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ziprasidone

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Description

Ziprasidone is an atypical antipsychotic medication used to treat schizophrenia and bipolar disorder. It is a dopamine and serotonin antagonist, meaning it blocks the action of these neurotransmitters in the brain. Ziprasidone is thought to work by reducing the activity of dopamine and serotonin in the mesolimbic pathway, which is thought to be involved in the symptoms of schizophrenia. It is also thought to work by increasing the activity of serotonin in the prefrontal cortex, which is thought to be involved in cognitive function. Ziprasidone was first synthesized in the 1980s and was approved for use in the United States in 2001. It is typically taken orally, either as a tablet or as a suspension. Common side effects of ziprasidone include drowsiness, dizziness, weight gain, and constipation. More serious side effects can include movement disorders, such as tardive dyskinesia, and a potentially life-threatening condition called neuroleptic malignant syndrome. Ziprasidone is studied extensively because it is a relatively new antipsychotic that has been shown to be effective in treating both positive and negative symptoms of schizophrenia. It is also being studied for its potential to treat other mental health conditions, such as bipolar disorder, major depressive disorder, and anxiety disorders.'

ziprasidone: a benzisothiazoylpiperazine derivative; has combined dopamine and serotonin receptor antagonist activity; structurally related to tiospirone [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

ziprasidone : A piperazine compound having 1,2-benzothiazol-3-yl- and 2-(6-chloro-1,3-dihydro-2-oxindol-5-yl)ethyl substituents attached to the nitrogen atoms. [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 CID60854
CHEMBL ID708
CHEBI ID10119
SCHEMBL ID28028
MeSH IDM0243639

Synonyms (86)

Synonym
BIDD:GT0042
5-[2-(4-benzo[d]isothiazol-3-yl-piperazin-1-yl)-ethyl]-6-chloro-1,3-dihydro-indol-2-one
5-[2-(4-benzo[d]isothiazol-3-yl-piperazin-1-yl)-ethyl]-6-chloro-1,3-dihydro-indol-2-one (ziprasidone)
5-[2-(4-benzo[d]isothiazol-3-yl-piperazin-1-yl)-ethyl]-6-chloro-1,3-dihydro-indol-2-one(norastemizole)
bdbm50048803
5-(2-(4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)ethyl)-6-chloroindolin-2-one
gtpl59
5-{2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-yl]ethyl}-6-chloro-1,3-dihydro-2h-indol-2-one
ziprasidone [inn:ban]
ziprazidone
2h-indol-2-one, 5-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)ethyl)-6-chloro-1,3-dihydro-
ziprasidonum
ziprasidona
CHEBI:10119 ,
5-{2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl}-6-chloro-1,3-dihydro-2h-indol-2-one
C07568 ,
146939-27-7
ziprasidone
MLS000759435
smr000466328
DB00246
5-(2-(4-(3-benzisothiazolyl)piperazinyl)ethyl)-6-chloro-1,3-dihydro-2h-indol-2-one
zipradon
CHEMBL708 ,
5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one
L000659
D08687
zipradon (tn)
ziprasidone (inn)
FT-0654208
FT-0655916
5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2h-indol-2-one hydrochloride monohydrate
A808568
cp88059;5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-indolin-2-one
A807468
6uka5vej6x ,
unii-6uka5vej6x
hsdb 7745
tox21_112194
tox21_113525
cas-146939-27-7
dtxsid4023753 ,
dtxcid403753
VU0286234-2
HY-14542
CS-1071
NCGC00263539-03
ziprasidone [mart.]
ziprasidone [inn]
ziprasidone [vandf]
ziprasidone [who-dd]
ziprasidone [hsdb]
ziprasidone [mi]
AKOS015900383
AB00639925-04
AB00639925-02
2h-indol-2-one, 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-
AM90310
SCHEMBL28028
NCGC00263539-01
tox21_112194_1
5-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)-ethyl)-6-chloro-1,3-dihydro-2h-indol-2-one
5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2h-indol-2-one
MVWVFYHBGMAFLY-UHFFFAOYSA-N
5-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)ethyl)-6-chloro-1,3-dihydro-2h-indole-2-one
AC-23360
Z0034
AB00639925_05
AB00639925_06
5-{2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl}-6-chloro-2,3-dihydro-1h-indol-2-one
5-(2-(4-(1,2-benzisothiazol-3-yl)piperazinyl)ethyl)-6-chlorooxindole
NCGC00263539-05
Q205517
SDCCGSBI-0633778.P001
NCGC00263539-13
HMS3742M19
D92803
ziprasidone- bio-x
BZ164575
BVB74558
EN300-7415908
n05ae04
ziprasidone (mart.)
6-chloro-5-
5-(2-(4-(1,2-benzothiazol-3-yl)piperazin-1-yl)ethyl)-6-chloro-1,3-dihydro-2h-indol-2-one
ziprasidone, 1mg/ml in 1,2-dimethoxyethane

Research Excerpts

Overview

Ziprasidone hydrochloride is a second-generation antipsychotic drug employed for the treatment of schizophrenia and acute mania or mixed episodes associated with bipolar disorder. It is an atypical antipsychotics recommended to be administered twice daily. Ziprasid one appears to be a good switching option for patients with bipolar I disorder.

ExcerptReferenceRelevance
"Ziprasidone hydrochloride is a second-generation antipsychotic drug employed for the treatment of schizophrenia and acute mania or mixed episodes associated with bipolar disorder. "( Identification of Novel Impurity of Ziprasidone.
Bhat, K; Godbole, HM; Murkute, SR; Singh, GP; Trivedi, A; Upadhyay, PR; Vasantharaju, SG, 2022
)
2.44
"Ziprasidone (ZP) is a novel atypical antipsychotic agent effective in the treatment of positive and negative symptoms of schizophrenia with low chances for extrapyramidal side effects (EPs) and cognitive deficits. "( Parenteral Sustained Release Lipid Phase-Transition System of Ziprasidone: Fabrication and Evaluation for Schizophrenia Therapy.
Ahmad, FJ; Ahmed, MZ; Hasan, N; Jain, GK; Khan, UA; Parveen, U; Saad, S, 2020
)
2.24
"Ziprasidone (ZIP) is an effective antipsychotic with low side effects than other second-generation antipsychotics. "( The Influence of a Xanthine-Catechin Chemical Matrix on in vitro Macrophage-Activation Triggered by Antipsychotic Ziprasidone.
Azzolin, VF; Barbisan, F; da Cruz Jung, IE; da Cruz, IBM; da Cunha, BSN; do Prado-Lima, PA; Duarte, MMMF; Duarte, T; Ribeiro, EE; Turra, BO, 2019
)
2.17
"Ziprasidone is an atypical antipsychotic recommended to be administered twice daily."( Dopamine D₂/₃ occupancy of ziprasidone across a day: a within-subject PET study.
Borlido, C; Caravaggio, F; Deluca, V; Graff-Guerrero, A; Ismail, Z; Mamo, D; Mulsant, B; Pollock, B; Remington, G; Suzuki, T; Uchida, H, 2013
)
2.13
"Ziprasidone is a second-generation antipsychotic with a lower propensity to cause extrapyramidal adverse effects that are seen at higher doses. "( Acute dystonia, akathisia, and parkinsonism induced by ziprasidone.
Jana, AK; Praharaj, SK; Sarkhel, S; Sinha, VK,
)
1.82
"Ziprasidone appears to be a good switching option for patients with bipolar I disorder experiencing suboptimal response or intolerance with olanzapine in combination with lithium or valproate. "( The efficacy and safety of switching to ziprasidone from olanzapine in patients with bipolar I disorder: an 8-week, multicenter, open-label study.
Bahk, WM; Kim, MD; Kwon, YJ; Lee, HB; Lee, JG; Woo, YS; Yoon, BH, 2013
)
2.1
"Ziprasidone is a second-generation antipsychotic (SGA) approved for agitation. "( Intramuscular ziprasidone: influence of alcohol and benzodiazepines on vital signs in the emergency setting.
Feifel, D; MacDonald, K; Ronquillo, L; Vilke, GM; Wilson, MP, 2013
)
2.19
"Ziprasidone is an atypical antipsychotic that can also cause dangerous interactions to cause SS because it is not only a potent 5-HT1A agonist but also has been reported to inhibit serotonin reuptake with an affinity similar to tricyclic antidepressants, in addition to inhibiting reuptake of norepinephrine."( Serotonin syndrome after the use of tramadol and ziprasidone in a patient with a deep brain stimulator for Parkinson disease.
Assaly, R; El-Okdi, NS; Ghose, A; Karanovic, D; Lumbrezer, D,
)
1.11
"Ziprasidone is a benzisothiazolyl piperazine derivative that was developed from the chemically related antipsychotic drug tiospirone, and it improves neurological functions of the ischemic brain and is effective in treatment of schizophrenia. "( Administration of mesenchymal stem cells and ziprasidone enhanced amelioration of ischemic brain damage in rats.
Baek, SE; Do, BR; Kaengkan, P; Kam, KY; Kang, SG; Kim, JY; Lee, ES, 2013
)
2.09
"Ziprasidone is a poorly water-soluble antipsychotic drug that demonstrates low fasted state oral bioavailability and a clinically significant two-fold increase in absorption when dosed postprandially. "( Silica encapsulated lipid-based drug delivery systems for reducing the fed/fasted variations of ziprasidone in vitro.
Dening, TJ; Prestidge, CA; Rao, S; Thomas, N, 2016
)
2.1
"Ziprasidone is a SGA that is efficacious in the treatment of schizophrenia."( Differential effects of ziprasidone and haloperidol on immobilization stress-induced mRNA BDNF expression in the hippocampus and neocortex of rats.
Choi, SM; Kim, NR; Kim, YH; Lee, CH; Lee, JG; Lee, SJ; Park, SW, 2009
)
1.38
"Ziprasidone is an atypical antipsychotic drug that was approved by the Food and Drug Administration in February 2001 for the general treatment of schizophrenia in adults."( Pediatric ziprasidone overdose.
Fasano, CJ; Lares, C; O'Malley, GF; Rowden, AK, 2009
)
1.48
"Ziprasidone is a newer "atypical" or "second-generation" antipsychotic. "( Using oral ziprasidone effectively: the food effect and dose-response.
Citrome, L, 2009
)
2.19
"Ziprasidone is an effective, safe, and well-tolerated adjunctive treatment with a mood stabilizer for long-term maintenance treatment of bipolar mania."( Ziprasidone plus a mood stabilizer in subjects with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind trial.
Bowden, CL; Ice, KS; Schwartz, JH; Versavel, M; Vieta, E; Wang, PP, 2010
)
3.25
"Ziprasidone is an atypical antipsychotic approved for the treatment of schizophrenia and bipolar mania in adults and is used off label in children and adolescents. "( Respiratory failure following isolated ziprasidone ingestion in a toddler.
Gresham, C; Ruha, AM, 2010
)
2.07
"Ziprasidone is an 'atypical' or 'second-generation' antipsychotic that has garnered clinical interest because of its metabolically friendly tolerability profile."( Ziprasidone HCl capsules for the adjunctive maintenance treatment of bipolar disorder in adults.
Citrome, L, 2010
)
2.52
"Ziprasidone is a psychotropic agent used for the treatment of schizophrenia. "( Electroanalytical characteristics of antipsychotic drug ziprasidone and its determination in pharmaceuticals and serum samples on solid electrodes.
Gumustas, M; Kul, D; Ozkan, SA; Uslu, B, 2010
)
2.05
"Ziprasidone is a second-generation antipsychotic approved for the treatment of schizophrenia and bipolar disorder. "( Drug safety evaluation of ziprasidone.
Citrome, L, 2011
)
2.11
"Ziprasidone is an atypical antipsychotic with affinity to the D2, 5HT2A, 5HT2C, 5HT1A, 5HT1B/1D receptors. "( [Practical aspects of the use of ziprasidone in schizophrenia].
Jarema, M; Ochedzan, D,
)
1.86
"Ziprasidone (ZPN) is an atypical antipsychotic drug used mainly for the treatment of schizophrenia."( Cytogenetic effects of valproic acid and ziprasidone in human lymphocyte cultures.
Akritopoulou, K; Anestakis, D; Ekonomopoulou, MT; Iakovidou-Kritsi, Z; Karapidaki, I, 2011
)
1.36
"Ziprasidone is an atypical antipsychotic drug used for the treatment of schizophrenia. "( Ziprasidone attenuates brain injury after focal cerebral ischemia induced by middle cerebral artery occlusion in rats.
Choi, YW; Jalin, AM; Kaengkan, P; Kam, KY; Kang, SG; Kim, YH; Park, SW, 2012
)
3.26
"Ziprasidone is a novel antipsychotic agent with a pharmacological profile distinct from that of other currently available novel or classical antipsychotics. "( Spotlight on ziprasidone in schizophrenia and schizoaffective disorder.
Gunasekara, NS; Keating, GM; Spencer, CM, 2002
)
2.13
"Ziprasidone is a promising new antipsychotic that has shown significant efficacy in the oral treatment of patients with schizophrenia or schizoaffective disorder. "( Spotlight on ziprasidone in schizophrenia and schizoaffective disorder.
Gunasekara, NS; Keating, GM; Spencer, CM, 2002
)
2.13
"Ziprasidone is a new antipsychotic with combined dopamine and serotonin receptor antagonist activity. "( Brief report on Ziprasidone.
Chowdhury, WA; Firoz, AH; Mamun, AA; Rahman, AH, 2002
)
2.1
"Ziprasidone is an atypical antipsychotic recently approved by the Food and Drug Administration for the treatment of psychosis."( Ziprasidone-associated mania: a case series and review of the mechanism.
Baldassano, CF; Ballas, C; Datto, SM; Kim, D; Littman, L; O'Reardon, J; Rynn, MA, 2003
)
2.48
"Ziprasidone is a new atypical antipsychotic recently marketed in a number of countries. "( Ziprasidone in the management of schizophrenia : the QT interval issue in context.
Taylor, D, 2003
)
3.2
"Ziprasidone is an atypical antipsychotic with a high ratio of 5-HT(2A) to D(2) receptor antagonism. "( Pharmacodynamics of ziprasidone in children and adolescents: impact on dopamine transmission.
Gilbert, DL; Miceli, JJ; Robarge, L; Sallee, FR; Vinks, AA; Wilner, K, 2003
)
2.09
"Ziprasidone is an atypical antipsychotic drug that shows a higher affinity for serotonin 5-HT(2) receptors compared with dopamine D(2) receptors in vitro. "( A PET study of dopamine D2 and serotonin 5-HT2 receptor occupancy in patients with schizophrenia treated with therapeutic doses of ziprasidone.
Kapur, S; Mamo, D; Mann, S; Papatheodorou, G; Remington, G; Shammi, CM; Therrien, F, 2004
)
1.97
"Ziprasidone is an atypical antipsychotic that is approved for the treatment of adults with schizophrenia. "( Ziprasidone treatment of two adolescents with psychosis.
McDougle, CJ; Meighen, KG; Shelton, HM, 2004
)
3.21
"Ziprasidone is an atypical antipsychotic drug that is believed to have a low propensity for inducing extrapyramidal symptoms, including tardive dyskinesia (TD). "( Tardive dyskinesia in 2 patients treated with ziprasidone.
Ananth, J; Burgoyne, KS; Niz, D; Smith, M, 2004
)
2.02
"Ziprasidone (Geodon) is a relatively new atypical antipsychotic medication with a unique pharmacological profile. "( Ziprasidone: a novel psychotropic with unique properties.
Baldassano, C; Ballas, C; Ballas, P; O'Reardon, J; Yang, C, 2004
)
3.21
"Ziprasidone is an atypical antipsychotic with a highly specific receptorbinding profile that has been shown to be effective for both positive and negative symptoms of schizophrenia. "( Ziprasidone overdose: cases recorded in the database of Pfizer-Spain and literature review.
Ayani, I; Bernardo, M; Florez, Td; Gandía, R; Gómez-Criado, MS; Gutiérrez, JR, 2005
)
3.21
"Ziprasidone is a neuroleptic drug recently sold in Spain. "( Ziprasidone overdose: cardiac safety.
Gutiérrez Casares, JR; Insa Gómez, FJ,
)
3.02
"Ziprasidone is a second-generation antipsychotic that received Food and Drug Administration approval in February 2001. "( From clinical research to clinical practice: a 4-year review of ziprasidone.
Daniel, DG; Harvey, PD; Kilts, CD; Lieberman, JA; Nemeroff, CB; Newcomer, JW; Schatzberg, AF; Weiden, PJ, 2005
)
2.01
"Ziprasidone is a new atypical antipsychotic with reported low potential for extrapyramidal side effects."( Acute dystonia after initial doses of ziprasidone: a case report.
Savas, E; Savas, HA; Selek, S; Yumru, M, 2006
)
1.33
"Ziprasidone is an effective treatment for hostility in patients with schizophrenia or schizoaffective disorder."( Efficacy of ziprasidone against hostility in schizophrenia: Post hoc analysis of randomized, open-label study data.
Brook, S; Citrome, L; Czobor, P; Loebel, A; Mandel, FS; Volavka, J, 2006
)
2.16
"Ziprasidone is a second-generation antipsychotic currently marketed for the treatment of schizophrenia and bipolar mania. "( Ziprasidone in bipolar disorder.
Versiani, M, 2006
)
3.22
"Ziprasidone is a valid and effective choice amongst antipsychotic medications, but this case calls for caution regarding ACRs at the time of prescribing."( Urticaria and angio-oedema due to ziprasidone.
Akkaya, C; Aydogan, K; Kirli, S; Sarandol, A, 2007
)
1.34
"Ziprasidone is a newer "atypical" or "second-generation" antipsychotic. "( Ziprasidone for schizophrenia and bipolar disorder: a review of the clinical trials.
Citrome, L; Greenberg, WM, 2007
)
3.23
"Ziprasidone is an atypical antipsychotic associated with QTc prolongation during therapeutic use. "( Prospective observational multi-poison center study of ziprasidone exposures.
Benson, BE; Crouch, BI; Klein-Schwartz, W; Lofton, AL; Spiller, HA,
)
1.82
"Ziprasidone (CP-88,059) is a combined 5-HT (serotonin) and dopamine receptor antagonist which exhibits potent effects in preclinical assays predictive of antipsychotic activity. "( Ziprasidone (CP-88,059): a new antipsychotic with combined dopamine and serotonin receptor antagonist activity.
Guanowsky, V; Howard, HR; Lebel, LA; Lowe, JA; McLean, S; Schmidt, AW; Schulz, DW; Seeger, TF; Seymour, PA; Zorn, SH, 1995
)
3.18
"Ziprasidone is a novel antipsychotic agent, with high affinity for dopamine D2 and serotonin (5-HT2) receptors in vitro and in animal models. "( Positron emission tomographic analysis of central 5-hydroxytryptamine2 receptor occupancy in healthy volunteers treated with the novel antipsychotic agent, ziprasidone.
Alpert, NM; Babich, JW; Bonab, AA; Elmaleh, DR; Fischman, AJ; Rauch, SL; Rubin, RH; Shoup, TM; Williams, SA, 1996
)
1.93
"Ziprasidone is an antipsychotic agent indicated primarily for the treatment of schizophrenia. "( Inclusion complexation of ziprasidone mesylate with beta-cyclodextrin sulfobutyl ether.
Blake, JF; Chrunyk, B; Duffy, EM; Kim, Y; Massefski, W; Oksanen, DA, 1998
)
2.04
"Ziprasidone is a novel antipsychotic agent which binds with high affinity to 5-HT1A receptors (Ki = 3.4 nM), in addition to 5-HT1D, 5-HT2, and D2 sites. "( Comparison of the novel antipsychotic ziprasidone with clozapine and olanzapine: inhibition of dorsal raphe cell firing and the role of 5-HT1A receptor activation.
Braselton, JP; Reynolds, LS; Rollema, H; Sprouse, JS; Zorn, SH, 1999
)
2.02
"Ziprasidone (Zeldox) is a novel antipsychotic with a unique combination of antagonist activities at monoaminergic receptors and transporters and potent agonist activity at serotonin 5-HT(1A) receptors. "( 5-HT(1A) receptor activation contributes to ziprasidone-induced dopamine release in the rat prefrontal cortex.
Lu, Y; Rollema, H; Schmidt, AW; Sprouse, JS; Zorn, SH, 2000
)
2.01
"Ziprasidone is a novel antipsychotic agent with a unique combination of pharmacological activities at human receptors. "( Ziprasidone: a novel antipsychotic agent with a unique human receptor binding profile.
Howard, HR; Lebel, LA; Schmidt, AW; Zorn, SH, 2001
)
3.2
"Ziprasidone is a new antipsychotic with combined dopamine and serotonin receptor antagonist activity. "( Focus on ziprasidone.
Green, B, 2001
)
2.17
"Ziprasidone is a benzisothiazolyl piperazine-type atypical antipsychotic that shares the serotonin(2A)/dopamine(2) (5-HT(2A)/D(2)) profile of the available atypical antipsychotics. "( Ziprasidone: the fifth atypical antipsychotic.
Caley, CF; Cooper, CK, 2002
)
3.2
"Ziprasidone is a safe and efficacious atypical antipsychotic for the acute management of schizophrenia. "( Ziprasidone: the fifth atypical antipsychotic.
Caley, CF; Cooper, CK, 2002
)
3.2
"Ziprasidone is a novel antipsychotic agent with a pharmacological profile distinct from that of other currently available novel or classical antipsychotics. "( Ziprasidone: a review of its use in schizophrenia and schizoaffective disorder.
Gunasekara, NS; Keating, GM; Spencer, CM, 2002
)
3.2
"Ziprasidone is a promising new antipsychotic that has shown significant efficacy in the oral treatment of patients with schizophrenia or schizoaffective disorder. "( Ziprasidone: a review of its use in schizophrenia and schizoaffective disorder.
Gunasekara, NS; Keating, GM; Spencer, CM, 2002
)
3.2
"Ziprasidone is a novel antipsychotic with a unique pharmacologic profile. "( A 28-week comparison of ziprasidone and haloperidol in outpatients with stable schizophrenia.
Bäuml, J; Hirsch, SR; Kissling, W; O'Connor, R; Power, A, 2002
)
2.06

Effects

Ziprasidone has been used to treat schizophrenia since 2000. It has relatively fewer side effects and yet has at least equivalent efficacy for florid 'positive' symptoms compared with conventional antipsychotics. Ziprasid one has been associated with prolonged QTc Intervals.

