, rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. A higher score indicates greater impairment. LOCF method was used for analyses. (NCT01111565)
Timeframe: Week 14

Interventionscore on a scale (Mean)
Phase C: Aripiprazole/Escitalopram Combination2.5
Phase C: Escitalopram Monotherapy3.0
Phase C: Aripiprazole Monotherapy2.9

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Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14)

The MADRS assessed severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms). Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. Last observation carried forward (LOCF) method was used for analyses. (NCT01111565)
Timeframe: Week 8 to Week 14

Interventionscore on a scale (Least Squares Mean)
Phase C: Aripiprazole/Escitalopram Combination-9.0
Phase C: Escitalopram Monotherapy-3.6
Phase C: Aripiprazole Monotherapy-3.8

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Phase C: Mean Change From End of Phase B (Week 8) in the Sheehan Disability Scale (SDS) Mean Score to End of Phase C (Week 14)

SDS is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. The participant is asked to rate the degree to which their functioning is impaired on an 11-point scale, ranging from 0 (not at all) to 10 (extremely). Scores of 0 to 3 indicate mild functional impairment, 4 to 6 indicate moderate functional impairment, and 7 to 9 indicate marked functional impairment. The scores for the 3 domains are summed into a total score that ranges from 0 (unimpaired) to 30 (highly impaired). A higher score indicates greater impairment. A negative change score indicates improvement. LOCF method was used for analyses. (NCT01111565)
Timeframe: Week 8 to Week 14

Interventionscore on a scale (Least Squares Mean)
Phase C: Aripiprazole/Escitalopram Combination-1.6
Phase C: Escitalopram Monotherapy-1.8
Phase C: Aripiprazole Monotherapy-0.6

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Number of Participants With Cognitive Impairment for Each New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT)

The NY-AACENT is not a validated scale. It was included in this trial because of concerns that regulatory authorities (the European Committee for Medicinal Products for Human Use [CHMP] and the Paediatric Sub-Committee of the European Medicinal Agency [PDCO]) had regarding drug induced cognitive impairment. No validated scale addressing these issues was available at the time of the trial. The NY-AACENT was used to detect changes in cognitive function subsequent to pharmacological or similar treatments for neurological or psychiatric problems. It was specifically designed to be used in pediatric populations (ages 12 to 17), but could have been utilized with other age groups, as appropriate. (NCT01122927)
Timeframe: Baseline to Month 24

Interventionparticipants (Number)
Working memoryAttention/vigilanceVerbal learning/memoryVisual learning/memoryReasoning and problem solvingSpeed of processingSocial congnition
Open-label Treatment Phase237306233138308276307

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Mean Change From Baseline by Week in Simpson-Angus Scale (SAS) Total Score

The SAS is a rating scale used to measure EPS. The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40. (NCT01122927)
Timeframe: Baseline to Month 24

InterventionUnits on a scale (Mean)
Week 1 (N=486)Week 2 (N=507)Week 3 (N=507)Week 4 (N=507)Week 6 (N=507)Week 8 (N=507)Month 3 (N=507)Month 6 (N=507)Month 9 (N=506)Month 12 (N=507)Month 15 (N=360)Month 18 (N=360)Month 21 (N=360)Month 24 (N=360)
Open-label Treatment Phase-0.08-0.11-0.08-0.18-0.12-0.21-0.23-0.31-0.35-0.36-0.43-0.48-0.49-0.53

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Mean Change From Baseline by Week in Abnormal Involuntary Movement Scale (AIMS)

The AIMS Scale was an extrapyramidal symptoms (EPS) rating scale. The AIMS is a 12 item scale. The first 10 items e.g. facial and oral movements (items 1-4), extremity movements (items 5 and 6), trunk movements (item 7), investigators global assessment of dyskinesia (items 8 to 10). The first 10 items are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28. (NCT01122927)
Timeframe: Baseline to Month 24

InterventionUnits on a scale (Mean)
Week 1 (N=486)Week 2 (N=507)Week 3 (N=507)Week 4 (N=507)Week 6 (N=507)Week 8 (N=507)Month 3 (N=507)Month 6 (N=507)Month 9 (N=506)Month 12 (N=507)Month 15 (N=360)Month 18 (N=360)Month 21 (N=360)Month 24 (N=360)
Open-label Treatment Phase-0.02-0.010.01-0.010.02-0.02-0.00-0.020.01-0.02-0.01-0.04-0.01-0.04

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Incidence of Vital Signs of Potential Clinical Relevance

Vital signs are taken at Baseline, Weeks 1, 2, 3, 4, 6, 8, and Months 3, 4, 6, 9, 12, 15, 18, 21, 24 of Phase 2 (Visits beyond Month 12 only for de novo subjects). Assessments included orthostatic (supine and standing) blood pressure (BP), heart rate and body temperature. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria. Abnormal vital signs in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report. (NCT01122927)
Timeframe: Baseline to Month 24

Interventionparticipants (Number)
Heart rate supine-Increase ≥15 bpmHeart rate supine-Decrease ≥15 bpmHeart rate standing-Increase ≥15 bpmHeart rate standing-Decrease ≥15 bpmSystolic supine bp-Increase ≥20 mmHgSystolic supine bp-Decrease ≥20 mmHgSystolic standing bp-Increase ≥20 mmHgSystolic standing bp-Decrease ≥20 mmHgDiastolic supine bp-Increase ≥15 mmHgDiastolic supine bp-Decrease ≥15 mmHgDiastolic standing bp-Increase ≥15 mmHgDiastolic standing bp-Decrease ≥15 mmHgWeight gain ≥7%Weight loss ≥7%
Open-label Treatment Phase1140363138404119531319545

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Number of Participants With Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a participant or participant enrolled in a clinical trial and which did not necessarily have a causal relationship with the study medication. A treatment emergent adverse event (TEAE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study medication, whether or not considered to have a causal relationship with the study medication. A serious-AE or reaction was any untoward occurrence that, at any dose, was fatal, life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was any other medically significant event that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above. (NCT01122927)
Timeframe: Adverse events were recorded from the time of the informed consent was signed throughout the 24 month treatment period until the follow-up visit 30 (± 3) days after the end of trial.

InterventionParticipants (Number)
Participants with TEAEsParticipants with serious TEAEsParticipants with severe TEAEsDiscontinued due to AEs
Open-label Treatment Phase349493332

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Incidence of Laboratory Values of Potential Clinical Relevance

The laboratory values were one of the parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria. Abnormal laboratory values in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report. (NCT01122927)
Timeframe: Baseline to Month 24

Interventionparticipants (Number)
Chemistry-Alanine transaminaseChemistry-Aspartate transaminaseChemistry-Bilirubin, totalChemistry-CalciumChemistry-ChlorideChemistry-Cholesterol, total, fastingChemistry-Creatine phosphokinase, totalChemistry-Glutamyl transferaseChemistry-HDL cholesterol, fastingChemistry-LDL cholesterol, calculation,Chemistry-Phosphorus inorganicChemistry-Protein, total serumChemistry-Triglycerides, fastingHematology-EosinophilsHematology-HemoglobinHematology-White blood cell countUrinalysis-Protein, urineUrinalysis-Specific gravityOthers-InsulinOthers-Insulin, fastingOthers-Prolactin
Open-label Treatment Phase118203015868407812821358146191493481884978324

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Mean Change From Baseline in Children's Global Assessment Scale (CGAS) in Bipolar (de Novo Participants)

The CGAS is a 100-point rating scale measuring psychological, social, and school functioning for children aged 6 to 17. It was adapted from the Adults Global Assessment Scale. The Global Assessment Scale was a rating scale for evaluating the overall functioning of a participant during a specified time period on a continuum from psychological or psychiatric sickness to health. The CGAS is a valid and reliable tool for rating a child's general level of functioning on a health-illness continuum. The CGAS was developed by Schaffer and colleagues to provide a global measure of severity of disturbance in children and adolescents. The CGAS Score (range 1 to 100) is a single-item score for rating a child's general level of functioning on a health-illness continuum, with higher scores representing better functioning. (NCT01122927)
Timeframe: Baseline to Month 24

InterventionUnits on a scale (Mean)
Month 12 (N= 93)Month 24 (N= 93)
Open-label Treatment Phase14.1714.00

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Mean Change From Baseline for Columbia-Suicide Severity Rating Scale (C-SSRS) in Suicidal Ideation Intensity Total Score

Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Suicidal ideation was defined as reporting any type of suicidal ideation. The suicidal ideation intensity total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) which leads to the range of the total score from 0 to 25. A missing score of any item resulted in a missing total score. If no suicidal ideation was reported, a score of 0 was given to the intensity scale. (NCT01122927)
Timeframe: Baseline to Month 24

InterventionUnits on a scale (Mean)
Week 1 (N= 487)Week 2 (N= 483)Week 3 (N= 477)Week 4 (N= 491)Week 6 (N= 488)Week 8 (N= 484)Month 3 (N= 478)Month 4 (N= 472)Month 6 (N= 458)Month 9 (N= 407)Month 12 (N= 302)Month 15 (N= 261)Month 18 (N= 247)Month 21 (N= 212)Month 24 (N= 180)Last Visit (N= 507)
Open-label Treatment Phase-0.4-0.4-0.4-0.4-0.3-0.4-0.3-0.3-0.2-0.2-0.3-0.2-0.1-0.1-0.0-0.1

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Incidence of Suicidality, Suicidal Behavior and Suicidal Ideation

Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Suicidal ideation was defined as reporting any type of suicidal ideation. The below reported N value is the number of participants with specified suicidal ideation/behavior at the given time point. (NCT01122927)
Timeframe: Baseline to Month 24

Interventionparticipants (Number)
Complete suicidalitySuicidalitySuicidal behaviorEmergence of suicidal behaviorSuicidal ideationEmergence of suicidal ideationEmergence of serious suicial ideationWorsening of suicidal ideation
Open-label Treatment Phase032533119226

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Mean Change From Baseline in PANSS Negative Subscale Score

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). (NCT01122927)
Timeframe: Baseline to Month 24

InterventionUnits on a scale (Mean)
Month 12 (N= 414)Month 24 (N= 267)
Open-label Treatment Phase-2.79-3.48

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Baseline and Post-Baseline Tanner Staging

Tanner staging was completed together with the physical examination by the same trial-affiliated clinician in the most inconspicuous manner for the participant as possible. Tanner staging assessment consisted of 2 domains (pubic hair and breast development) for girls and 3 domains (pubic hair, penis development, and testes development) for boys. A participant who reached Stage 5 (both in pubic hair and genitalia) did not need to continue with Tanner Staging assessment and the Tanner Staging scales of this participant were imputed as 5 for all of the following scheduled time points up to and including the completion visit/ET visit. The clinician arrived at a single score summarizing the domains (not individual domain scores) when evaluating the participant. The total shift data for last visit is presented below. (NCT01122927)
Timeframe: Baseline to Last Visit

,,,,
Interventionparticipants (Number)
Last Visit (Post-Baseline score of 1) (N= 1)Last Visit (Post-Baseline score of 2) (N= 9)Last Visit (Post-Baseline score of 3) (N= 39)Last Visit (Post-Baseline score of 4) (N= 134)Last Visit (Post-Baseline score of 5) (N= 327)
Tanner Score at Baseline of 114200
Tanner Score at Baseline of 205973
Tanner Score at Baseline of 300283318
Tanner Score at Baseline of 400094102
Tanner Score at Baseline of 50000204

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Incidence of Physical Examination Findings of Potential Clinical Relevance

The physical examination evaluation was one of the parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae. (NCT01122927)
Timeframe: Baseline to Month 24

Interventionparticipants (Number)
Open-label Treatment Phase0

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Mean Change From Baseline in Clinical Global Impression Scale - Bipolar (CGI-BP) Version Severity Score

The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rated the subject's Severity of Illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and Change From Preceding Phase (CGI-BP-Improvement: mania, depression, and overall bipolar illness) based on a 7- or 8-point scale. Severity of Illness (CGI-BP-Severity) was rated at all visits. At each visit other than Day 0 (Baseline), the Change From Preceding Phase (CGI-BP-Improvement) was judged with respect to participant's condition at Baseline. The CGI-BP Severity Scores (range 1 to 7), as well as CGI-BP Improvement Scores (range 1 to 7) are single-item rating scores, with higher scores representing greater severity or less improvement. Data for 94 de novo participants were available with bipolar disorder. (NCT01122927)
Timeframe: Baseline to Month 24

InterventionUnits on a scale (Mean)
Month 12 (N= 93)Month 24 (N= 93)
Open-label Treatment Phase-1.26-1.30

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Mean Change From Baseline in Clinical Global Impression Scale - Bipolar Version Improvement Score

The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rated the subject's Severity of Illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and Change From Preceding Phase (CGI-BP-Improvement: mania, depression, and overall bipolar illness) based on a 7- or 8-point scale. Severity of Illness (CGI-BP-Severity) was rated at all visits. At each visit other than Day 0 (Baseline), the Change From Preceding Phase (CGI-BP-Improvement) was judged with respect to participant's condition at Baseline. The CGI-BP Severity Scores (range 1 to 7), as well as CGI-BP Improvement Scores (range 1 to 7) are single-item rating scores, with higher scores representing greater severity or less improvement. Only 94 participants had data at Baseline to explain the N=94 in the table below and these were de novo participants. (NCT01122927)
Timeframe: Baseline to Month 24

InterventionUnits on a scale (Mean)
Month 12 (N= 93)Month 24 (N= 93)
Open-label Treatment Phase2.272.17

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Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score

"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants." (NCT01122927)
Timeframe: Baseline to Month 24

InterventionUnits on a scale (Mean)
Month 12 (N= 414)Month 24 (N= 267)
Open-label Treatment Phase-0.66-0.77

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Mean Change From Baseline in General Behavior Inventory (GBI) Scale Total Score for Mania and Depression in Both Parent/Guardian and Subject Version of the Scale

The GBI is a self-report inventory with 73 items focusing on mood-related behaviors, including depressive, hypomanic, and biphasic symptoms. For this trial, two 20-item subscales were utilized: one was completed by the parent/guardian or legal representative, as applicable for local laws, and the other was completed by the participant. Responses were given on a 4-point Likert scale, with 0 being never or hardly ever and 3 being very often or almost constantly. The GBI Total Score for mania (range 0 to 30) is the sum of scores for items 1 to 10 and the GBI Total Score for depression (range 0 to 30) is the sum of scores for items 11 to 20 in the GBI Parent/Guardian or Subject Version panel. Scores from the Parent/Guardian and participant Versions were summarized separately. A missing value for any GBI assessment items could have resulted in a missing GBI Total Score. High scores represent greater psychopathology. Data was only available for 80 de novo participants with bipolar disorder. (NCT01122927)
Timeframe: Baseline to Month 24

InterventionUnits on a scale (Mean)
Month 12 (N= 78)Month 24 (N= 78)
Open-label Treatment Phase-1.62-1.82

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Mean Change From Baseline in PANSS Positive Subscale Score

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). (NCT01122927)
Timeframe: Baseline to Month 24

InterventionUnits on a scale (Mean)
Month 12 (N= 414)Month 24 (N= 267)
Open-label Treatment Phase-2.57-2.91

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Mean Change From Baseline in Positive and Negative Symptoms Score (PANSS) Total Score

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). (NCT01122927)
Timeframe: Baseline to Month 24

InterventionUnits on a scale (Mean)
Month 12 (N= 414)Month 24 (N= 267)
Open-label Treatment Phase-9.98-12.52

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Mean Change From Baseline in the Attention Deficit Hyperactive Disorders Rating (ADHD-RS-IV) Scale Score

The ADHD-RS-IV is a reliable and easy-to-administer instrument both for diagnosing ADHD in children and adolescents and for assessing treatment response. Containing 18 items, the scale was linked directly to DSM-IV-TR diagnostic criteria for ADHD. There were 3 versions of the scale: a parent questionnaire on home behaviors (English), a parent questionnaire on home behaviors (Spanish), and a teacher questionnaire on classroom behaviors. For this trial, the parent questionnaire on home behaviors (English) was utilized. The ADHD-RS-IV Total Score (range 0 to 54) is the sum of rating scores for 18 items, with higher scores representing greater severity. A missing value for any ADHD-RS-IV assessment items could have resulted in a missing ADHD-RS-IV Total Score. Data were only available for 82 participants with bipolar disorder and these were de novo participants. (NCT01122927)
Timeframe: Baseline to Month 24

InterventionUnits on a scale (Mean)
Month 12 (N= 81)Month 24 (N= 81)
Open-label Treatment Phase-3.25-2.53

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Mean Change From Baseline in Young Mania Rating Scale (YMRS) Score

The YMRS consists of 11 items assessing the core symptoms of mania and was used to assess participants with bipolar I disorder, manic and mixed episodes with or without psychotic features: elevated mood, increased motor activity - energy, sexual interest, sleep, irritability, speech (rate and amount), language - thought disorder, content, disruptive - aggressive behavior, appearance, and insight. Each item had 5 or 9 grades of severity, with lower scores indicating milder symptoms. The number of raters within each trial center was to be kept to a minimum. The YMRS Total Score (range 0 to 44) is the sum of the rating scores for 11 items for assessing the core symptoms of mania. A missing value for any YMRS assessment item(s) could have resulted in a missing YMRS Total Score. A higher YMRS Total Score represents greater severity. In this study, 94 participants had bipolar disorder, this explains the N=94 in the table below and these were de novo participants. (NCT01122927)
Timeframe: Baseline to Month 24

InterventionUnits on a scale (Mean)
Month 12 (N= 93)Month 24 (N= 93)
Open-label Treatment Phase-9.71-10.02

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Mean Change in Clinical Global Impression-Improvement (CGI-I) Score

The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse. (NCT01122927)
Timeframe: Baseline to Month 24

InterventionUnits on a scale (Mean)
Month 12 (N= 408)Month 24 (N= 263)
Open-label Treatment Phase2.622.38

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Percentage of Participants Who Discontinued Due to All Adverse Events

The percentage of participants who discontinued due to all causes other than sponsor terminating the trial was measured from the date of entering the open-label treatment phase to the date of ET for discontinued participants in the open-label treatment phase (ie, time to discontinuation = date of discontinuation [or date of completion for completed participants] - date of participant entering the open-label treatment phase + 1). If the participants completed the trial or were discontinued due to the sponsor terminating the trial, they were censored at the time of completion or trial termination, respectively. (NCT01122927)
Timeframe: Baseline to Month 24

Interventionpercentage of participants (Number)
From study NCT01149655 (N= 148)De Novo (N= 362)
Open-label Treatment Phase3.47.7

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Mean Change From Baseline by Week in Barnes Akathisia Rating Scale (BARS) Score

The BARS was an EPS rating scale. The BARS was used to assess the presence and severity of akathisia. This scale consists of 4 items. Only the 4th item, the Global Clinical Assessment of Akathisia, was evaluated in this trial. This item is rated on a 6 point scale, with 0 being best (absent) and 5 being worst (severe akathisia). (NCT01122927)
Timeframe: Baseline to Month 24

InterventionUnits on a scale (Mean)
Week 1 (N=487)Week 2 (N=507)Week 3 (N=507)Week 4 (N=507)Week 6 (N=507)Week 8 (N=507)Month 3 (N=507)Month 6 (N=507)Month 9 (N=506)Month 12 (N=507)Month 15 (N=360)Month 18 (N=360)Month 21 (N=360)Month 24 (N=360)
Open-label Treatment Phase-0.02-0.02-0.02-0.03-0.03-0.02-0.00-0.03-0.04-0.04-0.02-0.05-0.04-0.05

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Mean Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Overall General Subscore

The Q-LES-Q-SF is a self-report measure designed to enable investigators to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning with the help of 14 items of total 16 items of the scale. The overall general subscore is obtained using 14 items of the scale. Each item is scored on a 5-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. The raw scores are computed to an overall general subscore of 0 to 100 where lower scores indicate less enjoyment or satisfaction with the activity. A positive change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline, Week 8, 26 and End of the study visit (Week 43 or before)

,,,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 8Change from Baseline at Week 26Change from Baseline at End of Study visit (Week 43 or before)
Prior Aripiprazole47.96.26.24.6
Prior Aripiprazole/Escitalopram Combination Therapy49.40.80.81.0
Prior Escitalopram50.23.6-0.55.0
Prior Single-blind Escitalopram52.29.54.310.0

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Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Total Score

The SDS is a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all, to 10= extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The SDS Mean Score of 0 to 10 was calculated as an average of the three item scores. All three item scores needed to be available with the exception of the work/school item score when this item was not applicable. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline, Weeks 8, 26 and End of the study visit (Week 43 or before)

,,,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 8Change from Baseline at Week 26Change from Baseline at End of Study visit (Week 43 or before)
Prior Aripiprazole5.1-2.0-2.6-1.6
Prior Aripiprazole/Escitalopram Combination Therapy4.6-1.1-1.9-0.6
Prior Escitalopram4.3-0.81.7-0.5
Prior Single-blind Escitalopram3.8-1.4-0.7-1.6

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Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score

The SAS is a rating scale used to measure extrapyramidal symptoms (EPS). The SAS is a 10-item scale, with each item rated from 1 to 5, with 1 being normal and 5 being the worst. The SAS total score is the sum of ratings for all 10 items, with possible total scores from 10 to 50. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 4Change from Baseline at Week 8Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole10.30.0-0.1-0.30.00.1

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Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score

The AIMS is a 12-item scale. The first 10 -items are rated from 0 to 4 (0=best, 4=worst). An item score of 0, depending on the item, either means: no abnormal involuntary movement (AIM), or no incapacitation due to AIM, or no awareness of AIM. An item score of 4 either means: severe AIM, or severe incapacitation due to AIM, or being aware of, and severe distress caused by AIM. Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28, where a higher score indicates worst outcome. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

,,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 4Change from Baseline at Week 8Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at Week 32Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole/Escitalopram Combination Therapy0.1-0.1-0.10.00.00.0-0.0
Prior Escitalopram0.0-0.00.00.00.00.0-0.0
Prior Single-blind Escitalopram0.10.2-0.1-0.20.00.0-0.0

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Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities

Incidence of clinically relevant abnormal ECG values were reported as change from Baseline in heart rate (Tachycardia - ≥15 beats per minute (bpm), Bradycardia ≤15 bpm; Rhythm (Sinus tachycardia ≥15 bpm increase, Sinus bradycardia decrease of ≥15 bpm from Baseline); Presence of - supraventricular premature beat; ventricular premature beat; supraventricular tachycardia; ventricular tachycardia; atrial fibrillation and flutter. Conduction - Presence of primary, secondary or tertiary atrioventricular block, left bundle-branch block, right bundle-branch block, pre-excitation syndrome, other intraventricular conduction blocked QRS ≥0.12 second increase of ≥0.02 second. Acute, subacute or old Infarction, Presence of myocardial ischemia, symmetrical T-wave inversion. Increase in QTc - QTc ≥450 msec ≥10% increase. Any clinically significant change from Baseline assessed by the Investigator are reported. Only categories with at least 1 participant with event are reported. (NCT01123707)
Timeframe: Up to 40 weeks

,,,
InterventionParticipants (Count of Participants)
Bradycardia: Decrease of ≥15 bpmSinus Bradycardia: Decrease of ≥15 bpmSupraventricular Premature Beat: Not Present to PresentVentricular Premature Beat: Not Present to Present1° Atrioventricular Block: Increase of ≥0.05 secondRight Bundle-branch Block: Not Present to PresentMyocardial Ischemia: Not Present to PresentSymmetrical T-wave Inversion: Not Present to PresentQTcBQTcFQTcN
Prior Aripiprazole00110000221
Prior Aripiprazole/Escitalopram Combination Therapy11100113100
Prior Escitalopram00011001111
Prior Single-blind Escitalopram00000100010

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Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities

The laboratory values were one of the parameters to measure the safety and tolerability of individual participants. Participants with potentially clinically significant lab values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria were reported. Any value outside the normal range was flagged for the attention of the investigator who assessed whether or not a flagged value is of clinical significance. The categories with at least one participants with abnormal lab value as assessed by the Investigator are reported. (NCT01123707)
Timeframe: Up to 40 weeks

,,,
InterventionParticipants (Count of Participants)
Alanine Aminotransferase [Serum Glutamic Pyruvic Transaminase (SGPT)] [unit(U)/L]: >=3×ULNAspartate Aminotransferase [Serum Glutamic Oxaloacetic Transaminase (SGOT)] (U/L): >=3×ULNBilirubin, Total [mg/deciliter(dL)]: ≥2.0Cholesterol, Total, Fasting (mg/dL): ≥240Creatine phosphokinase (CPK), Total (U/L): ≥3 x ULNHigh-density Lipoprotein (HDL) Cholesterol, Fasting (mg/dL): ≤30Low-density Lipoprotein (LDL) Cholesterol, Fasting (mg/dL): ≥160Triglycerides, Fasting (mg/dL): Men ≥160; Women ≥120Urea Nitrogen (mg/dL); >= 30 mg/dLUric Acid (mg/dL): Men ≥10.5; Women ≥8.5Eosinophils (%): ≥10Hematocrit (%): Female ≤32%; Male: ≤37% or 3 point decrease from baselineHemoglobin (g/dL): Men ≤11.5; Women ≤9.5Prolactin [nanograms (ng)/mL]: >1 ULN
Prior Aripiprazole000502414100111
Prior Aripiprazole/Escitalopram Combination Therapy0001000624000011
Prior Escitalopram111910516001101
Prior Single-blind Escitalopram000811825010000

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Number of Participants With Potentially Clinically Significant Physical Examination Findings

(NCT01123707)
Timeframe: Up to 40 weeks

InterventionParticipants (Count of Participants)
Prior Aripiprazole/Escitalopram Combination Therapy0
Prior Escitalopram0
Prior Aripiprazole0
Prior Single-blind Escitalopram0

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Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score

The AIMS is a 12-item scale. The first 10 -items are rated from 0 to 4 (0=best, 4=worst). An item score of 0, depending on the item, either means: no abnormal involuntary movement (AIM), or no incapacitation due to AIM, or no awareness of AIM. An item score of 4 either means: severe AIM, or severe incapacitation due to AIM, or being aware of, and severe distress caused by AIM. Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28, where a higher score indicates worst outcome. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 4Change from Baseline at Week 8Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole0.10.00.00.00.0-0.0

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Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment of Akathisia (Item 4) Score

The BARS is used to assess the presence and severity of akathisia. This scale consists of 4 items. Only item 4, the 'Global Clinical Assessment of Akathisia', was evaluated for this outcome measure. This item is rated on a 6-point scale, with 0 being best (absent) and 5 being worst (severe akathisia). A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 4Change from Baseline at Week 8Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole0.40.0-0.1-0.40.0-0.1

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Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score

The SAS is a rating scale used to measure extrapyramidal symptoms (EPS). The SAS is a 10-item scale, with each item rated from 1 to 5, with 1 being normal and 5 being the worst. The SAS total score is the sum of ratings for all 10 items, with possible total scores from 10 to 50. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

,,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 4Change from Baseline at Week 8Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at Week 32Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole/Escitalopram Combination Therapy10.10.0-0.10.00.00.00.1
Prior Escitalopram10.00.30.20.00.00.00.3
Prior Single-blind Escitalopram10.10.1-0.0-0.3-0.3-0.7-0.0

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Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment of Akathisia (Item 4) Score

The BARS is used to assess the presence and severity of akathisia. This scale consists of 4 items. Only item 4, the 'Global Clinical Assessment of Akathisia', was evaluated for this outcome measure. This item is rated on a 6-point scale, with 0 being best (absent) and 5 being worst (severe akathisia). A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

,,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 4Change from Baseline at Week 8Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at Week 32Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole/Escitalopram Combination Therapy0.20.1-0.1-0.1-0.20.0-0.0
Prior Escitalopram0.10.30.3-0.2-0.5-1.00.3
Prior Single-blind Escitalopram0.10.2-0.0-0.30.0-0.30.0

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Mean Change From Baseline in Body Mass Index (BMI)

BMI= weight(kg)/[height(m)^2]. (NCT01123707)
Timeframe: Baseline, Week 26 and End of the study visit (Week 43 or before)

Interventionkg/m^2 (Mean)
BaselineChange from Baseline at Last Visit (Week 43 or before)
Prior Aripiprazole31.1-0.1

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Mean Change From Baseline in Body Mass Index (BMI)

BMI= weight(kg)/[height(m)^2]. (NCT01123707)
Timeframe: Baseline, Week 26 and End of the study visit (Week 43 or before)

,,
Interventionkg/m^2 (Mean)
BaselineChange from Baseline at Week 26Change from Baseline at Last Visit (Week 43 or before)
Prior Aripiprazole/Escitalopram Combination Therapy33.42.30.0
Prior Escitalopram30.90.4-0.1
Prior Single-blind Escitalopram30.71.20.4

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Mean Change From Baseline in Body Weight

(NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

,
Interventionkg (Mean)
BaselineChange from Baseline at Week 1Change from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8Change from Baseline at Week 14Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at Last Visit (Week 43 or before)
Prior Aripiprazole/Escitalopram Combination Therapy93.00.00.50.30.3-0.02.03.85.7-0.2
Prior Single-blind Escitalopram84.70.10.40.20.30.20.61.43.31.0

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Mean Change From Baseline in Body Weight

(NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

Interventionkg (Mean)
BaselineChange from Baseline at Week 1Change from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8Change from Baseline at Week 14Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at Week 32Change from Baseline at Last Visit (Week 43 or before)
Prior Escitalopram88.30.10.20.40.1-0.5-0.92.01.4-3.60.1

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Mean Change From Baseline in Body Weight

(NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

Interventionkg (Mean)
BaselineChange from Baseline at Week 1Change from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8Change from Baseline at Week 14Change from Baseline at Week 20Change from Baseline at Last Visit (Week 43 or before)
Prior Aripiprazole87.00.10.20.40.30.40.70.40.1

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Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score

The severity of illness was rated using a 7-point CGI-S. CGI-S scores range from 1 to 7, where 1=normal, not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill participants. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 1Change from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8Change from Baseline at Week 14Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at End of the Study Visit (Week 43 or before)
Prior Aripiprazole3.4-0.2-0.4-0.6-0.5-0.7-1.0-1.2-1.0-0.7

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Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score

The severity of illness was rated using a 7-point CGI-S. CGI-S scores range from 1 to 7, where 1=normal, not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill participants. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

,,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 1Change from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8Change from Baseline at Week 14Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at Week 32Change from Baseline at End of the Study Visit (Week 43 or before)
Prior Aripiprazole/Escitalopram Combination Therapy3.1-0.0-0.3-0.1-0.3-0.3-0.3-0.6-0.8-1.0-0.2
Prior Escitalopram3.4-0.2-0.3-0.5-0.5-0.5-0.6-0.30.0-2.0-0.6
Prior Single-blind Escitalopram3.2-0.4-0.9-0.9-0.9-0.7-0.7-0.9-1.3-2.0-0.9

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Mean Change From Baseline in Each Item as Measured by Massachusetts General Hospital Sexual Functioning Inventory (MGH SFI) Subscale Score

The MGH SFI is a measure of a participant's self-reported sexual functioning. The MGH SFI included 5 questions at the baseline assessment, each addressing experiences over the last month: Question a) interest in sex, Question b) ability to get sexually aroused, Question c) ability to achieve orgasm, Question d) ability to get and maintain an erection, and Question e) overall sexual satisfaction. The MGH SFI at post-baseline visits included one additional question: Question f) overall improvement since the last medication change. Each question/item is rated from 1 through 6. For questions a) through e), a score of 1 indicates 'greater than normal', and 6 'totally absent'. For question f), a score of 1 indicates 'very much improved', and 6 'much worse'. All question scores are analyzed separately. No total or mean score is derived. Each subscale score ranges from 0 to 6, higher scores indicates worsening. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline, Weeks 8, 26 and End of the study visit (Week 43 or before)

,,,
Interventionscore on a scale (Mean)
Question a: BaselineQuestion a: Change from Baseline at Week 8Question a: Change from Baseline at Week 26Question a: Change from Baseline at End of Study Visit (Week 43 or before)Question b: BaselineQuestion b: Change from Baseline at Week 8Question b: Change from Baseline at Week 26Question b: Change from Baseline at End of Study Visit (Week 43 or before)Question c: BaselineQuestion c: Change from Baseline at Week 8Question c: Change from Baseline at Week 26Question c: Change from Baseline at End of Study Visit (Week 43 or before)Question d: BaselineQuestion d: Change from Baseline at Week 8Question d: Change from Baseline at Week 26Question d: Change from Baseline at End of Study Visit (Week 43 or before)Question e: BaselineQuestion e: Change from Baseline at Week 8Question e: Change from Baseline at Week 26Question e: Change from Baseline at End of Study Visit (Week 43 or before)Question f: BaselineQuestion f: Change from Baseline at Week 8Question f: Change from Baseline at Week 26Question f: Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole4.4-0.4-0.4-0.44.1-0.10.0-0.24.1-0.1-0.20.03.6-0.40.00.14.4-0.3-0.4-0.33.40.20.4-0.0
Prior Aripiprazole/Escitalopram Combination Therapy4.2-0.1-0.2-0.13.90.00.20.14.0-0.1-0.2-0.02.50.00.00.14.2-0.1-0.4-0.13.30.1-1.0-0.0
Prior Escitalopram3.8-0.40.0-0.33.7-0.20.0-0.33.8-0.30.0-0.43.00.00.50.03.9-0.30.5-0.33.5-0.30.0-0.2
Prior Single-blind Escitalopram3.6-0.30.0-0.43.5-0.3-0.2-0.33.5-0.2-0.2-0.12.9-0.20.0-0.13.7-0.20.0-0.33.6-0.7-0.8-0.6

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Mean Change From Baseline in Laboratory Test Results: Hemoglobin A1c (HbA1c)

The HbA1c is also known as glycosylated hemoglobin. It is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound. The mean change in the value of HbA1c was analyzed relative to Baseline. The HbA1c of <6.0% signifies the normal blood glucose level. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline, Week 8, and End of the study visit (Week 43 or before)

Interventionpercentage of HbA1c (Mean)
Mean Change from Baseline at Last Visit (Week 43 or before)
Prior Aripiprazole/Escitalopram Combination Therapy-0.30

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Mean Change From Baseline in Laboratory Test Results: Hemoglobin A1c (HbA1c)

The HbA1c is also known as glycosylated hemoglobin. It is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound. The mean change in the value of HbA1c was analyzed relative to Baseline. The HbA1c of <6.0% signifies the normal blood glucose level. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline, Week 8, and End of the study visit (Week 43 or before)

Interventionpercentage of HbA1c (Mean)
Mean Change from Baseline at Week 8Mean Change from Baseline at Last Visit (Week 43 or before)
Prior Escitalopram0.300.30

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Mean Change From Baseline in Laboratory Test Results: Prolactin

Prolactin is a hormone released by the pituitary gland. The prolactin test measures the amount of prolactin in the blood. Prolactin is responsible for the breast growth and milk production during pregnancy and after birth. The normal prolactin levels range from 20 to 25 ng/mL in males and females and 80 to 400 ng/mL in pregnant women. A negative mean change from Baseline indicates reduction in the prolactin levels. (NCT01123707)
Timeframe: Baseline, Weeks 8, 26, and End of the study visit (Week 43 or before)

Interventionng/mL (Mean)
Mean Change from Baseline at Week 8Mean Change from Baseline at Week Last Visit (Week 43 or before)
Prior Aripiprazole0.620.30

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Mean Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) Total Score

The CPFQ is a brief self-rated scale developed to measure cognitive and executive dysfunction in mood and anxiety disorders. It consists of 7 items. The CPFQ total score ranges from 7 to 42, with higher score representing less satisfaction in cognitive and physical functioning. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline, Weeks 8, 26 and End of the study visit (Week 43 or before)

,,,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 8Change from Baseline at Week 26Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole24.4-2.2-2.2-2.6
Prior Aripiprazole/Escitalopram Combination Therapy23.0-1.3-3.8-1.0
Prior Escitalopram22.1-1.82.0-0.2
Prior Single-blind Escitalopram22.0-4.8-2.5-3.5

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Mean Change From Baseline in Patient Global Impression - Severity of Depression Scale (PGI-S) Score

The severity of illness was rated using a 7-point PGI-S. PGI-S scores range from 1 to 7, where 1=not depressed at all, 2=only occasionally depressed to a mild degree, 3=mildly depressed half the time, 4=moderately depressed most of the time, 5=moderately depressed almost all of the time, 6=severely depressed all the time, 7=extremely depressed all the time. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 1Change from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8Change from Baseline at Week 14Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole3.3-0.2-0.4-0.2-0.4-0.3-0.8-1.0-0.6-0.3

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Mean Change From Baseline in Patient Global Impression - Severity of Depression Scale (PGI-S) Score

The severity of illness was rated using a 7-point PGI-S. PGI-S scores range from 1 to 7, where 1=not depressed at all, 2=only occasionally depressed to a mild degree, 3=mildly depressed half the time, 4=moderately depressed most of the time, 5=moderately depressed almost all of the time, 6=severely depressed all the time, 7=extremely depressed all the time. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

,,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 1Change from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8Change from Baseline at Week 14Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at Week 32Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole/Escitalopram Combination Therapy2.80.1-0.20.0-0.1-0.2-0.1-0.40.00.0-0.1
Prior Escitalopram3.1-0.2-0.4-0.5-0.4-0.4-0.2-0.30.0-1.0-0.3
Prior Single-blind Escitalopram3.2-0.6-1.0-0.9-1.1-0.9-0.9-1.3-1.00.0-0.9

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Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs), Severe (Grade 3 or Higher) TEAEs, and Discontinuations From the Trial Due to TEAEs

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it did not necessarily have to have a causal relationship with this treatment. An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention. TEAE is defined as an adverse event that started after start of study drug treatment. The Common Terminology Criteria for Adverse Events v3.0 (CTCAE) was used to determine the severity wherein Grade 1=mild AE, Grade 2=moderate AE, Grade 3=severe AE, Grade 4=life-threatening or disabling AE, Grade 5=death related to AE. (NCT01123707)
Timeframe: From first dose up to 30 days post last dose (Up to approximately 40 weeks)

,,,
Interventionpercentage of participants (Number)
TEAEsSTEAEsSevere (Grade 3 or Higher) TEAEsDiscontinuations from the Trial due to TEAEs
Prior Aripiprazole75.00.05.613.9
Prior Aripiprazole/Escitalopram Combination Therapy54.52.30.011.4
Prior Escitalopram70.79.84.917.1
Prior Single-blind Escitalopram67.30.02.06.1

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Percentage of Participants With Suicidal Ideation in Each Item as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)

The suicidal ideation compared to Baseline was measured by an increase in suicidal ideation category (1-5 on the C-SSRS) during treatment from the maximum suicidal ideation category at Baseline, or any suicidal ideation during treatment if there is none at Baseline. C-SSRS is used to assess whether participant experienced suicidal ideation (Question 1: wish to be dead; Question 2: non-specific active suicidal thoughts; Question 3: active suicidal ideation with any methods (not plan) without intent to act; Question 4: active suicidal ideation with some intent to act, without specific plan; Question 5: active suicidal ideation with specific plan and intent). A negative change from Baseline indicates improvement. Only those categories and timepoints which have data are reported. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14 and Last Visit (Week 43 or before)

,,,
Interventionpercentage of participants (Number)
Question 1: BaselineQuestion 1: Week 1Question 1: Week 2Question 1: Week 4Question 1: Week 6Question 1: Week 8Question 1: Week 14Question 1: Last Visit (Week 43 or before)Question 2: Week 8Question 2: Week 14Question 2: Last Visit (Week 43 or before)Question 3: Week 14Question 3: Last Visit (Week 43 or before)
Prior Aripiprazole8.32.82.82.82.82.80.05.60.00.02.80.02.8
Prior Aripiprazole/Escitalopram Combination Therapy0.00.00.02.32.30.02.32.30.02.30.02.30.0
Prior Escitalopram12.22.42.44.94.90.00.02.40.00.00.00.00.0
Prior Single-blind Escitalopram4.10.00.00.00.02.00.00.02.00.00.00.00.0

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Mean Change From Baseline in Laboratory Test Results: Prolactin

Prolactin is a hormone released by the pituitary gland. The prolactin test measures the amount of prolactin in the blood. Prolactin is responsible for the breast growth and milk production during pregnancy and after birth. The normal prolactin levels range from 20 to 25 ng/mL in males and females and 80 to 400 ng/mL in pregnant women. A negative mean change from Baseline indicates reduction in the prolactin levels. (NCT01123707)
Timeframe: Baseline, Weeks 8, 26, and End of the study visit (Week 43 or before)

,,
Interventionng/mL (Mean)
Mean Change from Baseline at Week 8Mean Change from Baseline at Week 26Mean Change from Baseline at Week Last Visit (Week 43 or before)
Prior Aripiprazole/Escitalopram Combination Therapy0.52-0.790.37
Prior Escitalopram0.31-2.751.33
Prior Single-blind Escitalopram-1.10-0.75-0.49

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Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities

Criteria for potentially clinically significant vital sign abnormalities: Heart rate [beats per minute (BPM)]: >120, increase >=15, <50, decrease >=15; systolic blood pressure [millimeter of mercury (mmHg)]: >180, increase >=20, <90, decrease >=20; diastolic blood pressure (mmHg): >105, increase >=15, <50, decrease >=15; orthostatic hypotension: >=20 mmHg decrease in systolic blood pressure and >=25 bpm increase in heart rate from supine to sitting; weight (kg) gain: increase >=7%; or weight loss: decrease >=7%. Only categories with at least 1 participant with event are reported. (NCT01123707)
Timeframe: Up to 40 weeks

,,,
InterventionParticipants (Count of Participants)
Orthostatic Hypotension (mmHg)Weight (kg): Weight Gain >=7%Weight (kg): Weight Loss >=7%
Prior Aripiprazole121
Prior Aripiprazole/Escitalopram Combination Therapy045
Prior Escitalopram002
Prior Single-blind Escitalopram042

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Mean Change In Clinical Global Impression-Severity (CGI-S) of Illness Scale Score From Baseline To Last Visit

"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the rater or investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The Last Visit was defined as the last available post-baseline evaluation. A decrease in the CGI-S score indicated disease stability or improvement." (NCT01129882)
Timeframe: Baseline, Month 91

Interventionunits on a scale (Mean)
Aripiprazole IM Depot-0.14

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Number Of Participants Reporting Severe Treatment-Emergent Adverse Events (TEAE)

"A TEAE was defined as an AE that started after start of investigational medicinal product (IMP) treatment or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of IMP. A severe AE was one that caused inability to work or perform normal daily activity.~A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module." (NCT01129882)
Timeframe: Baseline to Month 97 (+/- 3 days)

Interventionparticipants (Number)
Aripiprazole IM Depot50

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Mean Change From Baseline to Endpoint in PANSS Positive Subscale.