ExcerptReferenceRelevance
"Ziprasidone has a generally favourable adverse effect profile."( Ziprasidone for the treatment of acute manic or mixed episodes associated with bipolar disorder.
Ice, K; Loebel, A; Lombardo, I; Warrington, L, 2007
)
2.5
"Ziprasidone has less glucose and lipid metabolic effect for first-episode schizophrenia patients in short-term treatment. "( [Effects of ziprasidone and olanzapine on glucose and lipid metabolism in first-episode schizophrenia].
Chen, H; Fang, M; Ou, J; Shao, P; Wu, R; Xu, Y; Zhao, J, 2013
)
2.21
"Ziprasidone has been reported efficacious in this population but the evidence is limited."( Agitation and/or aggression after traumatic brain injury in the pediatric population treated with ziprasidone. Clinical article.
Conrad, SA; Green, R; McCarthy, PJ; Scott, LK, 2009
)
1.29
"Ziprasidone has similar efficacy and safety in black patients with schizophrenia compared with patients in the white and overall populations."( Ziprasidone in Black patients with schizophrenia: analysis of four short-term, double-blind studies.
Herman, BK; Lawson, WB; Lazariciu, I; Loebel, A; Malik, M, 2009
)
3.24
"Ziprasidone has been rarely associated with QT prolongation especially in patients (1) with no underlying cardiac or metabolic disorders, (2) who are receiving no concomitant medications known to prolong the QT interval, and (3) whom therapy is being initiated at a low dose. "( Single-dose ziprasidone associated with QT interval prolongation.
Mycyk, MB; Witsil, JC; Zell-Kanter, M, 2012
)
2.2
"Ziprasidone has been associated with prolonged QTc Intervals."( Continuum of care: stabilizing the acutely agitated patient.
Bellnier, TJ, 2002
)
1.04
"Ziprasidone has relatively fewer side effects and yet has at least equivalent efficacy for florid 'positive' symptoms compared to conventional anti psychotics."( Brief report on Ziprasidone.
Chowdhury, WA; Firoz, AH; Mamun, AA; Rahman, AH, 2002
)
1.38
"As ziprasidone has substantial serotonergic and noradrenergic action, we hypothesize, it may more likely induce mania than other atypical antipsychotics."( Ziprasidone-associated mania: a case series and review of the mechanism.
Baldassano, CF; Ballas, C; Datto, SM; Kim, D; Littman, L; O'Reardon, J; Rynn, MA, 2003
)
2.28
"Ziprasidone has moderate affinity for serotonin and norepinephrine reuptake sites, predicting antidepressant/anxiolytic activity."( The psychopharmacology of ziprasidone: receptor-binding properties and real-world psychiatric practice.
Shayegan, DK; Stahl, SM, 2003
)
1.34
"Ziprasidone has shown long-term antipsychotic efficacy in comparisons with haloperidol, olanzapine, and risperidone, as well as efficacy in patients switched from another antipsychotic agent."( Maintaining symptom control: review of ziprasidone long-term efficacy data.
Schooler, NR, 2003
)
1.31
"Ziprasidone has been shown to be effective in the treatment of bipolar disorder in patients experiencing manic or mixed episodes."( Ziprasidone for the treatment of acute manic or mixed episodes associated with bipolar disorder.
Ice, K; Loebel, A; Lombardo, I; Warrington, L, 2007
)
2.5
"Ziprasidone has been used to treat schizophrenia since 2000. "( The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC): design and baseline subject characteristics.
D'Agostino, RB; Eng, SM; Faich, GA; Kane, JM; Reynolds, RF; Ruskin, JN; Strom, BL, 2008
)
2.35
"Ziprasidone has been weight neutral in adult populations, but data from adolescents and patients with autism are sparse."( Ziprasidone in adolescents with autism: an open-label pilot study.
Cater, JR; Delaney, MA; Hyman, SB; Malone, RP, 2007
)
2.5
"Ziprasidone also has high affinity for the 5-HT1A, 5-HT1D and 5-HT2C receptor subtypes, which may further enhance its therapeutic potential."( Ziprasidone (CP-88,059): a new antipsychotic with combined dopamine and serotonin receptor antagonist activity.
Guanowsky, V; Howard, HR; Lebel, LA; Lowe, JA; McLean, S; Schmidt, AW; Schulz, DW; Seeger, TF; Seymour, PA; Zorn, SH, 1995
)
2.46
"Ziprasidone has high affinity for human 5-HT receptors and for human dopamine D(2) receptors."( Ziprasidone: a novel antipsychotic agent with a unique human receptor binding profile.
Howard, HR; Lebel, LA; Schmidt, AW; Zorn, SH, 2001
)
2.47
"Ziprasidone has relatively fewer side-effects and yet has at least equivalent efficacy for florid 'positive' symptoms compared with conventional antipsychotics."( Focus on ziprasidone.
Green, B, 2001
)
1.45
"Ziprasidone has been reported to be an effective antipsychotic drug for both positive and negative symptoms of schizophrenia, and long-term use has been effective in preventing relapse. "( Ziprasidone: an atypical antipsychotic drug for the treatment of schizophrenia.
Gutierrez, MA; Lee, V; Stimmel, GL, 2002
)
3.2
"Ziprasidone has demonstrated in vitro activity as a 5-HT(1A) receptor agonist and as a very weak inhibitor of serotonin and norepinephrine reuptake."( Ziprasidone: the fifth atypical antipsychotic.
Caley, CF; Cooper, CK, 2002
)
2.48

Actions

Ziprasidone induces lower D2 RO and EPS than haloperidol, which is consistent with an atypical antipsychotic profile. The drug did not increase body weight and was associated with a favorable metabolic profile.

ExcerptReferenceRelevance
"Ziprasidone induces lower D2 RO and EPS than haloperidol, which is consistent with an atypical antipsychotic profile. "( Striatal dopaminergic D2 receptor occupancy and clinical efficacy in psychosis exacerbation: a 123I-IBZM study with ziprasidone and haloperidol.
Aguilar, Y; Alvarez, E; Carrió, I; Catafau, AM; Corripio, I; Mena, E; Perez, V; Puigdemont, D, 2005
)
1.98
"Ziprasidone did not increase body weight and was associated with a favorable metabolic profile during the continuation study period."( Ziprasidone in treatment-resistant schizophrenia: a 52-week, open-label continuation study.
Giller, E; Khanna, S; Loebel, AD; Potkin, SG; Rajadhyaksha, S; Siu, CO, 2007
)
2.5

Treatment

Ziprasidone-treated patients had a significantly greater increase in global akathisia scores (P = .01) and significant weight increase (mean [SD] = 3.5 [11.8] kg, or 7.7 [26.1] lb) compared to placebo. Treatment with ziprasid one avoids relapse episodes at a reasonable cost, generating savings for the NHCS.

ExcerptReferenceRelevance
"In ziprasidone-treated rats only decreased CAT activity was found."( Effects of several atypical antipsychotics closapine, sertindole or ziprasidone on hepatic antioxidant enzymes: Possible role in drug-induced liver dysfunction.
Blagojević, D; Brkljačić, J; Miler, M; Miljević, Č; Milošević, V; Nikolić, M; Nikolić-Kokić, A; Oreščanin-Dušić, Z; Platanić Arizanović, L; Spasić, S; Tatalović, N; Vidonja Uzelac, T, 2021
)
1.37
"Ziprasidone treatment was also associated with statistically significant improvements in the GAF, WHO-DAS-II, and SF-12."( Switching to ziprasidone in the clinical practice setting: an open-label study.
Bobes García, J; de la Gándara Martín, JJ; Gutiérrez Fraile, M, 2013
)
1.48
"Ziprasidone treatment reduced both the rate of MetS and its individual risk factors in subjects with schizophrenia and related psychotic disorders. "( The effect of ziprasidone on metabolic syndrome risk factors in subjects with schizophrenia: a 1 year, open-label, prospective study.
Chue, P; Mandel, FS; Therrien, F, 2014
)
2.21
"Ziprasidone-treated patients had a significantly greater increase in global akathisia scores (P = .01) and significant weight increase (mean [SD] = 3.5 [11.8] kg, or 7.7 [26.1] lb) compared to placebo (1.0 [6.4] kg, or 2.2 [14.1] lb) (P = .03)."( Ziprasidone Augmentation of Escitalopram for Major Depressive Disorder: Cardiac, Endocrine, Metabolic, and Motoric Effects in a Randomized, Double-Blind, Placebo-Controlled Study.
Baer, L; Bobo, WV; Curren, L; Fava, M; Mischoulon, D; Papakostas, GI; Shelton, RC, 2017
)
2.62
"Ziprasidone-treated patients lost an average of 2.1 kg in the 12 weeks of the study, the mean weight for risperidone and quetiapine remained unchanged, and patients receiving olanzapine gained 3.1 kg on average."( Ziprasidone versus olanzapine, risperidone or quetiapine in patients with chronic schizophrenia: a 12-week open-label, multicentre clinical trial.
Haug, HJ; Kolb, SA; Koponen, H; Lublin, H; Sigmundsson, T, 2009
)
2.52
"Ziprasidone-treated patients who completed the study showed greater improvement in depressive symptoms assessed by Montgomery and Asberg Depression Rating Scale than risperidone-treated patients (P < 0.05)."( A comparison of ziprasidone and risperidone in the long-term treatment of schizophrenia: a 44-week, double-blind, continuation study.
Addington, DE; Johnson, G; Kulkarni, J; Labelle, A; Loebel, A; Mandel, FS, 2009
)
1.42
"Ziprasidone-treated patients also demonstrated significant improvements on the Mania Rating Scale and all secondary efficacy measures, and had significantly higher response and remission rates compared with placebo."( Efficacy of ziprasidone in dysphoric mania: pooled analysis of two double-blind studies.
Loebel, A; Lombardo, I; Mandel, FS; Stahl, S, 2010
)
1.46
"Ziprasidone treatment was indistinguishable from placebo in assessments of movement disorders and was not associated with weight gain or cardiovascular abnormalities."( A 1-year, double-blind, placebo-controlled trial of ziprasidone 40, 80 and 160 mg/day in chronic schizophrenia: the Ziprasidone Extended Use in Schizophrenia (ZEUS) study.
Arato, M; Meltzer, HY; O'Connor, R, 2002
)
1.29
"Ziprasidone treatment was associated with a significant weight loss of 8.1 lb (3.6 kg) as well as a significant reduction in total cholesterol and triglycerides (p < or =.05). "( Weight, lipids, glucose, and behavioral measures with ziprasidone treatment in a population with mental retardation.
Cohen, S; Fitzgerald, B; Khan, A; Khan, S; Okos, A, 2003
)
2.01
"Ziprasidone pretreatment decreased lethality in this mouse model of severe cocaine intoxication."( Ziprasidone pretreatment attenuates the lethal effects of cocaine in a mouse model.
Cleveland, NJ; Dewitt, CD; Heard, K, 2005
)
3.21
"All ziprasidone treated animals displayed a normal four-day oestrous cycle."( Investigation into the effects of the novel antipsychotic ziprasidone on weight gain and reproductive function in female rats.
Fell, MJ; Gibson, R; Marshall, KM; McDermott, E; Neill, JC; Sisodia, G, 2005
)
1.05
"ziprasidone for the treatment of acute agitation."( Naturalistic study of intramuscular ziprasidone versus conventional agents in agitated elderly patients: retrospective findings from a psychiatric emergency service.
Francis, A; Kohen, I; Preval, H; Southard, R, 2005
)
1.32
"ziprasidone treatment. There was one adverse event in a patient with untreated benign prostatic hypertrophy who developed urinary retention."( Intramuscular ziprasidone treatment of acute psychotic agitation in elderly patients with schizophrenia.
Barak, Y; Baruch, Y; Mazeh, D; Plopski, I, 2006
)
1.42
"Ziprasidone treatment was associated with clinically and statistically significant improvement in mean YMRS scores (-10.8 +/- 8.4, p < 0.0001) and 57% had a CGI-I ( A prospective open-label treatment trial of ziprasidone monotherapy in children and adolescents with bipolar disorder.
Aleardi, M; Biederman, J; Dougherty, M; Mick, E; Spencer, T; Wozniak, J, 2007
)
1.32
"Ziprasidone-treated patients were not clinically different from placebo-treated patients on the Simpson-Angus Rating scale, Barnes Akathisia scale and AIMS assessments."( Ziprasidone 40 and 120 mg/day in the acute exacerbation of schizophrenia and schizoaffective disorder: a 4-week placebo-controlled trial.
Buffenstein, A; Feighner, J; Ferguson, J; Harrigan, EP; Jaffe, W; Keck, P; Morrissey, MR, 1998
)
2.46
"Ziprasidone treatment appeared to have no significant effect on BMI or glucose level, perhaps due to the small number of subjects."( The apparent effects of ziprasidone on plasma lipids and glucose.
Fayek, M; Kingsbury, SJ; Simpson, GM; Trufasiu, D; Zada, J, 2001
)
1.34
"Treatment with ziprasidone was superior for extrapyramidal symptoms."( Dose reduction of high-dose first-generation antipsychotics or switch to ziprasidone in long-stay patients with schizophrenia: A 1-year double-blind randomized clinical trial.
Bogers, JPAM; Broekman, TG; de Haan, L; Moleman, P; Schulte, PFJ, 2018
)
1.05
"Treatment with ziprasidone avoids relapse episodes at a reasonable cost, generating savings for the NHCS."( Cost-effectiveness analysis of the prevention of relapse of schizophrenia in the longitudinal study Ziprasidone Extended Use in Schizophrenia (ZEUS).
Azanza, JR; Bernardo, M; Rejas, J; Rubio-Terrés, C,
)
0.69

Toxicity

Ziprasidone, a combined serotonin and dopamine receptor antagonist, is a second-generation antipsychotic agent with a lower incidence of extrapyramidal motor symptoms and prolactin elevation. They have apparently safe cardiac safety profiles in both therapeutic and supratherapeutic doses.

ExcerptReferenceRelevance
" This combination of effects may be responsible for its low rate of general adverse events, low rate of persistent prolactin elevation, low incidence of weight gain, low liability for inducing movement disorders, low rate of syncope and induction of decreases in lipid profile."( Ziprasidone: profile on safety.
Goodnick, PJ, 2001
)
1.75
"Psychopharmacology research aims to expand the therapeutic ratio between efficacy, on the one hand, and adverse events and safety, on the other."( Psychotropic drugs and adverse events in the treatment of bipolar disorders revisited.
McIntyre, RS, 2002
)
0.31
" They have apparently safe cardiac safety profiles in both therapeutic and supra-therapeutic doses."( Cardiotoxicity associated with intentional ziprasidone and bupropion overdose.
Biswas, AK; Mayes, KL; Morris-Kukoski, CL; Zabrocki, LA, 2003
)
0.58
" They have apparently safe cardiac safety profiles in both therapeutic and supratherapeutic doses, but recently the Federal Drug Administration has issued a caution regarding ziprasidone use in combination with other drugs that are known to prolong the QTc interval."( Cardiotoxicity associated with intentional ziprasidone and bupropion overdose.
Biswas, AK; Mayes, KL; Morris-Kukoski, CL; Zabrocki, LA, 2003
)
0.77
" This is because of their efficacy in the treatment of several psychiatric disorders, ease of administration, and absence of the well-known extrapyramidal adverse effects long-attributed to the standard dopamine blocking anti-psychotic medications."( Atypical psychotropic medications and their adverse effects: a review for the African-American primary care physician.
Bailey, RK, 2003
)
0.32
" The aim of this paper is to review literature about newer antipsychotics, focusing on their advantages in terms of efficacy and side effect profiles when compared to classical and older atypical antipsychotics, and to evaluate the efficacy of the different new antipsychotics when compared to one another."( New antipsychotics and schizophrenia: a review on efficacy and side effects.
Berardi, D; De Ronchi, D; Lorenzi, C; Serretti, A, 2004
)
0.32
"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
" Adverse events were generally mild to moderate, and no subjects were discontinued from the study."( Pharmacokinetics, safety, and tolerability of intramuscular ziprasidone in healthy volunteers.
Miceli, JJ; Swan, SK; Tensfeldt, TG; Wilner, KD, 2005
)
0.57
"Many adverse drug reactions are caused by the cytochrome P450 (CYP) dependent activation of drugs into reactive metabolites."( An in vitro approach to detect metabolite toxicity due to CYP3A4-dependent bioactivation of xenobiotics.
Grossi, P; Kanter, Rd; Monaci, S; Monshouwer, M; Turlizzi, E; Vignati, L, 2005
)
0.33
" No cardiovascular adverse event or significant increase of the QTc interval was observed."( Effectiveness, tolerability, and safety of ziprasidone in patients with schizophrenia or schizoaffective disorder: results of a multi-centre observational trial.
Domin, S; Kasper, S; Kudla, D; Lambert, M; Naber, D, 2007
)
0.6
" Outcome measures were taken at baseline, 6, and 12 months, and included the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression (CGI-S) scale, the Global Assessment of Functioning Scale (GAF) scores, treatment-emergent adverse events, body weight, and drug attitude."( Effectiveness, safety, and tolerability of ziprasidone for treating schizophrenia patients undergoing usual care: a 12-month, open-label, flexible-dose, naturalistic observational trial.
Gibel, A; Ratner, Y; Ritsner, MS; Yorkov, V, 2007
)
0.6
"6%), adverse events (11."( Effectiveness, safety, and tolerability of ziprasidone for treating schizophrenia patients undergoing usual care: a 12-month, open-label, flexible-dose, naturalistic observational trial.
Gibel, A; Ratner, Y; Ritsner, MS; Yorkov, V, 2007
)
0.6
" 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
)
0.81
" In this study, we determined if subacute administration of the atypical antipsychotic ziprasidone altered the toxic effects of cocaine in mice."( Administration of ziprasidone for 10 days increases cocaine toxicity in mice.
Heard, K; Krier, S; Zahniser, NR, 2008
)
0.9
" Insomnia and somnolence were the only adverse events with an incidence >10% in pooled subjects."( Long-term improvement in efficacy and safety after switching to ziprasidone in stable outpatients with schizophrenia.
Loebel, A; O'Gorman, CJ; Simpson, GM; Yang, R, 2008
)
0.58
" Safety evaluations included adverse event monitoring, electrocardiography, and standard laboratory assessments."( Long-term safety and efficacy of ziprasidone in subpopulations of patients with bipolar mania.
Horne, RL; Keck, PE; Loebel, AD; Versiani, M; Warrington, L, 2009
)
0.63
"Almost all adverse events (98%) were mild to moderate in severity."( Long-term safety and efficacy of ziprasidone in subpopulations of patients with bipolar mania.
Horne, RL; Keck, PE; Loebel, AD; Versiani, M; Warrington, L, 2009
)
0.63
" Treatment with antipsychotics in this limited pilot trial did not improve the number of days alive without delirium or coma, nor did it increase adverse outcomes."( Feasibility, efficacy, and safety of antipsychotics for intensive care unit delirium: the MIND randomized, placebo-controlled trial.
Bernard, GR; Canonico, AE; Carson, SS; Dittus, RS; Ely, EW; Girard, TD; Meltzer, HY; Pandharipande, PP; Pun, BT; Schmidt, GA; Shintani, AK; Thompson, JL; Wright, PE, 2010
)
0.36
" Ziprasidone, a combined serotonin and dopamine receptor antagonist, is a second-generation antipsychotic agent with a lower incidence of extrapyramidal motor symptoms and prolactin elevation and a safer profile of adverse effects on plasma lipids, glucose levels, and body weight than other antipsychotics."( Safety of the electroconvulsive therapy-ziprasidone combination.
Florakis, A; Markatou, M; Masdrakis, VG; Oulis, P; Tzanoulinos, G, 2010
)
1.54
"5, and 5mg/kg/day) administration caused no observable adverse effects."( Two models for weight gain and hyperphagia as side effects of atypical antipsychotics in male rats: validation with olanzapine and ziprasidone.
Harada, K; Irie, M; Kayama, Y; Kondo, Y; Matsuoka, N; Mihara, T; Ni, K; Shobo, M; Yamada, H, 2011
)
0.57
" Safety measures included adverse event (AE) reporting and administration of the Abnormal Involuntary Movement Scale (AIMS)."( Switching from quetiapine to ziprasidone: a sixteen-week, open-label, multicenter study evaluating the effectiveness and safety of ziprasidone in outpatient subjects with schizophrenia or schizoaffective disorder.
Bachinsky, M; Cavus, I; Chappell, P; Glue, P; Karayal, ON; Kolluri, S; Stewart, M, 2011
)
0.66
"7%); the proportion who discontinued due to adverse events was similar (10."( Double-blind comparison of the safety and efficacy of lurasidone and ziprasidone in clinically stable outpatients with schizophrenia or schizoaffective disorder.
Cucchiaro, J; Loebel, A; Ogasa, M; Potkin, SG, 2011
)
0.6
" To assess safety, we measured drug-related adverse events, weight, lipid variables, prolactin, and corrected QT (QTc) interval."( Efficacy and safety of ziprasidone in the treatment of first-episode psychosis: an 8-week, open-label, multicenter trial.
Chung, YC; Huang, GB; Kim, MG; Lee, KH; Park, TW; Yang, JC; Zhao, T, 2012
)
0.69
"Ziprasidone appeared well tolerated; most adverse events were of mild or moderate severity."( Long-term safety of ziprasidone in schizophrenic patients: an open trial.
Piazzi, G; Sciarretta, A, 2012
)
2.15
" Treatment-emergent adverse events (TEAEs), most mild to moderate in severity, included headache (13."( Long-term safety and tolerability of iloperidone: results from a 25-week, open-label extension trial.
Cutler, AJ; Kalali, AH; Kunovac, J; Mattingly, GW; Meng, X, 2013
)
0.39
"This study aimed to examine the risk difference (RD) in the discontinuation due to adverse events, akathisia, overall extrapyramidal symptoms (EPS), reported-somnolence, and 7% or greater weight gain between ziprasidone monotherapy and placebo in the acute treatment of bipolar depression (BPD), bipolar mania (BPM), and schizophrenia."( Risk for adverse events and discontinuation due to adverse events of ziprasidone monotherapy relative to placebo in the acute treatment of bipolar depression, mania, and schizophrenia.
Calabrese, JR; Gao, K; Karayal, ON; Kolluri, S; Pappadopulos, E, 2013
)
0.81
"The RD in discontinuation due to adverse events or 7% or greater weight gain between ziprasidone and placebo was not significant in all 3 psychiatric conditions."( Risk for adverse events and discontinuation due to adverse events of ziprasidone monotherapy relative to placebo in the acute treatment of bipolar depression, mania, and schizophrenia.
Calabrese, JR; Gao, K; Karayal, ON; Kolluri, S; Pappadopulos, E, 2013
)
0.85
"Ziprasidone was associated with significant differential adverse effects relative to placebo in BPM, BPD, and schizophrenia with no significant difference in weight gain in all 3 groups."( Risk for adverse events and discontinuation due to adverse events of ziprasidone monotherapy relative to placebo in the acute treatment of bipolar depression, mania, and schizophrenia.
Calabrese, JR; Gao, K; Karayal, ON; Kolluri, S; Pappadopulos, E, 2013
)
2.07
" Safety assessments included weight and body mass index (BMI), adverse events (AEs), vital signs, laboratory measures, electrocardiograms, and movement disorder ratings."( Efficacy, long-term safety, and tolerability of ziprasidone in children and adolescents with bipolar disorder.
Cavuş, I; DelBello, MP; Findling, RL; Gundapaneni, BK; Pappadopulos, E; Schwartz, JH; Vanderburg, DG, 2013
)
0.65
"The primary aim of the present study was to assess the possible associations between dopaminergic, serotonergic, and glutamatergic system-related genes and adverse events after antipsychotic treatment in paranoid schizophrenia patients."( Pharmacogenetics of adverse events in schizophrenia treatment: comparison study of ziprasidone, olanzapine and perazine.
Beszlej, A; Bienkowski, P; Frydecka, D; Grzywacz, A; Mierzejewski, P; Samochowiec, A; Samochowiec, J; Trześniowska-Drukała, B; Tybura, P, 2014
)
0.63
"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
)
0.64
"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
"While antipsychotic-induced extrapyramidal symptoms (EPS) and akathisia remain important concerns in the treatment of patients with schizophrenia, the relationship between movement disorder rating scales and spontaneously reported EPS-related adverse events (EPS-AEs) remains unexplored."( Relating Spontaneously Reported Extrapyramidal Adverse Events to Movement Disorder Rating Scales.
Fleischhacker, WW; Karayal, ON; Kemmler, G; Kolluri, S; Vanderburg, D; Widschwendter, CG, 2015
)
0.42
" 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
"Sexual dysfunction, as a noticeable adverse effect of atypical antipsychotic drugs (APDs) for the treatment of schizophrenia, has not been investigated in detail."( Antipsychotic Drug-Mediated Adverse Effects on Rat Testicles May Be Caused by Altered Redox and Hormonal Homeostasis.
Blagojević, D; Brkljačić, J; Mijović, M; Mijušković, A; Miljević, Č; Nestorović, V; Nikolić, M; Nikolić-Kokić, A; Oreščanin-Dušić, Z; Spasić, S; Tatalović, N; Vidonja Uzelac, T, 2022
)
0.72
" Lastly, adverse events were recorded during treatment."( The safety and efficacy of sequential intramuscular/oral ziprasidone treatment of acute episode in patients with schizophrenia: a multicenter, open-labeled study.
Bai, L; Guo, Y; Li, J; Li, K; Li, Y; Liang, W; Liu, L; Liu, Z; Wang, J; Wang, X; Wu, Y; Xu, J; Yang, F; Yu, J; Zhang, C; Zhang, Y, 2023
)
1.16
" In this study, 62 adverse events were reported."( The safety and efficacy of sequential intramuscular/oral ziprasidone treatment of acute episode in patients with schizophrenia: a multicenter, open-labeled study.
Bai, L; Guo, Y; Li, J; Li, K; Li, Y; Liang, W; Liu, L; Liu, Z; Wang, J; Wang, X; Wu, Y; Xu, J; Yang, F; Yu, J; Zhang, C; Zhang, Y, 2023
)
1.16