The PANSS consisted of 3 subscales were a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated (absence of symptoms) and a score of 7 indicated (extremely severe symptoms). The 7 positive symptom constructs were delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). (NCT01149655)
Timeframe: Baseline to Week 52/End of Phase 3 visit.

,
InterventionUnits on a scale (Mean)
Week 1 (Aripiprazole N= 95, Placebo N= 45)Week 2Week 3Week 4Week 6Week 8Week 10Week 12Week 14Week 16Week 18Week 20Week 22Week 24Week 26Week 28Week 30Week 32Week 34Week 36Week 38Week 40Week 42Week 44Week 46Week 48Week 50Week 52
Aripiprazole-Double Blind Maintenance0.080.090.01-0.12-0.20-0.19-0.160.230.280.320.240.180.390.380.220.170.240.220.180.290.220.270.240.270.210.300.200.16
Placebo-Double Blind Maintenance0.07-0.040.560.581.101.561.631.962.272.172.152.442.602.652.582.562.602.712.582.482.462.442.352.332.422.292.332.31

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Mean Change From Baseline to Endpoint in PANSS Total Score.

The PANSS consisted of 3 subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale were positive subscale, negative subscale and general psychopathology subscale. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). (NCT01149655)
Timeframe: Baseline to Week 52/End of Phase 3 visit.

,
InterventionUnits on a scale (Mean)
Week 1 (Aripiprazole N= 95, Placebo N= 45)Week 2Week 3Week 4Week 6Week 8Week 10Week 12Week 14Week 16Week 18Week 20Week 22Week 24Week 26Week 28Week 30Week 32Week 34Week 36Week 38Week 40Week 42Week 44Week 46Week 48Week 50Week 52
Aripiprazole-Double Blind Maintenance0.220.09-0.36-0.64-1.20-1.62-1.20-0.19-0.18-0.78-0.68-0.57-0.31-0.36-0.88-0.85-0.96-0.99-1.12-0.55-0.84-0.92-1.14-0.96-1.02-0.99-1.19-1.31
Placebo-Double Blind Maintenance-0.27-0.581.811.562.923.713.904.525.505.565.576.066.105.925.815.655.606.215.795.405.215.104.944.884.834.674.714.79

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Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.

"Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items. OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of yes to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury." (NCT01149655)
Timeframe: Baseline to Week 52/End of Phase 3 visit.

,
Interventionpercentage of participants (Number)
CGI-I + PANSSCGI-I of 6 or 7HospitalizationSuicidal BehaviorViolent Behavior
Aripiprazole-Double Blind Maintenance16.3311.221.021.024.08
Placebo-Double Blind Maintenance33.3325.0010.420.0010.42

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Overall Relapse Rate (in Percent) From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse.

"The primary efficacy variable was overall relapse rate from randomization, as assessed by Clinical Global Impression of Improvement (CGI-I) score ≥5, Positive and Negative Syndrome Scale (PANSS) scores for hostility or uncooperativeness ≥5, or ≥20% increase in PANSS Total Score. Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content). OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of yes to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury." (NCT01149655)
Timeframe: Baseline to Week 52/End of Phase 3 visit.

Interventionrelapse rate(percentage of participants) (Number)
Aripiprazole-Double Blind Maintenance19.39
Placebo-Double Blind Maintenance37.50

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Mean Change From Baseline to Endpoint in CGI-S Score.

"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-s, the Investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0= not assessed; 1= normal, not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants." (NCT01149655)
Timeframe: Baseline to Week 52/End of Phase 3 visit.

,
InterventionUnits on a scale (Mean)
Week 1 (Aripiprazole N= 94, Placebo N= 45)Week 2 (N= 97, 48)Week 3Week 4Week 6Week 8Week 10Week 12Week 14Week 16Week 18Week 20Week 22Week 24Week 26Week 28Week 30Week 32Week 34Week 36Week 38Week 40Week 42Week 44Week 46Week 48Week 50Week 52
Aripiprazole-Double Blind Maintenance0.010.000.010.030.040.040.020.050.030.020.040.050.080.060.050.050.040.040.050.070.070.070.060.080.070.060.050.05
Placebo-Double Blind Maintenance0.020.020.130.100.150.190.250.310.350.330.350.400.380.350.350.330.330.310.290.290.290.290.290.310.310.290.270.29

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Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).

The CGAS was developed by Schaffer and colleagues to provide a global measure of severity of disturbance in children and adolescents. The CGAS is a rating scale for evaluating the overall functioning of a participant during a specified time period on a continuum from psychological or psychiatric sickness to health. The CGAS is a valid and reliable tool for rating a child's general level of functioning on a health-illness continuum. CGAS score (range 1-100) was a single item score for rating a child's general level of functioning on a health-illness continuum, with higher scores represented better functioning. (NCT01149655)
Timeframe: Baseline to Week 52/End of Phase 3 visit.

,
InterventionUnits on a scale (Mean)
Week 1 (Aripiprazole N= 95, Placebo N= 45)Week 2Week 3Week 4Week 6Week 8Week 10Week 12Week 14Week 16Week 18Week 20Week 22Week 24Week 26Week 28Week 30Week 32Week 34Week 36Week 38Week 40Week 42Week 44Week 46Week 48Week 50Week 52
Aripiprazole-Double Blind Maintenance0.00-0.100.350.290.400.981.111.081.061.571.551.281.171.331.611.731.921.862.051.872.001.901.901.832.132.172.292.35
Placebo-Double Blind Maintenance-0.09-0.31-1.04-1.23-2.08-2.40-2.31-2.85-3.52-2.69-2.90-4.06-3.77-3.67-3.69-3.75-3.44-3.33-3.00-3.10-2.85-2.85-2.69-2.67-2.67-2.40-2.31-2.25

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Mean Change From Baseline to Endpoint in PANSS Negative Subscale.

The PANSS consisted of 3 subscales were a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated (absence of symptoms) and a score of 7 indicated (extremely severe symptoms). The 7 negative symptom constructs were blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). (NCT01149655)
Timeframe: Baseline to Week 52/End of Phase 3 visit.

,
InterventionUnits on a scale (Mean)
Week 1 (Aripiprazole N= 95, Placebo N= 45)Week 2Week 3Week 4Week 6Week 8Week 10Week 12Week 14Week 16Week 18Week 20Week 22Week 24Week 26Week 28Week 30Week 32Week 34Week 36Week 38Week 40Week 42Week 44Week 46Week 48Week 50Week 52
Aripiprazole-Double Blind Maintenance0.03-0.07-0.39-0.27-0.42-0.41-0.33-0.38-0.41-0.51-0.47-0.47-0.43-0.42-0.54-0.51-0.56-0.52-0.64-0.47-0.62-0.64-0.77-0.72-0.68-0.73-0.80-0.78
Placebo-Double Blind Maintenance-0.09-0.230.480.440.900.770.710.791.151.191.191.101.060.790.810.830.670.980.560.650.540.540.420.460.350.330.290.40

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Percentage of Responders in Each Treatment Group.

Percentage of responders in each treatment group (i.e, response defined as meeting stability criteria). Participants stabilized on aripiprazole (trial drug) within the approved dose range of 10 to 30 mg/day and are tolerable based on clinical judgment. (NCT01149655)
Timeframe: Baseline to Week 52/End of Phase 3 visit

,
Interventionpercentage of participants (Number)
Week 1 (Arirpiprazole N= 95, Placebo N= 45)Week 2 (N= 91, 46)Week 3 (N= 86, 45)Week 4 (N= 91, 43)Week 6 (N= 87, 41)Week 8 (N= 82, 38)Week 10 (N= 74, 32)Week 12 (N= 71, 30)Week 14 (N= 68, 26)Week 16 (N= 65, 25)Week 18 (N= 59, 23)Week 20 (N= 57, 23)Week 22 (N= 55, 21)Week 24 (N= 51, 19)Week 26 (N= 48, 19)Week 28 (N= 42, 17)Week 30 (N= 40, 16)Week 32 (N= 39, 16)Week 34 (N= 38, 14)Week 36 (N= 36, 15)Week 38 (N= 33, 12)Week 40 (N= 29, 11)Week 42 (N= 27, 11)Week 44 (N= 21, 8)Week 46 (N= 18, 8)Week 48 (N= 17, 8)Week 50 (N= 17, 6)Week 52 (N= 14, 7)Last Visit (N= 98, 48)
Aripiprazole-Double Blind Maintenance96.892.393.093.490.897.694.694.494.196.994.994.792.798.097.997.695.094.994.794.4100.0100.0100.0100.088.994.188.2100.077.6
Placebo-Double Blind Maintenance97.895.786.790.792.789.593.893.392.396.091.391.395.2100.0100.0100.0100.093.8100.0100.0100.0100.0100.0100.0100.0100.0100.0100.064.6

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Percentage of Participants Who Had Achieved Remission.

Percentage of participants who had achieved remission, where remission was defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of 6 months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/ posturing, blunted affect, social withdrawal, and lack of spontaneity. (NCT01149655)
Timeframe: Baseline to Week 52/End of Phase 3 visit.

Interventionpercentage of participants (Number)
Aripiprazole-Double Blind Maintenance43.8
Placebo-Double Blind Maintenance42.1

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Mean CGI-I Score at Endpoint.

Baseline for the double-blind maintenance phase was defined as the last visit with available data in the stabilization phase, and the CGI-I scale was completed prior to or on the first dose date in the double-blind maintenance phase. Response choices included: 0 = not assessed; 1 = very much improved,;2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse. (NCT01149655)
Timeframe: Baseline to Week 52/End of Phase 3 visit.

,
InterventionUnits on a scale (Mean)
BaselineWeek 1 (Aripiprazole N= 94, Placebo N= 45)Week 2 (N= 97, 48)Week 3Week 4Week 6Week 8Week 10Week 12Week 14Week 16Week 18Week 20Week 22Week 24Week 26Week 28Week 30Week 32Week 34Week 36Week 38Week 40Week 42Week 44Week 46Week 48Week 50Week 52
Aripiprazole-Double Blind Maintenance2.403.493.483.473.603.533.463.383.453.443.323.353.403.433.413.413.433.443.463.473.483.453.453.453.453.463.463.433.42
Placebo-Double Blind Maintenance2.523.513.523.633.603.733.833.903.964.044.004.024.084.044.064.064.024.003.983.943.943.943.923.923.943.943.923.923.92

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Time to First Treatment Failure

Time to first treatment failure was the time from participant randomization to the first treatment failure, which was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. (NCT01157351)
Timeframe: From date of randomization up to Month 15

InterventionDays (Median)
Paliperidone Palmitate416
Oral Antipsychotics226

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Time to First Psychiatric Hospitalization or Arrest/Incarceration

A time to parameter looking only at 2 component events of treatment failure: arrest or incarceration, and psychiatric hospitalization. An arrest was defined as the taking of a participant into custody by legal authority, for any reason. Incarceration was defined as involuntary confinement by an officer of the law. Psychiatric hospitalization was an inpatient psychiatric hospitalization that occurred due to the participant's clinically significant worsening of symptoms of schizophrenia. (NCT01157351)
Timeframe: From date of randomization up to Month 15

InterventionDays (Median)
Paliperidone PalmitateNA
Oral Antipsychotics274

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Time to First Psychiatric Hospitalization

"A time-to parameter looking only at 1 component event of treatment failure: psychiatric hospitalization. Time to first psychiatric hospitalization was admission date of the psychiatric hospitalization recorded in the Assessment of Treatment Failure - Psychiatric Hospitalization." (NCT01157351)
Timeframe: From date of randomization up to Month 15

InterventionDays (Median)
Paliperidone PalmitateNA
Oral AntipsychoticsNA

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Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration

The PSP score assesses the degree of difficulty a participant exhibit over a 1 month period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The investigators rate participants' degree of difficulty in each of the 4 domains using a 6-point Likert scale (from 0=absent to 5=very severe). The domain ratings were then transformed to PSP total score ranging from 1 to 100. Higher PSP total scores denote better functioning. A score between 71 and 100 represents normal to mild degree of dysfunction; a score between 31 and 70 represents varying degree of difficulty; and a score <=30 represents poor function that requires intensive supervision. (NCT01157351)
Timeframe: Baseline up to Month 15

InterventionUnits on a scale (Least Squares Mean)
Paliperidone Palmitate5.75
Oral Antipsychotics5.36

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Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration

The CGI-S rating scale was a 7-point global assessment of symptom severity with scores determined by clinician as follows: 1=Not ill, 2=Very Mild, 3= Mild, 4= Moderate, 5= Marked, 6= Severe, and 7= Extremely Severe. The higher the score the worse the illness. (NCT01157351)
Timeframe: Baseline up to Month 15

InterventionUnits on a scale (Least Squares Mean)
Paliperidone Palmitate-0.48
Oral Antipsychotics-0.43

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Percentage of Participants in Each Event Category of First Treatment Failure

First treatment failure was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation (D/C) of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. Percentage of participants who experienced treatment failure due to any event and for each specific category of event were assessed. (NCT01157351)
Timeframe: From date of randomization up to Month 15

,
Interventionpercentage of participants (Number)
Treatment Failure Due to Any EventArrest/incarcerationPsychiatric hospitalizationD/C due to safety/tolerabilityTreatment supplementationD/C due to inadequate efficacyIncrease in level of psychiatric servicesSuicide
Oral Antipsychotics53.729.411.93.72.84.11.80
Paliperidone Palmitate39.821.28.06.62.20.41.30

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Aripiprazole Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR

Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞); measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL). (NCT01188668)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20

Interventionng*hr/mL (Geometric Mean)
Aripiprazole 5 mg (Period 1)1494
Aripiprazole 5 mg + DVS SR 100 mg (Period 2)1604

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Aripiprazole Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR

Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min). (NCT01188668)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20

InterventionmL/min (Geometric Mean)
Aripiprazole 5 mg (Period 1)55.76
Aripiprazole 5 mg + DVS SR 100 mg (Period 2)51.92

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Aripiprazole Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR

Calculated as Dose / (AUCinf * kel); where kel=terminal phase rate constant. (NCT01188668)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20

Interventionliters (Geometric Mean)
Aripiprazole 5 mg (Period 1)397.3
Aripiprazole 5 mg + DVS SR 100 mg (Period 2)368.1

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Dehydro-aripiprazole (Metabolite) Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR

Time for maximum observed plasma concentration. (NCT01188668)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20

Interventionhours (Median)
Aripiprazole 5 mg (Period 1)59.9
Aripiprazole 5 mg + DVS SR 100 mg (Period 2)71.9

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Plasma Aripiprazole Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg + Aripiprazole 5 mg

Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0. (NCT01188668)
Timeframe: Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing

,
Interventionng/mL (Median)
0 hour0.5 hour post dose1 hour post dose2 hours post dose3 hours post dose4 hours post dose6 hours post dose8 hours post dose12 hours post dose16 hours post dose24 hours post dose48 hours post dose72 hours post dose120 hours post dose168 hours post dose216 hours post dose264 hours post dose312 hours post dose
Aripiprazole 5 mg (Period 1)NA0.480010.6923.4021.7521.3518.9516.6513.6511.5010.708.3106.2553.6802.3901.7301.0800.8040
Aripiprazole 5 mg + DVS SR 100 mg (Period 2)0.12901.2209.54521.7024.4025.4020.7018.0013.8012.5012.208.9406.8704.0002.7201.9601.3401.010

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Dehydro-aripiprazole (Metabolite) Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR

(NCT01188668)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing

Interventionng/mL (Geometric Mean)
Aripiprazole 5 mg (Period 1)3.007
Aripiprazole 5 mg + DVS SR 100 mg (Period 2)3.185

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Dehydro-aripiprazole (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR

Dehydro-aripiprazole is a metabolite of Aripiprazole. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). (NCT01188668)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20

Interventionng*hr/mL (Geometric Mean)
Aripiprazole 5 mg (Period 1)695.9
Aripiprazole 5 mg + DVS SR 100 mg (Period 2)685.8

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Aripiprazole Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR

Time for maximum observed plasma concentration. (NCT01188668)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20

Interventionhours (Median)
Aripiprazole 5 mg (Period 1)3.00
Aripiprazole 5 mg + DVS SR 100 mg (Period 2)4.00

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Dehydro-aripiprazole (Metabolite) Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR

Terminal half-life is the time measured for the plasma concentration to decrease by one half. (NCT01188668)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20

Interventionhours (Mean)
Aripiprazole 5 mg (Period 1)97.78
Aripiprazole 5 mg + DVS SR 100 mg (Period 2)94.27

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Aripiprazole Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR

Terminal half-life is the time measured for the plasma concentration to decrease by one half. (NCT01188668)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20

Interventionhours (Mean)
Aripiprazole 5 mg (Period 1)85.17
Aripiprazole 5 mg + DVS SR 100 mg (Period 2)84.18

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Plasma Dehydro-aripiprazole (Metabolite) Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg, Aripiprazole 5 mg

Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0. (NCT01188668)
Timeframe: Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing

,
Interventionng/mL (Median)
0 hour0.5 hour post dose1 hour post dose2 hours post dose3 hours post dose4 hours post dose6 hours post dose8 hours post dose12 hours post dose16 hours post dose24 hours post dose48 hours post dose72 hours post dose120 hours post dose168 hours post dose216 hours post dose264 hours post dose312 hours post dose
Aripiprazole 5 mg (Period 1)NA0.00000.27400.94701.2601.4951.6501.7801.8452.0102.5203.1352.9352.4401.9201.5701.0800.8660
Aripiprazole 5 mg + DVS SR 100 mg (Period 2)0.16400.21200.59651.2401.6601.8801.9101.9101.9501.9702.5503.1603.0202.3601.9801.4601.1300.9680

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Aripiprazole Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR

Cmax measured as nanograms per milliliters (ng/mL). (NCT01188668)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20

Interventionng/mL (Geometric Mean)
Aripiprazole 5 mg (Period 1)24.66
Aripiprazole 5 mg + DVS SR 100 mg (Period 2)24.69

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Percentage of Patients Relapsing by Week 16

"Time of relapse=date when patient meets relapse criteria. There are 4 definitions for relapse: 1. Patient meets the following criteria for 2 consecutive visits: (a) Aberrant Behavior Checklist Irritability score ≥25% than score at end of Phase 1 AND (b) Clinical Global Impression Improvement scale rating of 'Much Worse' or 'Very Much Worse' relative to rating at end of Phase 1. If relapse criteria met at 1 visit, 2nd visit should occur in about 1 week to reevaluate whether relapse criteria are still met. 2. Patient discontinues for Lost to Follow-up after a visit in which he or she met Definition 1 criteria (a&b). 3. Patient begins a prohibited drug (whether a study investigator or outside source prescribed) to treat worsening symptoms of irritability of autistic disorder after a visit where patient met Definition 1 criteria (a&b). 4. Patient discontinues due to hospitalization for worsening symptoms of irritability or due to lack of efficacy based on investigator's assessment." (NCT01227668)
Timeframe: From end of Phase 1 (Date of randomization) to Week 16 of Phase 2 and end of treatment

InterventionPercentage of participants (Number)
Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)32
Placebo50

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Adjusted Mean Change From Baseline to Week 16 on the Aberrant Behavior Checklist Irritability (ABC-I) Subscale Score (Last Observation Carried Forward [LOCF])

ABC is an informant-based checklist used to assess and classify problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0=not at all a problem to 3=the problem is severe in degree), and resolve into 5 subscales: 1) irritability, agitation; 2) lethargy, social withdrawal; 3) stereotypic behavior; 4) hyperactivity, noncompliance; and 5) inappropriate speech. The ABC can be completed by parents, special educators, psychologists, direct caregivers, nurses, and others knowing the participant. Psychometric assessment of the ABC indicates that its subscales have high internal consistency, adequate reliability, and established validity. The ABC-I Subscale Score ranges from 0 to 45, with a negative change in score signifying improvement. LOCF data set includes data recorded at a given visit or, if no observation was recorded at that visit, data carried forward from the prior visit. chg=change; BL=baseline; APR=aripiprazole; vs=versus. (NCT01227668)
Timeframe: From Baseline (end of Phase 1) to Week 16 of Phase 2

InterventionUnits on a scale (Mean)
Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)5.2
Placebo9.6

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Change From Baseline in Mean Clinical Global Impression Improvement (CGI-I) Scale Score at Week 16 (Last Observation Carried Forward [LOCF])

CG-I rating scale permits global evaluation of patient's improvement over time. At baseline (BL), CGI Severity of Illness assessment is performed, in which the clinician rates severity of patient's condition on a 7-point scale ranging from 1=no symptoms to 7=very severe symptoms. Higher total score=worse symptoms. At subsequent visits, clinician assesses patient's improvement relative to symptoms at baseline on CGI-I 7-point scale ranging from 1=very much improved to 7=very much worse. Since the drug targets irritability symptoms, the CGI focuses on severity of irritability secondary to autistic disorder. Lower score=more improved symptoms. LOCF data set includes data recorded at a given visit or, if nothing recorded, data areccarried forward from the prior visit. For secondary endpoints (endpt), hierarchical testing was used to keep overall experiment-wise type I error rate to <=0.05. diff=difference; IS=irritability scale; PA=primary analysis; signif=significance/significantly. (NCT01227668)
Timeframe: From Baseline (end of Phase 1) to Week 16 of Phase 2

InterventionUnits on a scale (Mean)
Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)4.2
Placebo4.8

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Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation During Phase 1

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. (NCT01227668)
Timeframe: Weekly from Week 1 to Week 26 and continuously to end of treatment

InterventionParticipants (Number)
DeathSAEsAEs leading to discontinuation
Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)0113

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Total Number of Drinks Per Day During Natural (Usual Environment) Conditions

"Natural alcohol consumption period -- drinks per day consumed during the 6-day observation period" (NCT01292057)
Timeframe: 6-day observation period

Interventionstandard drinks (Mean)
Aripiprazole5.8
Sugar Pill6.4

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Total Number of Drinks Consumed in Bar Lab

"This measure refers to a bar lab paradigm in which individuals received an initial priming drink of alcohol, targeted to produce a breath alcohol concentration (BrAC) of 30 mg%, and could then choose to consume up to 8 additional drinks, each targeted to produce a BrAC of 15 mg%, during the subsequent 2 hours. Thus, the total number of drinks consumed could range between 0 and 8." (NCT01292057)
Timeframe: 2 hours during the bar lab paradigm

Interventionbar lab drinks (Mean)
Aripiprazole3.3
Sugar Pill4.5

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Change From Baseline to 24 Weeks in Body Weight

Mixed model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigator, visit, prior olanzapine use, treatment-by-visit interaction and baseline-by-visit interaction. (NCT01328093)
Timeframe: Baseline, 24 weeks

Interventionkilograms (kg) (Least Squares Mean)
LY2140023-DB-2.8
Aripiprazole-DB0.4

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Change From Baseline up to 24 Weeks in 16-Item Negative Symptom Assessment (NSA-16)

"The NSA-16 scale is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates participants on 16 anchors. Each item (anchor) is rated from 1 (better) to 6 (worse). The NSA-16 Total Score is the sum of the 16 specific items and ranges from 16 to 96. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction." (NCT01328093)
Timeframe: Baseline, 24 weeks

Interventionunits on a scale (Least Squares Mean)
LY2140023-DB-6.22
Aripiprazole-DB-6.37

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Change From Baseline up to 24 Weeks in Abnormal Involuntary Movement Scale (AIMS)

AIMS is a 12-item scale designed to record the occurrence of dyskinetic movements. Items 1 to 10 are rated on a 5- point scale: 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 11 and 12 are yes/no questions regarding the dental condition of a participant. The AIMS 1-7 Total Score is the sum of Items 1 through 7 of the AIMS, and ranges from 0 to 28. Higher scores indicate greater severity of illness. Only AIMS 1-7 Total Score was analyzed and presented. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction. (NCT01328093)
Timeframe: Baseline, 24 weeks

Interventionunits on a scale (Least Squares Mean)
LY2140023-DB-0.11
Aripiprazole-DB-0.10

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Change From Baseline up to 24 Weeks in Barnes Akathisia Scale (BAS)

The BAS is a 4-item instrument that evaluates akathisia associated with use of antipsychotic medications. Item 4 Global Clinical Assessment of Akathisia is rated on a 6- point scale, with scores range from 0 (no symptoms) to 5 (increased severity of symptoms); Only Item 4 was analyzed and presented. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction. (NCT01328093)
Timeframe: Baseline, 24 weeks

Interventionunits on a scale (Least Squares Mean)
LY2140023-DB0.00
Aripiprazole-DB-0.04

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Change From Baseline up to 24 Weeks in Clinical Global Impression-Severity Scale (CGI-S)

The CGI-S instrument is used to record the severity of mental illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction. (NCT01328093)
Timeframe: Baseline, 24 weeks

Interventionunits on a scale (Least Squares Mean)
LY2140023-DB-0.51
Aripiprazole-DB-0.69

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Change From Baseline up to 24 Weeks in Personal and Social Performance (PSP) Score

The PSP scale is a 100-point (minimum 1, maximum 100), single item, clinician-rated scale to assess a participant's overall functioning, including personal and social relationships, socially useful activities, self-care, and disturbing and aggressive behaviors. Higher scores indicate a higher level of functioning. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction. (NCT01328093)
Timeframe: Baseline, 24 weeks

Interventionunits on a scale (Least Squares Mean)
LY2140023-DB5.9
Aripiprazole-DB6.4

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Change From Baseline up to 24 Weeks in Simpson-Angus Scale (SAS)

The SAS is used to measure Parkinsonian-type symptoms in participants exposed to antipsychotics. SAS consists of 10 items, each rated on a 5-point scale: 0 (complete absence of the condition) to 4 (presence of the condition in extreme form). The SAS Total Score is obtained by adding the ten items, and ranges from 0 to 40. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment by-visit-interaction and baseline-by-visit interaction. (NCT01328093)
Timeframe: Baseline, 24 weeks

Interventionunits on a scale (Least Squares Mean)
LY2140023-DB-0.17
Aripiprazole-DB-0.20

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Change From Baseline up to 24 Weeks in Subjective Well-Being Under Neuroleptic Treatment Scale- Short Form (SWN-SF) Total Score

The SWN-SF measures subjective well-being of the participant for the previous 7 days. The 20-item scale covers 5 health domains (subscales; 4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Each of the 5 subscale scores range from 4 to 24. SWN-SF Total Scores range from 20 to 120. Higher scores indicate greater well-being. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction. (NCT01328093)
Timeframe: Baseline, 24 weeks

Interventionunits on a scale (Least Squares Mean)
LY2140023-DB4.6
Aripiprazole-DB5.3

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Number of Participants With 30% or Greater Decrease in Positive and Negative Syndrome Scale (PANSS) Total Score

The PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (absence of symptoms) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210. Higher scores indicate greater severity of illness. Data presented are the number of participants with 30% or greater decrease from baseline in PANSS Total score. (NCT01328093)
Timeframe: Baseline up to 24 weeks

Interventionparticipants (Number)
LY2140023-DB133
Aripiprazole-DB49

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Schizophrenia Resource Use Module (S-RUM) - Number of Sessions With a Psychiatrist

The S-RUM is a 31-item questionnaire to assess the participant's occupation (work and home), living arrangements, encounters with law enforcement, victimization, emergency room (ER) visits, and outpatient medical visits for a specified period of time. Item 4 asks about the number of sessions with a psychiatrist a participant had. Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for pooled investigator, gender and treatment. (NCT01328093)
Timeframe: Baseline to 24 weeks

Interventionsessions (Least Squares Mean)
LY2140023-DB0.39
Aripiprazole-DB0.41

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Time to Discontinuation

The time to discontinuation due to any reason was defined as the total number of days between randomization and discontinuation date. The time to discontinuation was analyzed using Kaplan-Meier estimated survival curves. Participants who completed the study were considered censored. (NCT01328093)
Timeframe: Randomization up to 24 weeks

Interventiondays (Median)
LY2140023-DB140
Aripiprazole-DB169

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Change From Baseline up to 24 Weeks in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores

The PANSS consists of 30 items and 3 subscales and is designed to measure severity of psychopathology in schizophrenia. The PANSS Positive Subscale and the PANSS Negative Subscale each contain 7 items, and the remaining 16 items make up the PANSS General Psychopathology Subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). The PANSS Total Score is the sum of the 30 items, with scores range from 30 to 210. The PANSS Positive Subscale and PANSS Negative Subscale scores each range from 7 to 49. The PANSS General Psychopathology subscale score ranges from 16 to 112. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction. (NCT01328093)
Timeframe: Baseline, 24 weeks

,
Interventionunits on a scale (Least Squares Mean)
PANSS Total ScorePANSS Positive ScorePANSS Negative ScorePANSS General Psychopathology Score
Aripiprazole-DB-15.58-4.62-3.34-7.85
LY2140023-DB-12.03-3.40-2.98-5.80

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Number of Participants With Suicidal Behaviors and Ideations Measured by Columbia Suicide Severity Rating Scale (C-SSRS)

"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Data presented are the number of participants with treatment-emergent suicidal ideation or behavior during the treatment period (with a change from lead-in baseline in C-SSRS)." (NCT01328093)
Timeframe: Baseline to 24 weeks

,
Interventionparticipants (Number)
Treatment-Emergent Suicidal IdeationTreatment-Emergent Suicidal Behavior
Aripiprazole-DB70
LY2140023-DB467

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Percentage of Participants With Clinically Significant Weight Change

Clinically significant change in body weight is defined as either an increase or decrease in weight of ≥7% from baseline. (NCT01328093)
Timeframe: Baseline up to 24 weeks

,
Interventionpercentage of participants (Number)
≥7% Increase≥7% Decrease
Aripiprazole-DB7.13.2
LY2140023-DB4.113.1

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Schizophrenia Resource Utilization Module (S-RUM) - Number of Emergency Room (ER) or Equivalent Facility Visits and Outpatient Medical Visits

The S-RUM is a 31-item questionnaire to assess the participant's occupation (work and home), living arrangements, encounters with law enforcement, victimization, ER visits, and outpatient medical visits for a specified period of time. Item 1 asks about the number of ER or equivalent facility visits a participant had for psychiatric (psych) illness. Item 2 asks about the number of ER or equivalent facility visits a participant had for non-psychiatric (non-psych) illness or injury. Item 5 asks about the number of outpatient visits to other physicians (not psychiatrists or dentists). Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for pooled investigator, gender and treatment. (NCT01328093)
Timeframe: Baseline to 24 weeks

,
Interventionvisits (Least Squares Mean)
ER/Facility (Psych) visitsER/Facility (Non-Psych) visitsOutpatient (Non-Psych or Dentist) visits
Aripiprazole-DB0.040.020.30
LY2140023-DB0.060.060.28

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Change From Baseline up to 24 Weeks in EuroQol-5 Dimensions Questionnaire (EQ-5D) Visual Analog Scale (VAS) Health State Score

The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument that contains 2 parts: a health status profile and a visual analog scale (VAS) to rate global health-related quality of life. VAS health state scores range from 0 (worst imaginable health state) to 100 (best imaginable health state). The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction. (NCT01328093)
Timeframe: Baseline, 24 weeks

Interventionunits on a scale (Least Squares Mean)
LY2140023-DB4.2
Aripiprazole-DB3.1

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Changes in the Irritability Subscale of the Larger ABC (Abberent Behavior Checklist) That Occur From Baseline to 10 Weeks

"Multi-center, blinded clinical trial to evaluate biomarkers as predictors of efficacy and safety in children with autistic disorder to risperidone, an atypical antipsychotic drug and aripiprazole, an antipsychotic having a unique clinical and receptor-binding profile.~The major outcome measure was the score on the Irritability subscale of the Aberrant Behavior Checklist (ABC-I) . The ABC has 58 items describing some aspect of behavior and the Irritability sub-scale has 15 items, each completed by a parent or caregiver under the supervision of an investigator. Scores on each item range from 0 = no problem and 3 = severe problem (range of total scores 0 to 45). A fall in scores indicates behavioral improvement." (NCT01333072)
Timeframe: baseline to 10 weeks

Interventionunits on a scale (Mean)
Risperidone12.7
Aripiprazole14.1

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To Test Whether Adjunctive Aripiprazole Will Improve Quality/Perceived Quality of Life.

We will measure if patients' symptoms improve, improvement in their sexual dysfunction or distress and if they feel better with the elimination of the side effects. We hypothesize that aripiprazole will improve psychiatric symptoms, quality of life, sexual functioning and perceived wellness relative to placebo in women stabilized on risperidone (or paliperidone). (NCT01338298)
Timeframe: 16 Weeks

InterventionParticipants (Count of Participants)
Aripiprazole7
Placebo1

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Percentage of Participants With Worsening Severity From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)

"The Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Increases or higher scores indicate a worsening of symptoms.~The classification includes 0 = None, 1 = Minimal, may be extreme normal, 2 = Mild, 3 = Moderate, and 4 - Severe.~Only incidences of selected shifts of worsening severity (an increase in numbers on a scale within the 10-item construct) were reported for participants.~Part B of this study was not conducted; therefore, no data are available for analysis." (NCT01354353)
Timeframe: Baseline through Day 17 for Part A

,,,,,
InterventionPercentage of participants with shifts (Number)
Normal to Minimal - JawNormal to Minimal - Muscles of facial expression
160 mg LY214002300
240 mg LY214002300
320 mg LY21400239.10
400 mg LY214002309.1
480 mg LY214002300
Aripiprazole00

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Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests)

"Participants with at least 1 postdose (Day 10 through the end of study visit [Day 21]) treatment emergent adverse event (TEAE) were counted by dose cohort.~A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module." (NCT01354353)
Timeframe: Baseline up to Day 21 for Part A

,,,,,
Interventionparticipants (Number)
Days 10-16Follow-up (Days 17-20)End of Study (Day 21)
160 mg LY2140023621
240 mg LY2140023921
320 mg LY21400231121
400 mg LY21400231100
480 mg LY21400231121
Aripiprazole541

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Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Scale (BAS)

"Barnes Akathisia Rating Scale (BAS) evaluates observable, restless movements of drug-induced akathisia associated with use of antipsychotic medications, includes objective (1-item) and subjective component (2-items, awareness of movement and distress related to movement) plus Global Clinical Assessment for overall disorder. Components were rated on a 4-point scale for the objective (0 = normal and 3 = constantly restless) and subjective items ((0 = absence of inner restlessness and 3 = awareness of intense compulsion to move for one item; and 0 = no distress and 3 = severe for the other item) and scored on a 6-point scale for the Global Clinical Assessment (0 = absent and 5 = severe). Increases or higher scores indicate a worsening of symptoms.~Only incidences of selected shifts of worsening symptoms (an increase in numbers on a scale within the components) were reported for participants.~Part B of this study was not conducted; therefore, no data are available for analysis." (NCT01354353)
Timeframe: Baseline through Day 17 for Part A

,,,,,
InterventionPercentage of participants with shifts (Number)
Objective - Normal to presence restless movementsSubjective - Awareness - Absence to non-specificSubjective - Distress - No distress to mildGlobal - Absent to questionable
160 mg LY21400230000
240 mg LY214002310.010.010.010.0
320 mg LY214002309.109.1
400 mg LY214002309.109.1
480 mg LY214002309.109.1
Aripiprazole0006.3

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Part A: Pharmacokinetics, Area Under the Concentration - Time Curve (AUC)

The Day 10 parameter is area under the concentration versus time curve from time zero to infinity (AUC[0-inf]) post-single dose of LY2140023. The Day 16 parameter is area under the concentration versus time curve in a dosing interval (AUC[0-tau]) post-repeated daily doses of LY2140023. (NCT01354353)
Timeframe: Pre-dose and post-dose on Day 10 and Day 16

,,,,
Interventionnanograms*hours/milliliter (ng*hr/mL) (Geometric Mean)
Day 10 (single dose) (n=5, 7, 9, 9, 6)Day 16 (multiple doses) (n=4, 9, 7, 11, 4)
160 mg LY214002328004370
240 mg LY214002362906220
320 mg LY214002381007930
400 mg LY2140023106009890
480 mg LY21400231470010100

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Percentage of Participants With Increasing Impairment From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Simpson-Angus Scale (SAS)

"Simpson-Angus Scale (SAS) is used to measure Parkinsonian-type symptoms in participants exposed to antipsychotics. The scale consists of 10 items each rated on a 5-point scale, with 0 meaning complete absence of the condition and 4 meaning the presence of the condition in extreme form. The total score is obtained by adding the items. Increases or higher scores indicate a worsening of impairment.~Only incidences of selected shifts of increasing impairment (an increase in numbers on a scale within the 10-symptom construct) were reported for participants.~Part B of this study was not conducted; therefore, no data are available for analysis." (NCT01354353)
Timeframe: Baseline through Day 17 for Part A

,,,,,
InterventionPercentage of participants with shifts (Number)
Normal to Slight - GaitNormal to Slight - Head droppingNormal to Slight - TremorNormal to Slight - SalivationNormal to Slight - Glabella tap
160 mg LY214002300000
240 mg LY21400230010.000
320 mg LY2140023009.109.1
400 mg LY214002300000
480 mg LY2140023009.100
Aripiprazole6.36.312.56.30

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Part A: Pharmacokinetics, Maximum Concentration (Cmax)

(NCT01354353)
Timeframe: Pre-dose and post-dose on Day 10 and Day 16

,,,,
Interventionnanograms/milliliter (ng/mL) (Geometric Mean)
Day 10 (single dose)Day 16 (multiple doses)
160 mg LY2140023496799
240 mg LY214002311701090
320 mg LY214002314101510
400 mg LY214002318301760
480 mg LY214002326301810

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Percentage of Participants With Increased Severity From Baseline to Day 17 in Clinical Global Impression- Severity Scale (CGI-S)

"Clinical Global Impression- Severity Scale (CGI-S) measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The classification includes 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, and 7 = Among the most extremely ill patients. Increases or higher scores indicate increasing severity (=worse outcome) Only incidences of selected shifts of increasing severity (an increase in numbers on a scale) were reported for participants.~Part B of this study was not conducted; therefore, no data are available for analysis." (NCT01354353)
Timeframe: Baseline through Day 17 for Part A

,,,,,
Interventionpercentage of participants with shifts (Number)
Shift From Borderline to MildShift from Mild to Moderate
160 mg LY214002309.1
240 mg LY2140023020.0
320 mg LY21400239.10
400 mg LY2140023018.2
480 mg LY214002309.1
Aripiprazole06.3

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Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Brief Psychiatric Rating Scale (BPRS)

"Brief Psychiatric Rating Scale (BPRS) is an 18-item clinician-administered scale used to assess the degree of severity of a participant's general psychopathological symptoms. Item scores ranged from 0 (not assessed) to 7 (extremely severe). Total Scores ranged from 0 to 126. Increases or higher scores indicate a worsening of symptoms.~Only incidences of selected shifts of worsening symptoms (an increase in numbers on a scale within the 18-symptom construct) were reported for participants.~Part B of this study was not conducted; therefore, no data are available for analysis." (NCT01354353)
Timeframe: Baseline through Day 17 for Part A

,,,,,
InterventionPercentage of participants with shifts (Number)
Mild to moderately severe - Hallucinatory behaviorMild to moderately severe - AnxietyVery mild to moderate - Unusual thought contentVery mild to moderate - ExcitementVery mild to moderate - Conceptual disorganization
160 mg LY214002300000
240 mg LY2140023010.0010.00
320 mg LY214002300000
400 mg LY2140023009.109.1
480 mg LY214002300000
Aripiprazole12.506.300

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Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation

An Adverse Event (AE) is defined as any untoward medical occurrence in a participant enrolled in a clinical trial and which did not necessarily have a causal relationship with the study medication. Treatment emergent adverse events (TEAE) are adverse events occurring after the onset of study drug administration. (NCT01416441)
Timeframe: From signing of the informed consent up to 30 days after the last dose (Up to Week 52)

InterventionParticipants (Count of Participants)
Participants with Serious TEAEsParticipants with Severe TEAEsParticipants Discontinued Medication due to TEAE'sParticipants with TEAEs
Aripiprazole (Once Weekly)586104

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Response Rates

Response rates - clinical response was defined as percentage of participants >25% improvement from Baseline to endpoint in YGTSS TTS OR a CGI-TS change score of 1 [very much improved] or 2 [much improved] at endpoint. The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100) with higher score representing severe symptoms. (NCT01416441)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)

Interventionpercentage of participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 32Week 40Week 52Last Visit (Week 52 or early termination Visit before Week 52)
Aripiprazole (Once Weekly)66.269.772.672.374.271.877.880.876.571.3

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Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score

The BARS was an EPS rating scale. The BARS was used to assess the presence and severity of akathisia. This scale consists of 4 items. Only the 4th item, the Global Clinical Assessment of Akathisia, was evaluated in this trial. This item is rated on a 6 point scale, with 0 being best (absent) and 5 being worst (severe akathisia). A negative change from Baseline indicates improvement. (NCT01416441)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)

Interventionscore on a scale (Mean)
Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24Change at Week 32Change at Week 40Change at Week 52Change at Last Visit (Week 52 or early termination Visit before Week 52)
Aripiprazole (Once Weekly)0000000000

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Mean Change From Baseline in Body Weight

(NCT01416441)
Timeframe: Baseline to Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52)

Interventionkilogram (Mean)
Change at Week 12Change at Week 24Change at Week 52Change at Last Visit (Week 52 or early termination Visit before Week 52)
Aripiprazole (Once Weekly)1.42.54.73.8