Pharmacokinetics

The administration of cimetidine increased the ziprasidone AUC(0,infinity) by 6% but there were no statistically significant differences in Cmax, tmax or Lambda(z) between the groups. This paper will review the literature concerning real and theoretical implications of pharmacokinetic and pharmacodynamic interactions with zipraside.

ExcerptReferenceRelevance
" Ziprasidone had a significant effect on area under the curve (AUC0-infinity), maximum serum concentration, and half-life (analysis of variance all p<0."( The effect of timing of a standard meal on the pharmacokinetics and pharmacodynamics of the novel atypical antipsychotic agent ziprasidone.
Allard, S; Hamelin, BA; Laplante, L; LeBel, M; Miceli, J; Tremblay, J; Wilner, KD,
)
1.25
" The drug's longer half-life under fasting conditions may reflect dissolution-limited absorption, although this could not be directly assessed."( The effect of timing of a standard meal on the pharmacokinetics and pharmacodynamics of the novel atypical antipsychotic agent ziprasidone.
Allard, S; Hamelin, BA; Laplante, L; LeBel, M; Miceli, J; Tremblay, J; Wilner, KD,
)
0.34
" Mean Cmax and AUC(0,12 h) increased with increasing dose, with apparent dose-proportionality between the 20 and 60 mg dose levels."( Single- and multiple-dose pharmacokinetics of ziprasidone under non-fasting conditions in healthy male volunteers.
Apseloff, G; Gerber, N; Hansen, RA; Johnson, AC; Miceli, JJ; Wilner, KD, 2000
)
0.57
"Ziprasidone is characterized by a predictable pharmacokinetic profile resulting in symptoms that reflect its pharmacological action."( Single- and multiple-dose pharmacokinetics of ziprasidone under non-fasting conditions in healthy male volunteers.
Apseloff, G; Gerber, N; Hansen, RA; Johnson, AC; Miceli, JJ; Wilner, KD, 2000
)
2.01
" The resulting data were used to derive pharmacokinetic parameters of ziprasidone in each age and gender group."( Single- and multiple-dose pharmacokinetics of ziprasidone in healthy young and elderly volunteers.
Baris, B; Colburn, WA; Hansen, RA; Smolarek, TA; Tensfeldt, TG; Turncliff, RZ; Wilner, KD, 2000
)
0.8
" Assessment of gender effects by analysis of variance revealed statistically significant differences in Cmax (85 vs."( Single- and multiple-dose pharmacokinetics of ziprasidone in healthy young and elderly volunteers.
Baris, B; Colburn, WA; Hansen, RA; Smolarek, TA; Tensfeldt, TG; Turncliff, RZ; Wilner, KD, 2000
)
0.57
" On day 5 there were no statistically significant differences in the Cmax or tmax for ziprasidone between the two groups."( The pharmacokinetics of ziprasidone in subjects with normal and impaired hepatic function.
Anderson, KE; Anziano, RJ; Bauer, LA; Carithens, RL; Everson, G; Johnson, A; Lasseter, KC; Smolarek, TA; Turncliff, RZ; Wilner, KD, 2000
)
0.84
" Pharmacokinetic variables were determined from multiple venous blood samples collected on days 1 and 8 (haemodialysis day for subjects with severe renal impairment)."( The pharmacokinetics of ziprasidone in subjects with normal and impaired renal function.
Anziano, RJ; Aweeka, F; Horton, M; Jayesekara, D; Lambrecht, L; Sherwood, J; Smolarek, TA; Swan, S; Turncliff, RZ; Wilner, KD, 2000
)
0.61
" These were assayed for ethinyloestradiol and levonorgestrel and the resulting data used to derive pharmacokinetic data for these steroids."( Ziprasidone and the pharmacokinetics of a combined oral contraceptive.
Anziano, RJ; Harness, J; Holt, PR; Muirhead, GJ; Oliver, S, 2000
)
1.75
"The mean AUC(0,24 h), Cmax and tmax for ethinyloestradiol and the mean AUC(0, 24 h) and Cmax for levonorgestrel during ziprasidone co-administration were not statistically significantly different from corresponding values occurring during placebo co-administration."( Ziprasidone and the pharmacokinetics of a combined oral contraceptive.
Anziano, RJ; Harness, J; Holt, PR; Muirhead, GJ; Oliver, S, 2000
)
1.96
"The findings of this study suggest that, based on pharmacokinetic and tolerability data, ziprasidone may be co-administered with ethinyloestradiol and levonorgestrel without loss of contraceptive efficacy or increased risk of adverse events."( Ziprasidone and the pharmacokinetics of a combined oral contraceptive.
Anziano, RJ; Harness, J; Holt, PR; Muirhead, GJ; Oliver, S, 2000
)
1.97
"The administration of cimetidine increased the ziprasidone AUC(0,infinity) by 6% but there were no statistically significant differences in Cmax, tmax or lambda(z) between the ziprasidone+cimetidine group and the ziprasidone group."( The pharmacokinetics of ziprasidone in healthy volunteers treated with cimetidine or antacid.
Folger, CJ; Geoffroy, P; Hansen, RA; Wilner, KD, 2000
)
0.87
" Pharmacokinetic data were obtained on days 3 and 28."( The effect of carbamazepine on the steady-state pharmacokinetics of ziprasidone in healthy volunteers.
Anziano, RJ; Hansen, RA; Laurent, A; Miceli, JJ; Robarge, L, 2000
)
0.54
" Carbamazepine administration to group 1 was associated with modest reductions in ziprasidone exposure, with mean decreases in ziprasidone AUC(0,12 h) and Cmax values of 36% and 27%, respectively, on day 28 compared with day 3 (P<0."( The effect of carbamazepine on the steady-state pharmacokinetics of ziprasidone in healthy volunteers.
Anziano, RJ; Hansen, RA; Laurent, A; Miceli, JJ; Robarge, L, 2000
)
0.77
" Ziprasidone pharmacokinetic parameters were compared between placebo and ketoconazole administration periods."( The effects of ketoconazole on ziprasidone pharmacokinetics--a placebo-controlled crossover study in healthy volunteers.
Laurent, A; Miceli, JJ; Morse, T; Robarge, L; Smith, M, 2000
)
1.5
" Mean Cmax increased by 34%, from 89 ng ml(-1) to 119 ng ml(-1), respectively."( The effects of ketoconazole on ziprasidone pharmacokinetics--a placebo-controlled crossover study in healthy volunteers.
Laurent, A; Miceli, JJ; Morse, T; Robarge, L; Smith, M, 2000
)
0.59
" This paper will review the literature concerning real and theoretical implications of pharmacokinetic and pharmacodynamic interactions with ziprasidone, particularly with regard to these effects on the QTc interval."( Ziprasidone and the QTc interval: pharmacokinetic and pharmacodynamic considerations.
Kelly, DL; Love, RC, 2001
)
1.95
" The objective of this study was to probe the dopamine agonist and antagonist pharmacodynamic properties of ziprasidone in youth."( Pharmacodynamics of ziprasidone in children and adolescents: impact on dopamine transmission.
Gilbert, DL; Miceli, JJ; Robarge, L; Sallee, FR; Vinks, AA; Wilner, K, 2003
)
0.86
" The IM pharmacokinetic profile was consistent between studies and linear, with dose-related increases in exposure observed."( Pharmacokinetics, safety, and tolerability of intramuscular ziprasidone in healthy volunteers.
Miceli, JJ; Swan, SK; Tensfeldt, TG; Wilner, KD, 2005
)
0.57
" The pharmacokinetics of intramuscular ziprasidone include rapid attainment of therapeutic drug level (time to reach peak serum concentration [tmax]( Pharmacokinetics and therapeutics of acute intramuscular ziprasidone.
Preskorn, SH, 2005
)
0.84
" Regression analysis of AUC(0-infinity) and Cmax values versus weight-normalized dose showed linear, dose-related changes in ziprasidone exposure."( Single-dose pharmacokinetics and safety of ziprasidone in children and adolescents.
Miceli, JJ; Patel, NC; Robarge, L; Sallee, FR; Tensfeldt, T; Wilner, K, 2006
)
0.8
" 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
" Pharmacokinetic interactions with comedication played a minor role."( The use of ziprasidone in clinical practice: analysis of pharmacokinetic and pharmacodynamic aspects from data of a drug monitoring survey.
Dietmaier, O; Gansmüller, R; Gründer, G; Hiemke, C; Leiblein, T; Vogel, F; Wassmuth, H, 2009
)
0.74
" The pharmacokinetic parameters were analyzed by DAS software and the relative bioavailability was calculated according to the formula F=AUC(t)/AUC(r)x100%."( [Pharmacokinetics and relative bioavailability of ziprasidone tablets in Chinese healthy volunteers].
Chen, QX; Huang, WQ; Liu, WZ; Wang, GF; Zhang, JJ, 2009
)
0.61
" After intravenous injection, systemic clearance, steady-state volumes of distribution and half-life remained unaltered as a function of dose with values in the range 22."( Pharmacokinetics of lurasidone, a novel atypical anti-psychotic drug, in rats.
Chae, YJ; Koo, TS; Lee, KR, 2011
)
0.37
" Furthermore, a systematic review of the clinical pharmacokinetic and pharmacodynamic properties and tolerability of ziprasidone was conducted to explain the meta-analytic findings."( Ziprasidone for psychotic disorders: a meta-analysis and systematic review of the relationship between pharmacokinetics, pharmacodynamics, and clinical profile.
Létourneau, G; Moteshafi, H; Potvin, S; Stikarovska, I; Stip, E; Tourjman, V; Zhornitsky, S, 2011
)
2.02
" The determination of the pharmacokinetic behavior of this drug is of utmost importance in evaluating its bioavailability."( High-performance liquid chromatographic assay for ziprasidone in plasma samples: application to pharmacokinetic studies in rats.
Marghade, S; Moorkoth, S; Musmade, PB,
)
0.38
" 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
)
0.85
"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
)
0.86
" Pharmacokinetic parameters were derived from plasma concentrations of ziprasidone collected prior to and over the 48 h after each ziprasidone administration."( Evaluation of the potential for a pharmacokinetic drug-drug interaction between armodafinil and ziprasidone in healthy adults.
Bond, M; Darwish, M; Hellriegel, ET; Robertson, P; Yang, R, 2014
)
0.85
" In this process, particular attention has been paid to the drug pharmacokinetic characteristics and its safety in clinical use."( Evaluation of the pharmacokinetics, safety and clinical efficacy of ziprasidone for the treatment of schizophrenia and bipolar disorder.
Mandrioli, R; Mercolini, L; Protti, M, 2015
)
0.65
" Using GastroPlus™, a commercially available pharmacokinetic simulation software, a semiphysiological model-a kind of physiologically based pharmacokinetic (PBPK) absorption model-was developed that could predict the concentration-time profiles when ziprasidone was administered with any one of the five test meals or fasting."( The impact of gastric pH, volume, and emptying on the food effect of ziprasidone oral absorption.
Gandelman, K; Nause, R; Sutton, SC, 2017
)
0.87
"A full physiologically-based pharmacokinetic (PBPK) model of ziprasidone was developed and validated for the non-pregnant population (healthy adults, paediatrics, geriatrics), and this was extended to the pregnant state to assess the change in PK profile of ziprasidone throughout pregnancy."( Physiologically-based pharmacokinetics of ziprasidone in pregnant women.
Biesdorf, C; Diniz, A; Martins, FS; Sy, SKB, 2019
)
1.02
" The use of physiologically based pharmacokinetic models has gained importance and is nowadays a standard tool for food effect predictions at preclinical and clinical stages in the pharmaceutical industry."( Use of Physiologically Based Pharmacokinetic Modeling for Predicting Drug-Food Interactions: Recommendations for Improving Predictive Performance of Low Confidence Food Effect Models.
Emami Riedmaier, A; Kesisoglou, F; Parrott, N; Pepin, XJH; Wagner, C, 2021
)
0.62

Compound-Compound Interactions

Our data, showing that ziprasidone in combination with sertraline lead to a decrease of prolonged P3 latencies, are in line with previous studies. We recently obtained evidence for comparable efficacy and differential side effects of clozapine in combination versus risperidone.

ExcerptReferenceRelevance
"Our data, showing that ziprasidone in combination with sertraline lead to a decrease of prolonged P3 latencies, are in line with previous studies showing a decrease of prolonged P3 latencies by antidepressant treatment."( The impact of ziprasidone in combination with sertraline on visually-evoked event-related potentials in depressed patients with psychotic features.
Arolt, V; Baune, BT; Dannlowski, U; Deckert, J; Evers, S; Hetzel, G; Moeller, O; Nguyen, DH, 2007
)
1.01
" The need to provide effective therapeutic interventions to patients who do not have an optimal response to clozapine is the most common reason for simultaneously prescribing a second antipsychotic drug in combination with clozapine."( Clozapine combined with different antipsychotic drugs for treatment resistant schizophrenia.
Barbui, C; Boso, M; Cipriani, A, 2009
)
0.35
"In a randomized trial, we recently obtained evidence for comparable efficacy and differential side effects of clozapine in combination with ziprasidone (CZ, N=12) versus risperidone (CR, N=12)."( Long-term efficacy and tolerability of clozapine combined with ziprasidone or risperidone.
Dressing, H; Englisch, S; Krumm, B; Kuwilsky, A; Zink, M, 2010
)
0.8
"The use of polypharmacy in the present day clinical therapy has made the identification of clinical drug-drug interaction risk an important aspect of drug development process."( In Vitro Drug-Drug Interaction Potential of Sulfoxide and/or Sulfone Metabolites of Albendazole, Triclabendazole , Aldicarb, Methiocarb, Montelukast and Ziprasidone.
Giri, P; Giri, S; Gupta, L; Joshi, V; Naidu, S; Patel, N; Srinivas, NR, 2018
)
0.68
"In vitro drug-drug interaction potential of test compounds was investigated in two stages; 1) assessment of CYP450 inhibition potential of test compounds using human liver microsomes (HLM); and 2) assessment of test compounds as substrate of Phase I enzymes; including CYP450, FMO, AO and MAO using HLM, recombinant human CYP enzymes (rhCYP), Human Liver Cytosol (HLC) and Human Liver Mitochondrial (HLMit)."( In Vitro Drug-Drug Interaction Potential of Sulfoxide and/or Sulfone Metabolites of Albendazole, Triclabendazole , Aldicarb, Methiocarb, Montelukast and Ziprasidone.
Giri, P; Giri, S; Gupta, L; Joshi, V; Naidu, S; Patel, N; Srinivas, NR, 2018
)
0.68
", perpetrator and/or victim drug) to overcome any imminent risk of potential clinical drug-drug interaction when sulfoxide/sulfone metabolite(s) generating drugs are coadministered in therapy."( In Vitro Drug-Drug Interaction Potential of Sulfoxide and/or Sulfone Metabolites of Albendazole, Triclabendazole , Aldicarb, Methiocarb, Montelukast and Ziprasidone.
Giri, P; Giri, S; Gupta, L; Joshi, V; Naidu, S; Patel, N; Srinivas, NR, 2018
)
0.68
" This 24-week randomized, double-blinded, controlled clinical trial randomly allocated 452 FEDN SCZ patients to receive a usual dose of ziprasidone (control group) or half the dose of ziprasidone in combination with sertraline (ZS group)."( Low-Dose Ziprasidone in Combination with Sertraline for First-Episode Drug-Naïve Patients with Schizophrenia: a Randomized Controlled Trial.
Guan, X; Kosten, TR; Liu, J; Wang, Y; Wu, F; Xiu, M; Zhang, X; Zhu, C, 2022
)
1.34

Bioavailability

Food is known to increase the bioavailability of ziprasidone. A meal equal to or greater than 500 kcal, irrespective of fat content, is required for optimal and reproducible bioavailability.

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
" Oral bioavailability of ziprasidone taken with food is approximately 60%, half-life is approximately 6-7 hours, and protein binding is extensive at >99%."( Ziprasidone: the fifth atypical antipsychotic.
Caley, CF; Cooper, CK, 2002
)
2.06
" The mean bioavailability for the 5-mg IM ziprasidone dose was approximately 100%."( Pharmacokinetics, safety, and tolerability of intramuscular ziprasidone in healthy volunteers.
Miceli, JJ; Swan, SK; Tensfeldt, TG; Wilner, KD, 2005
)
0.84
" The pharmacokinetics of intramuscular ziprasidone include rapid attainment of therapeutic drug level (time to reach peak serum concentration [tmax]( Pharmacokinetics and therapeutics of acute intramuscular ziprasidone.
Preskorn, SH, 2005
)
0.84
" Human oral bioavailability is an important pharmacokinetic property, which is directly related to the amount of drug available in the systemic circulation to exert pharmacological and therapeutic effects."( Hologram QSAR model for the prediction of human oral bioavailability.
Andricopulo, AD; Moda, TL; Montanari, CA, 2007
)
0.34
"Oral ziprasidone bioavailability is increased when taken with food."( The effect of food on the absorption of oral ziprasidone.
Alderman, J; Glue, P; Miceli, JJ; Wilner, K, 2007
)
1.11
"Food is known to increase the bioavailability of ziprasidone."( The impact of calories and fat content of meals on oral ziprasidone absorption: a randomized, open-label, crossover trial.
Alderman, JA; Gandelman, K; Glue, P; LaBadie, RR; Lombardo, I; Preskorn, SH; Versavel, M, 2009
)
0.85
"These results confirm that ziprasidone should be taken with food and that a meal equal to or greater than 500 kcal, irrespective of fat content, is required for optimal and reproducible bioavailability of the administered dose."( The impact of calories and fat content of meals on oral ziprasidone absorption: a randomized, open-label, crossover trial.
Alderman, JA; Gandelman, K; Glue, P; LaBadie, RR; Lombardo, I; Preskorn, SH; Versavel, M, 2009
)
0.9
"To investigate the pharmacokinetics and bioavailability of ziprasidone tablets in Chinese healthy volunteers."( [Pharmacokinetics and relative bioavailability of ziprasidone tablets in Chinese healthy volunteers].
Chen, QX; Huang, WQ; Liu, WZ; Wang, GF; Zhang, JJ, 2009
)
0.85
" The pharmacokinetic parameters were analyzed by DAS software and the relative bioavailability was calculated according to the formula F=AUC(t)/AUC(r)x100%."( [Pharmacokinetics and relative bioavailability of ziprasidone tablets in Chinese healthy volunteers].
Chen, QX; Huang, WQ; Liu, WZ; Wang, GF; Zhang, JJ, 2009
)
0.61
"ml(-1), respectively, with the relative bioavailability of (98."( [Pharmacokinetics and relative bioavailability of ziprasidone tablets in Chinese healthy volunteers].
Chen, QX; Huang, WQ; Liu, WZ; Wang, GF; Zhang, JJ, 2009
)
0.61
"Oral bioavailability (F) is a product of fraction absorbed (Fa), fraction escaping gut-wall elimination (Fg), and fraction escaping hepatic elimination (Fh)."( Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
Chang, G; El-Kattan, A; Miller, HR; Obach, RS; Rotter, C; Steyn, SJ; Troutman, MD; Varma, MV, 2010
)
0.36
"Determining a drug dosing regimen that produces consistent bioavailability and patient effects is one of the goals of the drug development process."( How sequential studies inform drug development: evaluating the effect of food intake on optimal bioavailability of ziprasidone.
Lincoln, J; Preskorn, SH; Stewart, ME, 2010
)
0.57
"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
" It is well absorbed from the digestive tract and its absorption increases after the meal."( [Practical aspects of the use of ziprasidone in schizophrenia].
Jarema, M; Ochedzan, D,
)
0.41
" Pharmacokinetic studies were conducted with these formulations to examine the bioavailability of test formulations in fasted and fed state compared to commercial capsules (Geodon®) dosed in the fed state."( Improved ziprasidone formulations with enhanced bioavailability in the fasted state and a reduced food effect.
Alderman, JA; Herbig, SM; Thombre, AG, 2011
)
0.79
" Following oral administration, absolute oral bioavailability was not dose dependent with approximately 23%."( Pharmacokinetics of lurasidone, a novel atypical anti-psychotic drug, in rats.
Chae, YJ; Koo, TS; Lee, KR, 2011
)
0.37
"The SD-ZIP osmotic pump tablet could be able to enhance the bioavailability in the fasted state and showed sustained release with prolonged actions."( Controlled release of ziprasidone solid dispersion systems from osmotic pump tablets with enhanced bioavailability in the fasted state.
Guoguang, C; Lili, R; Pingkai, O; Yanfei, M, 2015
)
0.73
"The purpose of this work was to develop self-nanomulsifying drug delivery systems (SNEDDS) in sustained-release pellets of ziprasidone to enhance the oral bioavailability and overcome the food effect of ziprasidone."( Characterization and evaluation of self-nanoemulsifying sustained-release pellet formulation of ziprasidone with enhanced bioavailability and no food effect.
Chen, G; Miao, Y; Pingkai, O; Ren, L, 2016
)
0.86
" In order to achieve acceptable bioavailability and prolonged exposures for once-daily dosing, good colonic absorption and a reliable controlled release (CR) technology are necessary."( Pharmacoscintigraphy studies to assess the feasibility of a controlled release formulation of ziprasidone.
Caldwell, WB; Connor, AL; Malhotra, BK; Shamblin, SL; Thombre, AG; Wilding, IR, 2015
)
0.64
"The purpose of this work was to develop ziprasidone-phospholipid complex (ZIP-PLC) in sustained-release pellets to enhance the oral bioavailability and overcome the food effect of ziprasidone."( Preparation and evaluation of ziprasidone-phospholipid complex from sustained-release pellet formulation with enhanced bioavailability and no food effect.
Chen, G; Miao, Y; Ouyang, P; Ren, L, 2016
)
0.99
"Ziprasidone is a poorly water-soluble antipsychotic drug that demonstrates low fasted state oral bioavailability and a clinically significant two-fold increase in absorption when dosed postprandially."( Silica encapsulated lipid-based drug delivery systems for reducing the fed/fasted variations of ziprasidone in vitro.
Dening, TJ; Prestidge, CA; Rao, S; Thomas, N, 2016
)
2.1
"In a recent food effect clinical study, the authors concluded that a meal consisting of ≥500 kcal, regardless of fat content, produced the maximal bioavailability for ziprasidone."( The impact of gastric pH, volume, and emptying on the food effect of ziprasidone oral absorption.
Gandelman, K; Nause, R; Sutton, SC, 2017
)
0.88
"The purpose of this study was to research a novel combination of Plasdone-S630 and HPMCAS-HF as hot-melt carrier used in ziprasidone hydrochloride for enhanced oral bioavailability and dismissed food effect."( A Combined Utilization of Plasdone-S630 and HPMCAS-HF in Ziprasidone Hydrochloride Solid Dispersion by Hot-Melt Extrusion to Enhance the Oral Bioavailability and No Food Effect.
Chen, G; Ren, L; Wang, J; Xu, X; Xue, X, 2019
)
0.97
"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
" ZP possesses poor oral bioavailability (~50%), short biological half-life (~2."( Parenteral Sustained Release Lipid Phase-Transition System of Ziprasidone: Fabrication and Evaluation for Schizophrenia Therapy.
Ahmad, FJ; Ahmed, MZ; Hasan, N; Jain, GK; Khan, UA; Parveen, U; Saad, S, 2020
)
0.8

Dosage Studied

ziprasidone was effective at a dosage of 40-80 mg twice daily in patients experiencing a phase of acute illness. The 120mg/day dosage appeared to have the highest relapse prevention rate.

ExcerptRelevanceReference
" However, risperidone induced a U-shaped dose-response curve."( Differential effects of repeated administration of novel antipsychotic drugs on the activity of midbrain dopamine neurons in the rat.
Skarsfeldt, T, 1995
)
0.29
" RO was nearly complete at 4 hr after dosing (98%) and remained elevated at 18 hr (46%)."( Positron emission tomographic analysis of central 5-hydroxytryptamine2 receptor occupancy in healthy volunteers treated with the novel antipsychotic agent, ziprasidone.
Alpert, NM; Babich, JW; Bonab, AA; Elmaleh, DR; Fischman, AJ; Rauch, SL; Rubin, RH; Shoup, TM; Williams, SA, 1996
)
0.49
" With increasing time between dosing and PET scanning there was a curvilinear increase in BP, so that all studies performed at or after 18 h post-dose gave BPs in the normal range (mean +/- 2 SD)."( The time course of binding to striatal dopamine D2 receptors by the neuroleptic ziprasidone (CP-88,059-01) determined by positron emission tomography.
Bench, CJ; Boyce, M; Brannick, LY; Dolan, RJ; Frackowiak, RS; Grasby, PM; Gunn, KP; Lammertsma, AA; Warrington, SJ, 1996
)
0.52
" Metabolites designated M6 and M9 were isolated from urine and bile of the rat dosed with radiolabeled ZIP and purified by reversed phase HPLC."( Characterization of the novel benzisothiazole ring-cleaved products of the antipsychotic drug ziprasidone.
Cui, D; Kamel, A; Prakash, C, 1997
)
0.52
" An intramuscular dosage form of ziprasidone was developed using beta-cyclodextrin sulfobutyl ether (SBECD) to solubilize the drug by complexation."( Inclusion complexation of ziprasidone mesylate with beta-cyclodextrin sulfobutyl ether.
Blake, JF; Chrunyk, B; Duffy, EM; Kim, Y; Massefski, W; Oksanen, DA, 1998
)
0.88
" Ziprasidone was associated with transient prolactin elevation but levels of prolactin returned to baseline within the dosing interval at steady state."( Single- and multiple-dose pharmacokinetics of ziprasidone under non-fasting conditions in healthy male volunteers.
Apseloff, G; Gerber, N; Hansen, RA; Johnson, AC; Miceli, JJ; Wilner, KD, 2000
)
1.48
" The initial evidence suggests an effective dosage range of 80-160 mg/day."( Focus on ziprasidone.
Green, B, 2001
)
0.73
" The initial evidence suggests an effective dosage range of 80-160 mg/day."( Brief report on Ziprasidone.
Chowdhury, WA; Firoz, AH; Mamun, AA; Rahman, AH, 2002
)
0.66
" Unfortunately, this type of drugs cannot block the D2 receptors only in the mesolimbic dopaminergic pathway (which mediates their therapeutic effects), because of their non-selective D2 receptor blockage in both the mesolimbic and striatal regions, and the consequent appearance of side effects related to striatal interaction in the same dosage range as is needed for the therapeutical effects."( New antipsychotics and schizophrenia: a review on efficacy and side effects.
Berardi, D; De Ronchi, D; Lorenzi, C; Serretti, A, 2004
)
0.32
" Subjects who had received intramuscular ziprasidone were identified, and their age, gender, and dosage were recorded."( Intramuscular ziprasidone in youth: a retrospective chart review.
Staller, JA, 2004
)
0.95
" Several issues remain to be addressed, including the efficacy of once-daily dosing, the need to take the medication with food, and the correct dosing strategy."( Ziprasidone: efficacy, tolerability, and emerging data on wide-ranging effectiveness.
Bowie, CR; Harvey, PD, 2005
)
1.77
" Mice were acclimated to individual housing, given ad libitum access to chow and water, dosed with placebo peanut butter pills for 1 week, and then dosed daily with AAPD-laced peanut butter pills for 4 weeks."( Antipsychotic drug-induced weight gain: development of an animal model.
Allison, DB; Casey, DE; Cope, MB; Fernández, JR; Geary, N; Nagy, TR, 2005
)
0.33
" Dosage alterations of olanzapine and clozapine, dependent on cytochrome P450 1A2 (CYP1A2) for clearance, and quetiapine, dependent on cytochrome P450 3A (CYP3A), may be necessary when used with other drugs that inhibit or induce their metabolic enzymes."( The dosing of atypical antipsychotics.
Armstrong, SC; Cozza, KL; de Leon, J,
)
0.13
"The purpose of this study was to provide single-dose pharmacokinetic, safety, and tolerability data for ziprasidone in youths with tic disorder, for comparison to adult studies to discern whether ziprasidone pediatric dosing could be modeled from adult data."( Single-dose pharmacokinetics and safety of ziprasidone in children and adolescents.
Miceli, JJ; Patel, NC; Robarge, L; Sallee, FR; Tensfeldt, T; Wilner, K, 2006
)
0.81
" Dosing of ziprasidone oral suspension (40 mg/mL) was weight adjusted: >60 kg, 20 mg (group 1, n = 8); 31 to 60 kg, 10 mg (group 2, n = 8); and 16 to 30 kg, 5 mg (group 3, n = 8)."( Single-dose pharmacokinetics and safety of ziprasidone in children and adolescents.
Miceli, JJ; Patel, NC; Robarge, L; Sallee, FR; Tensfeldt, T; Wilner, K, 2006
)
0.99
" In adult patients with schizophrenia or schizoaffective disorder, oral ziprasidone was effective at a dosage of 40-80 mg twice daily in patients experiencing a phase of acute illness, and at a dosage of 20-80 mg twice daily in those with chronic schizophrenia or schizoaffective disorder, including those who were symptomatically stable."( Ziprasidone: a review of its use in schizophrenia and schizoaffective disorder.
Scott, LJ; Swainston Harrison, T, 2006
)
2.01
" Dosing between children and adolescents significantly differed in the olanzapine group, whereas dosing was comparable in the ziprasidone group."( A naturalistic evaluation of intramuscular ziprasidone versus intramuscular olanzapine for the management of acute agitation and aggression in children and adolescents.
Khan, SS; Mican, LM, 2006
)
0.8
" The study required fixed dosing with ziprasidone."( [Switching patients with schizophrenia to ziprasidone from conventional or other atypical antipsychotics].
Bartkó, G; Bitter, I; Degrell, I; Faludi, G; Füredi, J; Trixler, M, 2006
)
0.87
" Ziprasidone dosage ranged from 20 to 160 mg/day (mean, 98."( Ziprasidone in adolescents with autism: an open-label pilot study.
Cater, JR; Delaney, MA; Hyman, SB; Malone, RP, 2007
)
2.69
" Half maximal effective concentration values were consistently higher in striatal than in extrastriatal regions (temporal cortex: 39 ng/mL; putamen: 64 ng/mL), irrespective of the time between last dosing and scan."( Striatal and extrastriatal D2/D3-receptor-binding properties of ziprasidone: a positron emission tomography study with [18F]Fallypride and [11C]raclopride (D2/D3-receptor occupancy of ziprasidone).
Bartenstein, P; Boy, C; Bröcheler, A; Buchholz, HG; Cumming, P; Fellows, C; Gründer, G; Hiemke, C; Janouschek, H; Landvogt, C; Rösch, F; Schäfer, W; Spreckelmeyer, K; Vernaleken, I; Veselinovic, T; Wong, DF, 2008
)
0.58
"Community dwelling patients with schizophrenia were randomized to treatment with haloperidol (n=47) or ziprasidone dosed either once or twice daily (n=139)."( Reduction of functional disability with atypical antipsychotic treatment: a randomized long term comparison of ziprasidone and haloperidol.
Harvey, PD; Kremer, CM; Lombardo, I; Pappadopulos, E, 2009
)
0.78
" Occasional mild hypomania responded to dosage reduction."( Ziprasidone monotherapy in bipolar II depression: an open trial.
Akhtar, J; Dunner, D; Johnson, AE; Liebowitz, MR; Mech, A; Pratap, R; Salmán, E, 2009
)
1.8
"Consistent with previous reports, higher doses of ziprasidone (120-160 mg/d, dosed twice daily with meals) are associated with significantly lower all-cause discontinuation rates and more favorable NNTs versus placebo."( Effect of ziprasidone dose on all-cause discontinuation rates in acute schizophrenia and schizoaffective disorder: a post-hoc analysis of 4 fixed-dose randomized clinical trials.
Citrome, L; Glue, P; Karayal, ON; Yang, R, 2009
)
1.01
" A secondary objective of this case series was to attempt to establish an age-specific dosage and identify possible side effects of this medication."( Agitation and/or aggression after traumatic brain injury in the pediatric population treated with ziprasidone. Clinical article.
Conrad, SA; Green, R; McCarthy, PJ; Scott, LK, 2009
)
0.57
" The preferred switch strategy was immediate discontinuation, and the preferred dosing regimen was 120 mg/day."( Efficacy and tolerability of switching to ziprasidone from olanzapine, risperidone or haloperidol: an international, multicenter study.
Akkaya, C; Alptekin, K; Brook, S; Danaci, AE; El Tallawy, H; Hafez, J; Karayal, ON; Lowe, W; Tzebelikos, E; Ucok, A, 2009
)
0.62
"Although clozapine has been shown to be the treatment of choice in people with schizophrenia that are resistant to treatment, one third to two thirds of people still have persistent positive symptoms despite clozapine monotherapy of adequate dosage and duration."( Clozapine combined with different antipsychotic drugs for treatment resistant schizophrenia.
Barbui, C; Boso, M; Cipriani, A, 2009
)
0.35
"The purpose of this article is to review the utilization and dosing of ziprasidone in a state hospital system and to compare the dosing to dosing recommendations contained in product labeling that suggest a starting dose of 40 mg/day and a target dose range of 40 to 160 mg/day for schizophrenia."( How dosing of ziprasidone in a state hospital system differs from product labeling.
Citrome, L; Jaffe, A; Levine, J, 2009
)
0.95
" Mean time to discontinuation was evaluated across propensity score-matched dosing groups."( Impact of real-world ziprasidone dosing on treatment discontinuation rates in patients with schizophrenia or bipolar disorder.
Citrome, L; Cuffel, B; Harnett, J; Lenhart, G; Montejano, LB; Palmer, L; Reist, C; Sanders, KN, 2009
)
0.67
" Among the propensity score-matched dosing groups, the respective mean time to discontinuation for low, medium, and high doses was 90."( Impact of real-world ziprasidone dosing on treatment discontinuation rates in patients with schizophrenia or bipolar disorder.
Citrome, L; Cuffel, B; Harnett, J; Lenhart, G; Montejano, LB; Palmer, L; Reist, C; Sanders, KN, 2009
)
0.67
" The switch from conventional antipsychotics to ziprasidone was achieved using one of three discrete schedules: (1) abrupt discontinuation of conventional antipsychotics on day 1; (2) fast taper-50% of conventional antipsychotic dosage on days 1 through 7, followed by discontinuation and (3) slow taper-100% of conventional antipsychotic dosage on days 1 and 2, followed by 50% on days 3 through 7, then discontinuation."( Switching from conventional antipsychotics to ziprasidone: a randomized, open-label comparison of regimen strategies.
Potvin, S; Stip, E; Tourjman, V; Zhornitsky, S, 2010
)
0.87
"Determining a drug dosing regimen that produces consistent bioavailability and patient effects is one of the goals of the drug development process."( How sequential studies inform drug development: evaluating the effect of food intake on optimal bioavailability of ziprasidone.
Lincoln, J; Preskorn, SH; Stewart, ME, 2010
)
0.57
" Seventy-three subjects with treatment-resistant GAD were recruited, and 62 were randomized to either ziprasidone or placebo treatment at a ratio of 2:1 using a flexible dosing strategy (20-80 mg daily)."( Ziprasidone treatment of refractory generalized anxiety disorder: a placebo-controlled, double-blind study.
Etemad, B; Gallop, R; Lohoff, FW; Mandos, LA; Rickels, K, 2010
)
2.02
" The proposed methods were applied for the determination of ziprasidone from pharmaceutical dosage forms and human serum samples without any time-consuming extraction, separation, evaporation or adsorption steps prior to drug assay except precipitation of the proteins using acetonitrile."( Electroanalytical characteristics of antipsychotic drug ziprasidone and its determination in pharmaceuticals and serum samples on solid electrodes.
Gumustas, M; Kul, D; Ozkan, SA; Uslu, B, 2010
)
0.85
"This article addresses points to consider when switching patients to the second-generation antipsychotic (SGA), ziprasidone, in everyday clinical practice: 1) the pharmacologic properties of the pre-switch antipsychotic and of ziprasidone; 2) switch and dosing strategies to ensure maintenance or attainment of efficacy; 3) recognition and management of possible rebound effects of the pre-switch medication discontinuation; 4) recognition and management of potential side effects of ziprasidone; and 5) education and support for patients/caregivers concerning correct ziprasidone administration."( Switching among antipsychotics in everyday clinical practice: focus on ziprasidone.
Cañas, F; Correll, CU; Fagiolini, A; Larmo, I; Levy, P; Montes, JM; Papageorgiou, G; Rossi, A; Sturlason, R; Zink, M, 2011
)
0.81
" We found substantial differences in baseline characteristics of subjects, administered dosage and disease severity in India compared to the USA and Russia."( Impact of geographical and cultural factors on clinical trials in acute mania: lessons from a ziprasidone and haloperidol placebo-controlled study.
Lombardo, I; Mandel, FS; Pappadopulos, E; Vieta, E, 2011
)
0.59
" Pharmacokinetic studies were conducted with these formulations to examine the bioavailability of test formulations in fasted and fed state compared to commercial capsules (Geodon®) dosed in the fed state."( Improved ziprasidone formulations with enhanced bioavailability in the fasted state and a reduced food effect.
Alderman, JA; Herbig, SM; Thombre, AG, 2011
)
0.79
" Two formulations when taken in the fasted or fed state were comparable to the commercial capsules dosed in the fed state with respect to total exposure."( Improved ziprasidone formulations with enhanced bioavailability in the fasted state and a reduced food effect.
Alderman, JA; Herbig, SM; Thombre, AG, 2011
)
0.79
" Such formulations could provide simple and convenient dosing while retaining the familiar safety and efficacy profile of currently marketed capsules."( Improved ziprasidone formulations with enhanced bioavailability in the fasted state and a reduced food effect.
Alderman, JA; Herbig, SM; Thombre, AG, 2011
)
0.79
" The proposed validated method is convenient and reliable for the assay and purity control in both raw materials and dosage forms."( Development and validation of an HPLC method for determination of ziprasidone and its impurities in pharmaceutical dosage forms.
Agbaba, D; Malesevic, M; Nikolic, K; Pavlovic, M,
)
0.37
"The present meta-analysis examined premature study discontinuation (PSD) and dose-response associated with ziprasidone."( Ziprasidone for psychotic disorders: a meta-analysis and systematic review of the relationship between pharmacokinetics, pharmacodynamics, and clinical profile.
Létourneau, G; Moteshafi, H; Potvin, S; Stikarovska, I; Stip, E; Tourjman, V; Zhornitsky, S, 2011
)
2.03
" In the patient with laryngeal dystonia these symptoms appeared after restarting risperidone treatment, in the other patient after diminishing the dosage of risperidone and adding sertindole, and in the third patient the syndrome appeared after beginning ziprasidone."( Pisa syndrome and laryngeal dystonia induced by novel antipsychotics.
Lerner, V; Miodownik, C; Witztum, E, 2011
)
0.55
" Iloperidone 4-8, 10-16, and 20-24 mg/day (all dosed twice daily) were compared with placebo."( Efficacy of iloperidone in the short-term treatment of schizophrenia: a post hoc analysis of pooled patient data from four phase III, placebo- and active-controlled trials.
Citrome, L; Hochfeld, M; Meng, X; Stahl, SM, 2012
)
0.38
" The final mean dosage for clozapine was 32."( Ziprasidone versus clozapine in the treatment of psychotic symptoms in Parkinson disease: a randomized open clinical trial.
Baillés, E; Martí, MJ; Muñiz, A; Pintor, L; Tolosa, E; Valldeoriola, F,
)
1.57
"Optimization of the experimental conditions of a novel HPLC method for determination of the impurity levels with ziprasidone (in bulk substance and pharmaceutical dosage forms) was performed with use of Multi-Layer Perceptron (MLP) Artificial Neural Networks (ANN) and Response Surface Plots."( The chemometric study and quantitative structure retention relationship modeling of liquid chromatography separation of ziprasidone components.
Agbaba, D; Nikolic, K; Pavlovic, M; Smolinski, A, 2012
)
0.8
"These analyses confirm the effectiveness of ziprasidone (80-160mg/day) in preventing relapses in subjects with bipolar disorder, with the 120mg/day dosage appearing to have the highest relapse prevention rate."( Characterizing relapse prevention in bipolar disorder with adjunctive ziprasidone: clinical and methodological implications.
Bowden, CL; Gundapaneni, BK; Karayal, ON; O'Gorman, C; Schwartz, JH, 2013
)
0.88
"Ultra Performance Liquid Chromatography (UPLC) was employed to develop a rapid and robust method for the analysis of ziprasidone, both as a drug substance and in the final dosage forms."( Development of rapid and robust stability-indicating method for analysis of ziprasidone (hydrochloride and freebase) as drug substance and in medicines by UPLC.
Cal, K; Zakowiecki, D,
)
0.57
"Reducing the absorption difference between fed and fasted states is an important goal in the development of pharmaceutical dosage forms."( Solid nanocrystalline dispersions of ziprasidone with enhanced bioavailability in the fasted state.
Caldwell, WB; Friesen, DT; McCray, SB; Sutton, SC; Thombre, AG, 2012
)
0.65
"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 patient is a 52-year-old man with schizophrenia who developed severe, unremitting gingival pain after his ziprasidone dosage was increased from 80 to 120 mg."( Gingival pain: an unusual side effect of ziprasidone.
Raghunath, A, 2013
)
0.87
" The analysis reveals that general score from Positive and Negative Syndrome Scale (PANSS), cholesterol LDL, subjective well-being under neuroleptic, Simpson-Angus Scale (SAS) delta scores, drug dosage and premorbid intelligence entered in the equation."( Short-term remission in schizophrenia as a combination of several outcome measures.
Rossi, A; Stratta, P, 2013
)
0.39
" 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
" Plasma concentrations of armodafinil and its circulating metabolites, R-modafinil acid and modafinil sulfone, were also obtained after repeated daily dosing of armodafinil alone."( Evaluation of the potential for a pharmacokinetic drug-drug interaction between armodafinil and ziprasidone in healthy adults.
Bond, M; Darwish, M; Hellriegel, ET; Robertson, P; Yang, R, 2014
)
0.62
" The novel test methods simulate additional elements of mechanical and hydrodynamic stresses, which have an impact on solid oral dosage forms, especially during gastric emptying."( The improvement of the dissolution rate of ziprasidone free base from solid oral formulations.
Adrjanowicz, K; Cal, K; Garbacz, G; Kaminska, E; Kaminski, K; Swinder, L; Zakowiecki, D, 2015
)
0.68
"Ziprasidone, like many BCS Class II drugs with low intrinsic solubility and a strong tendency to crystallize from supersaturated solutions, presents significant technical challenges when developing an oral controlled release dosage form."( Pharmacoscintigraphy studies to assess the feasibility of a controlled release formulation of ziprasidone.
Caldwell, WB; Connor, AL; Malhotra, BK; Shamblin, SL; Thombre, AG; Wilding, IR, 2015
)
2.08
"Ziprasidone is a poorly water-soluble antipsychotic drug that demonstrates low fasted state oral bioavailability and a clinically significant two-fold increase in absorption when dosed postprandially."( Silica encapsulated lipid-based drug delivery systems for reducing the fed/fasted variations of ziprasidone in vitro.
Dening, TJ; Prestidge, CA; Rao, S; Thomas, N, 2016
)
2.1
" Limited data exist on the pediatric dosing of ziprasidone in the emergency department (ED)."( Intramuscular Ziprasidone Dosing for Acute Agitation in the Pediatric Emergency Department: An Observational Study.
Foster, R; Nguyen, T; Stanton, J, 2018
)
1.1
"To characterize the mg/kg dosing differences between pediatric ED patients who respond to an initial dose of ziprasidone versus patients who do not."( Intramuscular Ziprasidone Dosing for Acute Agitation in the Pediatric Emergency Department: An Observational Study.
Foster, R; Nguyen, T; Stanton, J, 2018
)
1.05
" Secondary objectives were to identify the patient population in which ketamine was initiated, assess the proportion of time patients were at their goal level of sedation, and determine the dosing patterns of adjunctive sedative agents."( Impact of Ketamine Use on Adjunctive Analgesic and Sedative Medications in Critically Ill Trauma Patients.
Chui, SJ; Harbourt, K; Pajoumand, M; Pruskowski, KA; Reynolds, HN, 2017
)
0.46
"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
" In conclusion, the novel formulation of ZHM nanocrystal-based ODTs was successfully developed for alternative dosage form."( Development of Nanocrystal Ziprasidone Orally Disintegrating Tablets: Optimization by Using Design of Experiment and In Vitro Evaluation.
Celebi, N; Karakucuk, A; Tashan, E, 2020
)
0.86
"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
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (6)