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Mean Change From Baseline in Body Mass Index (BMI)

The BMI kilogram/meter square (i.e. kg/m^2) was calculated from the Baseline height and the weight at the current visit using one of the following formulae, as appropriate: Weight (kg) divided by [Height (meters)]^2. (NCT01416441)
Timeframe: Baseline and Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52)

Interventionkg/m^2 (Mean)
Change at Week 12Change at Week 24Change at Week 52Change at Last Visit (Early Termination Visit Prior to or at Week 52
Aripiprazole (Once Weekly)0.60.40.70.6

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Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score

The AIMS Scale is an extrapyramidal symptoms (EPS) rating scale. The AIMS is a 12 item scale. The first 10 items e.g. facial and oral movements (items 1-4), extremity movements (items 5 and 6), trunk movements (item 7), investigators global assessment of dyskinesia (items 8 to 10) are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28. A negative change from Baseline indicates improvement. (NCT01416441)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 52; Last Visit (Week 52 or early termination Visit before Week 52)

Interventionscore on a scale (Mean)
Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24Change at Week 32Change at Week 40Change at Week 52Change at Last Visit (Early Termination Visit Prior to or at Week 52
Aripiprazole (Once Weekly)-0.1-0.1-0.4-0.5-0.5-0.6-0.8-0.8-0.9-0.8

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Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV)

The SNAP-IV, ADHD Inattention subscale contains 19 items, items 1 to 9 measure inattention, items 11 to 19 measure hyperactivity/impulsivity, and item 10 for inattention domain that scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 57. The negative change from Baseline indicates improvement. (NCT01416441)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)

Interventionscore on a scale (Mean)
Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24Change at Week 32Change at Week 40Change at Week 52Change at Last Visit (Week 52 or early termination Visit before Week 52)
Aripiprazole (Once Weekly)-0.10-0.1-0.1-0.1-0.2-0.2-0.2-0.1-0.1

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Treatment Discontinuation Rates

Treatment discontinuation rate was calculated as the percentage of participants who discontinued treatment. (NCT01416441)
Timeframe: Up to Week 53

Interventionpercentage of participants (Number)
All reasonsOther than sponsor discontinued study site
Aripiprazole (Once Weekly)47.622.4

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Mean Change From Baseline in Children's Depression Rating Scale Revised (CDRS-R) Total Score

The CDRS-R is composed of 17 interviewer-rated symptom areas: impaired schoolwork, difficulty having fun, social withdrawal, appetite disturbance, sleep disturbance, excessive fatigue, physical complaints, irritability, excessive guilt, low self-esteem, depressed feelings, morbid ideas, suicidal ideas, excessive weeping, depressed facial affect, listless speech, and hypoactivity. The CDRS-R total score is the sum of scores for the 17 symptom areas. A missing value for any CDRS-R item scale or a not rated item scale (indicated by the value of 0) could result in a missing total score. The CDRS-R total score is the sum of scores for the 17 symptom areas and could range from 17 to 113 with higher values indicating worse outcome. A negative change from Baseline indicates improvement. (NCT01416441)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)

Interventionscore on a scale (Mean)
Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24Change at Week 32Change at Week 40Change at Week 52Change at Last Visit (Week 52 or early termination Visit before Week 52)
Aripiprazole (Once Weekly)00-0.2-0.4-0.3-0.2-0.1-0.4-0.20.3

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Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score

"The CY-BOCS is used to assess characteristics of obsession and compulsion for the week prior to the interview. Nineteen items are rated in the CY-BOCS, but the total score is the sum of only items 1 to 10 (excluding items 1b and 6b). The obsession and compulsion subtotals are the sums of items 1 to 5 (excluding 1b) and 6 to 10 (excluding 6b), respectively. A missing value for any CY-BOCS item scale could result in a missing total score or obsession and compulsion subtotals of which the item scale is a component. At baseline, the full CY-BOCS interview is conducted. At all post-baseline time points, the Questions on Obsessions (items 1 to 5) and Questions on Compulsions (items 6 to 10) are reviewed and the target symptoms identified at baseline are the primary focus for rating severity. CY-BOCS total score could range from 0 to 40. Higher scores indicate worse outcome. A negative change from Baseline indicates improvement." (NCT01416441)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)

Interventionscore on a scale (Mean)
Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24Change at Week 32Change at Week 40Change at Week 52Change at Last Visit (Week 52 or early termination Visit before Week 52)
Aripiprazole (Once Weekly)-0.2-0.2-0.3-0.4-0.4-0.5-0.6-0.6-0.3-0.3

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Mean Change From Baseline in Clinical Global Impression for Tourette's Syndrome (CGI-TS) Severity of Illness Score

The severity of illness and efficacy of study medication for each participant were rated using the CGI-TS scale. The study physician rated the participants total improvement whether or not it is due to study treatment. All responses were compared to the participants condition at Baseline (Day 0). Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. A negative change from Baseline indicates improvement. (NCT01416441)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)

Interventionscore on a scale (Mean)
Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24Change at Week 32Change at Week 40Change at Week 52Change at Last Visit (Week 52 or early termination Visit before Week 52)
Aripiprazole (Once Weekly)-0.2-0.4-0.4-0.5-0.6-0.5-0.6-0.7-0.7-0.6

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Mean Change From Baseline in Gilles de la Tourette Quality of Life (GTS-QOL) Overall Score

The GTS-QOL is a disease-specific patient-reported scale for the measurement of health-related quality of life in participants with Tourette's Disorder, taking into account the complexity of the clinical picture of the disease. The questionnaire consists of a 27-item Tourette's Disorder-specific scale with 4 subscales (psychological, physical, obsessional, and cognitive). The GTS-QOL total score ranged from 0 (extremely dissatisfied with life) and 100 (extremely satisfied with life). A positive change from Baseline indicates improvement. (NCT01416441)
Timeframe: Baseline and Weeks 4, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52)

Interventionscore on a scale (Mean)
Change at Week 4Change at Week 24Change at Week 52Change at Last Visit (Week 52 or early termination Visit before Week 52)
Aripiprazole (Once Weekly)-2.9-3.6-4.3-3.8

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Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Total Severity Score

"The PARS has 2 sections: the symptom checklist and the severity items. The symptom checklist is used to determine the child's repertoire of symptoms during the past week. Information is elicited from the child and parent(s) and the rater then combines information from all informants using his/her best judgment. The 7-item severity list is used to determine severity of symptoms and the PARS total score. The time frame for the PARS rating is the past week. Only those symptoms endorsed for the past week are included in the symptom checklist and rated on the severity items. The PARS total severity score is the sum of items 2, 3, 5, 6, and 7. The total severity score ranges from 0 to 25, with 25 being the worst. Codes 8 (Not applicable) and 9 (Does not know) are not included in the summation (ie, equivalent to a score of 0 in the summation). A negative change from Baseline indicates improvement." (NCT01416441)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)

Interventionscore on a scale (Mean)
Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24Change at Week 32Change at Week 40Change at Week 52Change at Last Visit (Week 52 or early termination Visit before Week 52)
Aripiprazole (Once Weekly)-0.1-0.2-0.3-0.3-0.3-0.3-0.3-0.6-0.7-0.3

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Mean Change From Baseline in Simpson Angus Scale (SAS) Score

The SAS is a rating scale used to measure Extrapyramidal symptoms (EPS). The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40. A negative change from Baseline indicates improvement. (NCT01416441)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 52; Last Visit (Week 52 or early termination Visit before Week 52)

Interventionscore on scale (Mean)
Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24Change at Week 32Change at Week 40Change at Week 52Change at Last Visit (Week 52 or early termination Visit before Week 52)
Aripiprazole (Once Weekly)0000000000

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Mean Change From Baseline in Total YGTSS Score

The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100). A missing value of a YGTSS item scale could result in a missing Total YGTSS score. A negative change in Total YGTSS score from baseline represents an improvement in symptoms. (NCT01416441)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)

Interventionscore on a scale (Mean)
Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24Change at Week 32Change at Week 40Change at Week 52Change at Last Visit (Week 52 or early termination Visit before Week 52)
Aripiprazole (Once Weekly)-5.6-7.4-8.6-9.4-10.7-10.4-11.6-12.6-10.8-11.4

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Mean Change From Baseline in Waist Circumference

Waist circumference was recorded before a participant's meal and at approximately the same time at each visit. Measurement was accomplished by locating the upper hip bone and the top of the right iliac crest and placing the measuring tape in a horizontal plane around the abdomen at the level of the crest. Before reading the tape measure, the assessor assured that the tape was snug, but did not compress the skin, and is parallel to the floor. The measurement was made at the end of a normal exhalation. (NCT01416441)
Timeframe: Baseline to Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52)

Interventioncentimeter (Mean)
Change at Week 12Change at Week 24Change at Week 52Change at Last Visit (Week 52 or early termination Visit before Week 52)
Aripiprazole (Once Weekly)0.412.31.9

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Mean Change From Baseline in Yale Global Tic Severity Scale (YGTSS) Total Tic Score

The YGTSS is a semi-structured clinical interview designed to measure the tic severity. This scale consisted of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings were made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics, each including number, frequency, intensity, complexity, and interference. The YGTSS TTS was the summation of the severity scores of motor and vocal tics. The total tic score (TTS) ranged from 0 (none) to 50 (severe) with higher score represent more severe symptoms (A negative change from Baseline indicates improvement). (NCT01416441)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)

Interventionscore on scale (Mean)
Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24Change at Week 32Change at Week 40Change at Week 52Change at Last Visit (Week 52 or early termination Visit before Week 52)
Aripiprazole (Once Weekly)-2.6-3.8-4.5-4.6-5.5-5.8-6-6.4-5.8-5.9

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Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values

Incidence of clinically relevant abnormal ECG values were reported as change from Baseline in heart rate (Tachycardia - ≥15 beats per minute (bpm), Bradycardia ≤15 bpm; Rhythm (Sinus tachycardia ≥15 bpm increase, Sinus bradycardia decrease of ≥15 bpm from Baseline); Presence of - supraventricular premature beat; ventricular premature beat; supraventricular tachycardia; ventricular tachycardia; atrial fibrillation and flutter. Conduction - Presence of primary, secondary or tertiary atrioventricular block, left bundle-branch block, right bundle-branch block, pre-excitation syndrome, other intraventricular conduction blocked QRS ≥0.12 second increase of ≥0.02 second. Acute, subacute or old Infarction, Presence of myocardial ischemia, symmetrical T-wave inversion. Increase in QTc - QTc ≥450 msec ≥10% increase. Any clinically significant change from Baseline assessed by the Investigator are reported. (NCT01416441)
Timeframe: Baseline to Week 52

Interventionparticipants (Number)
TachycardiaBradycardiaSinus TachycardiaSinus BradycardiaSupraventricular Premature BeatVentricular Premature BeatSupraventricular TachycardiaVentricular TachycardiaAtrial FibrillationAtrial FlutterPrimary Atrioventricular BlockSecondary Atrioventricular BlockTertiary Atrioventricular BlockLeft Bundle Branch BlockRight Bundle Branch BlockPre-excitation SyndromeOther intraventricular conduction blockAcute or Sub-acute InfarctionOld InfarctionMyocardial IschemiaSymmetrical T-Wave InversionQT Interval cCorrected for Heart Rate by Bazett's Formula (QTB)QT Interval Corrected for Heart Rate by Fredericia's Formula (QTcF)QT Interval Corrected for Heart Rate by the US Food and Drug (QTcN)
Aripiprazole (Once Weekly)101043000000002000001301

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Number of Participants With Clinically Significant Changes in Laboratory Parameter Values

The laboratory values were one of the parameters to measure the safety and tolerability of individual participants. Participants with potentially clinically significant lab values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria were reported. Any value outside the normal range was flagged for the attention of the investigator who assessed whether or not a flagged value is of clinical significance. (NCT01416441)
Timeframe: Baseline to Week 52

InterventionParticipants (Count of Participants)
Chemistry-Alkaline PhosphataseChemistry-Alanine AminotransferaseChemistry-Aspartate AminotransferaseChemistry-Bilirubin, TotalChemistry-CalciumChemistry-ChlorideChemistry-Creatine PhosphokinaseChemistry-CreatinineChemistry-GlucoseChemistry-Glucose, FastingChemistry-HDL Cholesterol, FastingChemistry-Lactic DehydrogenaseChemistry-LDL-Cholesterol, FastingChemistry-PotassiumChemistry-SodiumChemistry- Triglycerides, FastingChemistry- Urea NitrogenChemistry-Uric AcidUrinalysis-Glucose, UrineUrinalysis-Protein, UrineOther-ProlactinHaematology-EosinophilsHaematology-HematocritHaematology-HemoglobinHaematology-NeutrophilsHaematology-Platelet CountHaematology-White Blood Count
Aripiprazole (Once Weekly)0114004011312001900313303004

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Number of Participants With Clinically Significant Changes in Vital Signs

Vital signs assessments included orthostatic (supine and standing) blood pressure (BP) measured as millimeter of mercury [mmHg]), heart rate, (measured in beats per minute [bpm]), body weight (measured in kilograms [kg]) and body temperature. Incidence of clinically relevant abnormal values in heart rate, systolic and diastolic blood pressure and weight were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant has been supine for at least 5 minutes and again after the participant has been standing for approximately 2 minutes, but not more than 3 minutes. (NCT01416441)
Timeframe: Baseline to Week 52

InterventionParticipants (Count of Participants)
Heart Rate Supine- Increase ≥15 bpmHeart Rate Supine- Decrease ≥15 bpmHeart Rate Standing-increase ≥15 bpmHeart Rate Standing- Decrease ≥15 bpmSystolic Supine BP- Increase ≥20 mmHgSystolic Supine BP- Decrease ≥20 mmHgSystolic Standing BP- Increase ≥20 mmHgSystolic Standing BP- Decrease ≥20 mmHgDiastolic Supine BP- Increase ≥15 mmHgDiastolic Supine BP- Decrease ≥15 mmHgDiastolic Standing BP- Increase ≥15 mmHgDiastolic Standing BP- Decrease ≥15 mmHgOrthostatic HypotensionWeight-Gain ≥ 7%Weight-Loss ≥ 7%
Aripiprazole (Once Weekly)1040010100102826

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Change From Baseline in Clinical Global Impressions Scale for Tourette's Syndrome (CGI-TS) Score

The severity of illness and efficacy of study medication for each participant were rated using the CGI-TS scale. The study physician rated the participants total improvement whether or not it is due to study treatment. All responses were compared to the participants condition at Baseline (Day 0). Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients), with lower score indicating better improvement. A negative change from Baseline indicates improvement. MMRM analysis was performed. (NCT01418339)
Timeframe: Baseline to Week 8

Interventionscore on a scale (Least Squares Mean)
Aripiprazole2.29
Placebo2.81

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Change From Baseline in Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) Total Score

The GTS-QOL is a disease-specific patient-reported scale for the measurement of health-related quality of life in participants with Tourette's Disorder, taking into account the complexity of the clinical picture of the disease. The questionnaire consists of a 27-item Tourette's Disorder-specific scale with 4 subscales (psychological, physical, obsessional, and cognitive). The GTS-QOL total score ranged from 0 (extremely dissatisfied with life) and 100 (extremely satisfied with life). A positive change from Baseline indicates improvement. MMRM analysis was performed. (NCT01418339)
Timeframe: Baseline to Week 8

Interventionscore on a scale (Least Squares Mean)
Aripiprazole10.04
Placebo12.04

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Change From Baseline in Yale Global Tic Severity Scale (YGTSS) - Total Tic Score (TTS)

The YGTSS is a semi-structured clinical interview designed to measure the tic severity. This scale consisted of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings were made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics, each including number, frequency, intensity, complexity, and interference. The YGTSS TTS was the summation of the severity scores of motor and vocal tics. The TTS ranged from 0 (none) to 50 (severe) with a higher score represent more severe symptoms (greater reduction from baseline for greater improvement). Mixed Effect Repeated Measure Model (MMRM) analysis was performed. (NCT01418339)
Timeframe: Baseline to Week 8

Interventionscore on a scale (Least Squares Mean)
Aripiprazole-12.34
Placebo-7.72

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Mean Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score

The YGTSS is a semi-structured clinical interview designed to measure the tic severity. This scale consisted of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings were made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics, each including number, frequency, intensity, complexity, and interference. The YGTSS TTS was the summation of the severity scores of motor and vocal tics. The total tic score (TTS) ranged from 0 (none) to 50 (severe) with higher score represent more severe symptoms (greater reduction from baseline for greater improvement). (NCT01418352)
Timeframe: Baseline and Week 8

Interventionscore on scale (Mean)
Aripiprazole 52.5 mg-8.2
Aripiprazole 77.5 mg-9.9
Aripiprazole 110 mg-14.5
Matching Placebo-9.6

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Mean Change From Baseline in Clinical Global Impressions Scale for Tourette's Syndrome (CGI-TS) Score

The severity of illness and efficacy of study medication for each participant were rated using the CGI-TS scale. The study physician rated the participants total improvement whether or not it is due to study treatment. All responses were compared to the participants condition at Baseline (Day 0). Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. A negative change from Baseline indicates improvement. (NCT01418352)
Timeframe: Baseline and Week 8

Interventionscore on scale (Mean)
Aripiprazole 52.5 mg-0.9
Aripiprazole 77.5 mg-1.1
Aripiprazole 110 mg-1.3
Matching Placebo-1.0

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Mean Change From Baseline in Gilles de la Tourette Quality of Life (GTS-QOL) Overall Score at Week 8

The GTS-QOL is a disease-specific patient-reported scale for the measurement of health-related quality of life in participants with Tourette's Disorder, taking into account the complexity of the clinical picture of the disease. The questionnaire consists of a 27-item Tourette's Disorder-specific scale with 4 subscales (psychological, physical, obsessional, and cognitive). The GTS-QOL total score ranged from 0 (extremely dissatisfied with life) and 100 (extremely satisfied with life). A positive change from Baseline indicates improvement. (NCT01418352)
Timeframe: Baseline and Week 8

Interventionscore on scale (Mean)
Aripiprazole 52.5 mg8.8
Aripiprazole 77.5 mg3.8
Aripiprazole 110 mg13.1
Matching Placebo13.4

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Rate of Protocol Relapse of Symptoms of Major Depression After Achieving Remission in the Acute Phase

Relapse in symptoms of major depression defined as a QIDS-C16 => 11 among those achieving remission in the acute phase. (NCT01421342)
Timeframe: Within 36 weeks after randomization (initiation of treatment)

InterventionParticipants (Count of Participants)
Switching: Bupropion-SR26
Augmenting: Antidepressant + Bupropion-SR35
Augmenting: Antidepressant + Aripiprazole37

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Rate of Protocol Remission of Symptoms of Major Depressive Disorder

Remission of symptoms of major depression during the acute treatment phase (12 weeks) defined as a sustained clinician-rated Quick Inventory of Depressive Symptoms (QIDS-C16) of <= 5 for two consecutive visits. (NCT01421342)
Timeframe: During acute phase (12 weeks)

InterventionParticipants (Count of Participants)
Switching: Bupropion-SR114
Augmenting: Antidepressant + Bupropion-SR136
Augmenting: Antidepressant + Aripiprazole146

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Rate of Protocol Response as Reduction in Symptoms of Major Depression (>= 50% Reduction in QIDS-C)

Response measured as reduction in symptom score for major depression defined as: 1. a reduction in QIDS-C16 of 50% or greater (NCT01421342)
Timeframe: During acute phase (up to 12 weeks)

InterventionParticipants (Count of Participants)
Switching: Bupropion-SR319
Augmenting: Antidepressant + Bupropion-SR332
Augmenting: Antidepressant + Aripiprazole375

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Rate of Protocol Response Measured as a Change in Clinical Global Impression (CGI) - Improvement Scale

Clinical assessment of a participant's level of depression and treatment response assessed by the Clinical Global Impression - Improvement (CGI -I) Scale, a 7-point clinician rating scale of improvement from baseline in severity of depression (Guy 1976). A secondary outcome measure of response was defined as achieving a score of 2 (much improved) or 1 (very much improved). (NCT01421342)
Timeframe: During acute phase (up to 12 weeks)

InterventionParticipants (Count of Participants)
Switching: Bupropion-SR356
Augmenting: Antidepressant + Bupropion-SR376
Augmenting: Antidepressant + Aripiprazole400

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Mean Clinical Global Impression-Improvement Score (CGI-I) by Week.

The efficacy of trial medication was rated for each participant using the CGI-I scale. The study physician would rate the participants total improvement whether or not it was entirely due to drug treatment. All responses were compared to the participants condition at Baseline of the appropriate phase. The CGI-I during Phase B were assessed relative to the participants condition at the Phase B Baseline visit. Response choices included: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse. (NCT01432444)
Timeframe: Week 4, 12 and 24

InterventionUnits on a scale (Mean)
Week 4 (N= 283)Week 12 (N= 293)Week 24 (N= 293)
Open-label Aripiprazole IM Depot Treatment Phase (Phase B)2.92.72.5

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Change From Baseline in PANSS Positive Subscale Score.

The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity suspiciousness/ persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). (NCT01432444)
Timeframe: Baseline to Week 24

InterventionUnits on a scale (Mean)
Week 4 (N= 390)Week 12 (N= 410)Week 24 (N= 410)
Open-label Aripiprazole IM Depot Treatment Phase (Phase B)-2.7-2.9-3.0

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Change From Baseline in PANSS Negative Subscale Score.

The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The 7 negative symptom constructs are blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). (NCT01432444)
Timeframe: Baseline to Week 24

InterventionUnits on a scale (Mean)
Week 4Week 12Week 24
Open-label Aripiprazole IM Depot Treatment Phase (Phase B)-1.7-1.6-1.6

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Change From Baseline in PANSS (Positive and Negative Syndrome Scale) Total Score.

The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The PANSS total score ranges from 30 to 210. (NCT01432444)
Timeframe: Baseline to Week 24

InterventionUnits on a scale (Mean)
Week 4 (N= 390)Week 12 (N= 410)Week 24 (N= 410)
Open-label Aripiprazole IM Depot Treatment Phase (Phase B)-7.9-8.4-8.4

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Change From Baseline in Clinical Global Impression-Severity Score (CGI-S).

"The severity of illness for each participant were rated using the CGI-S scale. To assess CGI-S, study physician were to answer the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients." (NCT01432444)
Timeframe: Baseline to Week 24

InterventionUnits on a scale (Mean)
Week 4 (N= 391)Week 12 (N= 410)Week 24 (N= 410)
Open-label Aripiprazole IM Depot Treatment Phase (Phase B)-0.3-0.4-0.5

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Number of Inpatient Psychiatric Hospitalization for Retrospective Period (Months 4-6) and Prospective Period (Months 4-6).

The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥ inpatient psychiatric hospitalizations) between the retrospective period months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot. Open-label Aripiprazole IM Depot Treatment Phase 3-month Completer sample comprised of all participants who entered open-label aripiprazole IM depot treatment Phase and completed at least 3 months of treatment. This sample was used for the primary endpoint analysis (N=336). (NCT01432444)
Timeframe: Retrospective period Months 4-6; Prospective period Months 4-6

Interventionparticipants (Number)
Retrospective periodProspective period
Open-label Aripiprazole IM Depot Treatment Phase (Phase B)919

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Change in Simpson-Angus Scale (SAS) Total Score During Extension Phase

The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50 (lower score=less severe). Negative change scores indicate improvement. (NCT01438060)
Timeframe: End of Acute Phase (Week 10), Weeks 18,26, 40, 52

InterventionUnits on Scale (Mean)
End of Acute Phase (Week 10); n=153Week 18; n=148Week 26; n=132Week 40; n=107Week 52; n=95Endpoint (LOCF data set); n=153
Aripiprazole14.340.621.241.251.142.01

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Clinical Global Impression (CGI) Improvement Score During Extension Phase

The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. (NCT01438060)
Timeframe: Weeks 12, 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 132, 140

InterventionUnits on Scale (Mean)
Week 12; n=158Week 14; n=151Week 18; n=152Week 22; n=145Week 26; n=140Week 30; n=129Week 34; n=121Week 40; n=114Week 46; n=103Week 52; n=100Week 68; n=70Week 84; n=62Week 100; n=53Week 116; n=47Week 132; n=36Week 140; n=26
Aripiprazole2.8732.7092.6252.5522.7072.6362.5542.4822.5922.5802.5142.3062.6602.7873.0282.385

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Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase

The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Weeks 1, 2, 3, 4, 6, 8, and 10

,
InterventionParticipants (Number)
Week 1Week 2Week 3Week 4Week 6Week 8Week 10
Aripiprazole11293337455053
Placebo12313544455247

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Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase

The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Weeks 1, 2, 3, 4, 6, 8, and 10

,
InterventionParticipants (Number)
Week 1Week 2Week 3Week 4Week 6Week 8Week 10
Aripiprazole18344447566470
Placebo24374552535860

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Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Extension Phase

AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. (NCT01438060)
Timeframe: Week 11 to Week 140

InterventionParticipants (Number)
DeathSAEAEDiscontinuation due to AE
Aripiprazole415914866

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Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Treatment Beyond 140 Weeks

AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. (NCT01438060)
Timeframe: Week 140 to Week 328

InterventionParticipants (Number)
Any AESAEDeathDiscontinuation due to AE
Aripiprazole7113

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Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs in Acute Phase

AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. (NCT01438060)
Timeframe: Week 1 to week 10

,
InterventionParticipants (Number)
Any adverse event (AE)Serious adverse eventDeathsDiscontinuations due to AE
Aripiprazole6716411
Placebo53907

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Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase

Systolic BP: increase defined as ≥180 and a ≥20-mmHg increase from baseline (BL); decrease defined as ≤90 and a ≤20mmHg decrease from BL. Diastolic BP: increase defined as ≥105 and a ≥15mmHg decrease from BL, decrease defined as ≤50 and a ≤15mmHg decrease from BL. Heart rate: increase defined as ≥120 and ≥15bpm increase from bBL, decrease defined as ≤50 and ≤15bpm decrease from BL; Weight: increase defined as ≥7% from baseline, decrease defined as ≤7% decrease BL. Criteria for identifying PCS measurements based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products (NCT01438060)
Timeframe: Week 11 to Week 140

InterventionParticipants (Number)
Increased Systolic BP, standing; n=159Decreased Systolic BP, standing; n=159Increased Systolic BP, supine; n=158Decreased Systolic BP, supine; n=158Decreased Systolic BP, sitting; n=45Increased Diastolic BP, standing; n=159Decreased Diastolic BP, standing; n=159Increased Diastolic BP, supine; n=158Decreased Diastolic BP, supine; n=158Decreased Diastolic BP, sitting; n=45Increased Heart rate, standing; n=159Decreased Heart rate, standing; n=159Increased Heart rate, supine; n=158Decreased Heart rate, supine; n=158Increased Weight; n=133Decreased Weight; n=133
Aripiprazole69671419125123152858

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Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase

Systolic BP: increase defined as ≥180 and a ≥20-mmHg increase from baseline (BL); decrease defined as ≤90 and a ≥20mmHg decrease from BL. Diastolic BP: increase defined as ≥105 and a ≥15mmHg decrease from BL, decrease defined as ≤50 and a ≥15mmHg decrease from BL. Heart rate: increase defined as ≥120 and ≥15bpm increase from BL, decrease defined as ≤50 and ≥15bpm decrease from BL; Weight: increase defined as ≥7% from BL, decrease defined as ≤7% decrease BL. Criteria for identifying PCS measurements are based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products (NCT01438060)
Timeframe: Week 1 to week 10

,
InterventionParticipants (Number)
Increased Systolic BP, standing; n=99, 100Decreased Systolic BP, standing; n=99, 100Increased Systolic BP, supine; n=101, 102Decreased Systolic BP, supine; n=101, 102Decreased Systolic BP, sitting; n=13, 20Increased Diastolic BP, standing; n=99, 100Decreased Diastolic BP, standing; n=99, 100Increased Diastolic BP, supine; n=101, 102Decreased Diastolic BP, supine; n=101, 102Decreased Diastolic BP, sitting; n=13, 20Increased Heart rate, standing; n=99, 100Decreased Heart rate, standing; n=99, 100Decreased Heart rate, supine; n=101, 102Increased Weight; n=89, 93Decreased Weight; n=89,93
Aripiprazole512212303001355
Placebo516002624210135

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Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase

Bradycardia:Heart rate ≤50 bpm and ≥15 bpm decrease from baseline; Supraventricular premature beat: ≥2 per 10 seconds and any increase from baseline; 1st degree A-V Block: PR ≥0.20 seconds and increase of ≥0.05 second from baseline; Intraventricular conduction block:QRS ≥0.12 second and increase of ≥0.02 second from baseline; QTcB= ≥450 msec and ≥10% increase from baseline; QTcN =≥450 msec and ≥10% increase from baseline. All other events were not present at baseline but observed during the study. Inc=increase (NCT01438060)
Timeframe: Week 1 to Week 10

,
InterventionParticipants (Number)
Bradycardia; n=99, 102Sinus Bradycardia; n=99, 102Supraventricular premature beat; n=99, 102Ventricular premature beat; n=99, 102Supraventricular tachycardia; n=99, 102Atrial fibrillation; n=99, 102Atrial flutter; n=99, 1021st degree A-V Block; n=95, 97Left bundle branch block; n=99, 102Right bundle branch block; n=99, 102Other intraventricular conduction block; n=99, 102Subacute infarction; n=99, 102Old infarction; n=99, 102Myocardial ischemia; n=99, 102Symmetrical T-wave inversion; n=99, 102Inc QTcB (≥450 msec≥,10% from baseline); n=99, 102Inc QTcN (≥450 msec,≥10% from baseline); n=99, 102
Aripiprazole117120110212024152
Placebo321071302120123251

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Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase

Criteria for identifying potentially clinically significant laboratory values were based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products. (NCT01438060)
Timeframe: Week 11 to Week 140

InterventionParticipants (Number)
High Alanine aminotransferase; ≥ 41 U/LHigh Aspartate aminotransferase; ≥ 38 U/LHigh Alkaline phosphatase; ≥ 117 U/LHigh Lactate dehydrogenase; >480 U/LHigh Urea; >8.4 mmol/LHigh Creatinine; ≥ 2.0 mg/dLHigh Uric acid; >5.7 mg/dLHigh Total Billirubin; > 1 mg/dLHigh Creatinine Kinase; ≥ 170 U/LHigh Serum Glucose Fasting; >118 mg/dLHigh Serum Glucose Non-fasting; >118 mg/dLHigh Cholesterol Total; > 220mg/dLHigh Serum Calcium; >10.2 mg/dLLow Serum Calcium; <8.6 mg/dLHigh Serum Chloride; >108 mEq/LLow Serum Chloride; <96 mEq/LHigh Serum Potassium; >5.1 mEq/LLow Serum Potassium; <3.3mEq/LHigh Serum Sodium; > 145 mEq/LLow Serum Sodium; < 133 mEq/LLow Hematocrit; <37%Low Hemoglobin; < 12 g/dLHigh Leukocyte count; > 10.8 x 10^3 c/uLLow Leukocyte count: < 4.8 x 10^3 c/uLHigh Eosinophil count; > 5%High Platelet count; >450 x 10^9 c/LLow Platelet count; < 150 x 10^9 c/LHigh Urine Protein; ≥ 2-unit increaseHigh Urine Glucose; ≥ 2-unit increase
Aripiprazole0121568902361713152624363611131221197430123

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Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase

Criteria for identifying potentially clinically significant laboratory values were based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products. Normal ranges are local lab data and vary according to the site. M=male, F=female. Criteria for hematocrit also includes a 3 point shift from baseline. (NCT01438060)
Timeframe: Week 1 to Week 10

,
InterventionParticipants (Number)
Alanine aminotransferase ≥3 x ULN; n=98, 98Aspartate aminotransferase ≥3 x ULN; n=98, 98Alkaline phosphatase ≥3 x ULN; n=98, 98Creatine phosphokinase (total) ≥3 x ULN; n=98, 98Creatinine ≥ 2.0 mg/dL; n=98, 98Uric acid ≥8.5 mg/dL (F);≥10.5 mg/dL(M); n=98, 98Calcium ≥ 10.6 mg/dL; n=98, 98Calcium ≤ 8.4 mg/dL; n=98, 98Serum Chloride ≥ 113 mEq/L; n=98, 98Serum Chloride ≤ 93 mEq/L; n=98, 98Cholesterol Total > ULN; n=98, 98Cholesterol Total < LLN; n=98, 98Serum Glucose Fasting > ULN; n=36, 31Serum Potassium ≥ 5.6 mEq/L; n=98, 98Serum Potassium ≤ 3.4 mEq/L; n=98, 98Serum Sodium ≥ 148 mEq/L; n=98, 98Serum Sodium ≤ 132 mEq/L; n=98, 98Urea ≥ 10.1mmol/L; n=98, 97Platelet ≥ 700,000 mm3; n=97, 96Platelet ≤ 75,000 mm3; n=97, 96Eosinophils ≥ 10%; n=97, 96Hematocrit ≤ 37% (M)/≤ 32% (F); n=97, 96Hemoglobin ≤ 11.5 (M)/≤ 9.5 g/dL (F); n=97, 96Urine Glucose ≥ 2-unit increase; n=92, 93Urine Protein ≥ 2-unit increase; n=92, 93
Aripiprazole3102222546360167413141016401
Placebo1111251465471137423190117622

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Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase

The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale:0=not at all distressing to 5=extremely distressing). The NPI Psychosis Subscale Caregiver Distress Score is calculated by adding Individual Item Scores for the domains of Delusions and Hallucinations, to yield a possible total score of 0 to 10. Lower score=less severity. A negative change score from baseline=improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

,
InterventionUnit on a Scale (Mean)
Baseline (Day 0)Week 1Week 2Week 3Week 4Week 6Week 8Week 10
Aripiprazole4.70-0.64-0.78-0.93-1.28-1.62-1.65-1.79
Placebo4.80-0.80-0.84-1.15-1.31-1.36-1.18-1.35

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Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase

Bradycardia:Heart rate ≤50 bpm and ≥15 bpm decrease from baseline; Supraventricular premature beat: ≥2 per 10 seconds and any increase from baseline; 1st degree A-V Block: PR ≥0.20 seconds and increase of ≥0.05 second from baseline; Intraventricular conduction block:QRS ≥0.12 second and increase of ≥0.02 second from baseline; QTcB= ≥450 msec and ≥10% increase from baseline; QTcN =≥450 msec and ≥10% increase from baseline. All other events were not present at baseline but observed during the study (NCT01438060)
Timeframe: Week 11 to Week 140

InterventionParticipants (Number)
Atrial Fibrillation; n=145Atrial Flutter; n=145Bradycardia; n=145Left Bundle Branch Block; n=145Myocardial Ischemia; n=145Old Infarction; n=145Right Bundle Branch Block; n=145Sinus Bradycardia; n=145Sinus Tachycardia; n=145Supraventricular Premature Beat; n=145Supraventricular Tachycardia; n=145Symmetrical T-wave Inversions; n=145Tachycardia; n=145Ventricular premature Beat; n=145
Aripiprazole51451023221228413

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Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior

The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

,
InterventionUnits on a Scale (Mean)
Baseline (Day 0)Week 1Week 2Week 3Week 4Week 6Week 8Week 10
Aripiprazole3.610.18-0.51-0.66-0.16-0.61-0.83-0.89
Placebo3.67-0.66-0.84-1.68-0.91-0.89-1.06-1.02

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CGI Improvement Score in Acute Phase

The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. (NCT01438060)
Timeframe: Weeks 1, 2, 3, 4, 6, 8, and 10

,
InterventionUnits on Scale (Mean)
Week 1; n=98, 102Week 2; n=98, 102Week 3; n=100, 103Week 4; n=100, 103Week 6; n=100, 103Week 8; n=100, 103Week 10; n=100, 103
Aripiprazole3.963.713.493.323.233.163.17
Placebo3.813.553.373.283.263.113.07

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Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score in Acute Phase

"The Abnormal Involuntary Movement Scale (AIMS) is a rating scale that was designed to measure involuntary movements (tardive dyskinesia). The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. These items are rated on a five-point scale of severity from 0-4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe).~AIMS Total Score is from 0 to 28. A negative change score signifies improvement." (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, and 10

,
InterventionUnits on scale (Mean)
Baseline (Day 0); n=99, 101Week 2; n=91, 95Week 4; n=97, 97Week 8; n=87, 87Week 10; n=85, 87
Aripiprazole0.93-0.17-0.08-0.14-0.17
Placebo0.87-0.10-0.050.070.05

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Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase

The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

,
InterventionUnit on scale (Mean)
Baseline (Day 0); n=100,101Week 1; n=99, 101Week 2; n=91, 95Week 3; n=95, 99Week 4; n=97, 98Week 6; n=91, 92Week 8; n=87, 87Week 10; n=85, 87
Aripiprazole0.19-0.06-0.05-0.06-0.08-0.02-0.03-0.05
Placebo0.20-0.06-0.02-0.030.00-0.07-0.05-0.05

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Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase

"The BPRS is designed to measure clinical change in participants and is used as a global measure of psychopathology. The BPRS includes 18 items with items devoted to hallucinatory behavior, suspiciousness, unusual thought content, etc. BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126.~A negative change score signifies improvement." (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

,
InterventionUnit on Scale (Mean)
Baseline (Day 0); n=95, 100Week 2; n=87, 95Week 4; n=95, 100Week 6; n=95, 100Week 8; n=95, 100Week 10; n=95, 100
Aripiprazole43.63-5.82-7.44-8.50-8.47-8.53
Placebo43.42-4.65-5.80-6.13-6.45-6.28

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Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase

The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Severity scale is a 7-point scale that requires the clinician to rate the severity of the illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. The assessment is based on severity of mental illness at the time of rating, 0=not assessed, 1=normal, 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

,
InterventionUnits on Scale (Mean)
Baseline (Day 0)Week 1Week 2Week 3Week 4Week 6Week 8Week 10
Aripiprazole4.83-0.10-0.19-0.44-0.49-0.58-0.65-0.69
Placebo4.84-0.19-0.29-0.44-0.47-0.44-0.56-0.54

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Change From Baseline in Mini Mental State Examination (MMSE) Total Score in Acute Phase

The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language). It is a 19 item scale, the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline. (NCT01438060)
Timeframe: Baseline (Day 0), Week 10

,
InterventionUnits on Scale (Mean)
Baseline (Day 0); N=86,94Week 10; n=82, 87
Aripiprazole14.35-0.81
Placebo14.130.53

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Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase

The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Week 10

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Mean Change from Baseline at Week 10
Aripiprazole12.29-6.55
Placebo12.12-5.52

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Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression

The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

,
InterventionUnits on a Scale (Mean)
Baseline (Day 0)Week 1Week 2Week 3Week 4Week 6Week 8Week 10
Aripiprazole4.040.10-0.69-0.59-1.38-0.94-0.84-1.12
Placebo3.52-0.34-1.16-0.73-0.78-0.31-0.12-0.47

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Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety

The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

,
InterventionUnits on a Scale (Mean)
Baseline (Day 0)Week 1Week 2Week 3Week 4Week 6Week 8Week 10
Aripiprazole3.170.050.080.07-0.38-0.13-0.21-0.31
Placebo3.640.02-0.08-0.43-0.80-0.79-0.23-0.43

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Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference

The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

,
InterventionUnits on a Scale (Mean)
Baseline (Day 0)Week 1Week 2Week 3Week 4Week 6Week 8Week 10
Aripiprazole3.47-0.70-0.76-0.36-0.67-0.40-0.21-0.09
Placebo4.140.03-0.48-0.09-0.65-0.63-0.87-0.95

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Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors

The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

,
InterventionUnits on a Scale (Mean)
Baseline (Day 0)Week 1Week 2Week 3Week 4Week 6Week 8Week 10
Aripiprazole1.47-0.18-0.210.23-0.040.230.450.56
Placebo1.78-0.24-0.36-0.14-0.44-0.27-0.11-0.17

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Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions

The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

,
InterventionUnits on a Scale (Mean)
Baseline (Day 0)Week 1Week 2Week 3Week 4Week 6Week 8Week 10
Aripiprazole8.11-1.61-2.72-3.50-3.89-3.95-3.91-4.28
Placebo7.85-2.37-2.84-3.25-3.72-3.45-3.52-3.94

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Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria

The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

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InterventionUnits on a Scale (Mean)
Baseline (Day 0)Week 1Week 2Week 3Week 4Week 6Week 8Week 10
Aripiprazole2.28-0.04-0.36-0.33-0.50-0.55-0.54-0.42
Placebo3.270.21-0.44-0.77-0.72-0.47-0.65-0.32

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Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition

The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

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InterventionUnits on a Scale (Mean)
Baseline (Day 0)Week 1Week 2Week 3Week 4Week 6Week 8Week 10
Aripiprazole1.36-0.39-0.44-0.21-0.67-0.72-0.44-0.35
Placebo0.98-0.14-0.42-0.27-0.55-0.19-0.200.07

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Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria

The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

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InterventionUnits on a Scale (Mean)
Baseline (Day 0)Week 1Week 2Week 3Week 4Week 6Week 8Week 10
Aripiprazole0.73-0.26-0.18-0.27-0.40-0.39-0.25-0.36
Placebo0.56-0.48-0.37-0.48-0.47-0.38-0.32-0.42

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Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations

The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

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InterventionUnits on a Scale (Mean)
Baseline (Day 0)Week 1Week 2Week 3Week 4Week 6Week 8Week 10
Aripiprazole4.18-0.65-1.09-1.37-1.79-2.03-2.12-2.30
Placebo4.27-0.98-1.15-1.34-1.71-1.43-1.57-1.65

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Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability

The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

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InterventionUnits on a Scale (Mean)
Baseline (Day 0)Week 1Week 2Week 3Week 4Week 6Week 8Week 10
Aripiprazole4.36-0.09-0.69-1.09-1.53-1.29-0.99-1.26
Placebo3.73-0.73-0.89-1.11-0.75-0.42-0.33-0.24

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Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep

The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

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InterventionUnits on a Scale (Mean)
Baseline (Day 0)Week 1Week 2Week 3Week 4Week 6Week 8Week 10
Aripiprazole3.03-0.07-0.070.100.15-0.03-0.06-0.06
Placebo2.67-0.10-0.20-0.200.02-0.39-0.060.05

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Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase

The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, and 8

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InterventionUnits on Scale (Mean)
Baseline (Day 0)Week 1Week 2Week 3Week 4Week 6Week 8
Aripiprazole12.29-2.26-3.81-4.86-5.66-6.00-6.01
Placebo12.12-3.33-3.96-4.54-5.38-4.87-5.04

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Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase

The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The total NPI Caregiver Distress Score is calculated by adding the 12 Caregiver Distress Individual Item Scores, to yield a possible total score of 0 to 60. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

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InterventionUnits on a Scale (Mean)
Baseline (Day 0)Week 1Week 2Week 3Week 4Week 6Week 8Week 10
Aripiprazole17.06-1.64-3.04-2.58-3.48-3.72-3.46-3.53
Placebo16.58-1.81-3.25-4.10-4.01-3.58-3.20-3.15

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Change From Baseline in NPI Total Score in Acute Phase

The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

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InterventionUnits on a Scale (Mean)
Baseline (Day 0)Week 1Week 2Week 3Week 4Week 6Week 8Week 10
Aripiprazole39.82-4.13-8.40-8.61-11.74-11.61-10.71-11.20
Placebo40.08-6.26-9.98-10.85-11.81-10.47-9.68-9.75

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Change From Baseline in Simpson-Angus Scale (SAS) Total Score in Acute Phase

The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50.(lower score=less severe). Negative change scores indicate improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 2, 4, and 10

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InterventionUnits on scale (Mean)
Baseline (Day 0); n=97, 100Week 2; n=89, 94Week 4; n=93, 96Week 10; n=82, 85
Aripiprazole14.47-0.35-0.060.33
Placebo14.410.02-0.15-0.44

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Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase

"AIMS is a rating scale that was designed to measure involuntary movements (tardive dyskinesia). The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. These items are rated on a five-point scale of severity from 0-4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe).~AIMS Total Score is from 0 to 28. A negative change score signifies improvement." (NCT01438060)
Timeframe: End of Acute Phase (Week 10), Weeks 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 140

InterventionUnits on Scale (Mean)
End of Acute Phase (Week 10); n=157Week 14; n=151Week 18; n=152Week 22; n=145Week 26; n=140Week 30; n=128Week 34; n=121Week 40; n=115Week 46; n=104Week 52; n=100Week 68; n=70Week 84; n=62Week 100; n=52Week 116; n=47Week 140; n=15Endpoint (LOCF data set); n=157
Aripiprazole0.950.250.090.02-0.12-0.01-0.10-0.01-0.02-0.02-0.29-0.24-0.21-0.210.00-0.03

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Change in Barnes Global Clinical Assessment of Akathisia Score During Extension Phase

The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia. (NCT01438060)
Timeframe: End of Acute Phase (Week 10), Weeks 18,26, 40, 52

Interventionunits on a scale (Mean)
End of Acute Phase (Week 10); n=155Week 18; n=151Week 26; n=139Week 40; n=114Week 52; n=99Endpoint (LOCF data set); n=155
Aripiprazole0.140.040.030.040.060.06

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Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase

The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement. (NCT01438060)
Timeframe: Baseline (Day 0), Weeks 18,26,40,52,68,84,100,116,132,140

InterventionUnits on a Scale (Mean)
Baseline, Day 0 (n=154)Week 18 (n=151)Week 26 (n=139)Week 40 (n=115)Week 52 (n=98)Week 68 (n=69)Week 84 (n=62)Week 100 (n=52)Week 116 (n=47)Week 132 (n=31)Week 140 (n=25)
Aripiprazole12.312-8.589-8.993-8.270-8.582-9.232-10.18-10.06-10.19-11.68-13.12

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Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score

PANSS total score comprises Positive (Delusions, Conceptual disorganization, Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness/persecution, Hostility), Negative (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking), and General Psychopathology (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance) Scales. Scores are obtained by adding the ratings of each item in each scale. Range is 7-49 for Positive and Negative scores; 16-112 for General Psychopathology score; and 30-210 for Total score. Higher score reflects worse outcome; larger reduction from baseline reflects better outcome. (NCT01490086)
Timeframe: Baseline to Day 28

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Interventionscores on a scale (Mean)
BaselineDay 28
Aripiprazole 15 mg91.6882.37
Placebo89.8478.43
RP5063 15 mg87.5767.34
RP5063 30 mg88.7473.32
RP5063 50 mg85.8866.67

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Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale

The Positive Scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility) and is calculated by adding the subscale item scores to obtain results ranging from 7 to 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy. (NCT01490086)
Timeframe: Baseline to Day 28

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Interventionscores on a scale (Mean)
BaselineDay 28
Aripiprazole 15 mg25.4223.47
Placebo24.5419.95
RP5063 15 mg24.7917.82
RP5063 30 mg23.7718.75
RP5063 50 mg23.6816.72

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Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale

The Negative Scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking) and is calculated by adding the negative subscale item scores to obtain results ranging from 7 to 49. Minimum score is 7, maximum score is 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy. (NCT01490086)
Timeframe: Baseline to Day 28

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Interventionscores on a scale (Mean)
BaselineDay 28
Aripiprazole 15 mg22.5319.47
Placebo22.2420.57
RP5063 15 mg21.8016.96
RP5063 30 mg22.8919.21
RP5063 50 mg21.3717.72

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Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale

The General Psychopathology Scale consists of 16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). The General Psychopathology score is obtained by adding the ratings of each item in the scale, with results ranging from 16 to 112. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy. (NCT01490086)
Timeframe: Baseline to Day 28

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Interventionscores on a scale (Mean)
BaselineDay 28
Aripiprazole 15 mg43.7439.42
Placebo43.0537.92
RP5063 15 mg40.9832.55
RP5063 30 mg42.0735.35
RP5063 50 mg40.8232.23

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Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S)

Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject's mental illness. Scores range from 1 (not ill at all) to 7 (among the most extremely ill). A reduction in score indicates an improvement in the subject's condition. (NCT01490086)
Timeframe: Baseline to Day 28

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Interventionscores on a scale (Mean)
BaselineDay 28
Aripiprazole 15 mg4.844.53
Placebo4.764.05
RP5063 15 mg4.793.48
RP5063 30 mg4.813.93
RP5063 50 mg4.753.54

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Change From Baseline in PANSS Positive Sub-scale Score for LOCF Data.

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). (NCT01552772)
Timeframe: Baseline, Week 1, 2 and 4

InterventionUnits on a scale (Mean)
Week 1 (N= 59)Week 2 (N= 59)Week 4 (N= 59)
Aripiprazole IM Depot 400mg-0.81-0.78-1.25

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CGI-I Scale Score in LOCF Data.

The efficacy of trial medication were rated for each participant using the Clinical Global Impression Improvement (CGI-I) scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition a baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse. (NCT01552772)
Timeframe: Week 1, 2 and 4

InterventionUnits on a scale (Mean)
Week 1 (N= 59)Week 2 (N= 59)Week 4 (N= 59)
Total3.853.693.58

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Change From Baseline in PANSS Negative Sub-scale Score for LOCF Data.

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). (NCT01552772)
Timeframe: Baseline, Week 1, 2 and 4

InterventionUnits on a scale (Mean)
Week 1 (N= 59)Week 2 (N= 59)Week 4 (N= 59)
Aripiprazole IM Depot 400mg-0.78-1.08-0.92

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Change From Baseline in Clinical Global Impression Severity (CGI-S) Score in OC Data.

"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants." (NCT01552772)
Timeframe: Baseline, Week 1, 2, 4 and Last visit (Day 28).

InterventionUnits on a scale (Mean)
Week 1 (N= 59)Week 2 (N= 56)Week 4 (N= 57)Last visit (N= 59)
Aripiprazole IM Depot 400mg0.02-0.09-1.14-1.14

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Change From Baseline in CGI-S Score in LOCF Data.

"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the rater or investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants." (NCT01552772)
Timeframe: Baseline, Week 1, 2 and 4.

InterventionUnits on a scale (Mean)
Week 1 (N= 59)Week 2 (N= 59)Week 4 (N= 59)
Aripiprazole IM Depot 400mg0.02-0.08-0.14

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Change From Baseline in PANSS Positive Sub-scale Score for OC Data.

The Positive and Negative Syndrome Scale (PANSS) consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). (NCT01552772)
Timeframe: Baseline, Week 1, 2, 4 and Last visit (Day 28).

InterventionUnits on a scale (Mean)
Week 1 (N= 59)Week 2 (N= 56)Week 4 (N= 57)Last visit (N= 59)
Aripiprazole IM Depot 400mg-0.81-0.79-1.28-1.25

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Change From Baseline in Total Score of PANSS for Last Observation Carried Forward (LOCF) Data.

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). (NCT01552772)
Timeframe: Baseline, Week 1, 2 and 4

InterventionUnits on a scale (Mean)
Week 1 (N= 59)Week 2 (N= 59)Week 4 (N= 59)
Aripiprazole IM Depot 400mg-2.42-2.80-3.68

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Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Observed Cases (OC) Data.

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). (NCT01552772)
Timeframe: Baseline, Week 1, 2, 4 and Last visit (Day 28).

InterventionUnits on a scale (Mean)
Week 1 (N= 59)Week 2 (N= 56)Week 4 (N= 57)Last visit (N= 59)
Aripiprazole IM Depot 400mg-2.42-2.86-3.82-3.68

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Clinical Global Impression Improvement (CGI-I) Scale Score in OC Data.

The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition a baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse. (NCT01552772)
Timeframe: Week 1, 2, 4 and Last visit (Day 28).

InterventionUnits on a scale (Mean)
Week 1 (N= 59)Week 2 (N= 56)Week 4 (N= 57)Last visit (N= 59)
Aripiprazole IM Depot 400mg3.853.703.563.58

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Number of Participants With Adverse Events (AE).

An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the study physician. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. TEAE stands for treatment emergent adverse events. (NCT01552772)
Timeframe: From the time the informed consent (ICF) was signed until follow-up at 30 days after the last trial visit (Day 28).

InterventionParticipants (Number)
Participants with TEAEParticipants with serious TEAE
Aripiprazole IM Depot 400mg351

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Change From Baseline in PANSS Negative Sub-scale Score for OC Data.

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). (NCT01552772)
Timeframe: Baseline, Week 1, 2, 4 and Last visit (Day 28).

InterventionUnits on a scale (Mean)
Week 1 (N= 59)Week 2 (N= 56)Week 4 (N= 57)Last visit (N= 59)
Aripiprazole IM Depot 400mg-0.78-1.14-0.96-0.92

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Mean Change From Randomization to Endpoint in the CGI-BP-S (Mania) Score.

CGI-BP-S assessed the subject's severity of Illness (mania) based on a 7-point scale ranging from 1 (normal/ not ill at all) to 7 (very severely ill). (NCT01567527)
Timeframe: Baseline of the Double-blind, Placebo-controlled Phase up to the end of the study (Week 52).

InterventionUnits on a scale (Least Squares Mean)
Aripiprazole IM Depot-0.16
Placebo0.27

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Time From Randomization to Recurrence Defined by Hospitalization for a Mood Episode.

"Analysis of time from randomization to recurrence defined by hospitalization for a mood episode (Double-blind, Placebo-controlled Phase efficacy sample).~Time to recurrence is presented in the following table." (NCT01567527)
Timeframe: Baseline of the Double-blind, Placebo-controlled Phase up to the end of the study (Week 52).

InterventionDays (Median)
Aripiprazole IM DepotNA
PlaceboNA

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Time From Randomization to Recurrence of Any Mood Episode During Double-bind Placebo-controlled Phase.

"This endpoint was defined as meeting any of the following criteria:~Hospitalization for any mood episode OR~Any of the following:~YMRS total score ≥ 15 OR~MADRS total score ≥ 15 OR~CGI-BP-S score > 4 (overall score) OR~SAE of worsening disease (bipolar I disorder) OR~Discontinuation due to lack of efficacy or discontinuation due to an AE of worsening disease OR~Clinical worsening with the need for treatment of symptoms of an underlying mood disorder by addition of a mood stabilizer, antidepressant treatment, antipsychotic medication, or increase greater than the allowed benzodiazepine doses, or~Active suicidality, which is defined as a score of 4 or more on the MADRS item 10 OR an answer of yes on question 4 or 5 on the C-SSRS.~The time to event is presented in the following table." (NCT01567527)
Timeframe: Baseline of the Double-blind, Placebo-controlled Phase Up to the end of the study (Week 52).

InterventionDays (Median)
Aripiprazole IM DepotNA
Placebo308

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Number of Subjects Meeting Criteria for Recurrence of Any Mood Episode.

To assess the proportion of subjects who met criteria for recurrence of any mood episode (manic, mixed or depressive). Hierarchical procedure was used to preserve the overall Type I error at 0.05. (NCT01567527)
Timeframe: Baseline of the Double-blind, Placebo-controlled Phase Up to the end of the study (Week 52).

InterventionParticipants (Count of Participants)
Aripiprazole IM Depot35
Placebo68

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Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score

The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition. (NCT01617447)
Timeframe: baseline, 8 weeks after dosing

Interventionunits on a scale (Mean)
Aripiprazole-11.4
Placebo-7.5

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Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score

The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition. (NCT01617460)
Timeframe: Baseline, the final administration

Interventionunits on a scale (Mean)
Aripiprazole-3.2

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Maximum Observed Plasma Concentration (Cmax) of Aripriprazole

Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter. (NCT01646827)
Timeframe: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination

Interventionng/mL (Mean)
Aripiprazole IM Depot 400 mg: Deltoid170
Aripiprazole IM Depot 400 mg: Gluteal136

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Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.

This scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post baseline evaluation that focuses on suicidality since the last trial visit. (NCT01646827)
Timeframe: Screening, Baseline, Week 1, Week 2, Week 8, Week 18 visit and Last visit.

,
InterventionParticipants (Number)
Screening: Suicidality (n=17,18)Screening: Suicidal behaviour (n=17,18)Screening: Suicidal ideation (n=17,18)Baseline: Suicidality (n=17,18)Baseline: Suicidal behaviour (n=17,18)Baseline: Suicidal ideation (n=17,18)Week 1: Suicidality (n=17,18)Week 1: Suicidal behaviour (n=17,18)Week 1: Suicidal ideation (n=17,18)Week 2: Suicidality (n=16,18)Week 2: Suicidal behaviour (n=16,18)Week 2: Suicidal ideation (n=16,18)Week 8: Suicidality (n=16,18)Week 8: Suicidal behaviour (n=16,18)Week 8: Suicidal ideation (n=16,18)Week 18: Suicidality (n=16,14)Week 18: Suicidal behaviour (n=16,14)Week 18: Suicidal ideation (n=16,14)Last visit: Suicidality (n=17,18)Last visit: Suicidal behaviour (n=17,18)Last visit: Suicidal ideation (n=17,18)
Aripiprazole IM Depot 400 mg: Deltoid424000000000000000000
Aripiprazole IM Depot 400 mg: Gluteal757000000000000000000

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Maximum Observed Plasma Concentration (Cmax) of Dehydro-Aripiprazole

Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter. (NCT01646827)
Timeframe: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination

Interventionng/mL (Mean)
Aripiprazole IM Depot 400 mg: Deltoid51.7
Aripiprazole IM Depot 400 mg: Gluteal34.6

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Number of Participants With Vital Signs of Potential Clinical Relevance-Temperature

Vital sign assessment included body temperature measured in centigrade(C). Temperatures >=37.8°C and increase of >= 1.1°C were recorded. (NCT01646827)
Timeframe: Day 1, Day 14, Day 28 and Day 126/Early termination

InterventionParticipants (Number)
Aripiprazole IM Depot 400 mg: Deltoid0
Aripiprazole IM Depot 400 mg: Gluteal0

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Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Aripiprazole

Relative bioavailability (Frel) of aripiprazole IM depot injected in the deltoid muscle compared to the gluteal muscle based on area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt), AUC time curve 28, and AUC from time zero to infinity PK parameters. (NCT01646827)
Timeframe: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination

,
Interventionng day/mL (Mean)
AUC infinity (n=16,14)AUC 28 (n=16,17)AUC t (n=16,17)
Aripiprazole IM Depot 400 mg: Deltoid759031207360
Aripiprazole IM Depot 400 mg: Gluteal792023807340

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Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Dehydro-Aripiprazole

Relative bioavailability (Frel) of aripiprazole IM depot injected in the deltoid muscle compared to the gluteal muscle based on area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt), AUC time curve 28 and AUC from time zero to infinity PK parameters. (NCT01646827)
Timeframe: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination

,
Interventionng day/mL (Mean)
AUC infinity (n=16,14)AUC 28 (n=16,17)AUC t (n=16,17)
Aripiprazole IM Depot 400 mg: Deltoid25208862420
Aripiprazole IM Depot 400 mg: Gluteal22305381990

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Number of Participants Reporting Treatment Emergent Adverse Events (TEAE).

Safety was measured according to standard adverse event collection as described in the adverse event section of the results. (NCT01646827)
Timeframe: Starting at the time the ICF was signed to Day 126/Early termination

,
InterventionParticipants (Number)
Subjects with TEAEsSubjects with serious TEAEsSubjects with severe TEAEs
Aripiprazole IM Depot 400 mg: Deltoid1401
Aripiprazole IM Depot 400 mg: Gluteal1801

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Number of Participants With Electrocardiogram (ECG) Measurements of Potential Clinical Relevance

Three 12 lead ECGs were performed approximately 5 minutes apart at each time point. The participant were supine and at rest (for at least 10 minutes) prior to the first ECG and will remain supine through the final ECG. Based on criteria for identifying ECG measurements of potential clinical relevance, the abnormal values were noted. Some of the criteria are as follows: For bradycardia: ≤ 50 beats per minute (bpm); and for increase in QTc: QTc ≥ 450msec. (NCT01646827)
Timeframe: Day 1, Day 14, Day 28 and Day 126/Early termination

,
InterventionParticipants (Number)
premature ventricular contractionsT-wave inversionsBradycardia and sinus bradycardiaAbnormalities in QTc intervals
Aripiprazole IM Depot 400 mg: Deltoid2200
Aripiprazole IM Depot 400 mg: Gluteal1210

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Number of Participants With Laboratory Values of Potential Clinical Relevance.

The laboratory tests were collected and processed in accordance with directions from the clinical chemistry laboratory. Based on criteria for identifying laboratory values of potential clinical relevance, the abnormal values were noted. Some of the criteria are as follows: For fasting triglycerides: men: ≥ 160 mg/dL and women: ≥ 120 mg/dL; Fasting glucose: ≥ 115 mg/dL; Prolactin: > upper limit of normal (ULN); Neutrophils: ≤ 1,500/mm3; and Creatine phosphokinase: ≥ 3 x ULN. (NCT01646827)
Timeframe: Day 1, Day 28, Day 126/Early termination

,
InterventionParticipants (Number)
High fasting triglycerides (n=9,11)High fasting glucose (n=9,11)High prolactin (n=17,18)Low absolute neutrophils (n=17,18)High creatine phosphokinase (n=17,18)
Aripiprazole IM Depot 400 mg: Deltoid33312
Aripiprazole IM Depot 400 mg: Gluteal50320

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Number of Participants With Vital Signs of Potential Clinical Relevance-Blood Pressure

Vital sign assessment included orthostatic (supine and standing) blood pressure. Orthostatic assessments were made after participants had been in the supine position for at least 5 minutes and again after participants had been standing for 2 minutes, but not more than 3 minutes. Orthostatic hypotension defined as >/= 20 mm Hg decrease in systolic blood pressure and >/= 25 beats per minute increase in heart rate from supine to standing. (NCT01646827)
Timeframe: Day 1, Day 14, Day 28 and Day 126/Early termination

,
InterventionParticipants (Number)
Increase >/=15 mmHg in diastolic standing BPOrthostatic hypotension
Aripiprazole IM Depot 400 mg: Deltoid00
Aripiprazole IM Depot 400 mg: Gluteal10

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Number of Participants With Vital Signs of Potential Clinical Relevance-Heart Rate

Vital sign assessment included heart rate (supine and standing). Heart rate with increase or decrease of >/= 15 beats per minute were recorded. (NCT01646827)
Timeframe: Day 1, Day 14, Day 28 and Day 126/Early termination

,
InterventionParticipants (Number)
Heart rate: Supine: increaseHeart rate: Supine: decreaseHeart rate: Standing: increaseHeart rate: Standing: decrease
Aripiprazole IM Depot 400 mg: Deltoid0000
Aripiprazole IM Depot 400 mg: Gluteal0000

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Visual Analog Scale (VAS) Score at Day 1, Day 14, Day 28 and Last Visit.

Injection site pain was assessed using a VAS, which was completed by the trial participant, and the investigator's assessment of most recent injection site, which was completed by the investigator. VAS is 100 mm line, 0=no pain, 100=unbearably painful. (NCT01646827)
Timeframe: Day 1, Day 14, Day 28 and last visit

,
InterventionUnits on a scale (Mean)
Day 1: 0.5 hour pre-dose (n=17, 18)Day 1: 1 hour post-dose (n=17, 18)Day 14 (n=16, 18)Day 28 (n=16, 18)Last visit (n=17, 18)
Aripiprazole IM Depot 400 mg: Deltoid1.23.11.30.52.2
Aripiprazole IM Depot 400 mg: Gluteal0.81.70.30.50.5

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Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.

The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS Positive Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). (NCT01663532)
Timeframe: Baseline to Week 10

,
InterventionUnits on a scale (Least Squares Mean)
Week 1 (N= 162, 167)Week 2 (N= 144, 157)Week 4 (N= 134, 140)Week 6 (N= 126, 117)Week 8 (N= 108, 96)Week 10 (N= 99, 81)
Aripiprazole IM Depot 400/300mg-3.5-5.7-7.0-8.2-8.9-10.0
Placebo-2.1-3.4-3.9-4.4-4.1-4.9

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Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Score.

The PSP was a validated clinician scale that measured personal and social functionining in 4 domains: socially useful activities eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviours. Impairement in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval and the study physician's judgement to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented varying degrees of disability (31 to 70) and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision. (NCT01663532)
Timeframe: Week 10

InterventionUnits on a scale (Least Squares Mean)
Aripiprazole IM Depot 400/300mg12.3
Placebo5.2

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Mean Clinical Global Impression-Improvement Scale (CGI-I) Score at Endpoint.

"The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: Considering your total experience with this particular population, how mentally ill is the patient at this time? Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants." (NCT01663532)
Timeframe: Week 10

InterventionUnits on a scale (Mean)
Aripiprazole IM Depot 400/300mg2.7
Placebo3.7

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Responder Rate Based on PANSS Total Score.

Responder rate was defined as ≥30% reduction from Baseline in PANSS Total Score. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). (NCT01663532)
Timeframe: Week 10

Interventionparticipants (Number)
Aripiprazole IM Depot 400/300mg60
Placebo24

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Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.

"The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: Considering your total experience with this particular population, how mentally ill is the patient at this time? Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants." (NCT01663532)
Timeframe: Baseline to Week 10

,
InterventionUnits on a scale (Least Squares Mean)
Week 1 (N= 162, 168)Week 2 (N= 144, 157)Week 4 (N= 134, 140)Week 6 (N= 126, 117)Week 8 (N= 108, 96)Week 10 (N= 99, 81)
Aripiprazole IM Depot 400/300mg-0.4-0.8-1.0-1.2-1.3-1.4
Placebo-0.2-0.4-0.4-0.5-0.6-0.6

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Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated- absence of symptoms and a score of 7 indicated- extremely severe symptoms. The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs were: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. PANSS Negative Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). (NCT01663532)
Timeframe: Baseline to Week 10

,
InterventionUnits on a scale (Least Squares Mean)
Week 1 (N= 162, 167)Week 2 (N= 144, 157)Week 4 (N= 134, 140)Week 6 (N= 126, 117)Week 8 (N= 108, 96)Week 10 (N= 99, 81)
Aripiprazole IM Depot 400/300mg-1.6-2.4-3.1-3.5-4.0-4.5
Placebo-0.7-1.2-1.3-1.3-1.4-1.6

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Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.

The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). The primary statistical comparison was performed using the Mixed Model Repeated Measure (MMRM) approach. (NCT01663532)
Timeframe: Baseline to Week 10

,
InterventionUnits on a scale (Least Squares Mean)
Week 1 (N= 162, 167)Week 2 (N= 144, 157)Week 4 (N= 134, 140)Week 6 (N= 126, 117)Week 8 (N= 108, 96)Week 10 (N= 99, 81)
Aripiprazole IM Depot 400/300mg-8.9-15.2-19.0-21.5-23.7-26.8
Placebo-5.0-8.3-9.8-10.3-9.7-11.7

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Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Discontinued Investigational Medicinal Product (IMP) Due to AEs, Serious TEAEs and Outcome of Death

A TEAE was defined as an AE that began after the first injection or was continuous from Baseline and was serious, study drug-related, or resulted in death. (NCT01683058)
Timeframe: Baseline to Week 24

InterventionPercentage of participants (Number)
Participants with TEAEsParticipants with serious TEAEsParticipants with severe TEAEsParticipants discontinued IMP due to AEsDeaths
Aripiprazole IM Depot 400/300 mg66.26.88.18.10.0

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Number of Participants With Clinically Relevant Laboratory Values.

The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria. (NCT01683058)
Timeframe: Baseline to last visit

Interventionparticipants (Number)
Aripiprazole IM Depot 400/ 300 mg0

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Number of Participants With Clinically Relevant Physical Examination.

The physical examination evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae. (NCT01683058)
Timeframe: Baseline to last visit

Interventionparticipants (Number)
Aripiprazole IM Depot 400/ 300 mg0

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Mean Change From Baseline by Week by EPS Evaluated Using Barnes Akathisia Rating Scale (BARS)

The BARS global score (range 0-5) was derived from the global clinical assessment of akathisia from the BARS panel were, 0= absent; 1= questionable; 2= mild akathisia; 3= moderate akathisia; 4= marked akathisia; 5= severe akathisia. Patients were observed while they were seated and then standing (for a minimum of 2 minutes in each position). Symptoms were observed in other situations (e.g., while engaged in neutral conversation, engaged in activity on the ward) was also rated. (NCT01683058)
Timeframe: Baseline to Week 24

InterventionUnits on a scale (Mean)
Week 12 (N= 65)Week 24 (N= 70)
Aripiprazole IM Depot 400/300 mg0.190.14

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Mean Change From Baseline by Week by EPS Evaluated Using the Abnormal Involuntary Movement Scale (AIMS)

EPS rating scale included the AIMS movement rating score (range 0-28) was the sum of the rating scores for facial and oral movements (i.e., item 1 - 4), extremity movements (i.e. item 5 - 6), and trunk movements (i.e. item 7). The symptoms for facial and oral movements were 1= muscles of facial expression, 2= lips and perioral area, 3= jaw and 4=tongue; extremity movements were, 5= upper (arms, wrists, hands, fingers), lower (legs, knees, ankles, toes), 7= neck, shoulders, hips). This scale consisted of 10 items, each to be rated on a 4-point scale of severity, and 2 questions to be answered by yes or no. To complete the scale, the patient was observed unobtrusively at rest (e.g., in waiting room). The chair used for this examination was hard, firm one without arms. (NCT01683058)
Timeframe: Baseline to Week 24

InterventionUnits on a scale (Mean)
Week 12 (N= 65)Week 24 (N= 70)
Aripiprazole IM Depot 400/300 mg-0.060.07

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Mean Change From Baseline by Week by Extrapyramidal Symptoms (EPS) Evaluated Using the Simpson-Angus Scale (SAS)

The EPS rating scales included SAS total score (range 10-50) was the sum of the rating scores for 10 items from the SAS panel. This scale consists of a list of 10 symptoms, each to be rated on a 5-point scale of severity. For each symptom, the rating which best described the patient's condition were, 1= gait; 2= arm dropping; 3= shoulder shaking; 4= elbow rigidity; 5= wrist rigidity; 6= head rotation; 8= tremor; 9= salivation; 10= akathisia. (NCT01683058)
Timeframe: Baseline to Week 24

InterventionUnits on a scale (Mean)
Week 12 (N= 66)Week 24 (N= 70)
Aripiprazole IM Depot 400/300 mg0.190.04

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Mean Change From Baseline in Suicidal Ideation Intensity Total Score by the Columbia Suicide Severity Rating Scale (C-SSRS)

Data collected from C-SSRS were mapped into C-CASA. The Columbia Classification Algorithm of Suicide Assessment (C-CASA) method and C-SSRS(text in parentheses as said below) were mapped as; 1= completed suicide(completed suicide); 2= suicide attempt(actual attempt); 3= preparatory actions toward imminent suicidal behavior (interrupted attempt, aborted attempt and preparatory acts/behavior); 4= suicidal ideation(wish to die,active suicidal thought, active suicidal thought with method, active suicidal thought with intent,active suicidal thought with plan/intent); 5= self-injurious behavior, intent unknown; 6= not enough information: death; 7= non-suicidal self-injurious behavior(nonsuicidal self-injurious behavior); 8= other accident; psychiatric/medical; 9= not enough information/non-death. C-CASA category 5, 6, 8 and 9 are not applicable. For each item, each participant received an intensity score from 0(none) to 5(worst). Suicidal ideation intensity total score range from 0 to 25. (NCT01683058)
Timeframe: Baseline to Week 24

InterventionUnits on a scale (Mean)
Week 4 (N= 69)Week 8 (N= 61)Week 12 (N= 57)Week 16 (N= 52)Week 20 (N= 44)Week 24 (N= 45)Last Visit (N= 71)
Aripiprazole IM Depot 400/300 mg-0.1-0.1-0.30.70.30.00.6

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Mean Change in Body Temperature From Baseline in All Participants.

The body temperature, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria. (NCT01683058)
Timeframe: Baseline to last visit

Intervention°C (Mean)
Week 4 (N= 69)Week 8 (N= 61)Week 12 (N= 58)Week 16 (N= 53)Week 20 (N= 44)Week 24 (N= 45)Last visit (N= 72)
Aripiprazole IM Depot 400/ 300 mg0.1-0.00.00.00.10.10.0

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Mean Change in Clinically Relevant Body Mass Index From Baseline in All Participants.

Clinically relevant body mass index was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss. (NCT01683058)
Timeframe: Baseline to last visit

InterventionKg/m2 (Mean)
Week 12 (N= 57)Week 24 (N= 44)Last visit (N= 71)
Aripiprazole IM Depot 400/ 300 mg-0.00.50.2

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Mean Change in Clinically Relevant Body Weight Changes From Baseline in All Participants.

Clinically relevant body weight changes was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss. (NCT01683058)
Timeframe: Baseline to last visit

InterventionKg (Mean)
Week 12 (N= 57)Week 24 (N= 44)Last visit (N= 71)
Aripiprazole IM Depot 400/ 300 mg-0.11.30.5

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Mean Change in Clinically Relevant Waist Circumference From Baseline in All Participants.

Clinically relevant waist circumference was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss. (NCT01683058)
Timeframe: Baseline to last visit

Interventioncm (Mean)
Week 24 (N= 44)Last visit (N= 64)
Aripiprazole IM Depot 400/ 300 mg1.61.3

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Mean Change in Diastolic BP From Baseline in All Participants.

The diastolic sitting BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes. (NCT01683058)
Timeframe: Baseline to last visit

InterventionmmHg (Mean)
Week 4 (N= 69)Week 8 (N= 61)Week 12 (N= 58)Week 16 (N= 53)Week 20 (N= 44)Week 24 (N= 45)Last visit (N= 72)
Aripiprazole IM Depot 400/ 300 mg-0.9-1.7-0.20.8-0.20.41.4

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Mean Change in Diastolic Supine BP From Baseline in All Participants.

The diastolic supine BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. (NCT01683058)
Timeframe: Baseline to last visit

InterventionmmHg (Mean)
Week 4 (N= 69)Week 8 (N= 61)Week 12 (N= 58)Week 16 (N= 53)Week 20 (N= 44)Week 24 (N= 45)Last visit (N= 72)
Aripiprazole IM Depot 400/ 300 mg0.1-1.3-0.90.3-0.00.40.5

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Mean Change in Heart Rate From Baseline in All Participants.

The heart rate sitting, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes. (NCT01683058)
Timeframe: Baseline to last visit

Interventionbeats/min (Mean)
Week 4 (N= 69)Week 8 (N= 61)Week 12 (N= 58)Week 16 (N= 53)Week 20 (N= 44)Week 24 (N= 45)Last visit (N= 72)
Aripiprazole IM Depot 400/ 300 mg1.21.4-1.14.33.30.61.9

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Mean Change in Heart Rate Supine From Baseline in All Participants.

The heart rate supine, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria. (NCT01683058)
Timeframe: Baseline to last visit

Interventionbeats/min (Mean)
Week 4 (N= 69)Week 8 (N= 61)Week 12 (N= 58)Week 16 (N= 53)Week 20 (N= 44)Week 24 (N= 45)Last visit (N= 72)
Aripiprazole IM Depot 400/ 300 mg3.82.31.34.73.61.73.4

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Mean Change in PR Interval From Baseline in All Participants.

The measurement PR interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria. (NCT01683058)
Timeframe: Baseline to last visit

Interventionmsec (Mean)
Week 12 (N= 56)Week 24 (N= 43)Last visit (N= 70)
Aripiprazole IM Depot 400/ 300 mg3.50.50.9

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Mean Change in QRS Interval From Baseline in All Participants.

The measurement QRS interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria. (NCT01683058)
Timeframe: Baseline to last visit

Interventionmsec (Mean)
Week 12 (N= 56)Week 24 (N= 43)Last visit (N= 70)
Aripiprazole IM Depot 400/ 300 mg-0.10.40.0

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Mean Change in QT Interval From Baseline in All Participants.

The measurement QT interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria. (NCT01683058)
Timeframe: Baseline to last visit

Interventionmsec (Mean)
Week 12 (N= 56)Week 24 (N= 43)Last visit (N= 70)
Aripiprazole IM Depot 400/ 300 mg3.11.51.0

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Mean Change in QTcB Interval From Baseline in All Participants.

The measurement QTcB interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria. (NCT01683058)
Timeframe: Baseline to last visit

Interventionmsec (Mean)
Week 12 (N= 56)Week 24 (N= 43)Last visit (N= 70)
Aripiprazole IM Depot 400/ 300 mg-1.6-2.40.3

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Mean Change in QTcF Interval From Baseline in All Participants.

The measurement QTcF interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria. (NCT01683058)
Timeframe: Baseline to last visit

Interventionmsec (Mean)
Week 12 (N= 56)Week 24 (N= 43)Last visit (N= 70)
Aripiprazole IM Depot 400/ 300 mg-0.2-1.30.3

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Mean Change in QTcN Interval From Baseline in All Participants.

The measurement QTcN interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria. (NCT01683058)
Timeframe: Baseline to last visit

Interventionmsec (Mean)
Week 12 (N= 56)Week 24 (N= 43)Last visit (N= 70)
Aripiprazole IM Depot 400/ 300 mg-0.5-1.70.3

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Mean Change in RR Interval From Baseline in All Participants.

The measurement RR interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria. (NCT01683058)
Timeframe: Baseline to last visit

Interventionmsec (Mean)
Week 12 (N= 56)Week 24 (N= 43)Last visit (N= 70)
Aripiprazole IM Depot 400/ 300 mg23.723.38.0

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Mean Change in Systolic BP From Baseline in All Participants.

The systolic sitting BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes. (NCT01683058)
Timeframe: Baseline to last visit

InterventionmmHg (Mean)
Week 4 (N= 69)Week 8 (N= 61)Week 12 (N= 58)Week 16 (N= 53)Week 20 (N= 44)Week 24 (N= 45)Last visit (N= 72)
Aripiprazole IM Depot 400/ 300 mg-0.1-0.3-0.71.61.0-0.4-0.7

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Mean Change in Systolic Supine Blood Pressure (BP) From Baseline in All Participants.

The systolic supine BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria. (NCT01683058)
Timeframe: Baseline to last visit

InterventionmmHg (Mean)
Week 4 (N= 69)Week 8 (N= 61)Week 12 (N= 58)Week 16 (N= 53)Week 20 (N= 44)Week 24 (N= 45)Last visit (N= 72)
Aripiprazole IM Depot 400/ 300 mg1.91.3-0.22.04.80.70.4

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Mean Change in Ventricular Rate From Baseline in All Participants.

The measurement ventricular rate is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria. (NCT01683058)
Timeframe: Baseline to last visit

InterventionBeats/min (Mean)
Week 12 (N= 56)Week 24 (N= 43)Last visit (N= 70)
Aripiprazole IM Depot 400/ 300 mg-1.5-1.1-0.1

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Number of Participants With Adverse Events

An adverse event (AE) is defined as any untoward medical occurrence in a patient or participant enrolled in the clinical trial and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP). AEs were assessed as a criteria for safety and tolerability. (NCT01710709)
Timeframe: Up to Week 52

InterventionParticipants (Count of Participants)
Participants with adverse eventsParticipants with TEAEsParticipants with serious TEAEsParticipants with severe TEAEsParticipants discontinued from IMP due to AEsParticipants discont. from IMP due to AEs or deathDeaths
Phase C: Open-label IM Depot Maintenance Phase374374304147481

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Number of Participants Experiencing Suicidal Events and Their Classification According to the Completion of Columbia Suicide Severity Rating Scale (C-SSRS)

"Suicidality was monitored throughout the trial using the C-SSRS at every visit. The C-SSRS scale consisted of a screening/baseline evaluation that assessed the participant's lifetime experience and experience over the last 90 days with suicide events and suicidal ideation and a post-baseline/ Since Last Visit evaluation that focused on suicidality since the last trial visit." (NCT01710709)
Timeframe: Up to Week 52

InterventionParticipants (Count of Participants)
Completed SuicideSuicide AttemptPreparatory action toward imminent suicideSuicidal ideationNon-suicidal self-injurious behavior
Phase C: Open-label IM Depot Maintenance Phase034464

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Injection Site Pain Measured by the Visual Analog Scale (VAS)

Injection-site pain was evaluated by mean visual analog scale (VAS) scores as reported by the participant after each injection at visits where an injection occurred. Ratings ranged from 0 (no pain) to 100 (unbearably painful). (NCT01710709)
Timeframe: Up to Week 52

InterventionUnits on a scale (Mean)
1ST Injection2ND Injection3RD Injection4TH Injection5TH Injection6TH Injection7TH Injection8TH Injection9TH Injection10TH Injection11TH Injection12TH Injection13TH InjectionLast Injection
Phase C: Open-label IM Depot Maintenance Phase4.94.13.43.62.92.42.62.42.62.52.41.82.22.4

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Number of Participants With Clinically Significant Abnormal Laboratory Test Results

Standard safety variables to be analyzed included clinical laboratory tests. Incidence of treatment emergent adverse events (TEAEs) of potential clinical relevance included abnormal values in serum chemistry, hematology, urinalysis, and other laboratory test that were identified based on pre-defined criteria. Abnormal laboratory values in participants were reported as serious adverse event/adverse events (SAE/AEs) and are reported in the SAE/other AE section of this report. (NCT01710709)
Timeframe: Up to Week 52

InterventionParticipants (Count of Participants)
Fasting cholesterolFasting glucoseFasting low-density lipoprotein cholesterolFasting triglycerides
Phase C: Open-label IM Depot Maintenance Phase533932124

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Number of Participants With Clinically Significant Abnormal Vital Signs

TEAEs of potential clinical relevance included abnormal values in body weight, systolic and diastolic blood pressure, heart rate, and body temperature that were identified based on pre-defined criteria. Abnormal laboratory values in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report. (NCT01710709)
Timeframe: Up to Week 52

InterventionParticipants (Count of Participants)
Weight gain of ≥ 7%Weight loss of ≥ 7%Blood pressure increasedHeart rate increasedBlood pressure decreasedBody temperature
Phase C: Open-label IM Depot Maintenance Phase93664320

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Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating

Injection-site reactions were assessed by the investigator (or qualified designee) and the participant. Investigators rated localized pain, redness, swelling, and induration at the most recent injection site using a 4-point categorical scale (absent, mild, moderate, severe) . The participant indicated the degree of pain at the most recent injection site using a VAS. Ratings ranged from 0 (no pain) to 100 (unbearably painful). Ratings included were: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. These assessments occurred at trial visits where injections occurred (scheduled and unscheduled), beginning with the first dose of open-label aripiprazole IM depot administered at the final visit of the Oral Stabilization Phase and continued through the last injection prior to the end of the IM Depot Maintenance Phase/Early termination (ET) visit (ie, evaluations were not done at end of the IM Depot Maintenance Phase/ET visit). (NCT01710709)
Timeframe: Up to Week 52

InterventionParticipants (Count of Participants)
Injection Site BruisingInjection Site ErythemaInjection Site IndurationInjection Site MassInjection Site PainInjection Site Swelling
Phase C: Open-label IM Depot Maintenance Phase2112344

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Extrapyramidal Symptoms Will be Assessed by Mean Change From Baseline on Abnormal Involuntary Movement Scale(AIMS), Simpson-Angus Scale (SAS), Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS Only Used in Japan) and Barnes Akathisia Rating Scale (BARS)

AIMS: 10 items described dyskinesia signs; 0-absence/no awareness; 4-severe condition/severe distress. Total score for Items 1-10 ranges from 0 to 40; a higher score reflects severe condition. SAS:Consisted of 10 parkinsonism signs;1-no symptoms;5-severe.Total score for Items 1-10 ranges from 1 to 50;a higher score reflects severe condition.DIEPSS:A 9-item rating scale (8 assessed individual symptoms [4 categories of parkinsonism, akathisia, dystonia & dyskinesia]+1 assessed general severity) was used;0-no symptoms/normal, 4-severe.Total score (8 individual symptom items) was in range of 0 to 32 (a higher score reflects severe condition).BARS:Consisted of 4 items related to akathisia:objective observation, subjective feelings of restlessness, distress, global clinical evaluation.Only BARS global clinical assessment score has been presented and rated using scale:0-absence of symptoms;5-severe akathisia.Total BARS global score ranges from 0 to 5,a higher score reflects severe condition. (NCT01710709)
Timeframe: Baseline, Week 28, and Week 52

InterventionUnits on a scale (Mean)
AIMS, Week 28AIMS, Week 52SAS, Week 28SAS, Week 52DIEPSS, Week 28DIEPSS, Week 52BARS, Week 28BARS, Week 52
Phase C: Open-label IM Depot Maintenance Phase0.070.050.210.200.320.210.050.04

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Percentage of Participants Who Remained Stable at End of Treatment in Phase C

The secondary objective was to evaluate the efficacy, as measured by the percentage of stable participants at baseline who remained stable at the end of treatment in the IM depot maintenance phase, of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to subjects with bipolar I disorder. (NCT01710709)
Timeframe: Up to Week 52

InterventionPercentage of participants (Number)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52Last Visit
Phase C: Open-label IM Depot Maintenance Phase100.0096.9897.2295.6496.3196.4695.5496.4095.0997.9195.9498.0497.5997.5395.7888.91

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Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECGs)

Twelve-lead ECGs were recorded at specified visits. For each time point, three 12-lead ECG recordings were obtained approximately 5 minutes apart. Additional 12-lead ECGs were permitted to be obtained at the investigator's discretion and were to always be obtained in the event of an early termination. The ECGs were evaluated at the investigational site to determine the participant's eligibility and to monitor safety during the trial. (NCT01710709)
Timeframe: Up to Week 52

InterventionParticipants (Count of Participants)
Symmetrical T-wave inversionSupraventricular premature beatVentricular premature beatMyocardial ischemia
Phase C: Open-label IM Depot Maintenance Phase9842

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Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS).