RoleDescription
psychotropic drugA loosely defined grouping of drugs that have effects on psychological function.
histamine antagonistHistamine antagonists are the drugs that bind to but do not activate histamine receptors, thereby blocking the actions of histamine or histamine agonists.
muscarinic antagonistA drug that binds to but does not activate muscarinic cholinergic receptors, thereby blocking the actions of endogenous acetylcholine or exogenous agonists.
serotonergic antagonistDrugs that bind to but do not activate serotonin receptors, thereby blocking the actions of serotonin or serotonergic agonists.
dopaminergic antagonistA drug that binds to but does not activate dopamine receptors, thereby blocking the actions of dopamine or exogenous agonists.
antipsychotic agentAntipsychotic drugs are agents that control agitated psychotic behaviour, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect.
[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 (4)

ClassDescription
piperazines
organochlorine compoundAn organochlorine compound is a compound containing at least one carbon-chlorine bond.
indolones
1,2-benzisothiazoleA benzothiazole consisting of a benzene ring fused to an isothiazole.
[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]

Protein Targets (83)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
acetylcholinesteraseHomo sapiens (human)Potency13.80290.002541.796015,848.9004AID1347398
hypoxia-inducible factor 1 alpha subunitHomo sapiens (human)Potency26.83253.189029.884159.4836AID1224846
RAR-related orphan receptor gammaMus musculus (house mouse)Potency15.40980.006038.004119,952.5996AID1159521; AID1159523
TDP1 proteinHomo sapiens (human)Potency27.69590.000811.382244.6684AID686978; AID686979
GLI family zinc finger 3Homo sapiens (human)Potency26.77970.000714.592883.7951AID1259369; AID1259392
Microtubule-associated protein tauHomo sapiens (human)Potency18.85410.180013.557439.8107AID1460; AID1468
AR proteinHomo sapiens (human)Potency23.29190.000221.22318,912.5098AID1259243; AID1259247; AID743035; AID743036; AID743040; AID743042; AID743053; AID743054; AID743063
thioredoxin glutathione reductaseSchistosoma mansoniPotency31.62280.100022.9075100.0000AID485364
nuclear receptor subfamily 1, group I, member 3Homo sapiens (human)Potency14.71220.001022.650876.6163AID1224838; AID1224893
progesterone receptorHomo sapiens (human)Potency31.67040.000417.946075.1148AID1346784; AID1347036
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency15.04230.01237.983543.2770AID1346984; AID1645841
EWS/FLI fusion proteinHomo sapiens (human)Potency22.84650.001310.157742.8575AID1259252; AID1259253; AID1259255; AID1259256
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency20.12600.000214.376460.0339AID720691; AID720692; AID720719
retinoic acid nuclear receptor alpha variant 1Homo sapiens (human)Potency21.13170.003041.611522,387.1992AID1159555
retinoid X nuclear receptor alphaHomo sapiens (human)Potency8.32990.000817.505159.3239AID1159527; AID1159531
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency21.84330.001530.607315,848.9004AID1224841; AID1224842; AID1224848; AID1224849; AID1259401; AID1259403
farnesoid X nuclear receptorHomo sapiens (human)Potency23.41050.375827.485161.6524AID743217; AID743220
pregnane X nuclear receptorHomo sapiens (human)Potency11.88320.005428.02631,258.9301AID1346982
estrogen nuclear receptor alphaHomo sapiens (human)Potency23.43520.000229.305416,493.5996AID1259248; AID743069; AID743075; AID743078; AID743079; AID743091
GVesicular stomatitis virusPotency12.30180.01238.964839.8107AID1645842
cytochrome P450 2D6Homo sapiens (human)Potency9.77170.00108.379861.1304AID1645840
bromodomain adjacent to zinc finger domain 2BHomo sapiens (human)Potency50.11870.707936.904389.1251AID504333
peroxisome proliferator-activated receptor deltaHomo sapiens (human)Potency22.68560.001024.504861.6448AID743212; AID743215
arylsulfatase AHomo sapiens (human)Potency37.93301.069113.955137.9330AID720538
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency22.38720.035520.977089.1251AID504332
aryl hydrocarbon receptorHomo sapiens (human)Potency19.79890.000723.06741,258.9301AID743085; AID743122
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_aHomo sapiens (human)Potency22.68740.001723.839378.1014AID743083
nuclear factor of kappa light polypeptide gene enhancer in B-cells 1 (p105), isoform CRA_aHomo sapiens (human)Potency26.832519.739145.978464.9432AID1159509
v-jun sarcoma virus 17 oncogene homolog (avian)Homo sapiens (human)Potency23.91450.057821.109761.2679AID1159526
potassium voltage-gated channel subfamily H member 2 isoform dHomo sapiens (human)Potency1.41250.01789.637444.6684AID588834
thyroid hormone receptor beta isoform 2Rattus norvegicus (Norway rat)Potency23.21430.000323.4451159.6830AID743065; AID743067
heat shock protein beta-1Homo sapiens (human)Potency33.48890.042027.378961.6448AID743210; AID743228
nuclear receptor ROR-gamma isoform 1Mus musculus (house mouse)Potency4.46680.00798.23321,122.0200AID2551
Interferon betaHomo sapiens (human)Potency12.30180.00339.158239.8107AID1645842
HLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)Potency12.30180.01238.964839.8107AID1645842
Cellular tumor antigen p53Homo sapiens (human)Potency33.49150.002319.595674.0614AID651631
Inositol hexakisphosphate kinase 1Homo sapiens (human)Potency12.30180.01238.964839.8107AID1645842
ATPase family AAA domain-containing protein 5Homo sapiens (human)Potency26.60320.011917.942071.5630AID651632; AID720516
Ataxin-2Homo sapiens (human)Potency26.60320.011912.222168.7989AID651632
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)Ki0.39810.00100.88359.9000AID298488
5-hydroxytryptamine receptor 3BHomo sapiens (human)Ki0.39810.00100.87119.9000AID298488
Muscarinic acetylcholine receptor M2Homo sapiens (human)Ki5.00000.00000.690210.0000AID141100
Muscarinic acetylcholine receptor M4Homo sapiens (human)Ki5.00000.00000.79519.1201AID141100
Cytochrome P450 3A4Homo sapiens (human)Ki0.06100.00011.41629.9000AID599884
5-hydroxytryptamine receptor 1AHomo sapiens (human)Ki0.00940.00010.532610.0000AID1393366; AID298481; AID313956; AID342783; AID3657
Muscarinic acetylcholine receptor M5Homo sapiens (human)Ki5.00000.00000.72926.9183AID141100
Alpha-2A adrenergic receptorHomo sapiens (human)Ki0.39000.00010.807410.0000AID36197; AID36199
Muscarinic acetylcholine receptor M1Homo sapiens (human)Ki6.70000.00000.59729.1201AID141100; AID141174; AID342774
D(2) dopamine receptorHomo sapiens (human)IC50 (µMol)0.00500.00000.74728.0000AID254688
D(2) dopamine receptorHomo sapiens (human)Ki0.00420.00000.651810.0000AID1054120; AID1393368; AID1430534; AID1520010; AID1556426; AID1595147; AID298478; AID313953; AID342777; AID63060; AID63070; AID714109
5-hydroxytryptamine receptor 2ARattus norvegicus (Norway rat)Ki0.00040.00010.601710.0000AID5328
Alpha-1B adrenergic receptorRattus norvegicus (Norway rat)Ki0.02000.00010.949010.0000AID298478; AID36016; AID3657
Aspartate aminotransferase, cytoplasmicHomo sapiens (human)IC50 (µMol)5.39005.39005.39005.3900AID1850916
Alpha-2B adrenergic receptorHomo sapiens (human)Ki0.39000.00020.725710.0000AID36197; AID36199
Alpha-2C adrenergic receptorHomo sapiens (human)Ki0.39000.00030.483410.0000AID36197; AID36199
DRattus norvegicus (Norway rat)IC50 (µMol)0.15140.00030.50267.7625AID243189
Alpha-2B adrenergic receptorRattus norvegicus (Norway rat)IC50 (µMol)0.15140.00031.09147.7625AID243189
Muscarinic acetylcholine receptor M3Homo sapiens (human)Ki5.00000.00000.54057.7600AID141100
D(1A) dopamine receptorHomo sapiens (human)Ki0.15650.00010.836310.0000AID342775; AID63345; AID63347
D(4) dopamine receptorHomo sapiens (human)Ki0.04000.00000.436210.0000AID298480; AID342779; AID61808; AID63537
Alpha-2C adrenergic receptorRattus norvegicus (Norway rat)IC50 (µMol)0.15140.00031.09147.7625AID243189
Alpha-2A adrenergic receptorRattus norvegicus (Norway rat)IC50 (µMol)0.15140.00031.06917.7625AID243189
Alpha-1D adrenergic receptorRattus norvegicus (Norway rat)Ki0.02000.00000.575110.0000AID298478; AID36016; AID3657
Sodium-dependent dopamine transporterRattus norvegicus (Norway rat)IC50 (µMol)0.15140.00070.97749.7000AID243189
Alpha-1D adrenergic receptorHomo sapiens (human)IC50 (µMol)0.01100.00020.75688.8970AID254726
Alpha-1D adrenergic receptorHomo sapiens (human)Ki0.00900.00000.360910.0000AID1054113; AID1682829; AID36113; AID36116
5-hydroxytryptamine receptor 2AHomo sapiens (human)IC50 (µMol)0.00040.00010.88018.8500AID254754
5-hydroxytryptamine receptor 2AHomo sapiens (human)Ki0.00050.00000.385510.0000AID1054119; AID1393364; AID298482; AID313955; AID342784; AID5197; AID5199
5-hydroxytryptamine receptor 2CHomo sapiens (human)Ki0.00500.00010.954910.0000AID1054116; AID298485; AID342781; AID5614; AID5616; AID599883
Sodium-dependent serotonin transporterHomo sapiens (human)Ki0.06620.00000.70488.1930AID298489; AID342787
5-hydroxytryptamine receptor 7Homo sapiens (human)Ki0.00530.00030.380610.0000AID1054114; AID1393367; AID298487
Alpha-1A adrenergic receptorHomo sapiens (human)IC50 (µMol)0.01100.00020.56145.4000AID254726
Alpha-1A adrenergic receptorHomo sapiens (human)Ki0.00900.00000.272610.0000AID1054113; AID1682829; AID36113; AID36116
Histamine H1 receptorHomo sapiens (human)Ki0.15310.00000.511010.0000AID1682828; AID342782; AID87226; AID87242
Alpha-1B adrenergic receptorHomo sapiens (human)IC50 (µMol)0.01100.00020.65268.3300AID254726
Alpha-1B adrenergic receptorHomo sapiens (human)Ki0.00900.00000.471310.0000AID1054113; AID1682829; AID36113; AID36116
D(3) dopamine receptorHomo sapiens (human)Ki0.00760.00000.602010.0000AID1054117; AID298479; AID342778; AID65121; AID65785
5-hydroxytryptamine receptor 2BHomo sapiens (human)Ki0.00160.00030.769310.0000AID298483
Alpha-1A adrenergic receptorRattus norvegicus (Norway rat)Ki0.01510.00000.965010.0000AID298478; AID313957; AID36016; AID3657
5-hydroxytryptamine receptor 3AHomo sapiens (human)Ki0.39810.00000.74119.9000AID298488
5-hydroxytryptamine receptor 6Homo sapiens (human)Ki0.05620.00020.522910.0000AID1054115; AID1393365; AID298486; AID342773; AID599884
3-hydroxy-3-methylglutaryl-coenzyme A reductase Rattus norvegicus (Norway rat)Ki0.01300.00100.01630.0330AID599883
D(2) dopamine receptorRattus norvegicus (Norway rat)Ki0.00480.00000.437510.0000AID63811; AID65713
Potassium voltage-gated channel subfamily H member 2Homo sapiens (human)IC50 (µMol)0.23010.00091.901410.0000AID222148; AID243151; AID243189; AID397743; AID408340; AID420668; AID539465; AID576612
TransporterRattus norvegicus (Norway rat)Ki0.04800.00010.76295.5000AID342786
5-hydroxytryptamine receptor 3DHomo sapiens (human)Ki0.39810.00100.88359.9000AID298488
5-hydroxytryptamine receptor 3CHomo sapiens (human)Ki0.39810.00100.88359.9000AID298488
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Other Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
D(2) dopamine receptorHomo sapiens (human)Activity0.00970.00970.58492.0000AID1506227
5-hydroxytryptamine receptor 2AHomo sapiens (human)Activity0.00030.00030.00430.0071AID1506226
Histamine H1 receptorHomo sapiens (human)Activity0.04300.00120.04750.0982AID1506225
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (552)

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)
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)
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)
G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
phospholipase C-activating G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
nervous system developmentMuscarinic acetylcholine receptor M2Homo sapiens (human)
regulation of heart contractionMuscarinic acetylcholine receptor M2Homo sapiens (human)
response to virusMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
presynaptic modulation of chemical synaptic transmissionMuscarinic acetylcholine receptor M2Homo sapiens (human)
regulation of smooth muscle contractionMuscarinic acetylcholine receptor M2Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M2Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M2Homo sapiens (human)
signal transductionMuscarinic acetylcholine receptor M4Homo sapiens (human)
cell surface receptor signaling pathwayMuscarinic acetylcholine receptor M4Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M4Homo sapiens (human)
regulation of locomotionMuscarinic acetylcholine receptor M4Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M4Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M4Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M4Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M4Homo 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)
gastric acid secretionMuscarinic acetylcholine receptor M5Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M5Homo sapiens (human)
dopamine transportMuscarinic acetylcholine receptor M5Homo sapiens (human)
transmission of nerve impulseMuscarinic acetylcholine receptor M5Homo sapiens (human)
regulation of phosphatidylinositol dephosphorylationMuscarinic acetylcholine receptor M5Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M5Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M5Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M5Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M5Homo sapiens (human)
positive regulation of cytokine productionAlpha-2A adrenergic receptorHomo sapiens (human)
DNA replicationAlpha-2A adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
Ras protein signal transductionAlpha-2A adrenergic receptorHomo sapiens (human)
Rho protein signal transductionAlpha-2A adrenergic receptorHomo sapiens (human)
female pregnancyAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of cell population proliferationAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of norepinephrine secretionAlpha-2A adrenergic receptorHomo sapiens (human)
regulation of vasoconstrictionAlpha-2A adrenergic receptorHomo sapiens (human)
actin cytoskeleton organizationAlpha-2A adrenergic receptorHomo sapiens (human)
platelet activationAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of cell migrationAlpha-2A adrenergic receptorHomo sapiens (human)
activation of protein kinase activityAlpha-2A adrenergic receptorHomo sapiens (human)
activation of protein kinase B activityAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of epinephrine secretionAlpha-2A adrenergic receptorHomo sapiens (human)
cellular response to hormone stimulusAlpha-2A adrenergic receptorHomo sapiens (human)
receptor transactivationAlpha-2A adrenergic receptorHomo sapiens (human)
vasodilationAlpha-2A adrenergic receptorHomo sapiens (human)
glucose homeostasisAlpha-2A adrenergic receptorHomo sapiens (human)
fear responseAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of potassium ion transportAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of MAP kinase activityAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of epidermal growth factor receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of calcium ion-dependent exocytosisAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretionAlpha-2A adrenergic receptorHomo sapiens (human)
intestinal absorptionAlpha-2A adrenergic receptorHomo sapiens (human)
thermoceptionAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of lipid catabolic processAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of membrane protein ectodomain proteolysisAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of calcium ion transportAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretion involved in cellular response to glucose stimulusAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of uterine smooth muscle contractionAlpha-2A adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-inhibiting adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
phospholipase C-activating adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of wound healingAlpha-2A adrenergic receptorHomo sapiens (human)
presynaptic modulation of chemical synaptic transmissionAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of calcium ion transmembrane transporter activityAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of monoatomic ion transportMuscarinic acetylcholine receptor M1Homo sapiens (human)
signal transductionMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
protein kinase C-activating G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
phospholipase C-activating G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
neuromuscular synaptic transmissionMuscarinic acetylcholine receptor M1Homo sapiens (human)
nervous system developmentMuscarinic acetylcholine receptor M1Homo sapiens (human)
regulation of locomotionMuscarinic acetylcholine receptor M1Homo sapiens (human)
saliva secretionMuscarinic acetylcholine receptor M1Homo sapiens (human)
cognitionMuscarinic acetylcholine receptor M1Homo sapiens (human)
regulation of postsynaptic membrane potentialMuscarinic acetylcholine receptor M1Homo sapiens (human)
regulation of glial cell proliferationMuscarinic acetylcholine receptor M1Homo sapiens (human)
positive regulation of intracellular protein transportMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
postsynaptic modulation of chemical synaptic transmissionMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M1Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M1Homo 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)
gluconeogenesisAspartate aminotransferase, cytoplasmicHomo sapiens (human)
2-oxoglutarate metabolic processAspartate aminotransferase, cytoplasmicHomo sapiens (human)
oxaloacetate metabolic processAspartate aminotransferase, cytoplasmicHomo sapiens (human)
glycerol biosynthetic processAspartate aminotransferase, cytoplasmicHomo sapiens (human)
aspartate metabolic processAspartate aminotransferase, cytoplasmicHomo sapiens (human)
aspartate catabolic processAspartate aminotransferase, cytoplasmicHomo sapiens (human)
glutamate metabolic processAspartate aminotransferase, cytoplasmicHomo sapiens (human)
Notch signaling pathwayAspartate aminotransferase, cytoplasmicHomo sapiens (human)
glutamate catabolic process to aspartateAspartate aminotransferase, cytoplasmicHomo sapiens (human)
glutamate catabolic process to 2-oxoglutarateAspartate aminotransferase, cytoplasmicHomo sapiens (human)
cellular response to insulin stimulusAspartate aminotransferase, cytoplasmicHomo sapiens (human)
response to glucocorticoidAspartate aminotransferase, cytoplasmicHomo sapiens (human)
fatty acid homeostasisAspartate aminotransferase, cytoplasmicHomo sapiens (human)
aspartate biosynthetic processAspartate aminotransferase, cytoplasmicHomo sapiens (human)
MAPK cascadeAlpha-2B adrenergic receptorHomo sapiens (human)
angiogenesisAlpha-2B adrenergic receptorHomo sapiens (human)
regulation of vascular associated smooth muscle contractionAlpha-2B adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-2B adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-2B adrenergic receptorHomo sapiens (human)
female pregnancyAlpha-2B adrenergic receptorHomo sapiens (human)
negative regulation of norepinephrine secretionAlpha-2B adrenergic receptorHomo sapiens (human)
platelet activationAlpha-2B adrenergic receptorHomo sapiens (human)
activation of protein kinase B activityAlpha-2B adrenergic receptorHomo sapiens (human)
negative regulation of epinephrine secretionAlpha-2B adrenergic receptorHomo sapiens (human)
receptor transactivationAlpha-2B adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-2B adrenergic receptorHomo sapiens (human)
positive regulation of neuron differentiationAlpha-2B adrenergic receptorHomo sapiens (human)
positive regulation of blood pressureAlpha-2B adrenergic receptorHomo sapiens (human)
positive regulation of uterine smooth muscle contractionAlpha-2B adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayAlpha-2B adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-2B adrenergic 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)
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)
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)
cell population proliferationATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of B cell proliferationATPase family AAA domain-containing protein 5Homo sapiens (human)
nuclear DNA replicationATPase family AAA domain-containing protein 5Homo sapiens (human)
signal transduction in response to DNA damageATPase family AAA domain-containing protein 5Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorATPase family AAA domain-containing protein 5Homo sapiens (human)
isotype switchingATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of DNA replicationATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of isotype switching to IgG isotypesATPase family AAA domain-containing protein 5Homo sapiens (human)
DNA clamp unloadingATPase family AAA domain-containing protein 5Homo sapiens (human)
regulation of mitotic cell cycle phase transitionATPase family AAA domain-containing protein 5Homo sapiens (human)
negative regulation of intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of cell cycle G2/M phase transitionATPase family AAA domain-containing protein 5Homo sapiens (human)
negative regulation of receptor internalizationAtaxin-2Homo sapiens (human)
regulation of translationAtaxin-2Homo sapiens (human)
RNA metabolic processAtaxin-2Homo sapiens (human)
P-body assemblyAtaxin-2Homo sapiens (human)
stress granule assemblyAtaxin-2Homo sapiens (human)
RNA transportAtaxin-2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (141)