The YGTSS is a semi-structured clinical interview designed to measure current (time frame of the past 1 week) tic severity. This scale consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the primary outcome measure in this trial. The YGTSS ranking of impairment score rated on a 50-point scale anchored from 0 (no impairment) to 50 (severe impairment) to assess impairment experienced in areas of self-esteem, family life, social acceptance, and school scores. This is a fully validated scale in adults and has become a standard instrument for the evaluation of the severity of TD in children. (NCT01727700)
Timeframe: Baseline to Week 8

InterventionUnits on a scale (Least Squares Mean)
Aripiprazole Low Dose-13.35
Aripiprazole High Dose-16.94
Placebo-7.09

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Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8.

"To assess CGI-TS severity, the rater or physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? However, the evaluation of illness was limited to manifestations of TD only. Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The change score was obtained from CGI-TS improvement scale assessment: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse." (NCT01727700)
Timeframe: Week 8

InterventionUnits on a scale (Least Squares Mean)
Aripiprazole Low Dose2.12
Aripiprazole High Dose2.13
Placebo3.15

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Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score

The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100). A missing value of a YGTSS item scale could result in a missing Total YGTSS score. A reduction in Total YGTSS score from baseline represents an improvement in symptoms. (NCT01727700)
Timeframe: Baseline to Week 8

InterventionUnits on a scale (Least Squares Mean)
Aripiprazole Low Dose-26.69
Aripiprazole High Dose-32.80
Placebo-13.43

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Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score

The CGI-TS Severity scale (range 0-7) is a single-item rating score, with higher scores representing greater severity or less improvement. A response of 0 (not assessed) is considered and handled as missing data. (NCT01727700)
Timeframe: Baseline to Week 8

InterventionUnits on a scale (Least Squares Mean)
Aripiprazole Low Dose-1.35
Aripiprazole High Dose-1.47
Placebo-0.55

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Response Rate

Clinical response is defined as > 25% improvement from baseline to Week 8 in YGTSS TTS or a CGI-TS Change score of 1 [very much improved] or 2 [much improved] at Week 8. Response will be considered as missing only if both YGTSS TTS and CGI-TS change score are missing. As long as one of them is non-missing, response outcome will be determined based on the non-missing score. (NCT01727700)
Timeframe: Week 8

InterventionPercentage of Responders (Number)
Aripiprazole Low Dose73.8
Aripiprazole High Dose88.6
Placebo54.8

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Treatment Discontinuation Rate

Treatment discontinuation rate will be calculated as the number of discontinued participants (ie, those who were withdrawn from the trial without completing the Week 8 visit) over the number of all randomized participants. (NCT01727700)
Timeframe: Week 8

InterventionPercentage of participants (Number)
Aripiprazole Low Dose4.5
Aripiprazole High Dose22.5
Placebo4.5

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Change From Baseline to Endpoint on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS).

The YGTSS is a semi-structured clinical interview which consists of a tic inventory, with 5 separate ratings to assess the number, intensity, frequency, complexity and interference of tics, plus an overall impairment/disability score. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the secondary outcome measure in this trial. The YGTSS ranking of impairment, with a maximum of 50 points, is based on the impact of the tic disorder on areas of self-esteem, family life, social acceptance, and school scores. The total severity score ranged from 0 (no impairment) to 50 (worst impairment). (NCT01727713)
Timeframe: Baseline to Week 52

InterventionUnits on a scale (Mean)
Week 52 (N=77)Last visit (N=109)
Open-label Aripiprazole-8.6-6.6

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Mean Change From Baseline in Body Mass Index (BMI).

BMI was calculated at the Baseline visit (using the Baseline height from study 31-12-293) and at Weeks 28 and 52/ET where height measured at baseline in the current trial was used to calculate BMI. (NCT01727713)
Timeframe: Baseline to Weeks 28, 52 and Last visit.

InterventionKg/M^2 (Mean)
Week 28 (N=90)Week 52 (N=77)Last visit (N=106)
Open-label Aripiprazole3.31.91.8

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Mean Change From Baseline in Body Weight.

Criteria for identifying weight of potential clinical relevance was: ≥ 7% kilogram increase/decrease from Baseline (Final visit of Trial 31-12-293). (NCT01727713)
Timeframe: Baseline to Weeks 12, 28, 36, 44, 52/Last visit.

InterventionKilogram (Mean)
Week 12 (N=102)Week 28 (N=90)Week 36 (N=88)Week 44 (N=81)Week 52 (N=77)Last visit (N=106)
Open-label Aripiprazole1.84.85.86.88.07.2

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Mean Change From Baseline in Waist Circumference.

Waist circumference was measured at Baseline, Weeks 12, 28, 36, 44, and the Week 52/last visit in centimeters. (NCT01727713)
Timeframe: Baseline to Weeks 12, 28, 36, 44, and 52/last visit.

InterventionCentimeter (Mean)
Week 12 (N=102)Week 28 (N=90)Week 36 (N=87)Week 44 (N=80)Week 52 (N=75)Last visit (N=106)
Open-label Aripiprazole2.23.73.54.55.54.6

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Mean Change From Baseline to Endpoint in Total YGTSS Score.

The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) for motor and vocal tics, and an impairment ranking. The YGTSS TTS is the summation of the severity scores of motor and vocal tics (range of 0 [no impairment] to 50 [maximum impairment]). The total YGTSS score is the summation of the severity scores of motor and vocal tics and the ranking of impairment (total range of 0 [no impairment] to 100 [maximum impairment]). (NCT01727713)
Timeframe: Baseline to Week 52

InterventionUnits on a scale (Mean)
Week 52 (N=77)Last visit (N=109)
Open-label Aripiprazole-18.0-14.0

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Mean Clinical Global Impressions for Tourette's Syndrome (CGI-TS) Change Score at Endpoint.

"The CGI is a 7-point Likert scale used in a multitude of clinical trials as a clinical global measure to assess the severity and change in disease symptomatology (ie, tics). The CGI was included as a secondary scale to provide a more complete assessment of clinical efficacy. To assess CGI-TS severity, the rater or investigator will answer the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? However, the evaluation of illness will be limited to manifestations of Tourette's Disorder only. Response choices include: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients." (NCT01727713)
Timeframe: Baseline to Week 52

InterventionUnits on a scale (Mean)
Week 52 (N=77)Last visit (N=109)
Open-label Aripiprazole2.52.5

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Percentage of Participants With Adverse Events.

An AE is defined as any untoward medical occurrence in a patient or participant enrolled in the clinical trial and which does not necessarily have to have a causal relationship with the study drug. A treatment emergent adverse event (TEAE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to have a causal relationship with the study drug. Serious adverse event (SAE) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolonged hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect. (NCT01727713)
Timeframe: Baseline, throighout the 52-week treatmetn and 30±3 days after last trial visit

InterventionPercentage of participants (Number)
Participants with TEAEsParticipants with severe TEAEsParticipants with serious TEAEs
Open-label Aripiprazole76.44.53.6

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Percentage of Participants With Clinically Significant Abnormal Electrocardiogram (ECG).

Three 12-lead ECGs (scheduled 5 minutes apart) were recorded. Some of the pre-defined criteria for identifying ECG measurements of potential clinical relevance included: Tachycardia/sinus tachycardia: increase of ≥15 bpm from Baseline; increase in QTc of ≥10% from Baseline. The other abnormalities not present at Baseline and were present during the time of measurement were recorded. Percentage of participants noted with abnormal ECG findings are reported below. (NCT01727713)
Timeframe: Baseline to Week 52

InterventionPercentage of participants (Number)
Tachycardia (N=106)Sinus Tachycardia (N=106)Supraventricular premature beat (N=106)Ventricular premature beat (N=106)Right bundle branch block (N=106)QTcB (N=106)QTcN (N=106)
Open-label Aripiprazole0.90.91.90.91.90.90.9

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Percentage of Participants With Clinically Significant Abnormal Laboratory Test Results.

Laboratory tests including hematology, serum chemistry, and urinalysis were performed for all the participants. The central laboratory was used for all laboratory testing whenever possible. Any value outside the normal range was flagged for the attention of the study physician who was to indicate whether the value was clinically significant based on the pre-defined criteria for identifying laboratory values of potential clinical relevance. Percentage of participants noted with abnormal laboratory values are reported below. (NCT01727713)
Timeframe: Baseline to Week 52

InterventionPercentage of participants (Number)
Eosinophils (high) (N=108)Hemoglobin A1C (high) (N=107)Absolute neutrophils (low) (N=108)White blood count (low) (N=108)Total bilirubin (high) (N=108)Creatine phosphokinase (high) (N=108)Fasting glucose (high) (N=93)LDL cholesterol (high) (N=92)Triglycerides (high) (N=92)Uric acid (high) (N=108)Potassium (high) (N=108)Urine glucose (high) (N=104)Urine protein (high) (N=104)Prolactin (high) (N=104)
Open-label Aripiprazole3.70.913.04.61.90.93.23.317.40.90.91.01.93.8

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Percentage of Participants With Clinically Significant Abnormal Vital Signs.

Vital sign measurements included systolic and diastolic blood pressure (BP) and heart rate, which were performed at all clinic visits. Criteria for identifying vital signs of potential clinical relevance included: Heart rate: ≥ 15 beats per minute (bpm) increase/decrease from Baseline (final visit of study 31-12-293); Systolic BP: ≥ 20 mmHg increase/decrease from Baseline; Diastolic BP: ≥ 15mmHg increase/decrease from Baseline; Orthostatic hypotension: ≥ 20 mmHg decrease in systolic BP and a ≥ 25 bpm increase in heart rate from supine to sitting/standing. Percentage of participants noted with abnormal vital sign measurements are reported below. (NCT01727713)
Timeframe: Baseline to Week 52

InterventionPercentage of participants (Number)
Heart rate-Supine (increase) (N=108)Heart rate-Supine (decrease) (N=108)Heart rate-Standing (increase) (N=108)Systolic Supine BP (decrease) (N=108)Systolic Standing BP (decrease) (N=108)Diastolic Supine BP (decrease) (N=108)Diastolic Standing BP (decrease) (N=108)Orthostatic hypotension (N=110)
Open-label Aripiprazole0.90.99.36.53.70.95.62.7

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Percentage of Participants With Response (Response Rate).

Clinical response was defined as > 25% improvement from Baseline to endpoint in YGTSS TTS or a CGI-TS change score of 1 (very much improved) or 2 (much improved) at endpoint. (NCT01727713)
Timeframe: Weeks 4, 8, 12, 20, 28, 36, 44 and 52

InterventionPercentage of participants with response (Number)
Week 4 (N=107)Week 8 (N=105)Week 12 (N=104)Week 20 (N=100)Week 28 (N=92)Week 36 (N=88)Week 44 (N=81)Week 52 (N=77)
Open-label Aripiprazole80.481.982.775.077.275.075.367.5

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Percentage of Participants With Treatment Discontinuation (Treatment Discontinuation Rate).

The treatment discontinuation rate was calculated as the number of discontinued participants (ie, those withdrawn from the study without completing the Week 52 visit) divided by the number of all enrolled participants. (NCT01727713)
Timeframe: Baseline to Week 52

InterventionPercentage of discontinued participants (Number)
Open-label Aripiprazole31.8

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Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score.

The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest, and the investigator also made global judgments on the participant's dyskinesias (items 8 through 10). Each item was rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness/severe distress). In addition, the AIMS included 2 yes/no questions that addressed the subject's dental status (since an edentulous state can cause lingual dyskinesias). The AIMS movement rating score (range 0 to 28) was the sum of the rating scores for facial and oral moments (ie, items 1 to 4), extremity movements (ie, items 5 and 6), and trunk movements (ie, item 7). (NCT01727713)
Timeframe: Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit

InterventionUnits on a scale (Mean)
Week 4 (N=107)Week 8 (N=105)Week 12 (N=104)Week 20 (N=100)Week 28 (N=92)Week 36 (N=88)Week 44 (N=82)Week 52 (N=77)Last vist (N=109)
Open-label Aripiprazole-1.0-1.3-1.7-1.8-2.0-2.2-2.3-2.3-1.8

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Change From Baseline in Average Score of Attention Deficit Disorder/Attention-deficit Hyperactivity Disorder (ADD/ADHD) of Swanson, Nolan, and Pelham-IV Rating Scale (SNAP-IV).

The SNAP-IV Rating Scale is a revision of the SNAP Questionnaire. The SNAP-IV assesses inattention and hyperactivity/impulsivity, as well as oppositional defiant disorder that are often present in children with ADD/ADHD. The SNAP-IV was administered as a semi-structured interview with the participant and caregiver. The SNAP-IV is based on a 0 to 3 rating scale: not at all = 0, just a little = 1, quite a bit = 2, and very much = 3. The ADD/ADHD subscale includes items 1 through 19 (items 1-9 measure inattention, items 11-19 measure hyperactivity/ impulsivity, and item 10 for inattention domain), items 4, 8, 11, 31, and 32 measure inattention/overactivity, and items 21, 23, 29, 34, and 35 measure aggression/defiance. Items 4, 8, 11, 21, 32, 33, 36, 37, 38, and 39 form the Conners Index. Subscale average scores on the SNAP IV were calculated by summing the scores on the items in the subset and dividing by the number of items in the subset. (NCT01727713)
Timeframe: Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit

InterventionUnits on a scale (Mean)
Week 4 (N=107)Week 8 (N=105)Week 12 (N=104)Week 20 (N=100)Week 28 (N=92)Week 36 (N=88)Week 44 (N=82)Week 52 (N=77)Last vist (N=109)
Open-label Aripiprazole-0.2-0.2-0.3-0.2-0.2-0.2-0.2-0.2-0.2

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Change From Baseline in Barnes Akathisia Rating Scale (BARS) Total Score.

The BARS Global Score is derived from the global clinical evaluation of akathisia on a 6-point scale, with 0 representing absence of symptoms and a score of 5 representing severe akathisia. (NCT01727713)
Timeframe: Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit

InterventionUnits on a scale (Mean)
Week 4 (N=107)Week 8 (N=105)Week 12 (N=104)Week 20 (N=100)Week 28 (N=92)Week 36 (N=88)Week 44 (N=82)Week 52 (N=77)Last vist (N=109)
Open-label Aripiprazole0.00.0-0.0-0.1-0.1-0.1-0.1-0.1-0.0

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Change From Baseline in Children's Depression Rating Scale - Revised (CDRS-R).

The CDRS-R is a brief rating scale based on a semi-structured interview with the child and an adult informant who knows the child well. Designed for 6- to 12-year-old children, and successfully used with adolescents, it can be administered in 15 to 20 minutes. The interviewer rates 17 symptom areas (including those that serve as Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision criteria for a diagnosis of depression): impaired schoolwork, difficulty having fun, social withdrawal, appetite disturbance, sleep disturbance, excessive fatigue, physical complaints, irritability, excessive guilt, low self-esteem, depressed feelings, morbid ideas, suicidal ideas, excessive weeping, depressed facial affect, listless speech, and hypoactivity. The CDRS-R total score is the sum of scores for the 17 symptom areas and could range from 17 to 113 with higher values indicating worse outcome. (NCT01727713)
Timeframe: Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit

InterventionUnits on a scale (Mean)
Week 4 (N=104)Week 8 (N=100)Week 12 (N=100)Week 20 (N=97)Week 28 (N=91)Week 36 (N=87)Week 44 (N=82)Week 52 (N=77)Last vist (N=107)
Open-label Aripiprazole-0.4-0.4-0.3-0.10.20.4-0.30.60.7

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Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS).

The CY-BOCS is a semi-structured interview used with children and adolescents aged 6 to 17 years to rate the severity and type of symptoms in participants with obsessive compulsive disorder. In general, the items depend on the participant's report; however, the final rating is based on the clinical judgment of the interviewer and should include additional information supplied by others. Nineteen items are rated in the CY-BOCS, but only items 1 through 10 (excluding items lb and 6b) are used to determine the total score. The total CY-BOCS score is the sum of items 1 through 10 (excluding lb and 6b), whereas the obsession and compulsion subtotals are the sums of items 1 through 5 (excluding lb) and 6 through 10 (excluding 6b), respectively. CY-BOCS total score could range from 0 to 40, and the obsession and compulsion subscale total scores could each range from 0 to 20. Higher scores indicate worse outcome. (NCT01727713)
Timeframe: Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit

InterventionUnits on a scale (Mean)
Week 4 (N=107)Week 8 (N=105)Week 12 (N=104)Week 20 (N=100)Week 28 (N=92)Week 36 (N=88)Week 44 (N=82)Week 52 (N=77)Last vist (N=109)
Open-label Aripiprazole-0.2-0.1-0.5-0.6-0.5-0.7-0.8-0.9-0.7

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Change From Baseline in Pediatric Anxiety Rating Scale (PARS).

The PARS is used to rate the severity of anxiety in children and adolescents, aged 6 to 17 years. The PARS has 2 sections: the symptom checklist and the severity items. The symptom checklist is used to determine the child's repertoire of symptoms during the past week. The 7-item severity list is used to determine severity of symptoms and the PARS total score. The time frame for the PARS is the past week. Only those symptoms endorsed for the past week are included in the symptom checklist and rated on the severity items. The PARS total severity score was the sum of items 2, 3, 5, 6, and 7. The total severity score ranged from 0 (no anxiety) to 25 (worst anxiety). (NCT01727713)
Timeframe: Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit

InterventionUnits on a scale (Mean)
Week 4 (N=107)Week 8 (N=105)Week 12 (N=104)Week 20 (N=100)Week 28 (N=91)Week 36 (N=88)Week 44 (N=82)Week 52 (N=77)Last vist (N=109)
Open-label Aripiprazole-0.3-0.3-0.5-0.4-0.2-0.7-0.5-0.4-0.4

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Change From Baseline in Simpson-Angus Scale (SAS) Total Score.

The SAS consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item was rated on a 5-point scale, with a score of 1 representing absence of symptoms, and a score of 5 representing a severe condition. The SAS total score (range 10 to 50) was the sum of the rating scores for 10 items from the SAS panel. (NCT01727713)
Timeframe: Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit

InterventionUnits on a scale (Mean)
Week 4 (N=107)Week 8 (N=104)Week 12 (N=104)Week 20 (N=100)Week 28 (N=92)Week 36 (N=88)Week 44 (N=82)Week 52 (N=77)Last vist (N=109)
Open-label Aripiprazole0.0-0.0-0.0-0.1-0.2-0.2-0.2-0.1-0.1

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Change From Baseline in Suicidal Ideation Intensity Total Score Based on Columbia-Suicide Severity Rating Scale (C-SSRS).

"The C-SSRS consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post baseline/since last visit evaluation that focuses on suicidality since the last trial visit. The C-SSRS data at Baseline and post baseline were summarized for incidence of reporting: Suicidality, Suicidal behavior (and its 4 types), Suicidal ideation (and its 5 types). The intensity score of each item ranges from 1 (least severe) to 5 (most severe), which leads to the range of the total score from 0 to 25." (NCT01727713)
Timeframe: Baseline, Weeks 1, 2, 4, 8, 12, 20, 28, 36, 44, 52, and Last visit

InterventionUnits on a scale (Mean)
Week 1 (N=108)Week 2 (N=106)Week 4 (N=107)Week 8 (N=105)Week 12 (N=104)Week 20 (N=100)Week 28 (N=92)Week 36 (N=88)Week 44 (N=82)Week 52 (N=77)Last vist (N=110)
Open-label Aripiprazole-0.1-0.00.0-0.1-0.0-0.10.10.10.00.20.0

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Change From Baseline to Endpoint in CGI-TS Severity of Illness Score.

The final CGI-TS score was compared to the participant's baseline condition at the time of entry into the open-label study, rather than the CGI-TS baseline condition at the time participants enrolled into the preceding study. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. (NCT01727713)
Timeframe: Baseline to Week 52

InterventionUnits on a scale (Mean)
Week 52 (N=77)Last visit (N=109)
Open-label Aripiprazole-0.9-0.7

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Change From Baseline to Week 28 in the TooL Total Score

Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact). (NCT01795547)
Timeframe: Baseline, Week 28

Interventionunits on a scale (Least Squares Mean)
Aripiprazole-1.75
Paliperidone-1.05

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Investigator's Assessment Questionnaire (IAQ) Total Score at Week 28

The IAQ is a clinician-rated scale designed to assess the relative effectiveness (efficacy, safety and tolerability) of antipsychotic medications in patients with schizophrenia or schizoaffective disorder. The IAQ consists of 12 items: positive symptoms, negative symptoms, other efficacy symptoms, cognition, energy, mood, somnolence, weight gain, signs and symptoms of prolactin elevation, akathisia, EPS (other than akathisia) and other safety or tolerability issues. For each item, the current medication was compared with previous antipsychotic medication on a five-point scale from 1 (Much better) to 5 (Much worse), or that item is Not applicable. The sum of the 12 items ranged from 12 (the current medication was much better than previous antipsychotic medication) to 60 (the current medication was much worse than previous antipsychotic medication). (NCT01795547)
Timeframe: Week 28

Interventionunits on a scale (Least Squares Mean)
Aripiprazole32.32
Paliperidone33.81

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Change From Baseline to Week 28 in the 'Instrumental Role' QLS Domain Score

The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning. (NCT01795547)
Timeframe: Baseline, Week 28

Interventionunits on a scale (Least Squares Mean)
Aripiprazole1.76
Paliperidone0.83

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Change From Baseline to Week 28 in CGI-S Score

Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). (NCT01795547)
Timeframe: Baseline, Week 28

Interventionunits on a scale (Least Squares Mean)
Aripiprazole-0.75
Paliperidone-0.46

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Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score

The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning. (NCT01795547)
Timeframe: Baseline, Week 28

Interventionunits on a scale (Least Squares Mean)
Aripiprazole7.47
Paliperidone2.80

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Change From Baseline to Week 28 in the 'Common Objects and Activities' QLS Domain Score

The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning. (NCT01795547)
Timeframe: Baseline, Week 28

Interventionunits on a scale (Least Squares Mean)
Aripiprazole0.52
Paliperidone0.18

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Change From Baseline to Week 28 in SWN-S Total Score

The SWN-S is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being. (NCT01795547)
Timeframe: Baseline, Week 28

Interventionunits on a scale (Least Squares Mean)
Aripiprazole4.82
Paliperidone3.81

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Change From Baseline to Week 28 in the 'Interpersonal Relations' QLS Domain Score

The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning. (NCT01795547)
Timeframe: Baseline, Week 28

Interventionunits on a scale (Least Squares Mean)
Aripiprazole3.24
Paliperidone1.47

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Change From Baseline to Week 28 in the 'Intrapsychic Foundations' QLS Domain Score

The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning. (NCT01795547)
Timeframe: Baseline, Week 28

Interventionunits on a scale (Least Squares Mean)
Aripiprazole2.25
Paliperidone0.50

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Percent Weight Change Compared to Baseline Weight

(NCT01844700)
Timeframe: baseline to week 12

Interventionpercentage of weight change (Mean)
Ziprasidone11.58
Aripiprazole, Quetiapine, Risperidone5.66

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BMI Z-scores

(NCT01844700)
Timeframe: baseline to week 12

,
InterventionBMI z-score (Mean)
baselineweek 12 (n=1, n=2)
Aripiprazole, Quetiapine, Risperidone-0.370.38
Ziprasidone-0.510.22

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Weight Change

(NCT01844700)
Timeframe: baseline to week 12

,
Interventionlbs (Mean)
baselineweek 12 (n=1,2)
Aripiprazole, Quetiapine, Risperidone118.5141
Ziprasidone120.5151

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BMI Percentile

(NCT01844700)
Timeframe: baseline to week 12

,
InterventionBMI percentile (Mean)
baselineweek 12 (n=1, n=2)
Aripiprazole, Quetiapine, Risperidone37.6762.5
Ziprasidone3259

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"Number of Participants Hospitalized for Adverse Event Worsening Schizophrenia"

"The number of participants hospitalized for the Adverse Event Worsening Schizophrenia included all participants who were hospitalized for any Adverse Event pertaining to the exacerbation of schizophrenic symptoms." (NCT01870999)
Timeframe: 7 Months

InterventionParticipants (Number)
400 mg Aripiprazole IM Depot0
300 mg Aripiprazole IM Depot1
200 mg Aripiprazole IM Depot0

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Aripiprazole Area Under the Concentration-time Curve at Steady-state (AUCτ)

Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule during each dosing interval from 0 to 1344 hours post-dose. (NCT01870999)
Timeframe: Pre-dose and 1 to 1344 hours post-dose at Month 5

Interventionμg*h/mL (Mean)
400 mg Aripiprazole IM Depot163
300 mg Aripiprazole IM Depot140
200 mg Aripiprazole IM Depot54.5

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Aripiprazole Maximum (Peak) Plasma Concentration (Tmax)

Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for tmax were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection. (NCT01870999)
Timeframe: Pre-dose and 1 to 1344 hours post-dose at Month 5

InterventionDay (Median)
400 mg Aripiprazole IM Depot7.1
300 mg Aripiprazole IM Depot6.5
200 mg Aripiprazole IM Depot5.0

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Aripiprazole Maximum Steady State Plasma Concentration (Css,Max)

Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,max were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection. (NCT01870999)
Timeframe: Pre-dose and 1 to 1344 hours post-dose at Month 5

Interventionng/mL (Mean)
400 mg Aripiprazole IM Depot316
300 mg Aripiprazole IM Depot269
200 mg Aripiprazole IM Depot100

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Aripiprazole Minimum Steady State Plasma Concentration (Css,Min)

Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,min were determined directly from the observed data at 672 hours after the fifth monthly injection. (NCT01870999)
Timeframe: 672 hours post-dose at Month 5

Interventionng/mL (Mean)
400 mg Aripiprazole IM Depot212
300 mg Aripiprazole IM Depot156
200 mg Aripiprazole IM Depot95.0

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Aripiprazole Steady-state Plasma Concentration (Css,Avg)

Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,avg were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection. (NCT01870999)
Timeframe: Pre-dose and 1 to 1344 hours post-dose at Month 5

Interventionng/mL (Mean)
400 mg Aripiprazole IM Depot242
300 mg Aripiprazole IM Depot208
200 mg Aripiprazole IM Depot81.1

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Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 and Week 24

The PANSS consisted of 3 subscales with a total of 30 symptom constructs each rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The Positive Subscale consisted of 7 positive symptom constructs with a possible subscale score of 7 to 49, the Negative Subscale consisted of 7 negative symptom constructs with a possible subscale score of 7 to 49 and the General Psychopathology Subscale consisted of 16 symptom constructs for a possible subscale score of 16 to 112. The PANSS Total Score ranged from 30 (best) to 210 (worst; indicating more severe symptoms). A Negative change from Baseline indicated improvement. (NCT01870999)
Timeframe: Baseline, Week 12, Week 24

,,
Interventionunits on a scale (Mean)
Week 12Week 24
200 mg Aripiprazole IM Depot-1.3-1.3
300 mg Aripiprazole IM Depot1.1-1.6
400 mg Aripiprazole IM Depot0.0-0.8

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Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Positive Subscale Scores at Week 12 and Week 24

The PANSS Positive Subscale consisted of 7 symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Severity was rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Positive Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A Negative change from Baseline indicated improvement. (NCT01870999)
Timeframe: Baseline, Week 12, Week 24

,,
Interventionunits on a scale (Mean)
Week 12Week 24
200 mg Aripiprazole IM Depot-1.0-1.0
300 mg Aripiprazole IM Depot1.30.4
400 mg Aripiprazole IM Depot-1.2-1.6

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Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Subscale Scores at Week 12 and Week 24

The PANSS Negative Subscale consisted of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Severity was rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Negative Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A negative change from Baseline indicated improvement. (NCT01870999)
Timeframe: Baseline, Week 12, Week 24

,,
Interventionunits on a scale (Mean)
Week 12Week 24
200 mg Aripiprazole IM Depot0.0-0.6
300 mg Aripiprazole IM Depot0.1-0.1
400 mg Aripiprazole IM Depot1.10.5

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Change From Baseline in the Clinical Global Impression- Severity of Illness Score (CGI-S) at Week 12 and Week 24

"The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? using an 8-point scale where 0=not assessed to 7=among the most extremely ill patients. A negative change from Baseline indicated improvement." (NCT01870999)
Timeframe: Baseline, Week 12, Week 24

,,
Interventionunits on a scale (Mean)
Week 12Week 24
200 mg Aripiprazole IM Depot-0.2-0.2
300 mg Aripiprazole IM Depot0.0-0.1
400 mg Aripiprazole IM Depot-0.1-0.1

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Number of Participants With Adverse Events as a Measure of Safety

Safety and tolerability was assessed by the number of participants with adverse events (AE). An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it was considered drug-related by the investigator. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (ie, clinically significant) change from baseline for that individual participant. (NCT01870999)
Timeframe: 7 Months

InterventionParticipants (Number)
400 mg Aripiprazole IM Depot11
300 mg Aripiprazole IM Depot11
200 mg Aripiprazole IM Depot6

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Dehydro-aripiprazole Maximum Steady State Plasma Concentration (Css,Max)

Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for Css,max were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection. (NCT01870999)
Timeframe: Pre-dose and 1 to 1344 hours post-dose at Month 5

Interventionng/mL (Mean)
400 mg Aripiprazole IM Depot89.4
300 mg Aripiprazole IM Depot74.7
200 mg Aripiprazole IM Depot30.3

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Dehydro-aripiprazole Maximum (Peak) Plasma Concentration (Tmax)

Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for tmax were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection. (NCT01870999)
Timeframe: Pre-dose and 1 to 1344 hours post-dose at Month 5

InterventionDay (Median)
400 mg Aripiprazole IM Depot6.6
300 mg Aripiprazole IM Depot12.5
200 mg Aripiprazole IM Depot5.5

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Dehydro-aripiprazole Area Under the Concentration-Time Curve at Steady-State (AUCτ)

Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule during each dosing interval from 0 to 1344 hours post-dose. (NCT01870999)
Timeframe: Pre-dose and 1 to 1344 hours post-dose at Month 5

Interventionμg*h/mL (Mean)
400 mg Aripiprazole IM Depot47.8
300 mg Aripiprazole IM Depot38.9
200 mg Aripiprazole IM Depot14.7

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Aripiprazole Terminal-phase Elimination Half-life (t1/2,z)

Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for t1/2,z were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection. (NCT01870999)
Timeframe: Pre-dose and 1 to 1344 hours post-dose at Month 5

InterventionDay (Mean)
400 mg Aripiprazole IM Depot46.5
300 mg Aripiprazole IM Depot29.9

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Dehydro-aripiprazole Minimum Steady State Plasma Concentration (Css,Min)

Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for Css,min were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection. (NCT01870999)
Timeframe: Pre-dose and 1 to 1344 hours post-dose at Month 5

Interventionng/mL (Mean)
400 mg Aripiprazole IM Depot64.1
300 mg Aripiprazole IM Depot54.1
200 mg Aripiprazole IM Depot26.2

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Clinical Global Impression-Improvement Scale (CGI-I) at Week 12 and Week 24

"The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: Compared to his/her condition at baseline (prior to randomization), how much has the patient changed? using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement." (NCT01870999)
Timeframe: Baseline, Week 12, Week 24

,,
Interventionunits on a scale (Mean)
Week 12 (n=12, 13, 9)Week 24
200 mg Aripiprazole IM Depot3.43.7
300 mg Aripiprazole IM Depot3.63.4
400 mg Aripiprazole IM Depot3.33.7

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Number of Participants With Adverse Events (AEs).

AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication. (NCT01909466)
Timeframe: AEs were recorded from the time the informed consent was signed until follow-up for 28 days after last

Interventionparticipants (Number)
Participants with TEAEsParticipants with serious TEAEsParticipants with non-serious TEAEsParticipants with severe TEAEs
Aripiprazole IM Depot 400 mg - Total11241122

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Mean Visual Analog Scale (VAS) Score for Rating of Pain at the Injection Site.

Participants assessed the pain associated with injection of aripiprazole IM using the VAS instrument. This was done approximately 30 minutes pre-dose and 1 hour (±15 min) Post-dose on Days 1, 29, 57, 85 and 113. For the first injection, the pre-dose assessment was of the current injection site. For the injections 2 through 5, the pre-dose assessment was of the prior injection site. Investigator's Assessment of Most Recent Injection Site including pain, swelling, redness, and induration were reported in 4-point categorical scale (1 = absent, 2 = mild, 3 = moderate and 4 = severe) by first injection site at each injection. (NCT01909466)
Timeframe: Days 1 and 113

InterventionUnits on a scale (Mean)
First injection (Day 1)Last injection (Day 113)
Aripiprazole IM Depot 400 mg - Total2.01.2

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Mean Change From Baseline Measured by EPS by Barnes Akathisia Rating Scale (BARS).

The BARS consisted of 4 items related to akathisia: objective observation of akathisia by the study physician, subjective feelings of restlessness by the participant, participant distress due to akathisia, and global evaluation of akathisia. To complete this scale, participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were to be elicited by direct questioning. The first 3 items were rated on a 4-point scale, with a score of 0 = absence of symptoms and a score of 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe). (NCT01909466)
Timeframe: Baseline to Week 20

InterventionUnits on a scale (Mean)
Week 1(N=135)Week 2 (N=136)Week 3 (N=136)Week 4 (N=136)Week 8 (N=136)Week 12 (N=136)Week 16 (N=136)Week 20 (N=136)
Aripiprazole IM Depot 400 mg - Total0.030.080.080.060.110.060.060.04

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Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score.

"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants." (NCT01909466)
Timeframe: Baseline to Week 20

InterventionUnits on a scale (Mean)
Week 8 (N= 128)Week 20 (N= 128)
Aripiprazole IM Depot 400 mg - Total-0.02-0.09

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Mean Change From Baseline in Emotional Regulation Score of SWN-S.

The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit. (NCT01909466)
Timeframe: Baseline to Week 20

InterventionUnits on a scale (Mean)
Week 8 (N= 128)Week 20 (N= 128)
Aripiprazole IM Depot 400 mg - Total0.300.46

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Mean Change From Baseline in Mental Functioning Score of SWN-S.

The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit. (NCT01909466)
Timeframe: Baseline to Week 20

InterventionUnits on a scale (Mean)
Week 8 (N= 128)Week 20 (N= 128)
Aripiprazole IM Depot 400 mg - Total-0.180.01

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Mean Change From Baseline in Suicidal Ideation Intensity Total Score Via Columbia-suicide Severity Rating Scale (C-SSRS).

Suicidality was monitored throughout the trial using C-SSRS. The C-SSRS addresses the need for standardized classification of suicide reports to assess suicide risk. This scale consisted of Baseline evaluation that assessed the lifetime experience of the participant with suicidal events and suicidal ideation and a post baseline evaluation that focuses on suicidality since the last trial visit. The C-SSRS since last visit form were completed on Day 1 pre-dose and prior to dosing on Days 29, 57, 85, 113, 141/ Early Termination(ET) and prior to pharmacokinetics(PK) sampling on Days 8, 15, 22, 120, 127 and 134. The suicidal ideation intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore,the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation. (NCT01909466)
Timeframe: Baseline to Last Visit (Day 141)

InterventionUnits on a scale (Mean)
Week 1 (N= 135)Week 2 (N= 132)Week 3 (N= 131)Week 4 (N= 129)Week 8 (N= 112)Week 12 (N= 109)Week 16 (N= 99)Week 17 (N=100)Week 18 (N= 98)Week 19 (N= 99)Week 20 (N= 97)Last Visit (N= 136)
Aripiprazole IM Depot 400 mg - Total0.00.00.00.20.10.10.00.00.00.00.00.1

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Mean Change From Baseline in PANSS Negative Sub-scale Score.

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). (NCT01909466)
Timeframe: Baseline to Week 20

InterventionUnits on a scale (Mean)
Week 8 (N= 128)Week 20 (N= 128)
Aripiprazole IM Depot 400 mg - Total-0.30-0.33

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Mean Change From Baseline Measured by Extrapyramidal Symptoms (EPS) by Simpson-Angus Scale (SAS).

The SAS consisted of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). The SAS Total Score was the sum of the scores for all 10 items. SAS total score can range from 10 to 50. Each item was rated on a 5-point scale, with a score of 1 =absence of symptoms and a score of 5 =severe condition. (NCT01909466)
Timeframe: Baseline to Week 20

InterventionUnits on a scale (Mean)
Week 1(N= 135)Week 2 (N= 136)Week 3 (N= 136)Week 4 (N= 136)Week 8 (N= 136)Week 12 (N= 136)Week 16 (N= 136)Week 20 (N= 136)
Aripiprazole IM Depot 400 mg - Total0.010.04-0.020.010.020.040.070.07

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Clinical Global Impression-Improvement (CGI-I) Score.

The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition a baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse. (NCT01909466)
Timeframe: Baseline to Week 20

InterventionUnits on a scale (Mean)
Week 8 (N= 128)Week 20 (N= 128)
Aripiprazole IM Depot 400 mg - Total3.863.70

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Mean Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS).

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). (NCT01909466)
Timeframe: Baseline to Week 20

InterventionUnits on a scale (Mean)
Week 8 (N= 128)Week 20 (N= 128)
Aripiprazole IM Depot 400 mg - Total-0.94-2.23

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Mean Change From Baseline in Total Score of Subject Well-being Under Neuroleptic Treatment-Short Form (SWN-S).

The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. The total score from the scale ranges from 20 (bad subjective experience) to 120 (perfect subjective experience). (NCT01909466)
Timeframe: Baseline to Week 20+

InterventionUnits on a scale (Mean)
Week 8 (N= 128)Week 20 (N= 128)
Aripiprazole IM Depot 400 mg - Total-1.17-0.81

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Mean Change From Baseline in Physical Functioning Score of SWN-S.

The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit. (NCT01909466)
Timeframe: Baseline to Week 20

InterventionUnits on a scale (Mean)
Week 8 (N= 128)Week 20 (N= 128)
Aripiprazole IM Depot 400 mg - Total-0.39-0.37

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Mean Change From Baseline Measured by EPS by Abnormal Involuntary Movement Scale (AIMS).

The AIMS assessment consisted of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest (e.g., in the waiting room), and the study physician would make global judgments on the participant's dyskinesia's (items 8 through 10). These items are rated on a five-point scale of severity from 0-4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Overall AIMS scores range from 0 to 42. (NCT01909466)
Timeframe: Baseline to Week 20

InterventionUnits on a scale (Mean)
Week 1(N= 135)Week 2 (N= 136)Week 3 (N= 136)Week 4 (N= 136)Week 8 (N= 136)Week 12 (N= 136)Week 16 (N= 136)Week 20 (N= 136)
Aripiprazole IM Depot 400 mg - Total-0.03-0.05-0.01-0.03-0.050.00-0.030.03

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Mean Change From Baseline in PANSS Positive Sub-scale Score.

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). (NCT01909466)
Timeframe: Baseline to Week 20

InterventionUnits on a scale (Mean)
Week 8 (N= 128)Week 20 (N= 128)
Aripiprazole IM Depot 400 mg - Total-0.14-0.52

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Mean Change From Baseline in Self Control Score of SWN-S.

The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit. (NCT01909466)
Timeframe: Baseline to Week 20

InterventionUnits on a scale (Mean)
Week 8 (N= 128)Week 20 (N= 128)
Aripiprazole IM Depot 400 mg - Total-0.47-0.64

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Mean Change From Baseline in Social Integration Score of SWN-S.

The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit. (NCT01909466)
Timeframe: Baseline to Week 20

InterventionUnits on a scale (Mean)
Week 8 (N= 128)Week 20 (N= 128)
Aripiprazole IM Depot 400 mg - Total-0.47-0.32

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Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score

The Clinical Global Impression-Severity of Illness (CGI-S) Score is a clinician rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition. (NCT01942148)
Timeframe: Basline and Week52

Interventionunits on a scale (Mean)
Aripiprazole-0.3

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Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS)

The Children's Global Assessment Score (CGAS) is a rating scale which measures psychological, social and school functioning for children aged 6-17. Scores range from 0 to 100, with higher scores indicating better condition. (NCT01942148)
Timeframe: Baseline and Week52

Interventionunits on a scale (Mean)
Aripiprazole5.6

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Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score

The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7: 1 =Absent, 2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme. PANSS total score is calculated by adding score of 30 items, which ranges from 30-210. Higher scores indicate worse condition. (NCT01942148)
Timeframe: Basline and Week52

Interventionunits on a scale (Mean)
Aripiprazole-7.9

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Mean Change From Baseline at Final Assessment in Children's Global Assessment Scale (C-GAS) Score

The Children's Global Assessment Scale (C-GAS) is a rating scale which measures psychological, social and school functioning for children aged 6-17. Scores range from 0 to 100, with higher scores indicating better condition. (NCT01942161)
Timeframe: Baseline (Day 1) and Day 43

Interventionunits on a scale (Mean)
Low (2 mg/Day)10.5
Mid (6 - 12 mg/Day)8.5
High (24 - 30 mg/Day)8.6

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Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score

The Clinical Global Impression-Severity of Illness (CGI-S) Score is a clinician rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition. (NCT01942161)
Timeframe: Baseline (Day 1) and Day43

Interventionunits on a scale (Mean)
Low (2 mg/Day)-0.9
Mid (6 - 12 mg/Day)-0.8
High (24 - 30 mg/Day)-1.0

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Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Total Score

The Positive and Negative Syndrome Scale (PANSS) positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49, with higher values indicating worse condition. (NCT01942161)
Timeframe: Baseline (Day 1) and Day 43

Interventionunits on a scale (Mean)
Low (2 mg/Day)-5.2
Mid (6 - 12 mg/Day)-4.9
High (24 - 30 mg/Day)-5.8

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Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score

The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7: 1 =Absent, 2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme. PANSS total score is calculated by adding score of 30 items, which ranges from 30-210. Higher scores indicate worse condition. (NCT01942161)
Timeframe: Baseline (Day 1) and Day 43

Interventionunits on a scale (Mean)
Low (2 mg/Day)-19.6
Mid (6 - 12 mg/Day)-16.5
High (24 - 30 mg/Day)-21.6

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Mean Change From Baseline at Final Assessment in Clinical Global Impression-Improvement (CGI-I) Score

The Clinical Global Impression-Improvement (CGI-I) Score is a clinician rated scale which assesses the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition. (NCT01942161)
Timeframe: Baseline (Day 1) and day43

Interventionunits on a scale (Mean)
Low (2 mg/Day)3.0
Mid (6 - 12 mg/Day)3.2
High (24 - 30 mg/Day)2.7

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Change From Baseline to Week 12 in the 'Instrumental Role' QLS Domain Score

The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning. (NCT01959035)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Aripiprazole Once-monthly0.02

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Change From Baseline to Week 12 in the 'Interpersonal Relations' QLS Domain Score

The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning (NCT01959035)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Aripiprazole Once-monthly0.67

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Change From Baseline to Week 12 in the 'Intrapsychic Foundations' QLS Domain Score

The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning (NCT01959035)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Aripiprazole Once-monthly0.73

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Change From Baseline to Week 12 in the TooL Total Score

Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact). (NCT01959035)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Aripiprazole Once-monthly-0.16

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Change From Baseline to Week 12 in the WoRQ Total Score

The Readiness for Work Questionnaire (WoRQ) is a clinician-rated scale designed to measure a schizophrenic patient's ability to work. The WoRQ consists of 8 items: the clinician had to rate 7 statements and answer 1 question. The statements were rated on a four-point scale, from 'strongly agree', 'agree', 'disagree' or 'strongly disagree' based on all material available (for example, personal notes, medical records, input from other health professionals, family members or caregivers); and in the final item, the clinician had to indicate if the patient was ready for work or not (by indicating either 'yes' or 'no'). Possible total scores range from 4 to 28. Lower WoRQ total scores indicate better functioning. (NCT01959035)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Aripiprazole Once-monthly-0.55

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Change From Baseline to Week 24 in ASEX Total Score

"The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient's recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction)." (NCT01959035)
Timeframe: Baseline and Week 24

Interventionunits on a scale (Least Squares Mean)
Aripiprazole Once-monthly-0.42

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Change From Baseline to Week 24 in CGI-S Score

Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). (NCT01959035)
Timeframe: Baseline and Week 24

Interventionunits on a scale (Least Squares Mean)
Aripiprazole Once-monthly-0.10

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Change From Baseline to Week 24 in QLS Total Score

The Quality of Life Scale (QLS) is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning. (NCT01959035)
Timeframe: Baseline and Week 24

Interventionunits on a scale (Least Squares Mean)
Aripiprazole Once-monthly2.32

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Change From Baseline to Week 24 in SWN-S Total Score

The Subjective Well-Being under Neuroleptic Treatment - Short Version (SWN-S) is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being. (NCT01959035)
Timeframe: Baseline and Week 24

Interventionunits on a scale (Least Squares Mean)
Aripiprazole Once-monthly0.19

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Change From Baseline to Week 24 in the 'Common Objects and Activities' QLS Domain Score

The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning (NCT01959035)
Timeframe: Baseline and Week 24

Interventionunits on a scale (Mean)
Aripiprazole Once-monthly0.21

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Change From Baseline to Week 24 in the 'Instrumental Role' QLS Domain Score

The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning. (NCT01959035)
Timeframe: Baseline and Week 24

Interventionunits on a scale (Mean)
Aripiprazole Once-monthly0.42

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Change From Baseline to Week 24 in the 'Interpersonal Relations' QLS Domain Score

The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning. (NCT01959035)
Timeframe: Baseline and Week 24

Interventionunits on a scale (Mean)
Aripiprazole Once-monthly0.58

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Change From Baseline to Week 24 in the 'Intrapsychic Foundations' QLS Domain Score

The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning (NCT01959035)
Timeframe: Baseline and Week 24

Interventionunits on a scale (Mean)
Aripiprazole Once-monthly0.72

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Change From Baseline to Week 24 in the TooL Total Score

Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact). (NCT01959035)
Timeframe: Baseline and Week 24

Interventionunits on a scale (Least Squares Mean)
Aripiprazole Once-monthly-0.47

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Change From Baseline to Week 24 in the WoRQ Total Score

The Readiness for Work Questionnaire (WoRQ) is a clinician-rated scale designed to measure a schizophrenic patient's ability to work. The WoRQ consists of 8 items: the clinician had to rate 7 statements and answer 1 question. The statements were rated on a four-point scale, from 'strongly agree', 'agree', 'disagree' or 'strongly disagree' based on all material available (for example, personal notes, medical records, input from other health professionals, family members or caregivers); and in the final item, the clinician had to indicate if the patient was ready for work or not (by indicating either 'yes' or 'no'). Possible total scores range from 4 to 28. Lower WoRQ total scores indicate better functioning. (NCT01959035)
Timeframe: Baseline and Week 24

Interventionunits on a scale (Least Squares Mean)
Aripiprazole Once-monthly-0.53

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Patients Categorised As Sexually Dysfunctional Measured at Week 12 on the ASEX Scale

"The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient's recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction). The presence of sexual dysfunction based on the ASEX scale was defined as an ASEX total score of ≥19, or a score of ≥5 on any item, or a score of ≥4 on any 3 items." (NCT01959035)
Timeframe: Week 12

Interventionparticipants (Number)
Aripiprazole Once-monthly32

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Patients Categorised As Sexually Dysfunctional Measured at Week 24 on the ASEX Scale

"The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient's recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction). The presence of sexual dysfunction based on the ASEX scale was defined as an ASEX total score of ≥19, or a score of ≥5 on any item, or a score of ≥4 on any 3 items." (NCT01959035)
Timeframe: Week 24

Interventionparticipants (Number)
Aripiprazole Once-monthly31

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Safety and Tolerability

Number of treatment emergent adverse events (TEAEs). (NCT01959035)
Timeframe: Up to 24 weeks and 4-week safety follow up

Interventionnumber of events (Number)
Aripiprazole Once-monthly65

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Change From Baseline to Week 12 in ASEX Total Score

"The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient's recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction)." (NCT01959035)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Aripiprazole Once-monthly-0.74

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Change From Baseline to Week 12 in CGI-S Score

Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). (NCT01959035)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Aripiprazole Once-monthly0.00

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Change From Baseline to Week 12 in QLS Total Score

The Quality of Life Scale (QLS) is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning. (NCT01959035)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Aripiprazole Once-monthly2.08

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Change From Baseline to Week 12 in SWN-S Total Score

The Subjective Well-Being under Neuroleptic Treatment - Short Version (SWN-S) is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being. (NCT01959035)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Aripiprazole Once-monthly-1.57

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Change From Baseline to Week 12 in the 'Common Objects and Activities' QLS Domain Score

The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning (NCT01959035)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Aripiprazole Once-monthly0.10

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Change From Baseline in Cognitive Test Battery Composite Score

The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. (NCT02054702)
Timeframe: Baseline to Week 6

Interventionz-score (Least Squares Mean)
Brexpiprazole0.045
Aripiprazole-0.024

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Change From Baseline in Cognitive Test Battery of Early Phase Battery Score

The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. The cognitive test early phase battery was analyzed; tasks included Groton Maze Learning Task, Detection Task, Identification Task, and One Card Learning Task. (NCT02054702)
Timeframe: Baseline to Week 6

Interventionz-score (Least Squares Mean)
Brexpiprazole-0.010
Aripiprazole0.113

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Change From Baseline in Cognitive Test Battery Scores of Detection Task

The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. (NCT02054702)
Timeframe: Baseline to Week 6

Interventionz-score (Least Squares Mean)
Brexpiprazole0.024
Aripiprazole-0.029

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Change From Baseline in Cognitive Test Battery Scores of Groton Maze Learning (GML)

The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. (NCT02054702)
Timeframe: Baseline to Week 6

Interventionz-score (Least Squares Mean)
Brexpiprazole0.7
Aripiprazole-4.6

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Response Rate by Study Week

The response rate was defined as reduction of ≥30% from Baseline in PANSS Total Score or CGI-I score of of 1 (very much improved) or 2 (much improved). (NCT02054702)
Timeframe: Baseline to Week 6

Interventionpercentage of participants (Number)
Brexpiprazole60.9
Aripiprazole48.5

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Change From Baseline in Cognitive Test Battery Scores of Identification Task

The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. (NCT02054702)
Timeframe: Baseline to Week 6

Interventionz-score (Least Squares Mean)
Brexpiprazole-0.002
Aripiprazole-0.011

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Change From Baseline in Cognitive Test Battery Scores of One Card Learning Task

The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. (NCT02054702)
Timeframe: Baseline to Week 6

Interventionz-score (Least Squares Mean)
Brexpiprazole0.003
Aripiprazole0.000

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Change From Baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11 Item) Total Score

The BIS-11, a subject-rated scale designed to assess impulsive personality traits, was administered at the baseline and Week 6 visits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, nonplanning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, higher scores indicate better personality trait. (NCT02054702)
Timeframe: Baseline to Week 6

InterventionUnits on a scale (Least Squares Mean)
Brexpiprazole-2.6
Aripiprazole-0.1

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Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). (NCT02054702)
Timeframe: Baseline to Week 6

InterventionUnits on a scale (Least Squares Mean)
Brexpiprazole-22.9
Aripiprazole-19.4

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Change From Baseline to Week 6 in Specific Levels of Functioning Scale (SLOF) Total Score

"The SLOF questionnaire used in this trial consisted of 30 items grouped into 4 areas: interpersonal relationships, social acceptability, activities, and work skill. The SLOF correlates with a subject's quality of life. Each of the questions in the domains is rated on a 5-point Likert scale ranging from 1 not well at all to 5 very well. The possible total score range for SLOF is from 30 to 150, higher score indicating better overall functioning of the participant." (NCT02054702)
Timeframe: Baseline to Week 6

InterventionUnits on a scale (Least Squares Mean)
Brexpiprazole7.5
Aripiprazole6.0

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Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score

"The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants." (NCT02054702)
Timeframe: Baseline to Week 6

InterventionUnits on a scale (Least Squares Mean)
Brexpiprazole-1.6
Aripiprazole-1.3

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Mean Change in Clinical Global Impression-Improvement (CGI-I) Score at Week 6

The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. (NCT02054702)
Timeframe: Baseline to Week 6

InterventionUnits on a scale (Mean)
Brexpiprazole2.5
Aripiprazole2.7

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Latency Period From Ingestion to Detection of IEM

Latency period was defined as the time in minutes from the IEM ingestion for both aripiprazole and placebo to the time of detection of IEM by MIND1 system on a smartphone. The latency period is calculated as the difference in the time recorded by the clinic staff of IEM ingestion and the time displayed on the MIND1 application. (NCT02091882)
Timeframe: Day 1 at Hours 0, 2, 4, 6

Interventionminutes (Median)
Day 1, Hour 0Day 1, Hour 2Day 1, Hour 4Day 1, Hour 6
Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System4111

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Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection

The accuracy of IEM signal detection was collected by comparing the time of ingestion recorded by MIND1 system at different timepoints with the time recorded by the clinic staff. The percentage of participants with the accurate time of IEM detection are reported for each ingestion separately at Hours 0, 2, 4 and 6 on Day 1. (NCT02091882)
Timeframe: Up to Hour 6 on Day 1

Interventionpercentage of participants (Number)
Day 1, Hour 0Day 1, Hour 2Day 1, Hour 4Day 1, Hour 6
Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System73.363.376.793.3

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Proportion of Participants Who Are Able to Pair & Apply a Patch Independently & Successfully by the End of the Week 8 Study Visit as Defined by a Score of 91 to 100 on the Subject Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP)

Proportion of participants who are able to pair and apply a patch independently and successfully by the end of the Week 8 study visit (or early termination, if applicable), as defined as a score of 91 to 100 on the participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP). A participant was considered to have successfully and independently applied a patch if the SAUSS-HCP was at least 91 for at least one postbaseline score. (NCT02219009)
Timeframe: Baseline to Week 8

Interventionpercentage of participants (Number)
MIND1 System (Cohort 1)54.1
MIND 1 System (Cohort 2)56.7

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Proportion of Participants Able to Pair & Apply a Patch Successfully, Independently, or With Minimum Assistance, by the End of the Week 8 Study Visit, as Defined by a SAUSS-HCP Score of 71 to 100.

Proportion of participants who are able to pair and apply a patch successfully, independently, or with minimum assistance, by the end of the Week 8 study visit (or early termination, if applicable), as defined by a Participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP) score of 71 to 100. Participants were considered to have paired and applied a patch independently or with minimal assistance if their SAUSS-HCP score was at least 71 for at least one postbaseline score. (NCT02219009)
Timeframe: Baseline to Week 8

Interventionpercentage of participants (Number)
MIND1 System (Cohort 1)83.8
MIND 1 System (Cohort 2)80.0

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Proportion of Time During the Study Period When Participants Wear Their Patches

Proportion of time during the study period when participants wear their patches; the time duration of patch wearing will be calculated based on digital health data. Percentage of participants' patch wearing time was calculated as (total duration a patch was worn / trial duration) x 100. (NCT02219009)
Timeframe: Baseline to Week 8

Intervention% of time participants wore patch (Mean)
MIND1 System (Cohort 1)74.4
MIND 1 System (Cohort 2)66.2

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OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections

(NCT02220712)
Timeframe: 672 hours postdose of the first, second, third, fourth, and fifth IMD injections

Interventionng/mL (Mean)
OPC-14597 IMD (First Dose)91.9
OPC-14597 IMD (Second Dose)141
OPC-14597 IMD (Third Dose)171
OPC-14597 IMD (Fourth Dose)198
OPC-14597 IMD (Fifth201

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Number of Participants With Changes in Fractional Anisotropy (FA)

To determine if there are differences in prefrontal white matter fractional anisotropy (FA) in subjects with schizophrenia from baseline at 12 months of treatment with aripiprazole (Abilify®) once monthly compared with standard of care (SOC) oral antipsychotic medications (e.g., aripiprazole (Abilify®), risperidone (Risperdal®), lurasidone HCI (Latuda®), quetiapine fumarate (Seroquel®), olanzapine (Zyprexa®), and ziprasidone HCI (Geodon®)). (NCT02237417)
Timeframe: 12 months

Interventionparticipants (Number)
Healthy Control13
Individuals With Schizophrenia (Group A)9
Individuals With Schizophrenia (Group B)7

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Total Number of Psychiatric Hospitalizations Per Treatment Arm

Assessments are completed using best available data and patient interviews (NCT02360319)
Timeframe: Measured every 2 months from baseline to month 24

InterventionHospitalizations (Number)
Clinician's Choice208
Aripiprazole Once Monthly133

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Brief Psychotic Rating Scale (BPRS) Total Score

The Brief Psychotic Rating Scale is an 18 item scale where each item is rated 1-7, the minimum total score is 18 and the maximum total score is 126. Higher scores indicate more severe symptoms. (NCT02360319)
Timeframe: Measured at Month 12 and Month 24

,
InterventionScores on a scale (Mean)
BaselineMonth 12Month 24
Aripiprazole Once Monthly35.4531.3130.87
Clinician's Choice35.5930.730.73

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Quality of Life (QLS) Total Score

Quality of Life (QLS) is a 21 item scale where each item is rated from 0 to 7, the minimum score is 0 and the maximum score is 126 with higher scores indicating better overall functioning. (NCT02360319)
Timeframe: Measured at Month 12 and Month 24

,
InterventionScores on a scale (Mean)
BaselineMonth 12Month 24
Aripiprazole Once Monthly58.4065.0270.05
Clinician's Choice63.6068.4562.21

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Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Sum of Scores

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a 12 item scale with a total score range of 0 to 321 with higher scores indicating better cognitive functioning (NCT02360319)
Timeframe: Measured at Month 12 and Month 24

,
InterventionScores on a scale (Mean)
BaselineMonth 12Month 24
Aripiprazole Once Monthly177.7178.2180.8
Clinician's Choice182.4189.2194.1

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Time to First Hospitalization

Assessments are done using best available data and patient interviews (NCT02360319)
Timeframe: Hospitalizations assessed every 2 months from baseline to Month 24

Interventiondays (Number)
Clinician's Choice530.6
Aripiprazole Once Monthly613.7

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Part 3 (EDP): Change From Baseline in Clinical Global Impression Severity (CGI-S) Score

"The Clinical Global Impression Severity (CGI-S) rating scale is used to rate the severity of a participant's overall clinical condition on a 7 point scale. The total score ranges from 1 to 7, where 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening." (NCT02431702)
Timeframe: Baseline, up to 18 Months

Interventionunits on a scale (Mean)
Part 3-PP to PP-0.7
Part 3-OAP to OAP-0.7

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Part-2 (Disease Progression): Time to First Treatment Failure

Treatment failure is defined as the time from participant's randomization to first treatment failure, which was a composite endpoint consisting of any of the following: 1) Psychiatric hospitalization due to worsening symptoms; 2) Any deliberate self-injury, suicidal ideation or behavior, homicidal ideation or violent behavior that is clinically significant and needs immediate intervention as determined by the study physician; 3) New arrest/incarceration; 4) Discontinuation of antipsychotic treatment due to inadequate efficacy as determined by the study physician; 5) Discontinuation of antipsychotic treatment due to safety or tolerability as determined by the study physician; 6) Treatment supplementation with another antipsychotic due to inadequate efficacy as determined by the study physician; 7) Increase in the level of psychiatric services in order to prevent imminent psychiatric hospitalization as determined by the study physician. (NCT02431702)
Timeframe: From Day 1 up to 9 Months

Interventiondays (Median)
Part-2: Paliperidone Palmitate (PP)NA
Part-2: OAPNA

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Part 3 (Extended Disease Progression [EDP]): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score and composites scores. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and 18 Months

InterventionT-score (Mean)
Part 3-PP to PP1.6
Part 3-OAP to OAP3.2

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Part 3 (EDP): Time to First Treatment Failure

Treatment failure is defined as the time from participant's randomization to first treatment failure, which was a composite endpoint consisting of any of the following: 1) Psychiatric hospitalization due to worsening symptoms; 2) Any deliberate self-injury, suicidal ideation or behavior, homicidal ideation or violent behavior that is clinically significant and needs immediate intervention as determined by the study physician; 3) New arrest/incarceration; 4) Discontinuation of antipsychotic treatment due to inadequate efficacy as determined by the study physician; 5) Discontinuation of antipsychotic treatment due to safety or tolerability as determined by the study physician; 6) Treatment supplementation with another antipsychotic due to inadequate efficacy as determined by the study physician; 7) Increase in the level of psychiatric services in order to prevent imminent psychiatric hospitalization as determined by the study physician. (NCT02431702)
Timeframe: From Day 1 Up to 18 Months

Interventiondays (Median)
Part 3-PP to PPNA
Part 3-OAP to OAPNA

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Part 3 (EDP): Change From Baseline in Working Memory Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess working memory of participants. The range of working memory score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and 18 Months

InterventionT-score (Mean)
Part 3-PP to PP-1.7
Part 3-OAP to OAP0.7

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Part 3 (EDP): Change From Baseline in Verbal Learning Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess verbal learning score of participants. The range of verbal learning score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and 18 Months

InterventionT-score (Mean)
Part 3-PP to PP0.3
Part 3-OAP to OAP0.8

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Part 3 (EDP): Change From Baseline in Medication Satisfaction Questionnaire (MSQ) Score

The Medication Satisfaction Questionnaire (MSQ) is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied). Total score ranges from 1 to 7. Higher score indicate improvement. (NCT02431702)
Timeframe: Baseline, up to 18 Months

Interventionunits on a scale (Mean)
Part 3-PP to PP0.3
Part 3-OAP to OAP0.4

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Part 3 (EDP): Change From Baseline in Speed of Processing Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess speed of processing score of participants. The range of speed of processing score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and 18 Months

InterventionT-score (Mean)
Part 3-PP to PP2.5
Part 3-OAP to OAP4.9

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Part 3 (EDP): Change From Baseline in Social Cognition Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess social cognition score of participants. The range of social cognition score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and 18 Months

InterventionT-score (Mean)
Part 3-PP to PP-0.2
Part 3-OAP to OAP1.4

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Part 3 (EDP): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score

The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Each domain was assessed on a 6-point scale, from 1 (absent) to 6 (very severe) (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe). PSP total score was calculated as sum of all the domain scores and ranges from 1 to 100. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. Higher score indicate better performance. (NCT02431702)
Timeframe: Baseline and 18 Months

Interventionunits on a scale (Mean)
Part 3-PP to PP7.5
Part 3-OAP to OAP7.0

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Part 2 (Disease Progression): Number of Participants With Change From Baseline in Severity of Psychotic Symptoms, as Measured by Clinician-Rated Dimensions of Psychosis Symptom Severity Scale (CRDPSS)

The CRDPSS is an 8-item measure that assesses the severity of mental health symptoms that are important across psychotic disorders, including delusions, hallucinations, disorganized speech, abnormal psychomotor behavior, negative symptoms. Each item on the measure is rated on a 5-point scale (0=none; 1=equivocal; 2=present, but mild; 3=present and moderate; and 4=present and severe). Total Score is taken as summation. A higher score indicates a more severe condition. Worsened or improved is defined as increase or decrease compared to baseline. (NCT02431702)
Timeframe: Baseline, up to 9 Months

InterventionParticipants (Count of Participants)
Hallucinations72513608Hallucinations72513614Delusions72513614Delusions72513608Disorganized Speech72513614Disorganized Speech72513608Abnormal Psychomotor Behavior72513614Abnormal Psychomotor Behavior72513608Negative Symptoms72513608Negative Symptoms72513614Impaired Cognition72513614Impaired Cognition72513608Mania72513608Mania72513614Depression72513608Depression72513614
UnchangedImprovedWorsened
Part-2: OAP19
Part-2: Paliperidone Palmitate (PP)29
Part-2: OAP73
Part-2: Paliperidone Palmitate (PP)14
Part-2: OAP33
Part-2: Paliperidone Palmitate (PP)10
Part-2: OAP20
Part-2: Paliperidone Palmitate (PP)23
Part-2: OAP70
Part-2: OAP35
Part-2: OAP13
Part-2: Paliperidone Palmitate (PP)36
Part-2: OAP85
Part-2: Paliperidone Palmitate (PP)12
Part-2: OAP27
Part-2: Paliperidone Palmitate (PP)9
Part-2: OAP14
Part-2: Paliperidone Palmitate (PP)37
Part-2: OAP86
Part-2: Paliperidone Palmitate (PP)4
Part-2: OAP25
Part-2: Paliperidone Palmitate (PP)16
Part-2: OAP61
Part-2: Paliperidone Palmitate (PP)17
Part-2: OAP39
Part-2: Paliperidone Palmitate (PP)13
Part-2: OAP29
Part-2: Paliperidone Palmitate (PP)22
Part-2: OAP52
Part-2: Paliperidone Palmitate (PP)15
Part-2: OAP44
Part-2: Paliperidone Palmitate (PP)1
Part-2: OAP7
Part-2: Paliperidone Palmitate (PP)47
Part-2: OAP107
Part-2: Paliperidone Palmitate (PP)2
Part-2: OAP11
Part-2: Paliperidone Palmitate (PP)7
Part-2: OAP28
Part-2: Paliperidone Palmitate (PP)33
Part-2: OAP74
Part-2: OAP23

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Part 3 (Disease Modification): Change From Baseline in Adjusted Intracortical Myelin Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (SE MRI)

"The adjusted ICM fraction score is quantified as: 1. The volume of myelinated brain tissue is measured separately on co-localized IR and proton density (PD) MRI images, by outlining the boundary between gray matter and white matter on each image. 2. ICM is calculated from the difference of IR volume minus PD volume. 3. ICM is then expressed as a fraction of the total intracranial volume (ICM divided by intracranial volume). 4. The ICM fraction is then adjusted for effects of age, gender, and race/ethnicity in the sample of treated participants and healthy controls. A decrease in the adjusted ICM fraction score may be a sign of disease progression." (NCT02431702)
Timeframe: Baseline and Month 9 of Part 3

Interventionratio (Least Squares Mean)
Part 3-PP to PP-0.7
Part 3- OAP to PP (or Delayed-Start PP)-0.2
Part 3-OAP to OAP0.5

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Part 3 (Disease Modification): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score and composites scores. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and Day 260

InterventionT-score (Mean)
Part 3- PP to PP-0.7
Part 3- OAP to PP (or Delayed-Start PP)-0.2
Part 3-OAP to OAP0.5

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Part 3 (Disease Modification): Personal and Social Performance (PSP) Total Observed Score

The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe) in each of the 4 domains. Based on 4 domains there will be 1 transformed total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. (NCT02431702)
Timeframe: Month 9 of Part 3

Interventionunits on a scale (Least Squares Mean)
Part 3-PP to PP67.6
Part 3- OAP to PP (or Delayed-Start PP)66.1
Part 3-OAP to OAP66.6

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Part 3 (EDP): Change From Baseline in Adjusted Intracortical Myelin Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (MRI)

"The adjusted ICM fraction score is quantified as: 1. The volume of myelinated brain tissue is measured separately on co-localized IR and proton density (PD) MRI images, by outlining the boundary between gray matter and white matter on each image. 2. ICM is calculated from the difference of IR volume minus PD volume. 3. ICM is then expressed as a fraction of the total intracranial volume (ICM divided by intracranial volume). 4. The ICM fraction is then adjusted for effects of age, gender, and race/ethnicity in the sample of treated participants and healthy controls. A decrease in the adjusted ICM fraction score may be a sign of disease progression." (NCT02431702)
Timeframe: Baseline and 18 Months

Interventionratio (Mean)
Part 3-PP to PP-0.001
Part 3-OAP to OAP-0.003

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Part 3 (EDP): Change From Baseline in Attention/Vigilance Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess attention/vigilance score of participants. The range of attention/vigilance score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and 18 Months

InterventionT-score (Mean)
Part 3-PP to PP2.4
Part 3-OAP to OAP0.7

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Part 2 (Disease Progression): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score

The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Each domain was assessed on a 6-point scale, from 1 (absent) to 6 (very severe) (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe). PSP total score was calculated as sum of all the domain scores and ranges from 1 to 100. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. Higher score indicate better performance. (NCT02431702)
Timeframe: Baseline and Month 9

Interventionunits on a scale (Mean)
Part-2: Paliperidone Palmitate (PP)2.5
Part-2: OAP2.9

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Part 2 (Disease Progression): Change From Baseline in Adjusted Intracortical Myelin (ICM) Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (MRI)

"The adjusted ICM fraction score is quantified as: 1. The volume of myelinated brain tissue is measured separately on co-localized IR and proton density (PD) MRI images, by outlining the boundary between gray matter and white matter on each image. 2. ICM is calculated from the difference of IR volume minus PD volume. 3. ICM is then expressed as a fraction of the total intracranial volume (ICM divided by intracranial volume). 4. The ICM fraction is then adjusted for effects of age, gender, and race/ethnicity in the sample of treated participants and healthy controls. A decrease in the adjusted ICM fraction score may be a sign of disease progression." (NCT02431702)
Timeframe: Baseline and Day 260

Interventionratio (Mean)
Part-2: Paliperidone Palmitate (PP)-0.001
Part-2: OAP-0.004

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Part 3 (EDP): Change From Baseline in Reasoning and Problem Solving: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess reasoning and problem solving score of participants. The range of reasoning and problem solving T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and 18 Months

InterventionT-score (Mean)
Part 3-PP to PP3.4
Part 3-OAP to OAP4.7

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Part 2 (Disease Progression): Change From Baseline in Attention/Vigilance Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess attention/vigilance score of participants. The range of attention/vigilance score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and Day 260

InterventionT-score (Mean)
Part-2: Paliperidone Palmitate (PP)3.2
Part-2: OAP0.7

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Part 2 (Disease Progression): Change From Baseline in Clinical Global Impression Severity (CGI-S) Score

"The Clinical Global Impression Severity (CGI-S) rating scale is used to rate the severity of a participant's overall clinical condition on a 7 point scale. The score ranges from 1 to 7, where 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening." (NCT02431702)
Timeframe: Baseline, up to 9 Months of Part 2

Interventionunits on a scale (Mean)
Part-2: Paliperidone Palmitate (PP)-0.2
Part-2: OAP-0.3

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Part 2 (Disease Progression): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score and composites scores. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and Month 9

InterventionT-score (Least Squares Mean)
Part-2: Paliperidone Palmitate (PP)2.0
Part-2: OAP2.8

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Part 2 (Disease Progression): Change From Baseline in Medication Satisfaction Questionnaire (MSQ) Total Score

The Medication Satisfaction Questionnaire (MSQ) is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied). Total score ranges from 1 to 7. Higher score indicate improvement. (NCT02431702)
Timeframe: Baseline and endpoint Part 2 (up to 9 Months)

Interventionunits on a scale (Mean)
Part-2: Paliperidone Palmitate (PP)-0.2
Part-2: OAP0.1

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Part 2 (Disease Progression): Change From Baseline in Reasoning and Problem Solving: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess reasoning and problem solving of participants. The range of reasoning and problem solving T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and Day 260

InterventionT-score (Mean)
Part-2: Paliperidone Palmitate (PP)0.2
Part-2: OAP2.8

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Part 2 (Disease Progression): Change From Baseline in Social Cognition Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess social cognition score of participants. The range of social cognition score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and Day 260

InterventionT-score (Mean)
Part-2: Paliperidone Palmitate (PP)0.3
Part-2: OAP1.6

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Part 2 (Disease Progression): Change From Baseline in Speed of Processing Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess speed of processing score of participants. The range of speed of processing T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and Day 260

InterventionT-score (Mean)
Part-2: Paliperidone Palmitate (PP)1.8
Part-2: OAP3.5

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Part 2 (Disease Progression): Change From Baseline in Verbal Learning Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess verbal learning score of participants. The range of verbal learning score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and Day 260

InterventionT-score (Mean)
Part-2: Paliperidone Palmitate (PP)1.3
Part-2: OAP1.0

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Part 2 (Disease Progression): Change From Baseline in Working Memory Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess working memory of participants. The range of working memory score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and Day 260

InterventionT-score (Mean)
Part-2: Paliperidone Palmitate (PP)-0.2
Part-2: OAP-0.8

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Part 3 (EDP): Change From Baseline in Visual Learning Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess visual learning score of participants. The range of visual learning score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and 18 Months

InterventionT-score (Mean)
Part 3-PP to PP0.2
Part 3-OAP to OAP-0.2

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Part 2 (Disease Progression): Change From Baseline in Visual Learning Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess visual learning score of participants. The range of visual learning score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and Day 260

InterventionT-score (Mean)
Part-2: Paliperidone Palmitate (PP)1.3
Part-2: OAP1.4

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Part 3 (EDP): Number of Participants With Change From Baseline in Severity of Psychotic Symptoms, as Measured by CRDPSS

The CRDPSS is an 8-item measure that assesses the severity of mental health symptoms that are important across psychotic disorders, including delusions, hallucinations, disorganized speech, abnormal psychomotor behavior, negative symptoms. Each item on the measure is rated on a 5-point scale (0=none; 1=equivocal; 2=present, but mild; 3=present and moderate; and 4=present and severe). Total Score is taken as summation. A higher score indicates a more severe condition. Worsened or improved is defined as increase or decrease compared to baseline. (NCT02431702)
Timeframe: Baseline, up to 18 Months

InterventionParticipants (Count of Participants)
Hallucinations72513609Hallucinations72513610Delusions72513609Delusions72513610Disorganized Speech72513609Disorganized Speech72513610Abnormal Psychomotor Behavior72513609Abnormal Psychomotor Behavior72513610Negative Symptoms72513609Negative Symptoms72513610Impaired Cognition72513609Impaired Cognition72513610Mania72513609Mania72513610Depression72513609Depression72513610
WorsenedUnchangedImproved
Part 3-PP to PP3
Part 3-OAP to OAP8
Part 3-PP to PP27
Part 3-OAP to OAP29
Part 3-PP to PP11
Part 3-OAP to OAP10
Part 3-PP to PP6
Part 3-PP to PP21
Part 3-OAP to OAP20
Part 3-PP to PP14
Part 3-OAP to OAP17
Part 3-PP to PP2
Part 3-OAP to OAP36
Part 3-PP to PP12
Part 3-PP to PP4
Part 3-OAP to OAP2
Part 3-PP to PP32
Part 3-OAP to OAP37
Part 3-PP to PP5
Part 3-OAP to OAP4
Part 3-OAP to OAP22
Part 3-PP to PP19
Part 3-OAP to OAP21
Part 3-PP to PP10
Part 3-OAP to OAP9
Part 3-OAP to OAP23
Part 3-PP to PP17
Part 3-OAP to OAP15
Part 3-PP to PP0
Part 3-OAP to OAP3
Part 3-PP to PP40
Part 3-OAP to OAP39
Part 3-PP to PP1
Part 3-OAP to OAP5
Part 3-PP to PP7
Part 3-OAP to OAP6
Part 3-PP to PP26
Part 3-PP to PP8
Part 3-OAP to OAP12

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Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score

The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. The questionnaire includes questions on the following symptoms. 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The usual cut-off points are: 0 to 6 = normal/ symptom absent, 7 to 19 = mild depression, 20 to 34 = moderate depression, >34 = severe depression. (NCT02435836)
Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

InterventionUnits on a scale (Mean)
Week 1 (N= 619)Week 2 (N= 595)Week 4 (N= 586)Week 6 (N= 572)Week 8 (N= 552)Week 12 (N= 533)Week 16 (N= 517)Week 24 (N= 489)Week 36 (N= 458)Week 48 (N= 425)Week 60 (N= 395)Week 72 (N= 382)Week 84 (N= 362)Week 96 (N= 339)Week 108 (N= 328)Week 120 (N= 316)Week 132 (N= 306)Week 144 (N= 291)Week 156 (N= 279)Week 168 (N= 272)Week 180 (N= 268)Week 192 (N= 255)Week 204 (N= 239)Week 216 (N= 238)Week 228 (N= 224)Week 240 (N= 183)Week 252 (N= 139)Week 264 (N= 83)Week 276 (N= 58)Week 288 (N= 56)Week 300 (N= 55)Week 312 (N= 37)Week 324 (N= 38)Week 336 (N= 28)Week 348 (N= 8)Week 360 (N= 10)Week 372 (N= 3)Week 384 (N= 5)Week 396 (N= 10)Week 408 (N= 9)Week 420 (N= 4)Week 432 (N= 3)Week 444 (N= 1)Week 456 (N= 5)Week 468 (N= 2)Week 480 (N= 1)Week 492 (N= 9)Week 504 (N= 2)Week 636 (N= 5)Week 648 (N= 2)Week 660 (N= 3)Week 672 (N= 1)Week 696 (N= 1)Last Visit (N= 629)
Aripiprazole-0.78-1.13-1.38-1.54-1.40-1.31-1.60-1.61-1.66-1.75-2.13-2.21-2.33-2.26-2.30-2.40-2.22-2.47-2.51-2.51-2.73-2.53-2.69-2.50-2.62-2.92-3.63-5.52-7.71-7.57-6.15-7.24-6.32-7.21-4.00-2.80-2.670.00-1.40-1.890.75-2.33-1.00-9.60-3.000.00-6.56-13.500.40-1.00-4.33-2.00-1.00-0.31

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Mean Change From Baseline in PANSS Negative Sub-scale Score by Week

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). (NCT02435836)
Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

InterventionUnits on a scale (Mean)
Week 1 (N= 619)Week 2 (N= 595)Week 4 (N= 586)Week 6 (N= 573)Week 8 (N= 552)Week 12 (N= 532)Week 16 (N= 517)Week 24 (N= 489)Week 36 (N= 458)Week 48 (N= 426)Week 60 (N= 395)Week 72 (N= 382)Week 84 (N= 362)Week 96 (N= 340)Week 108 (N= 328)Week 120 (N= 316)Week 132 (N= 306)Week 144 (N= 288)Week 156 (N= 279)Week 168 (N= 272)Week 180 (N= 268)Week 192 (N= 255)Week 204 (N= 239)Week 216 (N= 238)Week 228 (N= 224)Week 240 (N= 183)Week 252 (N= 139)Week 264 (N= 83)Week 276 (N= 58)Week 288 (N= 56)Week 300 (N= 55)Week 312 (N= 37)Week 324 (N= 38)Week 336 (N= 28)Week 348 (N= 8)Week 360 (N= 10)Week 372 (N= 3)Week 384 (N= 5)Week 396 (N= 10)Week 408 (N= 9)Week 420 (N= 4)Week 432 (N= 3)Week 444 (N= 1)Week 456 (N= 4)Week 468 (N= 2)Week 480 (N= 1)Week 492 (N= 9)Week 504 (N= 2)Week 636 (N= 5)Week 648 (N= 2)Week 660 (N= 3)Week 672 (N= 1)Week 696 (N= 1)Last Visit (N= 629)
Aripiprazole-0.35-0.82-1.05-1.24-1.41-1.54-1.85-2.02-2.16-2.43-2.75-2.94-3.17-3.22-3.36-3.37-3.41-3.58-3.70-3.68-3.69-3.65-3.79-3.74-3.90-4.09-4.88-6.87-8.71-8.32-6.58-7.51-6.63-7.43-4.88-5.60-4.330.00-2.90-1.22-2.25-2.67-6.00-13.75-9.00-5.00-2.00-1.50-1.800.00-4.671.00-3.00-1.34

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Mean Change From Baseline in PANSS Positive Sub-scale Score by Week

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). (NCT02435836)
Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

InterventionUnits on a scale (Mean)
Week 1 (N= 619)Week 2 (N= 595)Week 4 (N= 586)Week 6 (N= 573)Week 8 (N= 552)Week 12 (N= 533)Week 16 (N= 517)Week 24 (N= 489)Week 36 (N= 458)Week 48 (N= 426)Week 60 (N= 395)Week 72 (N= 382)Week 84 (N= 362)Week 96 (N= 340)Week 108 (N= 328)Week 120 (N= 316)Week 132 (N= 306)Week 144 (N= 289)Week 156 (N= 279)Week 168 (N= 272)Week 180 (N= 268)Week 192 (N= 255)Week 204 (N= 239)Week 216 (N= 238)Week 228 (N= 224)Week 240 (N= 183)Week 252 (N= 139)Week 264 (N= 83)Week 276 (N= 58)Week 288 (N= 56)Week 300 (N= 55)Week 312 (N= 37)Week 324 (N= 38)Week 336 (N= 28)Week 348 (N= 8)Week 360 (N= 10)Week 372 (N= 3)Week 384 (N= 5)Week 396 (N= 10)Week 408 (N= 9)Week 420 (N= 4)Week 432 (N= 3)Week 444 (N= 1)Week 456 (N= 4)Week 468 (N= 2)Week 480 (N= 1)Week 492 (N= 9)Week 504 (N= 2)Week 636 (N= 5)Week 648 (N= 2)Week 660 (N= 3)Week 672 (N= 1)Week 696 (N= 1)Last Visit (N= 629)
Aripiprazole-0.39-0.81-1.13-1.23-1.30-1.24-1.43-1.54-1.56-1.73-2.01-2.08-2.26-2.26-2.50-2.45-2.25-2.49-2.46-2.35-2.40-2.22-2.48-2.21-2.42-2.10-2.74-4.24-5.90-6.30-4.16-5.27-4.45-5.46-0.75-3.80-0.67-0.80-2.40-0.89-0.75-4.67-9.00-10.50-6.50-2.00-2.00-2.50-1.80-4.50-2.001.00-1.000.23

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Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). (NCT02435836)
Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