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)
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)
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)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M2Homo sapiens (human)
arrestin family protein bindingMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M4Homo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M4Homo 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)
phosphatidylinositol phospholipase C activityMuscarinic acetylcholine receptor M5Homo sapiens (human)
protein bindingMuscarinic acetylcholine receptor M5Homo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M5Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M5Homo sapiens (human)
alpha2-adrenergic receptor activityAlpha-2A adrenergic receptorHomo sapiens (human)
protein bindingAlpha-2A adrenergic receptorHomo sapiens (human)
protein kinase bindingAlpha-2A adrenergic receptorHomo sapiens (human)
alpha-1B adrenergic receptor bindingAlpha-2A adrenergic receptorHomo sapiens (human)
alpha-2C adrenergic receptor bindingAlpha-2A adrenergic receptorHomo sapiens (human)
thioesterase bindingAlpha-2A adrenergic receptorHomo sapiens (human)
heterotrimeric G-protein bindingAlpha-2A adrenergic receptorHomo sapiens (human)
protein homodimerization activityAlpha-2A adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-2A adrenergic receptorHomo sapiens (human)
epinephrine bindingAlpha-2A adrenergic receptorHomo sapiens (human)
norepinephrine bindingAlpha-2A adrenergic receptorHomo sapiens (human)
guanyl-nucleotide exchange factor activityAlpha-2A adrenergic receptorHomo sapiens (human)
phosphatidylinositol phospholipase C activityMuscarinic acetylcholine receptor M1Homo sapiens (human)
protein bindingMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M1Homo 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)
L-aspartate:2-oxoglutarate aminotransferase activityAspartate aminotransferase, cytoplasmicHomo sapiens (human)
phosphatidylserine decarboxylase activityAspartate aminotransferase, cytoplasmicHomo sapiens (human)
pyridoxal phosphate bindingAspartate aminotransferase, cytoplasmicHomo sapiens (human)
L-cysteine transaminase activityAspartate aminotransferase, cytoplasmicHomo sapiens (human)
alpha2-adrenergic receptor activityAlpha-2B adrenergic receptorHomo sapiens (human)
protein bindingAlpha-2B adrenergic receptorHomo sapiens (human)
epinephrine bindingAlpha-2B adrenergic 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)
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)
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 bindingATPase family AAA domain-containing protein 5Homo sapiens (human)
ATP bindingATPase family AAA domain-containing protein 5Homo sapiens (human)
ATP hydrolysis activityATPase family AAA domain-containing protein 5Homo sapiens (human)
DNA clamp unloader activityATPase family AAA domain-containing protein 5Homo sapiens (human)
DNA bindingATPase family AAA domain-containing protein 5Homo sapiens (human)
RNA bindingAtaxin-2Homo sapiens (human)
epidermal growth factor receptor bindingAtaxin-2Homo sapiens (human)
protein bindingAtaxin-2Homo sapiens (human)
mRNA bindingAtaxin-2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (95)

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 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)
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)
plasma membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
clathrin-coated endocytic vesicle membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
asymmetric synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
symmetric synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
presynaptic membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
neuronal cell bodyMuscarinic acetylcholine receptor M2Homo sapiens (human)
axon terminusMuscarinic acetylcholine receptor M2Homo sapiens (human)
postsynaptic membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
glutamatergic synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
cholinergic synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M2Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M4Homo sapiens (human)
postsynaptic membraneMuscarinic acetylcholine receptor M4Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M4Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M4Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M4Homo 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)
plasma membraneMuscarinic acetylcholine receptor M5Homo sapiens (human)
postsynaptic membraneMuscarinic acetylcholine receptor M5Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M5Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M5Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M5Homo sapiens (human)
cytoplasmAlpha-2A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2A adrenergic receptorHomo sapiens (human)
basolateral plasma membraneAlpha-2A adrenergic receptorHomo sapiens (human)
neuronal cell bodyAlpha-2A adrenergic receptorHomo sapiens (human)
axon terminusAlpha-2A adrenergic receptorHomo sapiens (human)
presynaptic active zone membraneAlpha-2A adrenergic receptorHomo sapiens (human)
dopaminergic synapseAlpha-2A adrenergic receptorHomo sapiens (human)
postsynaptic density membraneAlpha-2A adrenergic receptorHomo sapiens (human)
glutamatergic synapseAlpha-2A adrenergic receptorHomo sapiens (human)
GABA-ergic synapseAlpha-2A adrenergic receptorHomo sapiens (human)
receptor complexAlpha-2A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2A adrenergic receptorHomo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
presynaptic membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
axon terminusMuscarinic acetylcholine receptor M1Homo sapiens (human)
Schaffer collateral - CA1 synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
postsynaptic density membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
glutamatergic synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
cholinergic synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M1Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M1Homo 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)
nucleusAspartate aminotransferase, cytoplasmicHomo sapiens (human)
cytoplasmAspartate aminotransferase, cytoplasmicHomo sapiens (human)
cytosolAspartate aminotransferase, cytoplasmicHomo sapiens (human)
extracellular exosomeAspartate aminotransferase, cytoplasmicHomo sapiens (human)
cytosolAspartate aminotransferase, cytoplasmicHomo sapiens (human)
cytosolAlpha-2B adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2B adrenergic receptorHomo sapiens (human)
cell surfaceAlpha-2B adrenergic receptorHomo sapiens (human)
intracellular membrane-bounded organelleAlpha-2B adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2B adrenergic 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)
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 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)
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 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)
Elg1 RFC-like complexATPase family AAA domain-containing protein 5Homo sapiens (human)
nucleusATPase family AAA domain-containing protein 5Homo sapiens (human)
cytoplasmAtaxin-2Homo sapiens (human)
Golgi apparatusAtaxin-2Homo sapiens (human)
trans-Golgi networkAtaxin-2Homo sapiens (human)
cytosolAtaxin-2Homo sapiens (human)
cytoplasmic stress granuleAtaxin-2Homo sapiens (human)
membraneAtaxin-2Homo sapiens (human)
perinuclear region of cytoplasmAtaxin-2Homo sapiens (human)
ribonucleoprotein complexAtaxin-2Homo sapiens (human)
cytoplasmic stress granuleAtaxin-2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (289)