InterventionUnits on a scale (Mean)
Week 1 (N= 619)Week 2 (N= 595)Week 4 (N= 586)Week 6 (N= 573)Week 8 (N= 552)Week 12 (N= 532)Week 16 (N= 517)Week 24 (N= 489)Week 36 (N= 458)Week 48 (N= 426)Week 60 (N= 395)Week 72 (N= 382)Week 84 (N= 362)Week 96 (N= 340)Week 108 (N= 328)Week 120 (N= 316)Week 132 (N= 306)Week 144 (N= 288)Week 156 (N= 279)Week 168 (N= 272)Week 180 (N= 268)Week 192 (N= 255)Week 204 (N= 239)Week 216 (N= 238)Week 228 (N= 224)Week 240 (N= 183)Week 252 (N= 139)Week 264 (N= 83)Week 276 (N= 58)Week 288 (N= 56)Week 300 (N= 55)Week 312 (N= 37)Week 324 (N= 38)Week 336 (N= 28)Week 348 (N= 8)Week 360 (N= 10)Week 372 (N= 3)Week 384 (N= 5)Week 396 (N= 10)Week 408 (N= 9)Week 420 (N= 4)Week 432 (N= 3)Week 444 (N= 1)Week 456 (N= 4)Week 468 (N= 2)Week 480 (N= 1)Week 492 (N= 9)Week 504 (N= 2)Week 636 (N= 5)Week 648 (N= 2)Week 660 (N= 3)Week 672 (N= 1)Week 696 (N= 1)Last Visit (N= 629)
Aripiprazole-1.63-3.19-4.27-4.93-5.35-5.47-6.28-6.78-7.22-8.07-9.28-9.81-10.54-10.68-11.46-11.43-11.05-11.70-11.90-11.69-11.83-11.46-12.10-11.54-12.24-12.14-15.19-22.16-29.45-28.79-21.95-25.35-21.95-24.86-12.88-17.70-10.67-4.60-10.10-5.56-8.00-13.67-28.00-48.25-36.00-10.00-10.00-9.50-7.60-10.00-15.331.00-7.00-2.30

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Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week

BARS consisted of 4 items: objective observation of akathisia by study physician, subjective feelings of restlessness by participant, participant distress due to akathisia, global evaluation of akathisia. The first 3 items were rated on a 4-point scale: 0 = absence of symptoms to 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe). Participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were elicited by direct questioning. The BARS Global Score was derived from the global clinical assessment of akathisia from the BARS panel. Total score ranges from 0 to 14. Negative changes from baseline indicate improvement, with higher negative values indicating better improvement. (NCT02435836)
Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

InterventionUnits on a scale (Mean)
Week 1 (N= 618)Week 2 (N= 595)Week 4 (N= 586)Week 6 (N= 572)Week 8 (N= 552)Week 12 (N= 533)Week 16 (N= 517)Week 24 (N= 489)Week 36 (N= 458)Week 48 (N= 425)Week 60 (N= 395)Week 72 (N= 382)Week 84 (N= 362)Week 96 (N= 340)Week 108 (N= 327)Week 120 (N= 316)Week 132 (N= 306)Week 144 (N= 291)Week 156 (N= 278)Week 168 (N= 272)Week 180 (N= 268)Week 192 (N= 255)Week 204 (N= 238)Week 216 (N= 237)Week 228 (N= 223)Week 240 (N= 183)Week 252 (N= 139)Week 264 (N= 83)Week 276 (N= 58)Week 288 (N= 56)Week 300 (N= 55)Week 312 (N= 37)Week 324 (N= 38)Week 336 (N= 28)Week 348 (N= 8)Week 360 (N= 9)Week 372 (N= 3)Week 384 (N= 5)Week 396 (N= 10)Week 408 (N= 9)Week 420 (N= 4)Week 432 (N= 3)Week 444 (N= 1)Week 456 (N= 5)Week 468 (N= 2)Week 480 (N= 1)Week 492 (N= 9)Week 504 (N= 2)Week 636 (N= 5)Week 648 (N= 2)Week 660 (N= 3)Week 672 (N= 1)Week 696 (N= 1)Last Visit (N= 629)
Aripiprazole-0.15-0.20-0.20-0.23-0.22-0.22-0.22-0.22-0.21-0.20-0.20-0.19-0.21-0.21-0.21-0.20-0.22-0.22-0.24-0.22-0.24-0.29-0.29-0.26-0.26-0.24-0.29-0.51-0.69-0.64-0.51-0.35-0.26-0.29-0.75-0.220.000.00-0.10-0.33-0.250.000.00-1.400.000.00-0.56-1.50-0.400.00-0.67-4.000.00-0.26

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Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week

The SAS is composed of 10 items. This scale contains 10 items: Gait, Arm dropping, Shoulder shaking, Elbow rigidity, Wrist rigidity, Head rotation, Glabella Tap, Tremor, Salivation, Akathisia. Grade of severity of each item is rated using a 5-point scale, 1 (normal) and 5 (most severe). The total score ranges from 10 to 50. Negative changes from baseline indicate an improvement, with higher negative values indicating better improvement. (NCT02435836)
Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

InterventionUnits on a scale (Mean)
Week 1 (N= 618)Week 2 (N= 594)Week 4 (N= 585)Week 6 (N= 572)Week 8 (N= 550)Week 12 (N= 532)Week 16 (N= 516)Week 24 (N= 488)Week 36 (N= 456)Week 48 (N= 426)Week 60 (N= 395)Week 72 (N= 382)Week 84 (N= 362)Week 96 (N= 338)Week 108 (N= 328)Week 120 (N= 316)Week 132 (N= 306)Week 144 (N= 289)Week 156 (N= 278)Week 168 (N= 272)Week 180 (N= 268)Week 192 (N= 255)Week 204 (N= 239)Week 216 (N= 238)Week 228 (N= 224)Week 240 (N= 183)Week 252 (N= 139)Week 264 (N= 83)Week 276 (N= 58)Week 288 (N= 56)Week 300 (N= 55)Week 312 (N= 37)Week 324 (N= 38)Week 336 (N= 28)Week 348 (N= 8)Week 360 (N= 9)Week 372 (N= 3)Week 384 (N= 5)Week 396 (N= 10)Week 408 (N= 9)Week 420 (N= 4)Week 432 (N= 3)Week 444 (N= 1)Week 456 (N= 5)Week 468 (N= 2)Week 480 (N= 1)Week 492 (N= 9)Week 504 (N= 2)Week 636 (N= 5)Week 648 (N= 2)Week 660 (N= 3)Week 672 (N= 1)Week 696 (N= 1)Last Visit (N= 628)
Aripiprazole-0.78-1.01-1.06-1.14-1.19-1.28-1.27-1.24-1.10-1.33-1.25-1.36-1.33-1.24-1.29-1.22-1.26-1.26-1.33-1.31-1.43-1.46-1.49-1.39-1.44-1.68-2.11-2.89-3.84-3.88-2.53-2.30-1.76-1.64-2.00-0.44-1.00-0.20-0.30-0.89-1.25-1.001.00-7.200.00-1.00-3.22-3.00-0.200.00-1.00-3.00-7.00-1.36

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Mean Clinical Global Impression of Improvement (CGI-I) by Week

"The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5~=minimally worse; 6 = much worse; and 7 = very much worse." (NCT02435836)
Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

InterventionUnits on a scale (Mean)
Week 1 (N= 619)Week 2 (N= 595)Week 4 (N= 586)Week 6 (N= 573)Week 8 (N= 552)Week 12 (N= 533)Week 16 (N= 517)Week 24 (N= 489)Week 36 (N= 458)Week 48 (N= 426)Week 60 (N= 395)Week 72 (N= 382)Week 84 (N= 362)Week 96 (N= 340)Week 108 (N= 328)Week 120 (N= 316)Week 132 (N= 306)Week 144 (N= 290)Week 156 (N= 279)Week 168 (N= 272)Week 180 (N= 268)Week 192 (N= 255)Week 204 (N= 239)Week 216 (N= 238)Week 228 (N= 232)Week 240 (N= 216)Week 252 (N= 208)Week 264 (N= 194)Week 276 (N= 187)Week 288 (N= 177)Week 300 (N= 167)Week 312 (N= 145)Week 324 (N= 137)Week 336 (N= 121)Week 348 (N= 114)Week 360 (N= 105)Week 372 (N= 93)Week 384 (N= 91)Week 396 (N= 80)Week 408 (N= 69)Week 420 (N= 61)Week 432 (N= 58)Week 444 (N= 51)Week 456 (N= 48)Week 468 (N= 37)Week 480 (N= 33)Week 492 (N= 9)Week 504 (N= 2)Week 528 (N= 1)Week 636 (N= 5)Week 648 (N= 2)Week 660 (N= 3)Week 672 (N= 3)Week 696 (N= 1)Last Visit (N= 629)
Aripiprazole3.603.423.293.213.173.163.083.032.952.882.762.732.672.672.602.582.622.592.582.572.572.592.562.562.492.482.372.142.162.262.262.182.232.032.452.532.142.503.002.502.432.001.001.832.002.002.332.504.002.001.502.331.001.003.35

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Number of Participants With Adverse Events (AEs)

The AEs were one of the primary parameters to measure the safety and tolerability of individual participants. The AEs were captured for all participants from the time the ICF was signed until the end of the trial. (NCT02435836)
Timeframe: Baseline to Last Visit

InterventionParticipants (Number)
Participants with serious TEAEsParticipants with severe TEAEsParticipants discontinued medication due to AEParticipants with TEAEsParticipants discontinued due to AEs or death
Aripiprazole179116140523140

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Percentage of Participants With ECG Measurements of Potential Clinical Relevance

The measurement of ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, and QTcF that were identified based on pre-defined criteria. (NCT02435836)
Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

InterventionPercentage of participants (Number)
Tachycardia (N=612)Bradycardia (N=612)Sinus tachycardia (N=612)Sinus bradycardia (N=612)Ventricular premature beat (N=612)Primary atrioventricular block (N=606)Secondary atrioventricular block (N=612)Left bundle branch block (N=612)Right bundle branch block (N=612)Pre-excitation syndrome (N=612)Other intraventricular conduction block (N=611)Acute infarction (N=612)Old infarction (N=612)QTcB (N=612)QTcF (N=611)QTcN (N=611)
Aripiprazole0.87.50.87.42.92.50.20.216.00.31.80.20.78.02.12.3

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Percentage of Participants With Vital Signs of Potential Clinical Relevance

The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria. (NCT02435836)
Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

Interventionpercentage of participants (Number)
Heart rate sitting increase ≥15 bpm (N=625)Systolic sitting BP increase ≥20 mmHg (N=627)Systolic sitting BP decrease ≥20 mmHg (N=627)Diastolic sitting BP increase ≥15mmHg (N=627)Weight gain ≥7% (N=622)Weight loss ≥7% (N=622)
Aripiprazole0.50.81.33.038.923.6

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Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week

"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants." (NCT02435836)
Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

InterventionUnits on a scale (Mean)
Week 1 (N= 619)Week 2 (N= 595)Week 4 (N= 586)Week 6 (N= 573)Week 8 (N= 552)Week 12 (N= 533)Week 16 (N= 517)Week 24 (N= 489)Week 36 (N= 458)Week 48 (N= 426)Week 60 (N= 395)Week 72 (N= 382)Week 84 (N= 362)Week 96 (N= 340)Week 108 (N= 328)Week 120 (N= 316)Week 132 (N= 306)Week 144 (N= 290)Week 156 (N= 279)Week 168 (N= 272)Week 180 (N= 268)Week 192 (N= 255)Week 204 (N= 239)Week 216 (N= 238)Week 228 (N= 232)Week 240 (N= 216)Week 252 (N= 208)Week 264 (N= 194)Week 276 (N= 187)Week 288 (N= 177)Week 300 (N= 167)Week 312 (N= 145)Week 324 (N= 137)Week 336 (N= 121)Week 348 (N= 114)Week 360 (N= 105)Week 372 (N= 93)Week 384 (N= 91)Week 396 (N= 80)Week 408 (N= 69)Week 420 (N= 61)Week 432 (N= 58)Week 444 (N= 51)Week 456 (N= 48)Week 468 (N= 37)Week 480 (N= 33)Week 492 (N= 31)Week 504 (N= 21)Week 516 (N= 19)Week 528 (N= 19)Week 540 (N= 18)Week 552 (N= 18)Week 564 (N= 17)Week 576 (N= 17)Week 588 (N= 17)Week 600 (N= 16)Week 612 (N= 16)Week 624 (N= 16)Week 636 (N= 16)Week 648 (N= 10)Week 660 (N= 8)Week 672 (N= 3)Week 684 (N= 1)Week 696 (N= 1)Last Visit (N= 629)
Aripiprazole-0.07-0.13-0.20-0.23-0.25-0.25-0.30-0.31-0.32-0.38-0.45-0.45-0.49-0.48-0.51-0.53-0.48-0.52-0.53-0.53-0.55-0.54-0.55-0.53-0.56-0.56-0.58-0.58-0.61-0.64-0.63-0.57-0.60-0.59-0.48-0.54-0.49-0.51-0.53-0.62-0.70-0.69-0.59-0.65-0.46-0.42-0.55-0.57-0.53-0.47-0.61-0.56-0.41-0.35-0.41-0.44-0.44-0.50-0.44-0.70-0.50-0.67-1.00-1.00-0.00

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Percentage of Participants With Laboratory Values of Potential Clinical Relevance

The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria. (NCT02435836)
Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

InterventionPercentage of participants (Number)
Alanine aminotransferase (IU/L) (N=626)Aspartate aminotransferase (IU/L) (N=626)Bilirubin (mg/dl) (high)(N=626)Calcium (mg/dl) (low) (N=626)Chloride (meq/l) (low) (N=626)Chloride (meq/l) (high) (N=626)Creatinine phosphokinase (IU/L) (N=626)Creatinine (mg/dl) (N=617)Glucose (mg/dl) (N=626)Lactic dehydrogenase (IU/L) (N=626)Potassium (meq/l) (low) (N=626)Potassium (meq/l) (high) (N=626)Sodium (meq/l) (low) (N=626)Sodium (meq/l) (high) (N=626)Urea nitrogen (mg/dl) (N=626)Uric acid (mg/dl) (N=626)Eosinophils (%) (N=624)Hematocrit (%) (N=623)Hemoglobin (g/dl) (N=625)Platelet count (per cubic mm) (low) (N=625)Platelet count (per cubic mm) (high) (N=625)White blood count (thou/mcl) (low) (N=625)White blood count (thou/mcl) (high) (N=625)Glucose, urine (N=613)Protein, urine (N=599)
Aripiprazole1.11.03.03.40.50.214.90.53.00.20.25.30.50.20.81.03.22.72.40.20.31.13.81.61.8

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Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week

The AIMS assessment consisted of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest (e.g., in the waiting room), and the study physician would make global judgments on the participant's dyskinesia's (items 8 through 10). For this scale, the participant was seated on a hard, firm chair. These items are rated on a five-point scale: 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). The total score ranges from 0 to 40. Negative changes from baseline indicate an improvement, with higher negative values indicating better improvement. (NCT02435836)
Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

InterventionUnits on a scale (Mean)
Week 1 (N= 619)Week 2 (N= 595)Week 4 (N= 586)Week 6 (N= 572)Week 8 (N= 552)Week 12 (N= 533)Week 16 (N= 517)Week 24 (N= 489)Week 36 (N= 458)Week 48 (N= 425)Week 60 (N= 395)Week 72 (N= 382)Week 84 (N= 362)Week 96 (N= 340)Week 108 (N= 328)Week 120 (N= 316)Week 132 (N= 306)Week 144 (N= 290)Week 156 (N= 279)Week 168 (N= 272)Week 180 (N= 268)Week 192 (N= 255)Week 204 (N= 239)Week 216 (N= 238)Week 228 (N= 224)Week 240 (N= 183)Week 252 (N= 139)Week 264 (N= 83)Week 276 (N= 58)Week 288 (N= 56)Week 300 (N= 55)Week 312 (N= 37)Week 324 (N= 38)Week 336 (N= 28)Week 348 (N= 8)Week 360 (N= 9)Week 372 (N= 3)Week 384 (N= 5)Week 396 (N= 10)Week 408 (N= 9)Week 420 (N= 4)Week 432 (N= 3)Week 444 (N= 1)Week 456 (N= 5)Week 468 (N= 2)Week 480 (N= 1)Week 492 (N= 9)Week 504 (N= 2)Week 636 (N= 5)Week 648 (N= 2)Week 660 (N= 3)Week 672 (N= 1)Week 696 (N= 1)Last Visit (N= 629)
Aripiprazole-0.21-0.29-0.28-0.34-0.34-0.37-0.39-0.35-0.21-0.35-0.33-0.31-0.31-0.25-0.27-0.26-0.26-0.29-0.31-0.29-0.34-0.35-0.30-0.26-0.31-0.31-0.40-0.61-0.76-0.57-0.18-0.35-0.32-0.36-0.50-0.440.000.000.000.000.000.000.00-1.000.000.00-0.44-0.500.200.000.000.000.00-0.39

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Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12

The PSS is a brief scale designed to capture a psychiatric patient's satisfaction with a clinician. The scale covers 6 domains: Trust (3 items), Communication (3 items), Exploration of Ideas/Options (2 items), Body Language (2 items), Active Listening (4 items), and Miscellaneous Items (6 items). Out of the 20 items, the first 19 are scored on a 5-point Likert Scale (1=strongly disagree, 2=disagree, 3=satisfactory, 4=agree, 5=strongly agree). The last question (6f) is a free-response question asking for input on how the clinician might improve. Sum of scores of individual items give a total score (range 9-95). Higher scores indicate greater degree of satisfaction. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported. (NCT02462473)
Timeframe: Week 0, Week 12

Interventionunits on a scale (Number)
Participant 1 (Week 0)Participant 1 (Week 12)Participant 2 (Week 0)Participant 2 (Week 12)Participant 3 (Week 0)Participant 3 (Week 12)Participant 4 (Week 0)Participant 5 (Week 0)Participant 5 (Week 12)Participant 6 (Week 0)Participant 6 (Week 12)Participant 7 (Week 0)Participant 7 (Week 12)Participant 8 (Week 0)Participant 8 (Week 12)Participant 9 (Week 0)Participant 9 (Week 12)
Cohort 17676525757574866647676767263727176

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Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP)

The CASP and data on concomitant medications and psychosocial treatments were used to evaluate the impact of AMPL results on other aspects of clinical decision making. (NCT02462473)
Timeframe: Up to Week 12

Interventionparticipants (Number)
Side Effects Of MedicationAttitude Toward TreatmentReport of Increased SymptomsReport of Decrease in SymptomsPatient Still SymptomaticPatient Ideation
Cohort 1324311

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Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12

The DPSS is a clinician-rated scale used to rate 8 domains commonly seen in patients with psychotic disorders. Each domain was rated on a 5-point scale (0 to 4) with anchored description of endpoints. Total score was computed by summing the scores of individual items (range of 0-32). Higher scores represent more severe condition. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported. (NCT02462473)
Timeframe: Week 0, Week 12

Interventionunits on a scale (Number)
Participant 1 (Week 0)Participant 1 (Week 12)Participant 2 (Week 0)Participant 2 (Week 12)Participant 3 (Week 0)Participant 3 (Week 12)Participant 4 (Week 0)Participant 5 (Week 0)Participant 5 (Week 12)Participant 6 (Week 0)Participant 6 (Week 12)Participant 7 (Week 0)Participant 7 (Week 12)Participant 8 (Week 0)Participant 8 (Week 12)Participant 9 (Week 0)Participant 9 (Week 12)
Cohort 11248288149474584446

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Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12

The CRS is an ordinal scale filled by the clinician. The scores range from 1 to 7 that were used to quantify the clinician's assessment of treatment adherence by the patient. Higher scores indicate greater adherence. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported. (NCT02462473)
Timeframe: Week 0, Week 12

Interventionunits on a scale (Number)
Participant 1 (Week 0)Participant 1 (Week 12)Participant 2 (Week 0)Participant 2 (Week 12)Participant 3 (Week 0)Participant 3 (Week 12)Participant 4 (Week 0)Participant 5 (Week 0)Participant 5 (Week 12)Participant 6 (Week 0)Participant 6 (Week 12)Participant 7 (Week 0)Participant 7 (Week 12)Participant 8 (Week 0)Participant 8 (Week 12)Participant 9 (Week 0)Participant 9 (Week 12)
Cohort 177777777777777777

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Number of Participants With Medication Treatment Modifications (MTM)

Information on MTMs derived from data collected in the clinical assessment of the schizophrenia patient (CASP) questionnaire. The CASP captured changes in medications, changes in psychosocial treatments, visit frequency, and the need for any acute interventions. The CASP comprised of 3 sections covering several parameters. The CASP captured changes in treatment options which was used to compute MTM, as well as factors in clinical decision making and the influence of antipsychotic medication plasma levels (AMPL), when they were available, on clinical decision making. (NCT02462473)
Timeframe: Up to Week 12

InterventionParticipants (Number)
Cohort 14

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Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12

The BARS is a 4-item scale that includes 3 questions and an overall visual analog rating scale that assesses participant's knowledge about his/her medication. The key measure of adherence is the visual analog scale and assesses the percentage of doses taken by the participants in the past month (0 percent [%] - 100%). The 3 questions include: number of prescribed doses per day, number of days in the past month when the participant did not take the prescribed doses, and the number of days in the past month when the participant took less than the prescribed dose. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported. (NCT02462473)
Timeframe: Week 0, Week 12

Interventionpercent adherence (Number)
Participant 1 (Week 0)Participant 1 (Week 12)Participant 2 (Week 0)Participant 2 (Week 12)Participant 3 (Week 0)Participant 3 (Week 12)Participant 4 (Week 0)Participant 5 (Week 0)Participant 5 (Week 12)Participant 6 (Week 0)Participant 6 (Week 12)Participant 7 (Week 0)Participant 7 (Week 12)Participant 8 (Week 0)Participant 8 (Week 12)Participant 9 (Week 0)Participant 9 (Week 12)
Cohort 110010010010010010097939090969095100100100100

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Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12

AMPL of the individual participant during the active assessment phase was reported. (NCT02462473)
Timeframe: Week 12

Interventionnanogram per milliliter (Number)
Participant 1- ARIPIPRAZOLEParticipant 1- DEHYDROARIPIPRAZOLEParticipant 2- OLANZAPINEParticipant 2- PALIPERIDONEParticipant 3- 7-OH QUETIAPINEParticipant 3-NORQUETIAPINEParticipant 3-QUETIAPINEParticipant 3-QUETIAPINE SULFOXIDEParticipant 5-7-OH QUETIAPINEParticipant 5-NORQUETIAPINEParticipant 5-QUETIAPINEParticipant 5-QUETIAPINE SULFOXIDEParticipant 6-ARIPIPRAZOLEParticipant 6-DEHYDROARIPIPRAZOLEParticipant 7-PALIPERIDONEParticipant 7-RISPERIDONEParticipant 8-ARIPIPRAZOLEParticipant 8-DEHYDROARIPIPRAZOLEParticipant 9- 7-OH QUETIAPINEParticipant 9- NORQUETIAPINEParticipant 9- PALIPERIDONEParticipant 9- QUETIAPINEParticipant 9- QUETIAPINE SULFOXIDEParticipant 9- RISPERIDONE
Cohort 1596.00139.0027.3045.1043.10660.00280.00660.007.72153.0050.30321.00464.00112.0031.0026.20168.0033.000.2002.000.1002.002.000.100

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Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12

Clinical Global Impression-Severity (CGI-S) rating scale used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported. (NCT02462473)
Timeframe: Week 0, Week 12

Interventionunits on a scale (Number)
Participant 1 (Week 0)Participant 1 (Week 12)Participant 2 (Week 0)Participant 2 (Week 12)Participant 3 (Week 0)Participant 3 (Week 12)Participant 4 (Week 0)Participant 5 (Week 0)Participant 5 (Week 12)Participant 6 (Week 0)Participant 6 (Week 12)Participant 7 (Week 0)Participant 7 (Week 12)Participant 8 (Week 0)Participant 8 (Week 12)Participant 9 (Week 0)Participant 9 (Week 12)
Cohort 143434453333344333

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Change in Arizona Sexual Experiences Scale (ASEX) Score

Subjects enrolled in this study will be followed for an average of about 5 months. The ASEX will be done at screening to ensure subjects meet criteria for sexual dysfunction as defined by the scale. In addition subjects must remember at least a 2 point change in the scale since starting Invega Sustenna or Risperdal Consta. Subjects must also score no greater than or equal to 25 on the scale to ensure a baseline of minimal sexual activity. The primary outcome of the study is the change in ASEX score from Baseline to Endpoint. Total scores range from 5 - 30 with the higher scores indicating more sexual dysfunction. (NCT02472652)
Timeframe: Baseline and 12 weeks

Interventionunits on a scale (Number)
Abilify Maintena11

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Prolactin Concentrations ng/ml (Normal Range 4.0 - 15.2ng/ml)

Subjects enrolled in this study will be followed for an average of about 5 months. Serum prolactin concentrations will be measured to assess change from Baseline to Endpoint (NCT02472652)
Timeframe: Baseline and Endpoint average of about 5 months

Interventionng/ml (Number)
Baseline5 months
Abilify Maintena49.214.2

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Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)

Responses to 4 mTSR-6 questions have been provided. Results include the number of participants who responded positively to the category during the entire post-baseline treatment period. (NCT02634320)
Timeframe: Up to 7 months

Interventionparticipants (Number)
Spent at least 1 overnight as an inpatientAttended an outpatient visit for mental healthHad at least 1 visit to an ERWere arrested, picked up, or transported by police
Aripiprazole Lauroxil31762

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Number of Participants With Adverse Events

(NCT02634320)
Timeframe: Up to 7 months

InterventionParticipants (Count of Participants)
Aripiprazole Lauroxil21

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Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores

The BPRS is an instrument for evaluating change in psychopathology in patients with schizophrenia. It consists of 18 items in which clinicians rate patient symptoms on a 7-point scale (1=not present, 7=extremely severe). Scores range from 18 to 126, with higher scores indicative of more severe psychopathology). (NCT02634320)
Timeframe: Up to 7 months

Interventionunits on a scale (Mean)
Aripiprazole Lauroxil-2.7

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Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores

"The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to last visit in the treatment period based on the observed data." (NCT02634320)
Timeframe: Up to 7 months

Interventionunits on a scale (Mean)
Aripiprazole Lauroxil-0.2

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Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS)

"The BAS is a 19-item scale completed by the caregiver that focuses on specific subjective and objective consequences of families caring for individuals with severe mental disorders. Respondents are required to indicate whether they have experienced each of the types of burden - 'Not at all', 'A little', 'Some' or A lot' - in the previous four weeks. These are scored 1, 2, 3 and 4, respectively. The total score ranges between 19 and 76. A higher score indicates more perceived burden. Subjects required a reliable informant (caregiver) in order to participate in the study. These caregivers did not receive study treatment, and they are not represented elsewhere in the results data. The data provided indicates the change from baseline to the last treatment visit." (NCT02634320)
Timeframe: Up to 7 months

Interventionunits on a scale (Mean)
Aripiprazole Lauroxil-3.2

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Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS)

The QLS is a clinician-rated scale that is used to assess health-related quality of life and functioning in patients with schizoprehnia during the preceding 4 weeks. The QLS consists of 21 items in 4 major domains (Intrapsychic Foundations, Interpersonal Relations, Instrumental Role, and Common Objects and Activities). Following a semi-structured interview, each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). (NCT02634320)
Timeframe: Up to 7 months

Interventionunits on a scale (Mean)
Aripiprazole Lauroxil0.4

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Assessment of the Functionality of an Integrated Call Center for DMS by Adult Subjects With SCH, MDD, or BP1 Who Were Treated With Oral Aripiprazole.

"The primary outcome was assessed as the establishment of a functional and operational integrated call center with coordinated feedback to the subject and investigative site to optimize the use of DMS as measured by:~Inbound calls (ie, calls from the subject to the integrated call center) by help type;~Outbound calls (ie, calls from the integrated call center to the subject) by help type.~The number presented in the table is the number of subjects in trial who made (inbound) or received (outbound) calls" (NCT02722967)
Timeframe: From baseline upto week 9

,,
Interventionparticipants (Number)
Inbound, BaselineInbound, Week 1Inbound, Week 2Inbound, Week 3Inbound, Week 4Inbound, Week 5Inbound, Week 6Inbound, Week 7Inbound, Week 8Inbound, Week >8Outbound, BaselineOutbound, Week 1Outbound, Week 2Outbound, Week 3Outbound, Week 4Outbound, Week 5Outbound, Week 6Outbound, Week 7Outbound, Week 8Outbound, Week >8
Bipolar 1 Disorder (BP1)0872440120022226657974
Major Depressive Disorder (MDD)0841223300012124332452
Schizophrenia (SCH)1963546341015153425450

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Number of Participants With Remission From Depression

Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depressive symptoms. (NCT02960763)
Timeframe: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks

InterventionParticipants (Count of Participants)
Aripiprazole Augmentation61
Bupropion Augmentation58
Switch to Bupropion39
Lithium Augmentation24
Switch to Nortriptyline26

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Psychological Well-Being

Psychological well-being was assessed using the NIH Toolbox Psychological Wellbeing subscales of Positive Affect and General Life Satisfaction, with a T score calculated as the average of these two subscales. Higher scores indicate greater positive affect and life satisfaction. Reference T-score (mean=50, SD=10). (NCT02960763)
Timeframe: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks

,,,,
Interventiont-score (Mean)
baseline10 weeks
Aripiprazole Augmentation34.738.8
Bupropion Augmentation35.038.7
Lithium Augmentation33.135.7
Switch to Bupropion34.836.1
Switch to Nortriptyline34.235.6

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Serious Adverse Events

Life threatening illness, hospitalization, or need of medical care. (NCT02960763)
Timeframe: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks

InterventionParticipants (Count of Participants)
Aripiprazole Augmentation15
Bupropion Augmentation15
Switch to Bupropion19
Lithium Augmentation12
Switch to Nortriptyline11

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Number of Participants With Relapse

The definition of relapse is as follows 1.50% or greater increase in total DIEPSS score, 2. an increase in the total PANSS score of 25% or more from baseline, 3. deliberate self-injury, 4. emergence of clinically significant suicidal ideation, 5. violent behavior resulting in clinically significant injury to another person or property damage. (NCT03019887)
Timeframe: One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first.

InterventionParticipants (Count of Participants)
Dose Reduction130

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Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline.

"Using caregiver-rated ABC-J, the degree of aberrant behaviors was scored on four levels ranging from 0 'not at all a problem', 1 'slight problem', 2 'moderately serious problem' to 3 'the problem is severe in degree' in irritability subscale (including 15 items describing symptoms of irritability, such as temper tantrums, aggression, mood changes, and self-injury).~The irritability subscale score ranging from 0 to 45 was derived from the sum of the 15 items and higher values represent a worse outcome." (NCT03179787)
Timeframe: Baseline, Week 4, 8, 16, 24, 52

Interventionscore on a scale (Mean)
BaselineWeek 4Week 8Week 16Week 24Week 52End-point (LOCF)
Safety Analysis Group19.814.712.912.713.413.113.0

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Percentage of Participants Achieving Response

Response was defined as at least 30% improvement from baseline in PANSS Total Score or CGI score of 1 or 2. The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel, and ranges from 30 (best possible outcome) to 210 (worst possible outcome). The CGI scale is an investigator-rated evaluation that assesses the severity of a participant's illness on a 7-point scale, ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Percentage of participants achieving response was determined by Last Observation Carried Forward (LOCF) method. (NCT03198078)
Timeframe: Up to 6 weeks

Interventionpercentage of participants (Number)
Brexpiprazole43.64
Aripiprazole43.56
Placebo28.16

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Percentage of Participants Achieving Remission

Remission was defined as a score of ≤ 3 on each of the following specific PANSS items: delusions (positive scale item [P] 1), unusual thought content (general scale item [G] 9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (negative scale item [N] 1), passive/apathetic social withdrawal (N4), and lack of spontaneity and conversation flow (N6). Each item's severity was rated on 7-point scale, with score of 1 (absence of symptoms) to 7 (extremely severe symptoms). Percentage of participants achieving remission was determined by LOCF method. (NCT03198078)
Timeframe: Up to 6 weeks

Interventionpercentage of participants (Number)
Brexpiprazole29.09
Aripiprazole35.64
Placebo23.30

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Number of Participants With At Least One Occurrence of Suicidal Behavior or Suicidal Ideation as Recorded on Columbia-Suicide Severity Rating Scale (C-SSRS)

C-SSRS is a scale used to report at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any of the following items: actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior. The suicidal ideation total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) and the total score ranges from 0 to 25. Lower scores indicate improvement. (NCT03198078)
Timeframe: From the first dose of study drug up to last dose of study drug (up to approximately 6 weeks)

InterventionParticipants (Count of Participants)
Brexpiprazole1
Aripiprazole2
Placebo2

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Change From Baseline to Week 6 in PANSS Positive and Negative Sub-Scales Scores

PANSS has 7 positive symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility; and 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Each item's severity was rated on 7-point scale, with score of 1 (absence of symptoms) to 7 (extremely severe symptoms). PANSS positive & negative subscale scores were the sum of rating scores for 7 positive & 7 negative items respectively. Both scores range from 7 (best possible outcome) to 49 (worst possible outcome). Higher scores denote worsening of symptoms. LS mean was determined by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance. (NCT03198078)
Timeframe: Baseline to Week 6

,,
Interventionscore on a scale (Least Squares Mean)
Change From Baseline to Week 6 in PANSS Positive Sub-scale ScoreChange From Baseline to Week 6 in PANSS Negative Sub-scale Score
Aripiprazole-7.29-4.77
Brexpiprazole-6.58-4.70
Placebo-5.14-3.82

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Mean Clinical Global Impression Improvement (CGI-I) Scale Score at Week 6

The efficacy of brexpiprazole in the treatment was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was entirely due to drug treatment on a 7-point scale, ranging from 0 to 7. Response choices were: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher scores indicate worse condition. Mean CGI-I scale score was determined by LOCF method. (NCT03198078)
Timeframe: Week 6

Interventionscore on a scale (Mean)
Brexpiprazole2.86
Aripiprazole2.79
Placebo3.17

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Mean Change From Baseline in Weight

Change in weight was reported, in kilograms (kg). (NCT03198078)
Timeframe: Baseline up to last visit (approximately 6 weeks)

Interventionkg (Mean)
Brexpiprazole0.8
Aripiprazole0.5
Placebo0.0

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Mean Change From Baseline in Waist Circumference

Change in waist circumference was reported in 'cm'. (NCT03198078)
Timeframe: Baseline up to last visit (approximately 6 weeks)

Interventioncm (Mean)
Brexpiprazole0.6
Aripiprazole-0.3
Placebo0.0

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Mean Change From Baseline in Height

Change in height was reported in centimeters (cm). (NCT03198078)
Timeframe: Baseline up to last visit (approximately 6 weeks)

Interventioncm (Mean)
Brexpiprazole0.2
Aripiprazole0.2
Placebo0.3

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Mean Change From Baseline in Body Mass Index (BMI)

Change in BMI was reported in kilograms per square meter (kg/m^2). (NCT03198078)
Timeframe: Baseline up to last visit (approximately 6 weeks)

Interventionkg/m^2 (Mean)
Brexpiprazole0.2
Aripiprazole0.3
Placebo0.0

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Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) to 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranges from 30 (best possible outcome) to 210 (worst possible outcome). Higher scores indicate worsening of symptoms. Least squares (LS) mean was determined by Mixed-effect model repeated measures (MMRM) method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value and baseline visit interaction as a covariate, and with an unstructured covariance. (NCT03198078)
Timeframe: Baseline to Week 6

Interventionscore on a scale (Least Squares Mean)
Brexpiprazole-22.75
Aripiprazole-23.95
Placebo-17.42

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Change From Baseline to Week 6 in Clinical Global Impression Severity (CGI-S) Scale Score

"The CGI-S scale is an investigator-rated evaluation that assesses the severity of a participant's illness on a 7-point scale, ranging from 1 to 7. The investigator answered the question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?. Response choices were: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. Higher scores indicate worse condition. LS mean was determined by the MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance." (NCT03198078)
Timeframe: Baseline to Week 6

Interventionscore on a scale (Least Squares Mean)
Brexpiprazole-0.92
Aripiprazole-1.01
Placebo-0.80

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Number of Participants With Potentially Clinically Relevant Laboratory Test Values

Potentially clinically relevant laboratory values assessed included - serum chemistry [including blinded prolactin], hematology, and urinalysis as defined in SAP. (NCT03198078)
Timeframe: From the first dose of study drug up to last dose of study drug (up to approximately 6 weeks)

,,
InterventionParticipants (Count of Participants)
Alanine Aminotransferase (U/L): HighBilirubin (mg/dL): HighCholesterol, Fasting (mg/dL): HighCreatine kinase (U/L): HighGlucose, Fasting (mg/dL): HighHDL Cholesterol, Fasting (mg/dL): LowLDL Cholesterol, Fasting (mg/dL): HighTriglycerides, Fasting (mg/dL): HighUrate (mg/dL): HighEosinophils/Leukocytes (%): HighHematocrit (%): LowHemoglobin (g/dL): LowLeukocytes (10^9/L): LowLeukocytes (10^9/L): HighProtein, Urine: High
Aripiprazole21341510370000102
Brexpiprazole102516122130242002
Placebo00019130101010010

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Number of Participants With Treatment-emergent AEs (TEAEs), Serious TEAEs, and TEAEs Graded by Severity

An AE was defined as any untoward medical occurrence in a participant administered with a medicinal product that does not necessarily have a causal relationship with the treatment. An SAE was any AE that results in the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions which is fatal, life-threatening, result in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, and requires inpatient hospitalization or prolongation of existing hospitalization. TEAE is any AE after the start of treatment or if the event was continuous from baseline, medicinal product related, or resulted in death, discontinuation, interruption or reduction of medicinal product. TEAEs were graded on a 3-point scale: 1 (Mild: Discomfort noticed, but no disruption to daily activity), 2 (Moderate: Discomfort sufficient to reduce or affect normal daily activity), and 3 (Severe: Inability to work or perform normal daily activity). (NCT03198078)
Timeframe: From the first dose of study drug up to 21 days after the last dose of study drug (up to approximately 9 weeks)

,,
InterventionParticipants (Count of Participants)
TEAEsSerious TEAEsMild TEAEsModerate TEAEsSevere TEAEs
Aripiprazole 10 to 20 mg/Day53147160
Brexpiprazole 2 to 4 mg/Day44133172
Placebo42332131

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Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters

Twelve-lead ECG recordings were obtained after the participant was supine and at rest for at least 5 minutes as defined in SAP. (NCT03198078)
Timeframe: From the first dose of study drug up to last dose of study drug (up to approximately 6 weeks)

,,
InterventionParticipants (Count of Participants)
Rate: BradycardiaRhythm: Sinus BradycardiaRhythm: Supraventricular Premature BeatRhythm: Ventricular Premature BeatST/T Morphology: QTcFST/T Morphology: QTcN
Aripiprazole001011
Brexpiprazole000100
Placebo111000

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Number of Participants With Severe Psychotropic Side Effects as Assessed by Udvalg for Kliniske Undersogelser (UKU) Rating Scale

The UKU rating scale is a semi-structured interview used to assess the side effects of participants being treated with antipsychotic drugs. The scale is divided into 6 sub-scales: Psychic, neurological, autonomic, other, global assessment by subject, and global assessment by doctor. The scale has a total of 48 items, each item is rated on a 4-point scale (0=not present; 1=mild; 2=moderate; 3=severe), and the total score ranges from 0 to 144. Higher ratings indicate greater impairment. The severe side effects are reported in this outcome measure. (NCT03198078)
Timeframe: From the first dose of study drug up to last dose of study drug (up to approximately 6 weeks)

,,
InterventionParticipants (Count of Participants)
Psychic: Concentration DifficultiesPsychic: Asthenia/LassitudePsychic: Failing MemoryPsychic: DepressionPsychic: Tension/Inner UnrestPsychic: Increased Duration of SleepPsychic: Reduced Duration of SleepPsychic: Increased Dream ActivityPsychic: Emotional IndifferenceNeurologic: AkathisiaAutonomic: Nausea/VomitingAutonomic: Micturition DisturbancesAutonomic: Palpitations/TachycardiaAutonomic: Increased Tendency to SweatingOther: Weight GainOther: AmenorrhoeaOther: Migraine
Aripiprazole103223112610100110
Brexpiprazole76204040310011000
Placebo81419010601010001

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Number of Participants With Adverse Events (AEs) and Trial Discontinuation Due to AEs

An AE was defined as any untoward medical occurrence in a participant administered with a medicinal product that does not necessarily have a causal relationship with the treatment. (NCT03198078)
Timeframe: From the first dose of study drug up to 21 days after the last dose of study drug (up to approximately 9 weeks)

,,
InterventionParticipants (Count of Participants)
AEsTrial Discontinuation Due to AEs
Aripiprazole561
Brexpiprazole460
Placebo442

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Number of Participants With Cognitive Adverse Effects Assessed by New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT)

The NY-AACENT is used to detect changes in cognitive function subsequent to pharmacological or similar treatments for neurological or psychiatric problems, specifically designed to be used in pediatric population (ages 12 to 17), but could have been utilized with other age groups, as appropriate. Number of participants with at least one occurrence of the corresponding signs/symptoms are reported in this outcome measure. (NCT03198078)
Timeframe: From the first dose of study drug up to last dose of study drug (up to approximately 6 weeks)

,,
InterventionParticipants (Count of Participants)
Working MemoryAttention/VigilanceVerbal LearningVisual LearningReasoningSpeed of ProcessingSocial CognitionAny Signs/Symptoms
Aripiprazole7990704686848791
Brexpiprazole88987146978891100
Placebo8391694483828492

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Number of Participants With Potentially Clinically Relevant Abnormalities in Vital Signs

Vital sign measurements included body weight, systolic blood pressure (SBP), and diastolic blood pressure (DBP). Blood pressure measurements were made in the supine, sitting, and standing positions after the participant had been in each position for at least 3 minutes as defined in SAP. (NCT03198078)
Timeframe: From the first dose of study drug up to last dose of study drug (up to approximately 6 weeks)

,,
InterventionParticipants (Count of Participants)
SBP Sitting (mmHg): LowSBP Standing (mmHg): LowSBP Supine (mmHg): LowDBP Standing (mmHg): LowDBP Supine (mmHg): LowWeight (kg): LowWeight (kg): HighOrthostatic Hypotension (mmHg): Low
Aripiprazole01001251
Brexpiprazole01010592
Placebo10100452

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Change From Baseline to Week 6 in Children's Global Assessment Scale (CGAS) Total Score

The CGAS is a 100-point rating scale measuring psychological, social, and school functioning for children aged 6-17 years and provides a global measure of the severity of disturbance. The scale is separated into 10-point sections that are headed with a description of the level of functioning and followed by examples matching the interval. The score ranges from 0-100, 1 to 10 indicates the need for constant supervision and 91 to 100 indicates superior functioning in all areas. Higher scores indicate better functioning. LS mean was determined by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance. (NCT03198078)
Timeframe: Baseline to Week 6