Assay IDTitleYearJournalArticle
AID1653802Substrate activity at human mARC1 expressed in Escherichia coli assessed as turnover rates at 200 uM pre-incubated for 3 mins followed by NADH addition and measured after 15 mins by LC-MS analysis based assay2020Journal of medicinal chemistry, 06-25, Volume: 63, Issue:12
Drug Metabolism by the Mitochondrial Amidoxime Reducing Component (mARC): Rapid Assay and Identification of New Substrates.
AID254754Inhibitory concentration against 5-hydroxytryptamine 2 receptor2005Journal of medicinal chemistry, Oct-20, Volume: 48, Issue:21
Designed multiple ligands. An emerging drug discovery paradigm.
AID330554Increase in phospho-AMPK level in paraventricular hyphalamic nuclei intact H1RKO mouse at 3 mg/kg, ip after 3 hrs by immunohistochemistry2007Proceedings 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.
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).
AID36199Binding affinity towards human alpha-2 adrenergic receptor2004Journal of medicinal chemistry, Mar-11, Volume: 47, Issue:6
Selective optimization of side activities: another way for drug discovery.
AID36116Binding affinity towards human alpha-1 adrenergic receptor2001Journal of medicinal chemistry, Feb-15, Volume: 44, Issue:4
Current and novel approaches to the drug treatment of schizophrenia.
AID1215943Metabolic stability in human intestinal S9 fraction assessed as compound remaining at 50 to 1000 nM after 60 mins by HPLC-MS/MS analysis2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Significance of reductive metabolism in human intestine and quantitative prediction of intestinal first-pass metabolism by cytosolic reductive enzymes.
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.
AID1393476Effect on failure incidence during conditioned avoidance response test in ip dosed Sprague-Dawley rat administered 60 mins prior to testing
AID3657Binding affinity towards human 5-hydroxytryptamine 1 receptor2001Journal of medicinal chemistry, Feb-15, Volume: 44, Issue:4
Current and novel approaches to the drug treatment of schizophrenia.
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).
AID588220Literature-mined public compounds from Kruhlak et al phospholipidosis modelling dataset2008Toxicology mechanisms and methods, , Volume: 18, Issue:2-3
Development of a phospholipidosis database and predictive quantitative structure-activity relationship (QSAR) models.
AID1682829Binding affinity to adrenergic alpha1 receptor (unknown origin)
AID1393482Reversal of ketamine-induced working social withdrawal in Sprague-Dawley rat at 1 mg/kg, ip pretreated for 60 mins followed by ketamine administration
AID63060Binding affinity towards human Dopamine receptor D22004Journal of medicinal chemistry, Mar-11, Volume: 47, Issue:6
Selective optimization of side activities: another way for drug discovery.
AID176744Dose inhibiting conditioned avoidance response in rats after oral administration1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
3-Benzisothiazolylpiperazine derivatives as potential atypical antipsychotic agents.
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.
AID714088Increase in DOPAC level in Sprague-Dawley rat striatum at 6.4 umol/kg, sc by HPLC analysis relative to saline-treated control2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Systematic in vivo screening of a series of 1-propyl-4-arylpiperidines against dopaminergic and serotonergic properties in rat brain: a scaffold-jumping approach.
AID374351Antiviral activity against BKV Gardner ATCC VR837 infected in human WI38 cells assessed as reduction in viral DNA level preincubated for 2 hrs before viral infection measured after 7 days by real time PCR assay2007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
BK Virus replication in vitro: limited effect of drugs interfering with viral uptake and intracellular transport.
AID63347Binding affinity towards human Dopamine receptor D12004Journal of medicinal chemistry, Mar-11, Volume: 47, Issue:6
Selective optimization of side activities: another way for drug discovery.
AID342778Binding affinity to human cloned dopamine D3 receptor2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Identification of a butyrophenone analog as a potential atypical antipsychotic agent: 4-[4-(4-chlorophenyl)-1,4-diazepan-1-yl]-1-(4-fluorophenyl)butan-1-one.
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.
AID420668Inhibition of human ERG in MCF7 cells2009European journal of medicinal chemistry, May, Volume: 44, Issue:5
GRIND-based 3D-QSAR and CoMFA to investigate topics dominated by hydrophobic interactions: the case of hERG K+ channel blockers.
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).
AID141100Binding affinity towards human muscarinic receptor2004Journal of medicinal chemistry, Mar-11, Volume: 47, Issue:6
Selective optimization of side activities: another way for drug discovery.
AID313956Displacement of [3H]8OHDPAT from human 5HT1A receptor2008Bioorganic & medicinal chemistry letters, Jan-15, Volume: 18, Issue:2
1-Aminoindanes as novel motif with potential atypical antipsychotic properties.
AID176735Dose (administered orally) inhibiting spontaneous locomotor behavior in rats1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
3-Benzisothiazolylpiperazine derivatives as potential atypical antipsychotic agents.
AID1653792Substrate activity at human mARC1 expressed in Escherichia coli assessed as turnover rates at 200 uM pre-incubated for 3 mins followed by NADH addition and measured after 15 mins by UV-Visible spectroscopy based NADH assay2020Journal of medicinal chemistry, 06-25, Volume: 63, Issue:12
Drug Metabolism by the Mitochondrial Amidoxime Reducing Component (mARC): Rapid Assay and Identification of New Substrates.
AID313953Displacement of [3H]spiperone from human D2L receptor expressed in CHO cells2008Bioorganic & medicinal chemistry letters, Jan-15, Volume: 18, Issue:2
1-Aminoindanes as novel motif with potential atypical antipsychotic properties.
AID342781Binding affinity to human cloned 5HT2C receptor2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Identification of a butyrophenone analog as a potential atypical antipsychotic agent: 4-[4-(4-chlorophenyl)-1,4-diazepan-1-yl]-1-(4-fluorophenyl)butan-1-one.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID342783Binding affinity to human cloned 5HT1A receptor2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Identification of a butyrophenone analog as a potential atypical antipsychotic agent: 4-[4-(4-chlorophenyl)-1,4-diazepan-1-yl]-1-(4-fluorophenyl)butan-1-one.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID1054116Binding affinity to 5HT2C receptor (unknown origin) by radioligand binding assay2013Journal of medicinal chemistry, Nov-27, Volume: 56, Issue:22
Polypharmacology - foe or friend?
AID1215949Metabolic stability in human intestinal cytosol at 200 nM after 60 mins in presence of menadione2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Significance of reductive metabolism in human intestine and quantitative prediction of intestinal first-pass metabolism by cytosolic reductive enzymes.
AID705396Antipsychotic activity in sc dosed rat prepulse inhibition model2012Journal of medicinal chemistry, Sep-13, Volume: 55, Issue:17
Current landscape of phosphodiesterase 10A (PDE10A) inhibition.
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.
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.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
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.
AID1393472Antipsychotic activity in ip dosed Sprague-Dawley rat assessed as suppression of avoidance behavior by avoiding foot shock administered 60 mins prior to test by conditioned avoidance response test
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.
AID420669Lipophilicity, log D at pH 7.02009European journal of medicinal chemistry, May, Volume: 44, Issue:5
GRIND-based 3D-QSAR and CoMFA to investigate topics dominated by hydrophobic interactions: the case of hERG K+ channel blockers.
AID1215940Unbound intrinsic clearance in human liver S9 fraction at 50 to 1000 nM after 30 to 60 mins by HPLC-MS/MS analysis2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Significance of reductive metabolism in human intestine and quantitative prediction of intestinal first-pass metabolism by cytosolic reductive enzymes.
AID342774Binding affinity to human cloned muscarinic M1 receptor2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Identification of a butyrophenone analog as a potential atypical antipsychotic agent: 4-[4-(4-chlorophenyl)-1,4-diazepan-1-yl]-1-(4-fluorophenyl)butan-1-one.
AID1393366Displacement of [3H]-8-OH-DPAT from human 5-HT1AR expressed in HEK293 cell membranes after 1 hr by microbeta counting method
AID1054120Binding affinity to dopamine D2 receptor (unknown origin) by radioligand binding assay2013Journal of medicinal chemistry, Nov-27, Volume: 56, Issue:22
Polypharmacology - foe or friend?
AID1653797Substrate activity at human mARC2 expressed in Escherichia coli assessed as turnover rates at 200 uM pre-incubated for 3 mins followed by NADH addition and measured after 15 mins by UV-Visible spectroscopy based NADH assay2020Journal of medicinal chemistry, 06-25, Volume: 63, Issue:12
Drug Metabolism by the Mitochondrial Amidoxime Reducing Component (mARC): Rapid Assay and Identification of New Substrates.
AID313958Displacement of [3H]dofetilide from human ERG channel expressed in HEK293 cells2008Bioorganic & medicinal chemistry letters, Jan-15, Volume: 18, Issue:2
1-Aminoindanes as novel motif with potential atypical antipsychotic properties.
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.
AID444055Fraction absorbed in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID342782Binding affinity to human cloned histamine H1 receptor2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Identification of a butyrophenone analog as a potential atypical antipsychotic agent: 4-[4-(4-chlorophenyl)-1,4-diazepan-1-yl]-1-(4-fluorophenyl)butan-1-one.
AID1595147Displacement of [3H] raclopride from human recombinant D2L receptor expressed in HEK293 cells measured after 1 hr by microbeta scintillation counting method
AID1682828Binding affinity to H1 histamine receptor (unknown origin)
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).
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.
AID176743Dose inducing catalepsy in rats after oral administration1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
3-Benzisothiazolylpiperazine derivatives as potential atypical antipsychotic agents.
AID1393467Toxicity in Wistar rat assessed as increase in prolactin level at 3 mg/kg, po after 60 mins by ELISA
AID1215955Apparent permeability of the compound at 50 uM at pH 7.4 after 240 mins by PAMPA2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Significance of reductive metabolism in human intestine and quantitative prediction of intestinal first-pass metabolism by cytosolic reductive enzymes.
AID1215938Unbound intrinsic clearance in human liver cytosol at 50 to 1000 nM after 30 to 60 mins by HPLC-MS/MS analysis2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Significance of reductive metabolism in human intestine and quantitative prediction of intestinal first-pass metabolism by cytosolic reductive enzymes.
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.
AID444056Fraction escaping gut-wall elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID63537Binding affinity towards human dopamine receptor D42001Journal of medicinal chemistry, Feb-15, Volume: 44, Issue:4
Current and novel approaches to the drug treatment of schizophrenia.
AID176734Dose (administered orally) inhibiting apomorphine-induced stereotypy in rats1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
3-Benzisothiazolylpiperazine derivatives as potential atypical antipsychotic agents.
AID5614Binding affinity towards human serotonin 5-hydroxytryptamine 2C receptor2004Journal of medicinal chemistry, Mar-11, Volume: 47, Issue:6
Selective optimization of side activities: another way for drug discovery.
AID1215935Unbound intrinsic clearance in human intestinal microsomes at 50 to 1000 nM after 30 to 60 mins by HPLC-MS/MS analysis2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Significance of reductive metabolism in human intestine and quantitative prediction of intestinal first-pass metabolism by cytosolic reductive enzymes.
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.
AID63345Binding affinity against dopamine receptor D12001Journal of medicinal chemistry, Feb-15, Volume: 44, Issue:4
Current and novel approaches to the drug treatment of schizophrenia.
AID468443Inhibition of human FAAH at 1 uM2009Bioorganic & medicinal chemistry letters, Dec-01, Volume: 19, Issue:23
Mining biologically-active molecules for inhibitors of fatty acid amide hydrolase (FAAH): identification of phenmedipham and amperozide as FAAH inhibitors.
AID1215939Unbound intrinsic clearance in human intestinal S9 fraction at 50 to 1000 nM after 30 to 60 mins by HPLC-MS/MS analysis2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Significance of reductive metabolism in human intestine and quantitative prediction of intestinal first-pass metabolism by cytosolic reductive enzymes.
AID1556426Displacement of [3H]-methylspiperone from human D2 long receptor expressed in HEK293 cells measured after 1 hr by liquid scintillation counter method2019European journal of medicinal chemistry, Oct-01, Volume: 1792-Aminoimidazole-based antagonists of the 5-HT
AID1578090Unbound brain-to-plasma concentration ratio in rat2019European journal of medicinal chemistry, Nov-15, Volume: 182Practical approaches to evaluating and optimizing brain exposure in early drug discovery.
AID254726Inhibitory concentration against alpha adrenergic receptor2005Journal of medicinal chemistry, Oct-20, Volume: 48, Issue:21
Designed multiple ligands. An emerging drug discovery paradigm.
AID1054114Binding affinity to 5HT7 receptor (unknown origin) by radioligand binding assay2013Journal of medicinal chemistry, Nov-27, Volume: 56, Issue:22
Polypharmacology - foe or friend?
AID5199Binding affinity for human 5-hydroxytryptamine 2A receptor2001Journal of medicinal chemistry, Feb-15, Volume: 44, Issue:4
Current and novel approaches to the drug treatment of schizophrenia.
AID419436Lipophilicity, log P of the compound2009Bioorganic & medicinal chemistry letters, Jun-01, Volume: 19, Issue:11
Synthesis and evaluation of 1-(quinoliloxypropyl)-4-aryl piperazines for atypical antipsychotic effect.
AID705400Antipsychotic activity in sc dosed rat by conditioned avoidance response test2012Journal of medicinal chemistry, Sep-13, Volume: 55, Issue:17
Current landscape of phosphodiesterase 10A (PDE10A) inhibition.
AID714109Displacement of [3H]methylspiperone from human low affinity Dopamine D2S receptor by competition binding assay2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Systematic in vivo screening of a series of 1-propyl-4-arylpiperidines against dopaminergic and serotonergic properties in rat brain: a scaffold-jumping approach.
AID35277Displacement of [3H]prazosin from Alpha-1 adrenergic receptor in rat brain1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
3-Benzisothiazolylpiperazine derivatives as potential atypical antipsychotic agents.
AID65713Displacement of [3H]NPA from rat brain Dopamine receptor D21996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
3-Benzisothiazolylpiperazine derivatives as potential atypical antipsychotic agents.
AID714104Increase in DOPAC level in sc dosed Sprague-Dawley rat striatum by HPLC analysis2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Systematic in vivo screening of a series of 1-propyl-4-arylpiperidines against dopaminergic and serotonergic properties in rat brain: a scaffold-jumping approach.
AID714107Displacement of [3H]imipramine from human SERT expressed in CHO cells by competition binding assay2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Systematic in vivo screening of a series of 1-propyl-4-arylpiperidines against dopaminergic and serotonergic properties in rat brain: a scaffold-jumping approach.
AID444054Oral bioavailability in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID714105Displacement of [3H]Ro 41-1049 from MAO-A in rat cerebral cortex by competition binding assay2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Systematic in vivo screening of a series of 1-propyl-4-arylpiperidines against dopaminergic and serotonergic properties in rat brain: a scaffold-jumping approach.
AID36197Binding affinity towards human alpha-2 adrenergic receptor2001Journal of medicinal chemistry, Feb-15, Volume: 44, Issue:4
Current and novel approaches to the drug treatment of schizophrenia.
AID231369Ratio representing inhibitory activity against catalepsy to inhibitory activity against amphetamine-induced locomotor behavior in rats1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
3-Benzisothiazolylpiperazine derivatives as potential atypical antipsychotic agents.
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.
AID1193218Displacement of [3H]-SB269970 from 5-HT7 receptor (unknown origin) at 10 uM after 60 mins2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
In vitro and in silico evaluation of twelve newly-synthesized 1-acetamide-5-methoxy-2-oxindoles as 5-Ht₇ receptor ligands.
AID342786Binding affinity to rat NET2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Identification of a butyrophenone analog as a potential atypical antipsychotic agent: 4-[4-(4-chlorophenyl)-1,4-diazepan-1-yl]-1-(4-fluorophenyl)butan-1-one.
AID36016Displacement of [3H]prazosin from rat brain Alpha-1 adrenergic receptor1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
3-Benzisothiazolylpiperazine derivatives as potential atypical antipsychotic agents.
AID1054119Binding affinity to 5HT2A receptor (unknown origin) by radioligand binding assay2013Journal of medicinal chemistry, Nov-27, Volume: 56, Issue:22
Polypharmacology - foe or friend?
AID231370Ratio representing inhibitory activity against spontaneous locomotor behavior to inhibitory activity against amphetamine-induced stereotypy in rats1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
3-Benzisothiazolylpiperazine derivatives as potential atypical antipsychotic agents.
AID705399Antipsychotic activity in sc dosed rat assessed as decrease in spontaneous locomotor activity2012Journal of medicinal chemistry, Sep-13, Volume: 55, Issue:17
Current landscape of phosphodiesterase 10A (PDE10A) inhibition.
AID227557In vitro ability to displace [3H]ketanserin from 5-hydroxytryptamine 2A receptor in rat brain1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
3-Benzisothiazolylpiperazine derivatives as potential atypical antipsychotic agents.
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.
AID65785Binding affinity towards human Dopamine receptor D32004Journal of medicinal chemistry, Mar-11, Volume: 47, Issue:6
Selective optimization of side activities: another way for drug discovery.
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).
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).
AID342773Binding affinity to human cloned 5HT6 receptor2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Identification of a butyrophenone analog as a potential atypical antipsychotic agent: 4-[4-(4-chlorophenyl)-1,4-diazepan-1-yl]-1-(4-fluorophenyl)butan-1-one.
AID1393468Antipsychotic activity in ip dosed Sprague-Dawley rat assessed as reduction in PCP-induced hyper-locomotion pretreated for 60 mins followed by PCP addition measured for 30 mins starting 15 min after rat reintroduction to auto-tracks
AID1215944Intrinsic clearance in human intestinal S9 fraction at 50 to 1000 nM after 60 mins by HPLC-MS/MS analysis2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Significance of reductive metabolism in human intestine and quantitative prediction of intestinal first-pass metabolism by cytosolic reductive enzymes.
AID227559Relative binding affinity for dopamine D2 and alpha receptors1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
3-Benzisothiazolylpiperazine derivatives as potential atypical antipsychotic agents.
AID705398Antipsychotic activity in sc dosed rat assessed as decrease in phencyclidine-induced locomotor activity2012Journal of medicinal chemistry, Sep-13, Volume: 55, Issue:17
Current landscape of phosphodiesterase 10A (PDE10A) inhibition.
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.
AID1393475Reversal of ketamine-induced cognitive flexibility in ip dosed Sprague-Dawley rat administered 30 mins prior to ketamine administration by attentional set-shifting test
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID539466Solubility of the compound2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Experimental solubility profiling of marketed CNS drugs, exploring solubility limit of CNS discovery candidate.
AID313955Displacement of [3H]ketanserin from human 5HT2A receptor expressed in Swiss 3T3 cells2008Bioorganic & medicinal chemistry letters, Jan-15, Volume: 18, Issue:2
1-Aminoindanes as novel motif with potential atypical antipsychotic properties.
AID1506227Binding affinity to DRD2 (unknown origin)
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID444052Hepatic clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1215947Unbound intrinsic clearance in human intestinal S9 fraction at 50 to 1000 nM after 30 to 60 mins by HPLC-MS/MS analysis in presence of NADH2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Significance of reductive metabolism in human intestine and quantitative prediction of intestinal first-pass metabolism by cytosolic reductive enzymes.
AID1393365Displacement of [3H]-LSD from human 5-HT6R expressed in HEK293 cell membranes after 1 hr at 37 degC by microbeta counting method
AID1506225Binding affinity to HRH1 (unknown origin)
AID397743Inhibition of human ERG channel2009Journal of medicinal chemistry, Jul-23, Volume: 52, Issue:14
Side chain flexibilities in the human ether-a-go-go related gene potassium channel (hERG) together with matched-pair binding studies suggest a new binding mode for channel blockers.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID1215948Unbound intrinsic clearance in human intestinal S9 fraction at 50 to 1000 nM after 30 to 60 mins by HPLC-MS/MS analysis in presence of NADPH2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Significance of reductive metabolism in human intestine and quantitative prediction of intestinal first-pass metabolism by cytosolic reductive enzymes.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID592681Apparent permeability across human Caco2 cell membrane after 2 hrs by LC-MS/MS analysis2011Bioorganic & medicinal chemistry, Apr-15, Volume: 19, Issue:8
QSAR-based permeability model for drug-like compounds.
AID87226Binding affinity towards human H1 receptor2001Journal of medicinal chemistry, Feb-15, Volume: 44, Issue:4
Current and novel approaches to the drug treatment of schizophrenia.
AID342779Binding affinity to human cloned dopamine D4 receptor2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Identification of a butyrophenone analog as a potential atypical antipsychotic agent: 4-[4-(4-chlorophenyl)-1,4-diazepan-1-yl]-1-(4-fluorophenyl)butan-1-one.
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.
AID1215936Unbound intrinsic clearance in human liver microsomes at 50 to 1000 nM after 30 to 60 mins by HPLC-MS/MS analysis2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Significance of reductive metabolism in human intestine and quantitative prediction of intestinal first-pass metabolism by cytosolic reductive enzymes.
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.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
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.
AID714108Displacement of [3H]7-OH-DPAT from human high affinity Dopamine D2S receptor by competition binding assay2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Systematic in vivo screening of a series of 1-propyl-4-arylpiperidines against dopaminergic and serotonergic properties in rat brain: a scaffold-jumping approach.
AID1393369Selectivity index, ratio of pKi for 5-HT2AR to pKi for human D2LR
AID444050Fraction unbound in human plasma2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
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.
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.
AID5573Relative binding affinity for D2 receptor and 5-hydroxytryptamine 2A receptor, ratio of Ki1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
3-Benzisothiazolylpiperazine derivatives as potential atypical antipsychotic agents.
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).
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.
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.
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID61808Binding affinity towards human dopamine-4.2 receptor2004Journal of medicinal chemistry, Mar-11, Volume: 47, Issue:6
Selective optimization of side activities: another way for drug discovery.
AID1054113Binding affinity to adrenergic alpha1 receptor (unknown origin) by radioligand binding assay2013Journal of medicinal chemistry, Nov-27, Volume: 56, Issue:22
Polypharmacology - foe or friend?
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).
AID1215951Drug metabolism in human intestinal cytosol at 200 nM after 60 mins in presence of flufenamic acid2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Significance of reductive metabolism in human intestine and quantitative prediction of intestinal first-pass metabolism by cytosolic reductive enzymes.
AID567091Drug absorption in human assessed as human intestinal absorption rate2011European journal of medicinal chemistry, Jan, Volume: 46, Issue:1
Prediction of drug intestinal absorption by new linear and non-linear QSPR.
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.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1430534Displacement of [3H]-Raclopride from D2L receptor (unknown origin)
AID63811Displacement of [3H]NPA from rat brain Dopamine receptor D21996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
3-Benzisothiazolylpiperazine derivatives as potential atypical antipsychotic agents.
AID476929Human intestinal absorption in po dosed human2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Neural computational prediction of oral drug absorption based on CODES 2D descriptors.
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.
AID313957Displacement of [3H]prazosin from rat adrenergic alpha1A receptor expressed in fibroblast cells2008Bioorganic & medicinal chemistry letters, Jan-15, Volume: 18, Issue:2
1-Aminoindanes as novel motif with potential atypical antipsychotic properties.
AID1054115Binding affinity to 5HT6 receptor (unknown origin) by radioligand binding assay2013Journal of medicinal chemistry, Nov-27, Volume: 56, Issue:22
Polypharmacology - foe or friend?
AID1215953Drug metabolism in human intestinal cytosol at 200 nM after 60 mins in presence of ondansetron2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Significance of reductive metabolism in human intestine and quantitative prediction of intestinal first-pass metabolism by cytosolic reductive enzymes.
AID254688Inhibitory concentration against dopamine receptor D22005Journal of medicinal chemistry, Oct-20, Volume: 48, Issue:21
Designed multiple ligands. An emerging drug discovery paradigm.
AID311524Oral bioavailability in human2007Bioorganic & medicinal chemistry, Dec-15, Volume: 15, Issue:24
Hologram QSAR model for the prediction of human oral bioavailability.
AID222148K+ channel blocking activity in human embryonic kidney cells expressing HERG Kv11.12002Journal of medicinal chemistry, Aug-29, Volume: 45, Issue:18
Toward a pharmacophore for drugs inducing the long QT syndrome: insights from a CoMFA study of HERG K(+) channel blockers.
AID87242Binding affinity towards human histamine H1 receptor2004Journal of medicinal chemistry, Mar-11, Volume: 47, Issue:6
Selective optimization of side activities: another way for drug discovery.
AID1653807Substrate activity at human mARC2 expressed in Escherichia coli assessed as turnover rates at 200 uM pre-incubated for 3 mins followed by NADH addition and measured after 15 mins by LC-MS analysis based assay2020Journal of medicinal chemistry, 06-25, Volume: 63, Issue:12
Drug Metabolism by the Mitochondrial Amidoxime Reducing Component (mARC): Rapid Assay and Identification of New Substrates.
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).
AID1215937Unbound intrinsic clearance in human intestinal cytosol at 50 to 1000 nM after 30 to 60 mins by HPLC-MS/MS analysis2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Significance of reductive metabolism in human intestine and quantitative prediction of intestinal first-pass metabolism by cytosolic reductive enzymes.
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.
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).
AID503306Antiproliferative activity against human PC3 cells at 2 uM after 120 hrs by MTT assay relative to DMSO2006Nature chemical biology, Jun, Volume: 2, Issue:6
Identifying off-target effects and hidden phenotypes of drugs in human cells.
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.
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.
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).
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1054117Binding affinity to dopamine D3 receptor (unknown origin) by radioligand binding assay2013Journal of medicinal chemistry, Nov-27, Volume: 56, Issue:22
Polypharmacology - foe or friend?
AID1079945Animal toxicity known. [column 'TOXIC' in source]
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.
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID243151Inhibitory concentration against potassium channel HERG2005Bioorganic & medicinal chemistry letters, Jun-02, Volume: 15, Issue:11
A discriminant model constructed by the support vector machine method for HERG potassium channel inhibitors.
AID141174Binding affinity towards human M1 receptor.2001Journal of medicinal chemistry, Feb-15, Volume: 44, Issue:4
Current and novel approaches to the drug treatment of schizophrenia.
AID1578087Brain to plasma partition coefficient, Kp of the compound in rat2019European journal of medicinal chemistry, Nov-15, Volume: 182Practical approaches to evaluating and optimizing brain exposure in early drug discovery.
AID1393471Reversal of PCP-induced cognitive impairment in ip dosed Sprague-Dawley rat assessed as reduction in time spent exploring novel object over familiar object pretreated for 60 mins followed by PCP addition by novel object recognition assay
AID408340Inhibition of human ERG expressed in CHO cells by whole cell patch clamp technique2008Bioorganic & medicinal chemistry, Jun-01, Volume: 16, Issue:11
Support vector machines classification of hERG liabilities based on atom types.
AID444057Fraction escaping hepatic elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
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).
AID444053Renal clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
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.
AID176733Dose (administered orally) inhibiting amphetamine-induced locomotor behavior in rats1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
3-Benzisothiazolylpiperazine derivatives as potential atypical antipsychotic agents.
AID342777Binding affinity to human cloned dopamine D2 receptor2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Identification of a butyrophenone analog as a potential atypical antipsychotic agent: 4-[4-(4-chlorophenyl)-1,4-diazepan-1-yl]-1-(4-fluorophenyl)butan-1-one.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID342784Binding affinity to human cloned 5HT2A receptor2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Identification of a butyrophenone analog as a potential atypical antipsychotic agent: 4-[4-(4-chlorophenyl)-1,4-diazepan-1-yl]-1-(4-fluorophenyl)butan-1-one.
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.
AID1393470Therapeutic index, ratio of MED for sedation in ip dosed Sprague-Dawley rat to MED for antipsychotic activity in ip dosed Sprague-Dawley rat assessed as reduction in PCP-induced hyper-locomotion
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.
AID65121Binding affinity towards human dopamine receptor D32001Journal of medicinal chemistry, Feb-15, Volume: 44, Issue:4
Current and novel approaches to the drug treatment of schizophrenia.
AID1520010Displacement of [3H]-raclopride from human D2R expressed in HEK293 cells after 1 hr by microbeta plate reader analysis
AID1393523Toxicity in Sprague-Dawley rat assessed as induction of catalepsy at 30 mg/kg, ip measured every 30 mins up to 240 mins by bar test
AID444058Volume of distribution at steady state in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
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).
AID5616Binding affinity towards human 5-hydroxytryptamine 2C receptor2001Journal of medicinal chemistry, Feb-15, Volume: 44, Issue:4
Current and novel approaches to the drug treatment of schizophrenia.
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.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID1393367Displacement of [3H]-5-CT from human 5-HT7R expressed in HEK293 cell membranes after 1 hr at 37 degC by microbeta counting method
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.
AID243189Inhibition of partially open human voltage-gated potassium channel subunit Kv11.1 (ERG K+ channel)2005Bioorganic & medicinal chemistry letters, Mar-15, Volume: 15, Issue:6
A two-state homology model of the hERG K+ channel: application to ligand binding.
AID1393364Displacement of [3H]-ketanserin from human 5-HT2AR expressed in CHO-K1 cell membranes after 1.5 hrs by microbeta counting method
AID1850916Inhibition of GOT1 (unknown origin)2022Bioorganic & medicinal chemistry letters, 10-01, Volume: 73The discovery of a non-competitive GOT1 inhibitor, hydralazine hydrochloride, via a coupling reaction-based high-throughput screening assay.
AID1506226Binding affinity to 5-HT2A (unknown origin)
AID444051Total clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
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.
AID342775Binding affinity to human cloned dopamine D1 receptor2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Identification of a butyrophenone analog as a potential atypical antipsychotic agent: 4-[4-(4-chlorophenyl)-1,4-diazepan-1-yl]-1-(4-fluorophenyl)butan-1-one.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID714083Decrease in 5-HIAA level in Sprague-Dawley rat striatum at 6.4 umol/kg, sc by HPLC analysis relative to saline-treated control2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Systematic in vivo screening of a series of 1-propyl-4-arylpiperidines against dopaminergic and serotonergic properties in rat brain: a scaffold-jumping approach.
AID5197Binding affinity towards human serotonin 5-hydroxytryptamine 2A receptor2004Journal of medicinal chemistry, Mar-11, Volume: 47, Issue:6
Selective optimization of side activities: another way for drug discovery.
AID1393368Displacement of [3H]-raclopride from human D2LR expressed in HEK293 cell membranes after 1 hr at 37 degC by microbeta counting method
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.
AID374353Cytotoxicity against human WI38 cells assessed as reduction in cellular DNA level preincubated for 2 hrs before viral infection measured after 7 days by real time PCR assay2007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
BK Virus replication in vitro: limited effect of drugs interfering with viral uptake and intracellular transport.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
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.
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.
AID1393469Toxicity in ip dosed Sprague-Dawley rat assessed as sedation pretreated for 60 mins followed by PCP addition measured for 30 mins starting 15 min after rat reintroduction to auto-tracks
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID36113Binding affinity towards human alpha-1 adrenergic receptor2004Journal of medicinal chemistry, Mar-11, Volume: 47, Issue:6
Selective optimization of side activities: another way for drug discovery.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
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).
AID714093Reduction in spontaneous locomotor activity in Sprague-Dawley rat at 6.4 umol/kg, sc measured after 15 to 60 mins relative to saline-treated control2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Systematic in vivo screening of a series of 1-propyl-4-arylpiperidines against dopaminergic and serotonergic properties in rat brain: a scaffold-jumping approach.
AID342787Binding affinity to human SERT2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Identification of a butyrophenone analog as a potential atypical antipsychotic agent: 4-[4-(4-chlorophenyl)-1,4-diazepan-1-yl]-1-(4-fluorophenyl)butan-1-one.
AID63070Binding affinity towards human D2 dopamine receptor.2001Journal of medicinal chemistry, Feb-15, Volume: 44, Issue:4
Current and novel approaches to the drug treatment of schizophrenia.
AID705397Antipsychotic activity in sc dosed rat assessed as decrease in amphetamine-induced spontaneous locomotor activity2012Journal of medicinal chemistry, Sep-13, Volume: 55, Issue:17
Current landscape of phosphodiesterase 10A (PDE10A) inhibition.
AID5328Displacement of [3H]-ketanserin from rat brain 5-hydroxytryptamine 2A receptor1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
3-Benzisothiazolylpiperazine derivatives as potential atypical antipsychotic agents.
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.
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.
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.
AID1259419Human 5-HT2A receptor (5-Hydroxytryptamine receptors)2009Journal of psychopharmacology (Oxford, England), Jan, Volume: 23, Issue:1
Asenapine: a novel psychopharmacologic agent with a unique human receptor signature.
AID624223Antagonists 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.
AID1346603Human 5-ht1e receptor (5-Hydroxytryptamine receptors)1996Psychopharmacology, Mar, Volume: 124, Issue:1-2
Risperidone compared with new and reference antipsychotic drugs: in vitro and in vivo receptor binding.
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.
AID1346528Human 5-HT1D receptor (5-Hydroxytryptamine receptors)1996Psychopharmacology, Mar, Volume: 124, Issue:1-2
Risperidone compared with new and reference antipsychotic drugs: in vitro and in vivo receptor binding.
AID624210Agonists at Human 5-Hydroxytryptamine receptor 5-HT1A1996Psychopharmacology, Mar, Volume: 124, Issue:1-2
Risperidone compared with new and reference antipsychotic drugs: in vitro and in vivo receptor binding.
AID1345788Human D2 receptor (Dopamine receptors)1998Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, Feb, Volume: 18, Issue:2
Do novel antipsychotics have similar pharmacological characteristics? A review of the evidence.
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.
AID1346037Human H1 receptor (Histamine receptors)1996Psychopharmacology, Mar, Volume: 124, Issue:1-2
Risperidone compared with new and reference antipsychotic drugs: in vitro and in vivo receptor binding.
AID1346893Human 5-HT2C receptor (5-Hydroxytryptamine receptors)2000The Journal of pharmacology and experimental therapeutics, Oct, Volume: 295, Issue:1
Inverse agonist activity of atypical antipsychotic drugs at human 5-hydroxytryptamine2C receptors.
AID624210Agonists at Human 5-Hydroxytryptamine receptor 5-HT1A1998European journal of pharmacology, Aug-21, Volume: 355, Issue:2-3
Agonist and antagonist actions of antipsychotic agents at 5-HT1A receptors: a [35S]GTPgammaS binding study.
AID624223Antagonists at Human 5-Hydroxytryptamine receptor 5-HT2A2002European journal of pharmacology, Aug-16, Volume: 450, Issue:1
A comparison of the receptor binding and HERG channel affinities for a series of antipsychotic drugs.
AID624230Agonists at Human 5-Hydroxytryptamine receptor 5-ht1e1996Psychopharmacology, Mar, Volume: 124, Issue:1-2
Risperidone compared with new and reference antipsychotic drugs: in vitro and in vivo receptor binding.
AID1346893Human 5-HT2C receptor (5-Hydroxytryptamine receptors)2009Journal of psychopharmacology (Oxford, England), Jan, Volume: 23, Issue:1
Asenapine: a novel psychopharmacologic agent with a unique human receptor signature.
AID1345615Human 5-HT1A receptor (5-Hydroxytryptamine receptors)1996Psychopharmacology, Mar, Volume: 124, Issue:1-2
Risperidone compared with new and reference antipsychotic drugs: in vitro and in vivo receptor binding.
AID624223Antagonists at Human 5-Hydroxytryptamine receptor 5-HT2A1996Psychopharmacology, Mar, Volume: 124, Issue:1-2
Risperidone compared with new and reference antipsychotic drugs: in vitro and in vivo receptor binding.
AID1259419Human 5-HT2A receptor (5-Hydroxytryptamine receptors)1996Psychopharmacology, Mar, Volume: 124, Issue:1-2
Risperidone compared with new and reference antipsychotic drugs: in vitro and in vivo receptor binding.
AID1259419Human 5-HT2A receptor (5-Hydroxytryptamine receptors)2002European journal of pharmacology, Aug-16, Volume: 450, Issue:1
A comparison of the receptor binding and HERG channel affinities for a series of antipsychotic drugs.
AID1346264Human 5-HT1B receptor (5-Hydroxytryptamine receptors)1996Psychopharmacology, Mar, Volume: 124, Issue:1-2
Risperidone compared with new and reference antipsychotic drugs: in vitro and in vivo receptor binding.
AID1346944Rat NET (Monoamine transporter subfamily)2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Identification of a butyrophenone analog as a potential atypical antipsychotic agent: 4-[4-(4-chlorophenyl)-1,4-diazepan-1-yl]-1-(4-fluorophenyl)butan-1-one.
AID1345291Human 5-HT7 receptor (5-Hydroxytryptamine receptors)2005Psychopharmacology, May, Volume: 179, Issue:2
Stable expression of constitutively activated mutant h5HT6 and h5HT7 serotonin receptors: inverse agonist activity of antipsychotic drugs.
AID1345615Human 5-HT1A receptor (5-Hydroxytryptamine receptors)1998European journal of pharmacology, Aug-21, Volume: 355, Issue:2-3
Agonist and antagonist actions of antipsychotic agents at 5-HT1A receptors: a [35S]GTPgammaS binding study.
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.
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.
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.
AID1347088qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): Viability assay - Alamar blue signal for LCMV Confirmatory Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347087qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Confirmatory Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347084qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Confirmatory Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347049Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot screen2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1347081qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Confirmatory Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
AID1745845Primary qHTS for Inhibitors of ATXN expression
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
AID1347164384 well plate NINDS Rhodamine confirmatory 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.
AID1347163384 well plate NINDS AMC confirmatory 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.
AID1347159Primary screen GU Rhodamine qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings 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.
AID1347160Primary screen NINDS Rhodamine 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.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (988)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's30 (3.04)18.2507
2000's529 (53.54)29.6817
2010's379 (38.36)24.3611
2020's50 (5.06)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 93.42