Interventionscore on a scale (Least Squares Mean)
Brexpiprazole10.56
Aripiprazole12.07
Placebo8.08

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Change From Baseline in Simpson Angus Scale (SAS) Total Score

The SAS consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Severity of each item was rated on a 5-point scale, with a score of 0 (absence of symptoms) to 4 (severe condition). The SAS total score is the sum of the scores of all 10 items, ranging from 0 to 40 where lower scores indicate less severe condition. LS mean was determined by Analysis of Covariance (ANCOVA) model with treatment and study center as main effects and baseline value as covariate. (NCT03198078)
Timeframe: Baseline up to last visit (approximately 6 weeks)

Interventionscore on a scale (Least Squares Mean)
Brexpiprazole0.04
Aripiprazole0.15
Placebo-0.03

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Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score

The BARS consists of 4 items related to akathisia: objective observation of akathisia by the investigator, subjective feelings of restlessness by the participant, subjective distress due to akathisia, and global clinical assessment of akathisia. The first 3 items were rated on a 4-point scale, with a score of 0 (absence of symptoms) to 3 (severe condition) and the global clinical assessment was rated on a 6-point scale, with a score of 0 (absence of symptoms) to 5 (severe akathisia). Total score is the sum of the scores of all 4 items, ranging from 0 to 14, higher scores indicate severe condition. LS mean was determined by ANCOVA model with treatment and study center as main effects and baseline value as covariate. (NCT03198078)
Timeframe: Baseline up to last visit (approximately 6 weeks)

Interventionscore on a scale (Least Squares Mean)
Brexpiprazole0.01
Aripiprazole0.06
Placebo0.01

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Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score

The AIMS assessment consists of 12 items rating the involuntary movements: Facial and oral movements (4 items), extremity movements (2 items), and trunk movements (1 item) were observed unobtrusively while the participant is at rest and the investigator also made global judgments on the participant's dyskinesias (2 items), and dental status (2 items). Severity of each item was rated on a 5-point scale, with a score of 0 (absence of symptoms) to 4 (severe condition). Total Score is the sum of the scores of all 12 items, ranging from 0 to 48, higher scores indicate severe condition. LS mean was determined by ANCOVA model with treatment and study center as main effects and baseline value as covariate. (NCT03198078)
Timeframe: Baseline up to last visit (approximately 6 weeks)

Interventionscore on a scale (Least Squares Mean)
Brexpiprazole-0.12
Aripiprazole0.05
Placebo-0.06

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Area Under the Plasma Concentration Versus Time Curve 168h (AUC168h) of Aripiprazole in Cohort 1

(NCT03342963)
Timeframe: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing

Interventionng*h/mL (Mean)
ASC-01783
Aripiprazole/Sertraline Concomitant779

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Cmax of Aripiprazole and Sertraline in Cohort 2

(NCT03342963)
Timeframe: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing

,
Interventionng/mL (Mean)
AripiprazoleSertraline
ASC-01 Under Fasted16.928.9
ASC-01 Under Fed16.636.5

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AUC168h of Aripiprazole and Sertraline in Cohort 2

(NCT03342963)
Timeframe: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing

,
Interventionng*h/mL (Mean)
AripiprazoleSertraline
ASC-01 Under Fasted701904
ASC-01 Under Fed8651060

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Peak Plasma Concentration (Cmax) of Aripiprazole in Cohort 1

(NCT03342963)
Timeframe: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing

Interventionng/mL (Mean)
ASC-0118.8
Aripiprazole/Sertraline Concomitant16.9

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Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4

Change within treatment groups of Positive and Negative Syndrome Scale (PANSS) total score between baseline and week 4 based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition. (NCT03345979)
Timeframe: Baseline and 4 weeks

Interventionunits on a scale (Mean)
Aripiprazole Lauroxil-17.4
Paliperidone Palmitate-20.1

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Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4

Least squares mean change in Positive and Negative Syndrome Scale (PANSS) between at 4 weeks from Mixed Models Repeated Measures (MMRM). The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition (NCT03345979)
Timeframe: Baseline and 4 weeks

Interventionunits on a scale (Least Squares Mean)
Aripiprazole Lauroxil-17.3
Paliperidone Palmitate-19.3

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Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9

Least squares mean change from baseline Positive and Negative Syndrome Scale (PANSS) and 9 weeks from Mixed Models Repeated Measures (MMRM).The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition (NCT03345979)
Timeframe: Baseline and 9 weeks

Interventionunits on a scale (Least Squares Mean)
Aripiprazole Lauroxil-18.8
Paliperidone Palmitate-21.5

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Number of Participants With Serious and Non-serious Adverse Events (AEs)

(NCT03345979)
Timeframe: Up to 25 weeks

InterventionParticipants (Count of Participants)
Aripiprazole Lauroxil69
Paliperidone Palmitate72

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Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9

Change within treatment groups from baseline Positive and Negative Syndrome Scale (PANSS) and 9 weeks based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition. (NCT03345979)
Timeframe: Baseline and 9 weeks

Interventionunits on a scale (Mean)
Aripiprazole Lauroxil-19.8
Paliperidone Palmitate-22.5

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Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25

Change within treatment groups at baseline Positive and Negative Syndrome Scale (PANSS) and at 25 weeks based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition (NCT03345979)
Timeframe: Baseline and 25 weeks

Interventionunits on a scale (Mean)
Aripiprazole Lauroxil-23.3
Paliperidone Palmitate-21.7

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Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25

Least squares mean change in Positive and Negative Syndrome Scale (PANSS) total score at week 25 from Mixed Models Repeated Measures. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition (NCT03345979)
Timeframe: Baseline and 25 weeks

Interventionunits on a scale (Least Squares Mean)
Aripiprazole Lauroxil-22.0
Paliperidone Palmitate-21.1

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Change in Social and Occupational Functioning Assessment Scale (SOFAS) Score

The SOFAS measures social and occupational functioning independent of the overall severity of the individual's psychological symptoms. The minimum score is 0 and the maximum score is 100. A higher rating implies a higher level of functioning. (NCT03408873)
Timeframe: Baseline to Week 24

Interventionscore on a scale (Mean)
BaselineWeek 24
CAE-L51.970.8

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Change in Communication Styles Scale Score

The Communication Styles Scale is a measure of the impact of physician communication style on medication beliefs and adherence behavior. Total scores range from 0-27 where the higher score indicates a more initial collaborative communication style. (NCT03408873)
Timeframe: Screen to Week 24

Interventionscore on a scale (Mean)
ScreenWeek 24
CAE-L22.422.1

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Change in Drug Attitude Inventory (DAI) Score

DAI-10 scoring ranges from -10 to +10 with a total score >0 indicating a positive attitude toward psychiatric medications and a total score of <0 indicating a negative attitude toward psychiatric medications (NCT03408873)
Timeframe: Screen to Week 24

Interventionscore on a scale (Mean)
ScreenWeek 24
CAE-L7.28.1

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Change in the Brief Psychiatric Rating Scale (BPRS) Score

The BPRS measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behavior. The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition. (NCT03408873)
Timeframe: Baseline to Week 24

Interventionscore on a scale (Mean)
BaselineWeek 24
CAE-L36.424.9

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Change in Global Assessment of Functioning (GAF) Score

The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning. (NCT03408873)
Timeframe: Baseline to Week 24

Interventionscore on a scale (Mean)
BaselineWeek 24
CAE-L53.570.7

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Change in Montgomery Asberg Rating Scale (MADRS) Score

The MADRS measures symptoms of depression. The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition. (NCT03408873)
Timeframe: Screen to Week 24

Interventionscore on a scale (Mean)
ScreenBaselineWeek 24
CAE-L24.518.17.95

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Change in Oxford Bipolar Knowledge Questionnaires (OBQ) Score

The OBQ assess knowledge of BD management. Total score rangers from 0-80, with a higher score indicative of better knowledge of bipolar mood management. (NCT03408873)
Timeframe: Screen to Week 24

Interventionscore on a scale (Mean)
ScreenWeek 24
CAE-L52.970.7

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Change in Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8A) Score

The SOCRATES measures motivation to reduce the use of substances. The minimum score is 10 and the maximum score is 50. A higher score indicates a higher desire to reduce drinking. (NCT03408873)
Timeframe: Screen to Week 24

Interventionscore on a scale (Mean)
ScreenWeek 24
CAE-L46.834.8

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Change in Tablets Routine Questionnaire (TRQ, Past Month)

"Treatment non-adherence is measured as a percentage of medications not taken within the past month at time of assessment.~The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence." (NCT03408873)
Timeframe: Screen to Week 24

Interventionpercentage of missed BD medications (Mean)
ScreenBaselineWeek 24
CAE-L40.629.419.2

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Change in Tablets Routine Questionnaire (TRQ, Past Week)

"Treatment non-adherence is measured as a percentage of medications not taken within the past week at time of assessment.~The minimum score is 0% and the maximum score is 100%. A higher score implies poorer treatment adherence." (NCT03408873)
Timeframe: Screen to Week 24

Interventionpercentage of missed BD medications (Mean)
ScreenBaselineWeek 24
CAE-L50.137.516.9

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Change in The Self-Report Habit Index (SRHI) Score

The SRHI is a measure of habit strength. The minimum score is 12 and the maximum score is 84. A higher score implies stronger habits. (NCT03408873)
Timeframe: Screen to Week 24

Interventionscore on a scale (Mean)
ScreenWeek 24
CAE-L47.368.5

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Change in Young Mania Rating Scale (YMRS) Score

The YMRS measures symptoms of mania. The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition. (NCT03408873)
Timeframe: Screen to Week 24

Interventionscore on a scale (Mean)
ScreenBaselineWeek 24
CAE-L13.210.45.6

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Change in Clinical Global Impressions (CGI) Score

The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition. (NCT03408873)
Timeframe: Screen to Week 24

Interventionscore on a scale (Mean)
ScreenBaselineWeek 24
CAE-L4.64.12.8

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LAI Injection Adherence

LAI injection adherence will be determined as a proportion of LAI injections received at the appropriate time (within 7 days of scheduled time). (NCT03408873)
Timeframe: Baseline to Week 24

Interventionpercentage of adherence (Mean)
CAE-L100

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Change in Attitude Towards Medication Questionnaire (AMSQ) Score

"A modification of the Lithium Attitudes Questionnaire (Harvey 1991) which evaluates an individual's attitudes towards mood stabilizers. The AMSQ is used to measure attitudes towards medications. The scale contains 19 items grouped into 7 subscales: general opposition to prophylaxis (4 items), denial of therapeutic effectiveness (2 items), fear of side effects (2 items), difficulty with medication routines (4 items), denial of illness severity (3 items), negative attitudes toward drugs in general (3 items), and lack of information about psychiatric medication (1 item). Responses which suggest positive attitudes towards medications are scored 0, while responses which suggest negative attitudes towards medications are scored 1. The items scores are added for a total score which is reported, with the minimum total score of 0 and maximum total score of 19. Higher scores on each subscale represent more negative attitudes toward mood stabilizers." (NCT03408873)
Timeframe: Screen to Week 24

Interventionscore on a scale (Mean)
ScreenWeek 24
CAE-L7.94.0

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Number of Participants With Clinically Significant Differences in Barnes Akathisia Rating Scale (BARS) Values

BARS is used to rate observable, restless movements of drug induced akathisia and subjective awareness of restlessness and any distress associated with the akathisia. BARS consists of the following 4 items: objective assessment of akathisia symptoms, subjective assessment of the participants's awareness of inner restlessness, distress restlessness, and global clinical assessment of akathisia. First three items are rated on a 4-point scale ranging from 0 (no abnormal movements or absence of inner restlessness or no distress) to 3 (severe akathisia or awareness of intense compulsion to move most of the time or severe distress). The last item, the global clinical assessment of akathisia, is rated on a 6-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Total BARS score ranges from 0 to 14 with a higher score representing worse results. (NCT03557931)
Timeframe: Baseline, week 6 and week 12

,,
Interventionparticipants (Number)
BaselineWeek 6Week 12
ASP4345 150 mg000
ASP4345 50 mg000
Placebo000

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Number of Participants With Clinically Significant Differences in Simpson Angus Scale (SAS) Values

SAS scale consists of 10 items including 7 items that address bradykinesia-rigidity and additional single items for tremor, glabellar tap, and salivation. Each item represents a specific physical condition and is rated on a 5-point category rating scale ranging from 0 (complete absence of the condition) to 4 (the condition is present to an extreme degree).The total score is obtained by adding the scores for the 10 individual items making the maximum possible score is 40. Higher scores are indicative of more severe Parkinsonian-type symptoms. (NCT03557931)
Timeframe: Baseline, week 6 and week 12

,,
Interventionparticipants (Number)
BaselineWeek 6Week 12
ASP4345 150 mg000
ASP4345 50 mg000
Placebo000

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Number of Participants With Clinically Significant Differences in Abnormal Involuntary Movement Scale (AIMS) Values

AIMS is a 14-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant's incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 to 14 are yes/no questions regarding the global judgement and dental status of the participant. The total score is the sum of the scores for the 14 items and the possible total score ranges from 0 to 44. A higher total score is indicative of more severe dyskinetic movements. (NCT03557931)
Timeframe: Baseline, week 6 and week 12

,,
Interventionparticipants (Number)
BaselineWeek 6Week 12
ASP4345 150 mg000
ASP4345 50 mg000
Placebo000

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Number of Participants With Adverse Event (AE)

Treatment emergent adverse event (TEAE) is defined as an AE observed after starting administration of the study drug and 28 days after the last dose of study drug. A study drug-related TEAE is defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, metabolic parameters etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. (NCT03557931)
Timeframe: Baseline up to end of study (EoS) (week 14)

,,
Interventionparticipants (Number)
TEAEDrug-Related TEAEsSerious TEAEsDrug-Related Serious TEAE
ASP4345 150 mg281110
ASP4345 50 mg281330
Placebo451110

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Concentration at Trough Level (Ctrough) for ASP4345

Ctrough concentration for ASP4345 was reported. (NCT03557931)
Timeframe: Predose: day 7, day 14, day 21, day 42 and day 84/EoT

,
Interventionnanogram per milliliter (ng/mL) (Mean)
Day 7 Pre-doseDay 14 Pre-doseDay 21 Pre-doseDay 42 Pre-doseDay 84 Pre-dose
ASP4345 150 mg483.84428.88384.48471.78433.56
ASP4345 50 mg175.041182.903172.040207.145204.914

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Number of Participants With Clinically Significant Differences in Columbia-Suicide Severity Rating Scale (C-SSRS) Values

The C-SSRS is a questionnaire used for suicide risk assessment. Affirmative or negative responses are provided to items 1 to 5 for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods [not plan] without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and items 6 to 10 for suicide behavior (6. Preparatory acts or behavior, 7. Aborted attempt, 8. Interrupted attempt, 9. Actual attempt, 10. Completed suicide). (NCT03557931)
Timeframe: Baseline up to EoS (week 14)

Interventionparticipants (Number)
Placebo0
ASP4345 50 mg0
ASP4345 150 mg0

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Change From Baseline to Week 12/EoT in University of California San Diego Performance-based Skills Assessment-2 Extended Range (UPSA-2-ER) Total Score

The UPSA-2-ER assesses the functional abilities of the participant with schizophrenia in 6 domains: household management, communication, financial skills, transportation, comprehension/planning and medication management. The UPSA-2-ER total score has a range from 0 to 105. A higher score indicates less impairment. (NCT03557931)
Timeframe: Baseline and week 12/EoT

Interventionunits on a scale (Least Squares Mean)
Placebo3.11
ASP4345 50 mg3.86
ASP4345 150 mg2.56

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Change From Baseline to Week 12/End of Treatment (EoT) in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score

The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (i.e., working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB neurocognitive composite score is a standardized mean of the six domain scores (excluding social cognition). Raw scores are converted to age and sex adjusted t-scores which are standardized to normative data, and have a mean of 50 and standard deviation of 10 in the general healthy population. A higher score indicates less impairment. (NCT03557931)
Timeframe: Baseline and week 12/end of treatment (EoT)

InterventionT-score (Least Squares Mean)
Placebo1.15
ASP4345 50 mg1.34
ASP4345 150 mg0.87

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Participant Adherence

The DMS includes a drug-device combination of a CoE product, a wearable sensor patch, and application software (smartphone) to record activity and rest and mark events through the act of ingestion. The CoE product consists of an approved antipsychotic medication enclosed with an Ingestible Sensor Pill (MIT). The sensor patch detects and records each MIT ingestion, as well as other physiologic and behavioral data. Participant adherence was measured as the detected MITs over the expected MITs ingested during the trial days with good patch coverage. The more the participant successfully engaged in a number of processes across the 8-week trial, the greater the measured adherence. Descriptive statistics were performed for this outcome measure. (NCT03568500)
Timeframe: Up to 8 weeks

Interventionpercentage of MITs (Mean)
Schizophrenia88.94
Schizoaffective Disorder72.29
First Episode Psychosis91.04
Total86.57

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Percentage Of Days With Good Patch Coverage

The DMS includes a drug-device combination of a CoE product, a wearable sensor patch, and application software (smartphone) to record activity and rest and mark events through the act of ingestion. The CoE product consists of an approved antipsychotic medication enclosed with an Ingestible Sensor Pill (miniature ingestible event marker in tablet [MIT]). The sensor patch detects and records each MIT ingestion, as well as other physiologic and behavioral data. Good patch coverage for a specific day was defined as having either at least 80% patch data available (80% of the day the patch was worn and data was collected as noted via the accelerometer channel) or the MIT was detected within the 24-hour period, for each day while the participant was in the trial. The percentage of days was calculated as the number of days with good patch coverage divided by the total number of trial days for each participant. Descriptive statistics were performed for this outcome measure. (NCT03568500)
Timeframe: Up to 8 weeks

Interventionpercentage of days (Mean)
Schizophrenia64.34
Schizoaffective Disorder62.99
First Episode Psychosis62.51
Total63.37

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Percentage of Participants With Relapse During the Double-blind Randomized Withdrawal Phase

Relapse was defined as a loss of ≥ 50% of the improvement experienced during the open-label stabilization phase (i.e., improvement at the last assessment of Yale Global Tic Severity Scale (YGTSS) before randomization) on the Yale Global Tic Severity Scale Total Tic Score (YGTSS TTS). YGTSS provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic symptoms. (NCT03661983)
Timeframe: From Randomization up to 12 weeks in Double-blind Randomized Withdrawal Phase

Interventionpercentage of participants (Number)
Double Blind Phase: Aripiprazole Full Dose0.0
Double Blind Phase: Aripiprazole Half Dose0.0
Double Blind Phase: Placebo75.0

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Percentage of Participants With Inpatient Psychiatric Hospitalization

Percentage of participants with inpatient psychiatric hospitalization in Prospective Period With at least one hospitalization in Retrospective Period. (NCT03892889)
Timeframe: Retrospective Period [Month -6 to Baseline (Day 1)] up to Prospective Period (Day 1 to Month 3)

Interventionpercentage of participants (Number)
Abilify MyCite®0.0

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Percentage of Days With Improved Adherence

Improved adherence was based on the overall proportion of days covered (PDC) in participants compliant with study drug administration in the Prospective period on Prospective Abilify MyCite® versus Retrospective Period on oral atypical antipsychotics. PDC was calculated as = number of days 'covered' in the Respective Period/number of days in the period * 100. (NCT03892889)
Timeframe: Retrospective Period [-1 to -3 months prior to Baseline (Day 1)] up to Prospective Period (1 to 3 months)

Interventionpercentage of days (Mean)
PDC in Retrospective PeriodPDC in Prospective Period
Abilify MyCite®51.077.5

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Plasma Concentration of Aripiprazole 7 Days Post First Dose (C7) of Aripiprazole 2M LAI 960 mg

(NCT04030143)
Timeframe: Day 8

Interventionng/mL (Mean)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder221

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Plasma Concentration of Aripiprazole 56 Days Postdose (C56) of Aripiprazole 2M LAI 960 mg After the Fourth Dose

(NCT04030143)
Timeframe: Day 225

Interventionng/mL (nanogram per milliliter) (Mean)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder250

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Plasma Concentration of Aripiprazole 28 Days Postdose (C28) of Aripiprazole IM Depot 400 mg After the Eighth Dose

(NCT04030143)
Timeframe: Day 225

Interventionng/mL (Mean)
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder257

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Plasma Concentration of Aripiprazole 28 Days (C28) After the First Dose of Aripiprazole IM Depot 400 mg

(NCT04030143)
Timeframe: Predose on Day 29

Interventionng/mL (Mean)
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder112

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Peak-to-Trough Percent Fluctuation (PTF%) After the Fourth Dose of Aripiprazole 2M LAI 960 mg

PTF% was determined as 100*(Cmax - Cmin [minimum plasma concentration of the drug])/Caverage (average steady-state plasma drug concentration during multiple-dose administration) following fourth dose. (NCT04030143)
Timeframe: Days 169 (Predose [within 2 hours prior to dosing] and 4, 8, 12 hours post dose), 170, 171, 173, 176, 178, 181, 183, 186, 190, 197, 204, 211, 218, and 225

Interventionpercentage fluctuation (Mean)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder63.4

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Number of Participants With Suicidality as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

"C-SSRS was used to assess the suicidality of participants during the study. The assessment included yes or no responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings were provided for suicidal ideation: Score range of 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent), higher total scores indicate more suicidal ideation; Suicidal behavior: Score range of 0 (no suicidal behavior) to 4 (actual suicide attempt), higher total scores indicate more suicidal behavior. Suicidality was defined as reporting any suicidal ideation or behavior." (NCT04030143)
Timeframe: Baseline to Day 225

InterventionParticipants (Count of Participants)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder4
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder4

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VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg

Injection-site pain was evaluated by mean VAS scores as reported by the participant after each injection at visits where an injection occurred. The last injection was the final injection for any given participant. Ratings ranged from 0 (no pain) to 100 (unbearably painful). (NCT04030143)
Timeframe: Day 1 (First injection) to Day 197 (Last injection)

Interventionscore on a scale (Mean)
First Injection: PredoseFirst Injection: Post doseSecond Injection: PredoseSecond Injection: Post doseThird Injection: PredoseThird Injection: Post doseFourth Injection: PredoseFourth Injection: Post doseFifth Injection: PredoseFifth Injection: Post doseSixth Injection: PredoseSixth Injection: Post doseSeventh Injection: PredoseSeventh Injection: Post doseEighth Injection: PredoseEighth Injection: Post doseLast Injection: PredoseLast Injection: Post dose
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder1.63.01.51.60.81.20.71.10.70.80.80.80.61.00.60.80.91.3

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Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg

Injection-site pain was evaluated by mean VAS scores as reported by the participant after each injection at visits where an injection occurred. The last injection was the final injection for any given participant. Ratings ranged from 0 (no pain) to 100 (unbearably painful). (NCT04030143)
Timeframe: Day 1 (First injection) to Day 169 (Last injection)

Interventionscore on a scale (Mean)
First Injection: PredoseFirst Injection: Post doseSecond Injection: PredoseSecond Injection: Post doseThird Injection: PredoseThird Injection: Post doseFourth Injection: PredoseFourth Injection: Post doseLast Injection: PredoseLast Injection: Post dose
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder1.03.71.01.41.02.00.81.40.81.4

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Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities

Potentially clinically significant vital sign abnormalities included: heart rate supine (high: >120 beats per minute [BPM] and increase >=15 BPM; low: <50 BPM and decrease >=15 BPM), systolic blood pressure supine (high >180 (millimetres of mercury [mmHg] and increase >=20 mmHg); low: <90 mmHg and decrease >=20 mmHg), diastolic blood pressure supine (high: >105 mmHg and increase >=15 mmHg; low: <50 mmHg and decrease >=15 mmHg), heart rate standing (high: >120 BPM and increase >=15 BPM), systolic blood pressure standing (high: >180 mmHg and increase >= 20 mmHg; low: <90 mmHg and decrease >=20 mmHg), diastolic blood pressure standing (high: >105 mmHg and increase >=15 mmHg), weight in kilograms (kg) (high: increase >=7%; low: decrease >=7%), temperature (high: >=37.8 degree celsius [°C] and increase >=1.1°C), orthostatic hypotension (low: >=20 mmHg decrease in systolic blood pressure and >=25 BPM increase in heart rate from supine to standing. (NCT04030143)
Timeframe: From first dose of study drug up to Day 225

,
InterventionParticipants (Count of Participants)
Heart Rate Supine: LowHeart Rate Supine: HighSystolic Blood Pressure Supine: LowSystolic Blood Pressure Supine: HighDiastolic Blood Pressure Supine: LowDiastolic Blood Pressure Supine: HighHeart Rate Standing: HighSystolic Blood Pressure Standing: LowSystolic Blood Pressure Standing: HighDiastolic Blood Pressure Standing: HighWeight: LowWeight: HighTemperature: HighOrthostatic Hypotension: Low
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder0210114102125242
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder1121116423115442

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Time to Reach the Maximum Plasma Concentration (Tmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg

(NCT04030143)
Timeframe: Days 1(predose [within 2 hours(h) prior to dosing]&4,8,12 h postdose),2,3,5,8,10,13,15,18,22,29,36,43,50,57(predose),85,113(predose),141,169(predose [within 2 h prior to dosing]& 4,8,12 h postdose),170,171,173,176,178,181,183,186,190,197,204,211,218 & 225

Interventiondays (Median)
Tmax After First Dose (Day 1)Tmax After Fourth Dose (Day 169)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder8.5828.0

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Area Under the Plasma Concentration-Time Curve From Time 0 to 56 Days (AUC0-56) of Aripiprazole After the Fourth Dose of Aripiprazole 2M LAI 960 mg

(NCT04030143)
Timeframe: Days 169 (predose and 4, 8, 12 hours post dose), 170, 171, 173, 176, 178, 181, 183, 186, 190, 197, 204, 211, 218, and 225

Interventionday*ng/mL (Mean)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder14700

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AUC0-28 After the First Dose of Aripiprazole IM Depot 400 mg

(NCT04030143)
Timeframe: Days 1 (predose and 4, 8, and 12 hours postdose), 2, 3, 5, 8, 10, 13, 15, 18, 22 and 29 (predose)

Interventionday*ng/mL (Mean)
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder5030

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AUC0-28 After the Fourth Dose of Aripiprazole 2M LAI 960 mg

(NCT04030143)
Timeframe: Days 169 (predose and 4, 8, 12 hours postdose), 170, 171, 173, 176, 178, 181, 183, 186, 190, and 197

Interventionday*ng/mL (Mean)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder7190

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Area Under the Plasma Concentration-Time Curve From Time 29 to 56 Days (AUC29-56) After the Fourth Dose of Aripiprazole 2M LAI 960 mg

(NCT04030143)
Timeframe: Days 204, 211, 218, and 225

Interventionday*ng/mL (Mean)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder7500

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Tmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg

(NCT04030143)
Timeframe: Predose [within 2 hours prior to dosing; 4,8,12h postdose] on Days 1,169,197; Predose on Days 29,57,85,113,141; and on Days 2, 3, 5, 8, 10, 13, 15, 18, 22, 170, 171, 173, 176, 178, 181, 183, 186, 190,198, 199, 201, 204, 206, 209, 211, 214, 218, 225

Interventiondays (Median)
Tmax After First Dose (Day 1)Tmax After Seventh Dose (Day 169)Tmax After Eighth Dose (Day 197)
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder9.046.974.07

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Mean Change From Baseline in Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness Score

The CGI-BP scale refers to the global impression of the participants with respect to bipolar disorder. The scale rates the participant's severity of illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and change from preceding phase (CGI-BP change from preceding phase: mania, depression, and overall bipolar illness) based on a 7-point scale ranging from 1 (normal, not ill) to 7 (very severely ill). A negative change score signifies improvement. The CGI-BP was assessed for bipolar I disorder participants only. (NCT04030143)
Timeframe: Baseline, Week 32

Interventionscore on a scale (Mean)
Aripiprazole 2M LAI 960 mg: Bipolar I Disorder-0.2
Aripiprazole IM Depot 400 mg: Bipolar I Disorder-0.6

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AUC0-56 After the First Dose of Aripiprazole 2M LAI 960 mg

(NCT04030143)
Timeframe: Days 1 (predose and 4, 8, 12 hours post-dose), 2, 3, 5, 8, 10, 13, 15, 18, 22, 29, 36, 43, 50 and 57 (pre-dose)

Interventionday*ng/mL (Mean)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder9180

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Plasma Concentration of Aripiprazole 56 Days (C56) After the First Dose of Aripiprazole 2M LAI 960 mg

(NCT04030143)
Timeframe: Predose on Day 57

Interventionng/mL (Mean)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder165

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Maximum Observed Plasma Concentration (Cmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg

(NCT04030143)
Timeframe: Days 1(predose [within 2 hours(h) prior to dosing]&4,8,12 h postdose),2,3,5,8,10,13,15,18,22,29,36,43,50,57(predose),85,113(predose),141,169(predose [within 2 h prior to dosing]& 4,8,12 h postdose),170,171,173,176,178,181,183,186,190,197,204,211,218 & 225

Interventionng/mL (Mean)
Cmax After First Dose (Day 1)Cmax After Fourth Dose (Day 169)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder286342

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Cmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg

(NCT04030143)
Timeframe: Predose [within 2 hours prior to dosing; 4,8,12h postdose] on Days 1,169,197; Predose on Days 29,57,85,113,141; and on Days 2, 3, 5, 8, 10, 13, 15, 18, 22, 170, 171, 173, 176, 178, 181, 183, 186, 190,198, 199, 201, 204, 206, 209, 211, 214, 218, 225

Interventionng/mL (Mean)
Cmax After First Dose (Day 1)Cmax After Seventh Dose (Day 169)Cmax After Eighth Dose (Day 197)
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder280339344

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PTF% After the Eighth Dose of Aripiprazole IM Depot 400 mg

PTF% was determined as 100*(Cmax - Cmin [minimum plasma concentration of the drug])/Caverage (average steady-state plasma drug concentration during multiple-dose administration) following eighth dose. (NCT04030143)
Timeframe: Days 197 (Predose [within 2 hours prior to dosing] and 4, 8, 12 hours post dose),198, 199, 201, 204, 206, 209, 211, 214, 218, 225

Interventionpercentage fluctuation (Mean)
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder48.3

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Mean Change From Baseline in Clinical Global Impression - Improvement Scale (CGI-I) Score

The CGI-I scale is a clinician rated scale which assesses the improvement of illness for each participant. To assess CGI-I, the rater or investigator rated the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared with the participant's condition at baseline. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Scores range from 0 to 7. Higher scores indicate worse condition. (NCT04030143)
Timeframe: Baseline, Week 32

Interventionscore on a scale (Mean)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder3.4
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder3.5

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Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities

Potentially clinically significant ECG abnormalities included rate: bradycardia (vent <=50 BPM] and decrease >=15 BPM); rhythm: sinus bradycardia (<= 50 BPM and decrease >= 15 BPM and no current diagnosis of atrial fibrillation, atrial flutter, or other rhythm abnormality); supraventricular premature beat (not present at baseline and present post baseline); ventricular premature beat (not present at baseline and present post baseline); conduction: right bundle branch block (not present at baseline and present post baseline); ST/T morphology: myocardial ischemia and symmetrical T-wave inversion (not present at baseline and present post baseline), QTcB, QTcF, and QTcN (>=450 milliseconds [msec] and >= 10% increase). (NCT04030143)
Timeframe: From first dose of study drug up to Day 225

,
InterventionParticipants (Count of Participants)
BradycardiaSinus BradycardiaSupraventricular Premature BeatVentricular Premature BeatRight Bundle Branch BlockMyocardial IschemiaSymmetrical T-Wave InversionQTcBQTcFQTcN
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder0013171312100
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder2210120712111

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Area Under the Plasma Concentration-Time Curve From Time 0 to 28 Days (AUC0-28) of Aripiprazole After the Seventh and Eighth Doses of Aripiprazole IM Depot 400 mg

(NCT04030143)
Timeframe: Days 169 (predose and 4, 8, 12 hours post dose), 170, 171, 173, 176, 178, 181, 183, 186, 190, 197 (predose and 4, 8, 12 hours post dose), 198, 199, 201, 204, 206, 209, 211, 214, 218, 225

Interventionday*ng/mL (Mean)
AUC0-28 After Seventh Dose (Day 169)AUC0-28 After Eighth Dose (Day 197)
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder77607840

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Plasma Concentration of Aripiprazole Post First Dose (C14) of Aripiprazole IM Depot 400 mg

(NCT04030143)
Timeframe: Day 15

Interventionng/mL (Mean)
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder229

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Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection

Injection-site reactions were assessed by the investigator (or qualified designee) and the participant. Investigators rated localized pain, redness, swelling, and induration at the most recent injection site using a 4-point categorical scale (absent, mild, moderate, severe). The participant indicated the degree of pain at the most recent injection site using a VAS instrument. Ratings included were: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The last injection was the final injection for any given participant. (NCT04030143)
Timeframe: Day 1 (First injection) to Day 197 (Last injection)

InterventionParticipants (Count of Participants)
First Injection: Mild PainSecond Injection: Mild PainThird Injection: Mild PainFourth Injection: Mild PainFifth Injection: Mild PainSeventh Injection: Mild PainEighth Injection: Mild PainLast injection: Mild PainFirst injection: Mild RednessSecond injection: Mild Redness
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder7371311313

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Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole 2M LAI 960 mg Injection

Injection-site reactions were assessed by the investigator (or qualified designee) and the participant. Investigators rated localized pain, redness, swelling, and induration at the most recent injection site using a 4-point categorical scale (absent, mild, moderate, severe). The participant indicated the degree of pain at the most recent injection site using a VAS instrument. Ratings included were: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The last injection was the final injection for any given participant. (NCT04030143)
Timeframe: Day 1 (First injection) to Day 169 (Last injection)

InterventionParticipants (Count of Participants)
First Injection: Mild PainSecond Injection: Mild PainThird Injection: Mild PainFourth Injection: Mild PainLast injection: Mild PainFirst injection: Mild RednessThird injection: Mild RednessLast injection: Mild Redness
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder112555311

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Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Score

The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7), dyskinesias (items 8 through 10). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, aware/severe distress). AIMS movement score is the sum of the ratings for the first seven items with the possible total scores of 0 to 28. Negative change from baseline indicates less symptoms. (NCT04030143)
Timeframe: Baseline, Week 32

,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 32
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder0.10.0
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder0.1-0.1

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Mean Change From Baseline in Simpson-Angus Neurologic Rating Scale (SAS) Total Score

The SAS scale is used to evaluate extrapyramidal symptoms (EPS) and consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item is rated on a 5-point scale, with a score of range of 0 (absence of symptoms) to 4 (severe condition). The SAS total score is the sum of the scores for all 10 items, possible total score is 0 to 40. Negative change from baseline indicates less symptoms. (NCT04030143)
Timeframe: Baseline, Week 32

,
Interventionscore on a scale (Mean)
BaselineChange From Baseline at Week 32
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder0.2-0.0
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder0.20.1

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Mean Change From Baseline in Barnes Akathisia Rating Score (BARS) Global Score

The BARS consists of 4 items related to akathisia: objective observation of akathisia by the investigator, subjective feelings of restlessness by the participant, participant distress due to akathisia, and global evaluation of akathisia. The first 3 items are rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation is made on a 6-point scale, with 0 representing absence of symptoms and a score of 5 representing severe akathisia. Total BARS score ranges from 0 to 14 where lower scores indicate less symptoms and negative change from baseline indicate less symptoms. (NCT04030143)
Timeframe: Baseline, Week 32

,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 32
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder0.10.1
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder0.10.1

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Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities

Potentially clinically relevant laboratory abnormalities included: In units per liter [U/L] (alanine aminotransferase: male[M]/female[F] >=3 x upper limit of normal (ULN); aspartate aminotransferase: M/F >= 3 x ULN; creatine kinase: M/F >= 3 x ULN); in milligrams per deciliter (mg/dL) (creatinine: M/F >= 2.0; glucose: M/F >= 200; urate: M >=10.5, F >=8.5); potassium [milliequivalents per liter (mEq/L)]: M/F >=5.5, in percentage (%) (eosinophils/leukocytes: M/F>=10%, hematocrit: M<=37%/F<=32% and 3 point decrease from baseline); hemoglobin (grams per deciliter [g/dL]): M<=11.5/F<=9.5; leukocytes [10^9 per liter (/L)]: M/F<=2.8 x 10^3 per microliters (/uL); platelets (10^9/L): M/F>=700 x 10^3/uL; glucose, urine and protein, urine: increase of >=2 units; and prolactin (nanograms per milliliter [ng/mL]: M/F > 1 x ULN. (NCT04030143)
Timeframe: From first dose of study drug up to Day 225

,
InterventionParticipants (Count of Participants)
High Alanine Aminotransferase (U/L)High Aspartate Aminotransferase (U/L)High Creatine Kinase (U/L)High Creatinine (mg/dL)High Glucose (mg/dL)High Potassium (mEq/L)High Urate (mg/dL)High Eosinophils/Leukocytes (%)Low Hematocrit (%)Low Hemoglobin (g/dL)Low Leukocytes (10^9/L)High Platelets (10^9/L)High Glucose, UrineHigh Protein, UrineHigh Prolactin (ng/mL)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder1012275227400512
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder221134008931624

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Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

The MADRS is a diagnostic questionnaire used by clinician to assess the participant's severity of depression. This scale consists of 10 items each with 7 defined grades of severity on 0 to 6 scale (reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). MADRS total score is sum of 10 individual item scores ranging from 0-60 categorized as: 0 to 6: normal/symptoms absent, 7 to 19: mild depression, 20 to 34: moderate depression, and 35 to 60: severe depression. Higher score indicates more depressive symptoms. The MADRS was assessed for bipolar I disorder participants only. (NCT04030143)
Timeframe: Baseline, Week 32

Interventionscore on a scale (Mean)
Aripiprazole 2M LAI 960 mg: Bipolar I Disorder-3.5
Aripiprazole IM Depot 400 mg: Bipolar I Disorder-3.3

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Mean Change From Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Total Score

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). Higher scores indicate worse condition. The PANSS was assessed for schizophrenia participants only. (NCT04030143)
Timeframe: Baseline, Week 32

Interventionscore on a scale (Mean)
Aripiprazole 2M LAI 960 mg: Schizophrenia-2.6
Aripiprazole IM Depot 400 mg: Schizophrenia-1.7

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Mean Change From Baseline in Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) Total Score

The participant's feeling of their own well-being was assessed using the 20-question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of well-being while receiving antipsychotic medication. The questionnaire consisted of 20 items (10 positive and 10 negative statements) and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', the response choices and scoring is not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, and very much = 6. For items marked with a '- ', the scoring is reversed; response choices and scoring are as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 1 (none) to 6 (severe), and total score ranged from 20 to 120, with higher scores indicating stronger subjective feeling (NCT04030143)
Timeframe: Baseline, Week 32

Interventionscore on a scale (Mean)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder3.2
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder0.5

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Mean Change From Baseline in Young Mania Rating Scale (YMRS) Total Score

The YMRS is an 11-item, multiple-choice diagnostic questionnaire which psychiatrists use to assess the core symptoms of mania and is based on the participants subjective report of their condition. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score is summed of 11 items. Total score range is from 0 to 60 and the higher score represent a worse outcome. The YMRS was assessed for bipolar I disorder participants only. (NCT04030143)
Timeframe: Baseline, Week 32

Interventionscore on a scale (Mean)
Aripiprazole 2M LAI 960 mg: Bipolar I Disorder-1.9
Aripiprazole IM Depot 400 mg: Bipolar I Disorder-4.7

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Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE that started after investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of the IMP. (NCT04030143)
Timeframe: From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months)

InterventionParticipants (Count of Participants)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder94
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder95

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Mean Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score

"The CGI-S is a standardized, clinician-administered global rating scale that measures disease severity. To assess CGI-S, the rater or investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. The cumulative score range is 0-7. A higher score on the CGI-S represents a higher severity of disease. The CGI-S scale was assessed for schizophrenia participants only." (NCT04030143)
Timeframe: Baseline, Week 32

Interventionscore on a scale (Mean)
Aripiprazole 2M LAI 960 mg: Schizophrenia-0.3
Aripiprazole IM Depot 400 mg: Schizophrenia-0.1

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Change in Role Ratings on the Global Functioning Scale From Baseline to 12 Months

The groups will be compared on change in this measure of role functioning. Scores range from 1 to 10, with higher indicating better role functioning. Change scores can theoretically range from 0 to 9 (NCT04203056)
Timeframe: mean change from baseline to the 12 month point

Interventionscore on a scale (Mean)
AL-LAI: Long-Acting Injectable Antipsychotic4.3
ARI-ORAL: Aripiprazole Oral Antipsychotic.06

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Exacerbation or Relapse of Psychotic Symptoms

Number of participants who experienced an exacerbation and/or relapse following a period of absence or relative low levels of psychotic symptoms based on the expanded 24-item version of the Brief Psychiatric Rating Scale (NCT04203056)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
AL-LAI: Long-Acting Injectable Antipsychotic2
ARI-ORAL: Aripiprazole Oral Antipsychotic2

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"Change From Baseline to One-Year in the MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T-Score."

"The change from Baseline to One-year on the MATRICS Consensus Cognitive Battery Overall Composite score. MATRICS is the abbreviation for Measurement and Treatment Research to Improve Cognition in Schizophrenia. T scores do not have an absolute minimum or maximum. Higher scores represent better cognition. The sex and age adjusted T-score was used. The T-Score has a population mean of 50 and standard deviation of 10.~Fewer subjects analyzed than enrolled because only 9 subjects reached the 12 month point by study discontinuation and had MCCB data." (NCT04203056)
Timeframe: 12 months

InterventionChange score: change in T scores (Mean)
AL-LAI: Long-Acting Injectable Antipsychotic9.3
ARI-ORAL: Aripiprazole Oral Antipsychotic4.6

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