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 Index93.42 (24.57)
Research Supply Index7.19 (2.92)
Research Growth Index5.42 (4.65)
Search Engine Demand Index169.18 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (93.42)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials254 (23.78%)5.53%
Reviews168 (15.73%)6.00%
Case Studies203 (19.01%)4.05%
Observational3 (0.28%)0.25%
Other440 (41.20%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (132)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Efficacy and Safety With Ziprasidone in the Treatment of First-episode Schizophrenia Spectrum Disorder: Multi-center Study [NCT01157559]Phase 427 participants (Actual)InterventionalCompleted
Ziprasidone in Pediatric Bipolar Disorder: a 6-week, Open-label Comparison of Rapid vs. Slow Dose Titration [NCT00622739]Phase 428 participants (Actual)Interventional2007-02-28Completed
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
Four Week, Double Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) [NCT01117220]Phase 30 participants (Actual)Interventional2010-06-30Withdrawn
26-WEEK OPEN-LABEL EXTENSION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPOLAR I DISORDER (MOST RECENT EPISODE MANIC) [NCT03768726]Phase 323 participants (Actual)Interventional2018-12-21Terminated(stopped due to Pfizer has decided to perform the pre-specified final analysis at the current enrollment using a re-estimation of the sample size.)
A Randomized, Double-Blind, Placebo-Controlled Study of Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder [NCT01172652]Phase 449 participants (Actual)Interventional2010-04-30Completed
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
26 Week Open Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) [NCT01124877]Phase 30 participants (Actual)Interventional2010-07-31Withdrawn
Study Evaluating Effectiveness of Ziprasidone Using the Overlapped Switching Strategy in Patients With Schizophrenia or Schizoaffective Disorder [NCT01198353]Phase 467 participants (Actual)Interventional2010-09-30Completed
An Observational Drug Utilization Study of SYCREST^® (Asenapine) in the United Kingdom [NCT01498770]42 participants (Actual)Observational2013-04-01Completed
Four Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) [NCT00257166]Phase 3238 participants (Actual)Interventional2006-01-31Completed
Outcomes of Antipsychotic Medication Use in the Emergency Department: A Retrospective Comparison Study [NCT02504450]93 participants (Actual)Observational2015-04-30Completed
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
An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression [NCT00835107]Phase 414 participants (Actual)Interventional2009-02-28Completed
Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics for the Prevention of Relapse in Long-term Stabilized Schizophrenic Patients: a Randomized, Single-blind, Longitudinal Trial [NCT02307396]Phase 421 participants (Actual)Interventional2015-02-01Completed
Randomized, 2-way Crossover, Bioequivalence Study of Ziprasidone HCL Capsules, 20 mg in Healthy Subjects Under Fasting Conditions. [NCT01581866]Phase 156 participants (Actual)Interventional2004-11-30Completed
Six Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Adolescent Subjects With Schizophrenia [NCT00257192]Phase 3284 participants (Actual)Interventional2006-04-30Terminated(stopped due to Please see Detailed Description for termination reason.)
Open Extension Study Evaluating the Safety and Tolerability of Oral Ziprasidone in the Treatment of Subjects Who Have Successfully Completed a Previous Ziprasidone Study [NCT00139737]Phase 3344 participants (Actual)Interventional2002-03-31Completed
Effect of Atypical Antipsychotics on Gene Expression in Soft Tissues of Healthy Subjects - A Placebo Controlled Randomised Pilot Study [NCT01185743]Phase 416 participants (Actual)Interventional2010-07-31Completed
Proposal To Develop A Rapid And Cost-Effective Diagnostic Test For Schizophrenia [NCT03781115]Phase 124 participants (Anticipated)Interventional2017-11-20Recruiting
An Open Label, Extension Study To Assess The Efficacy And Tolerability Of Oral Ziprasidone In Patients Successfully Completing A Previous Study With Ziprasidone [NCT00645320]Phase 475 participants (Actual)Interventional2003-08-31Completed
A Randomized Comparison of the Acute Effects of Olanzapine and Ziprasidone on Whole Body Insulin Sensitivity in Healthy Volunteers [NCT00910988]46 participants (Actual)Interventional2009-02-28Completed
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
Interventions to Test the Alpha7 Nicotinic Receptor Model in Schizophrenia [NCT00509067]Phase 243 participants (Actual)Interventional2007-11-30Completed
High-Dose Oral Ziprasidone Versus Conventional Dosing in Schizophrenia Patients With Residual Symptoms [NCT00403546]Phase 3131 participants (Actual)Interventional2006-01-31Completed
Evaluation of Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotic Medications [NCT00458211]Phase 440 participants (Actual)Interventional2005-05-31Completed
26-Week Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Adolescent Subjects With Schizophrenia [NCT00265382]Phase 3221 participants (Actual)Interventional2006-06-30Terminated(stopped due to Please see Detailed Description for termination reason.)
A Six Week, Multicenter, Double Blind, Double-Dummy, Parallel, Comparative Study To Compare The Efficacy, Safety And Tolerability Of Ziprasidone With Risperidone In The Treatment Of Chinese Subjects With Acute Exacerbation Of Schizophrenia [NCT00645372]Phase 3242 participants (Actual)Interventional2004-07-31Completed
A Multi-Center Study To Examine The Clinical Effects Of Cross Titration Of Antipsychotics With Ziprasidone In Subjects With Schizophrenia Or Schizoaffective Disorder [NCT00649064]Phase 446 participants (Actual)Interventional2003-12-31Completed
Treatment of Schizophrenic Patients With Geodon; Capsules/Oral Suspension/Solution for Injection (Ziprasidone) [NCT00579670]450 participants (Actual)Observational2007-10-31Completed
Double Blind, Double-Dummy Multicenter, Parallel Group Comparison Of The Efficacy And The Tolerability Of Ziprasidone Vs. Clozapine In Schizophrenic Patients Who Are Refractory And/Or Intolerant To Antipsychotic Therapy [NCT00649844]Phase 3147 participants (Actual)Interventional2003-01-31Completed
Ziprasidone in the Treatment of Borderline Personality Disorder: A Double-Blind, Placebo-Controlled, Randomized Study [NCT00635921]Phase 260 participants (Actual)Interventional2004-03-31Completed
Double-blind, Placebo-controlled Trial of Ziprasidone (Geodon) for the Depressive Mixed State [NCT00490542]Phase 273 participants (Actual)Interventional2006-12-31Completed
A Six-Week, Double-Blind, Multicenter, Placebo Controlled Study Evaluating The Efficacy And Safety Of Flexible Doses Of Oral Ziprasidone As Add-On, Adjunctive Therapy With Lithium, Valproate Or Lamotrigine In Bipolar I Depression [NCT00483548]Phase 3298 participants (Actual)Interventional2007-10-31Completed
26-Week Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) [NCT00265330]Phase 3169 participants (Actual)Interventional2006-03-31Completed
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
Ziprasidone Versus Risperidone In The Treatment Of Chronic Schizophrenia: A Six Months, Double Blind Randomized, Parallel Group Study [NCT00645515]Phase 3240 participants (Anticipated)Interventional2003-06-30Terminated(stopped due to This study was terminated on November 20, 2003 because of poor recruitment. This study was not terminated due to safety/efficacy.)
Ziprasidone Intramuscular/Oral In The Treatment Of Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder: A Six-Week Open Administration Study [NCT00650429]Phase 428 participants (Actual)Interventional2003-10-31Completed
A One-Year, Phase IV, Open-Label, Non-Comparative Trial Of The Effect Of Ziprasidone HCL On Metabolic Syndrome Risk Factors In Patients With Psychotic Disorders [NCT00748566]Phase 4172 participants (Actual)Interventional2008-12-31Terminated(stopped due to See Detailed Description)
A Randomized, Open Label, Rater Blind, Flexible Dose Multi-Center Study Comparing The Efficacy And Safety Of Intramuscular Ziprasidone With Haloperidol For Three Days In Patients With Agitation Of Schizophrenia [NCT00723606]Phase 3376 participants (Actual)Interventional2008-09-30Completed
Atypical Antipsychotics and Hyperglycemic Emergencies: Multicentre, Retrospective Cohort Study of Administrative Data [NCT02582736]725,489 participants (Actual)Observational2012-04-30Completed
Efficacy And Safety Of Ziprasidone In Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder, Including Patients With A Diagnosis Of Recent Onset [NCT00645229]Phase 31 participants (Actual)Interventional2004-09-30Terminated(stopped due to Please see Detailed Description for termination reason.)
A Sixteen-Week, Multi-Center, Open-Label Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone In Subjects Diagnosed With Schizophrenia Or Schizoaffective Disorder [NCT00406315]Phase 4255 participants (Actual)Interventional2006-11-30Completed
MIND-USA Study: Modifying the Impact of ICU-Associated Neurological Dysfunction [NCT01211522]Phase 3566 participants (Actual)Interventional2011-12-14Completed
Ziprasidone for Severe Conduct and Other Disruptive Behavior Disorders in Children and Adolescents - a Placebo Controlled, Randomized, Double Blind Clinical Trial [NCT00676429]Phase 251 participants (Actual)Interventional2006-07-31Completed
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
Ziprasidone in Early Onset Schizophrenia Spectrum Disorders [NCT01006551]Phase 240 participants (Actual)Interventional2002-12-31Completed
A Six-Week, Randomized, Double-Blind, Multicenter, Fixed-Flexible Dose, Placebo-Controlled Study Evaluating the Efficacy and Safety of Oral Ziprasidone in Outpatients With Bipolar I Depression [NCT00141271]Phase 3536 participants (Actual)Interventional2005-07-31Completed
Prospective Double Blind Randomized Trial of Intramuscular Ziprasidone Compared With Standard Antipsychotic Therapy For The Treatment Of The Acutely Agitated Patient In The Emergency Department [NCT00786318]Phase 40 participants (Actual)Interventional2008-09-30Withdrawn(stopped due to Sponsor terminated)
Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting. [NCT00932529]Phase 4226 participants (Actual)Interventional2003-02-28Completed
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
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
Treatment With Ziprasidone for Schizophrenia Patients With Obsessive Compulsive Disorder (OCD) [NCT00229385]45 participants (Actual)Interventional2006-01-31Completed
Ziprasidone vs Placebo in the Prevention of Psychosis Among Symptomatic Adolescents and Young Adults at Prodromal Risk [NCT00635700]Phase 251 participants (Actual)Interventional2008-03-31Completed
Phase 1 Study Of Ziprasidone Pharmacokinetics Of Reduced Food Effect Formulation B16 Under Fed And Fasting Conditions Compared To Commercial Geodon Capsules Under Fed Conditions In Healthy Subjects [NCT00821444]Phase 111 participants (Actual)Interventional2009-01-31Completed
The Metabolic Syndrome in Patients With Schizophrenia [NCT00338949]Phase 477 participants (Actual)Interventional2006-06-30Completed
Randomized, 2-way Crossover, Bioequivalence Study of Ziprasidone HCL Capsules, 20 mg in Healthy Subjects Under Fed Conditions. [NCT01581879]Phase 138 participants (Actual)Interventional2004-11-30Completed
Open Extension Study Evaluating The Long Term Efficacy , Safety And Tolerability Of Oral Ziprasidone In The Treatment Of Patients Who Have Successfully Completed The Previous Ziprasidone Study A1281031 [NCT00174447]Phase 343 participants (Actual)Interventional2001-10-31Completed
A Multicenter, Randomized, Double-Blind, Parallel Group Study, Comparing The Efficacy And Tolerability Of Ziprasidone (Zeldox, Geodon) vs. Olanzapine (Zyprexa) In The Treatment And Maintenance Of Response In Patients With Acute Mania [NCT00329108]Phase 429 participants (Actual)Interventional2006-11-30Terminated(stopped due to Please see Brief Summary for Termination Reason.)
A Phase 3, Randomized, 6-Month, Double-Blind Trial in Subjects With Bipolar I Disorder to Evaluate the Continued Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer (vs Placebo Plus a Mood Stabilizer) Following a Minimum of 2 Months of [NCT00280566]Phase 3584 participants (Actual)Interventional2005-12-31Completed
A Three-Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Add-On Oral Ziprasidone in Subjects With Acute Mania Treated With Lithium or Divalproex [NCT00312494]Phase 3680 participants (Actual)Interventional2006-04-30Completed
A Six-Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Flexible Doses of Oral Ziprasidone in Outpatients With Bipolar I Depression [NCT00282464]Phase 3392 participants (Actual)Interventional2006-02-28Completed
Comparative Efficacy and Acceptability of Lithium, Valproate, Oxcarbazepine, Quetiapine, Olanzapine, and Ziprasidone in Bipolar I Disorder, Manic or Mixed Phase [NCT01893229]Phase 4120 participants (Anticipated)Interventional2013-09-30Recruiting
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
Ziprasidone in Children With Autism: A Pilot Study [NCT00208559]Phase 215 participants (Actual)Interventional2002-02-28Completed
Ziprasidone Versus Olanzapine In The Treatment Of Schizophrenia: A Six Months, Double Blind Randomized, Parallel Group Study. [NCT00239109]Phase 4112 participants Interventional2003-04-30Completed
Reducing the Abuse Liability of Prescription Opioids [NCT04587115]Early Phase 115 participants (Actual)Interventional2017-06-16Completed
Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial [NCT00224315]Phase 424 participants Interventional2003-11-30Completed
Adjunctive Ziprasidone in Overweight and Obese Patients With Bipolar Disorder [NCT00472641]Phase 425 participants (Actual)Interventional2007-01-31Completed
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
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies [NCT02893371]1,037,352 participants (Actual)Observational2016-09-30Completed
A One-year, Phase III, Open-label, Non-comparative Trial of the Effect of Ziprasidone HCl on Metabolic Syndrome Risk Factors in Patients With Bipolar Disorder [NCT01113541]Phase 313 participants (Actual)Interventional2010-07-31Terminated(stopped due to See termination reason in detailed description.)
24-Hour Time Course of Striatal Dopamine D2 Receptor Occupancy of Ziprasidone: A PET Study [NCT00818298]12 participants (Actual)Interventional2009-01-31Completed
A 27-Week Open-Label Trial To Characterize The Safety And Tolerability Of Orally Administered Ziprasidone In Children And Adolescent Subjects With Bipolar I Disorder (Manic Or Mixed), Schizophrenia Or Schizoaffective Disorder [NCT00650611]Phase 263 participants (Actual)Interventional2003-12-31Completed
An Open, Multicenter, Non-Comparative Study To Assess The Efficacy And Tolerability Of Intramuscular Ziprasidone Followed By Oral Ziprasidone In Patients With Acute Psychosis [NCT00644800]Phase 489 participants (Actual)Interventional2003-07-31Completed
The Role of miR-30 Family Dysregulation in Response to Antipsychotic Treatment [NCT02650102]Phase 1/Phase 2200 participants (Anticipated)Interventional2013-01-31Recruiting
Post-Marketing Surveillance (PMS) Study to Evaluate Safety and Efficacy of Zeldox Capsule [NCT01053429]3,391 participants (Actual)Observational2005-06-30Completed
The Treatment Efficacy of Combination Atypical Antipsychotics With Sertraline in Patients With Schizophrenia [NCT04076371]1,640 participants (Actual)Interventional2012-01-31Completed
Glucose Regulation During Ziprasidone Treatment [NCT00205725]120 participants (Actual)Interventional2000-11-30Completed
Open-Label Study of Ziprasidone for the Treatment of Mania in Children and Adolescents With Bipolar Spectrum Disorder [NCT00181922]Phase 420 participants Interventional2002-03-31Completed
Treatment Of Manic Or Mixed Episodes Of Up To Moderate Severity In Patients With Bipolar Disorder And Schizoaffective Disorder [NCT00454883]379 participants (Actual)Observational2007-04-30Completed
A Multi-Center,Open-Labeled,Intervention Study:The Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic Agitation [NCT02935998]Phase 41,000 participants (Anticipated)Interventional2016-10-31Not yet recruiting
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care [NCT01431326]3,520 participants (Actual)Observational2011-11-30Completed
Safety and Efficacy of Four Intramuscular Interventions for the Management of Acute Psychomotor Agitation [NCT01485692]120 participants (Actual)Interventional2009-02-28Completed
An International, Multicenter, Large Simple Trial (LST) To Compare The Cardiovascular Safety Of Ziprasidone And Olanzapine [NCT00418171]Phase 418,239 participants (Actual)Interventional2002-02-28Completed
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
Delirium in the ICU: a Prospective, Randomized, Trial of Placebo vs. Haloperidol vs. Ziprasidone [NCT00096863]Phase 2102 participants (Actual)Interventional2004-12-31Completed
An Open Trial to Evaluate the Efficacy and Tolerability of Ziprasidone IM and Oral in Patients With Psychosis and Acute Agitation. [NCT00136994]Phase 3160 participants Interventional2003-03-31Completed
Open Extension Study Evaluating the Long-term Efficacy, Safety, and Tolerability of Oral Ziprasidone in the Treatment of Resistant/Intolerant Schizophrenic Patients Who Have Acutely Responded to Ziprasidone in the Mozart Study [NCT00143351]Phase 375 participants Interventional2003-06-30Completed
Predictors of Response to Augmentation With Ziprasidone (Geodon®) in Major Depressive Disorder : A 13-week, Double-Blind, Placebo-Controlled, Cross-Over Trial [NCT01168674]Phase 449 participants (Actual)Interventional2010-02-28Completed
Tolerability, Safety, And Efficacy Of Ziprasidone (80 - 160 Mg/D) Versus Olanzapine (10 - 20 Mg/D), Risperidone (4 - 8 Mg/D) Or Quetiapine (300 - 750 Mg/D) In Pretreated Patients With Schizophrenia, Schizoaffective Disorder Or Schizophreniform Disorders - [NCT00159770]Phase 3290 participants Interventional2001-11-30Completed
Geodon (Ziprasidone) for Posttraumatic Stress Disorder [NCT00208208]Phase 480 participants Interventional2002-12-31Completed
Ziprasidone for the Treatment of Generalized Anxiety Comorbidity in Patients With Bipolar Disorder [NCT00374543]Phase 43 participants (Actual)Interventional2006-02-28Terminated(stopped due to Recruitment goal could not be achieved)
Comparative Effectiveness of Antipsychotic Medications in Patients With Schizophrenia (CATIE Schizophrenia Trial) [NCT00014001]Phase 41,600 participants Interventional2000-12-31Completed
A Controlled Trial of Olanzapine Versus Active Comparator in the Treatment of Schizophrenic and Schizoaffective Subjects With Comorbid Depression [NCT00034801]Phase 4378 participants Interventional2001-09-30Completed
Treatment and Outcome of Early Onset Bipolar Disorder [NCT00048802]Phase 440 participants Interventional2002-08-31Completed
A Multi-Center Study to Examine The Clinical Effects of Cross Titration of Antipsychotics With Ziprasidone in Subjects With Schizophrenia or Schizoaffective Disorder [NCT00137020]Phase 4294 participants Interventional2004-11-30Completed
Ziprasidone for the Treatment of Refractory Social Anxiety Disorder [NCT00215150]Phase 251 participants (Actual)Interventional2004-11-30Completed
The Effects of Ziprasidone 320 mg on Glucose and Plasma Lipids in Patients With Diabetes Type II and Schizophrenia or Schizoaffective Disorder [NCT00395031]Phase 2/Phase 357 participants (Actual)Interventional2003-09-30Completed
PHARMACOLOGICAL TREATMENT OF COGNITIVE DEFICITS IN SCHIZOPHRENIC PATIENTS: The Effects of Central Cholinergic Augmentation on Cognitive Deficits and Psychopathology [NCT00206947]Phase 250 participants (Anticipated)Interventional2002-12-31Terminated(stopped due to No more funding)
A Multicenter, Double-Blind, Randomized Trial Of Ziprasidone (80 - 160 Mg) Versus Olanzapine (10 - 20 Mg) In Patients With Recent-Onset Schizophrenia, Schizoaffective And Schizophreniform Disorder. [NCT00145444]Phase 3100 participants Interventional2003-03-31Completed
Energy Homeostasis and Metabolism in Patients With Schizophrenic Disorders Under Treatment With Atypical Antipsychotics [NCT00148564]Phase 440 participants (Actual)Interventional2004-03-31Completed
12 Week Open Label, Multicenter, Non-Comparative Switch Study Evaluating Efficacy, Tolerability And Safety Of Oral Ziprasidone In Treatment Of Patients Suffering From Schizophrenia Who Have Already Been Treated With An Other Antipsychotic. [NCT00159757]Phase 4150 participants Interventional2003-11-30Terminated(stopped due to See Detailed Description for Termination Reason)
Preventing Relapse: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE) [NCT00330863]Phase 4357 participants (Actual)Interventional2006-05-31Completed
A Comparison of Two Different Treatments for Major Depression With Psychotic Features: Ziprasidone vs. Combined Sertraline and Haloperidol [NCT00340379]Phase 2/Phase 372 participants (Actual)Interventional2003-04-30Completed
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Sequential Trial of Ziprasidone as Monotherapy for Major Depressive Disorder [NCT00555997]Phase 2120 participants (Actual)Interventional2008-03-31Completed
Glucose and Lipid Metabolism on Antipsychotic Medication [NCT00515723]96 participants (Actual)Interventional2001-09-30Completed
Prospective Observational Investigation of Olanzapine Versus Haloperidol Versus Ziprasidone Versus Midazolam for the Treatment of Acute Undifferentiated Agitation in the Emergency Department [NCT03211897]737 participants (Actual)Observational2017-06-15Completed
A Pilot Open Trial Of Ziprasidone, Early In The Course Of Pediatric Psychotic Illness [NCT00199940]Phase 420 participants Interventional2003-12-31Completed
Effects of Ziprasidone vs. Placebo During the First Four Weeks of Eight Weeks Sertraline Treatment in Patients With Post-traumatic Stress Disorder (PTSD) [NCT00248261]7 participants (Actual)Observational2005-11-30Terminated(stopped due to High rate of early drop-outs)
Influence of Treatment With Olanzapine or Ziprasidone on Transcapillary Glucose Transport in Human Skeletal Muscle [NCT00297960]Phase 40 participants Interventional2005-04-30Completed
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)
[NCT03007303]30 participants (Anticipated)Observational [Patient Registry]2016-06-30Recruiting
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
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
Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building [NCT04446234]Phase 4350 participants (Anticipated)Interventional2021-05-31Not yet recruiting
Reducing the Abuse Liability of Prescription Opioids in Recreational Drug Users: A Pilot Study [NCT03837860]Early Phase 13 participants (Actual)Interventional2019-04-01Terminated(stopped due to PI leaving institution)
Open-label Feasibility Study for the Treatment of Psychotic Adolescents With Ziprasidone in the Inpatient and Day Hospital Settings [NCT00421954]Phase 38 participants (Actual)Interventional2006-05-31Completed
Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder [NCT01293825]Phase 430 participants (Actual)Interventional2011-01-31Completed
Neurocognitive Effects of Ziprasidone: Relationship to Working Memory and Dopamine Blockade [NCT00225498]35 participants (Actual)Interventional2002-06-30Completed
Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome [NCT00288366]49 participants (Actual)Interventional2006-01-31Completed
An Open-Label, Flexible-Dose Trial of the Safety and Efficacy of Geodon in Non-Rapid-Cycling Bipolar II Patients With Major Depression [NCT00237666]Phase 430 participants (Actual)Interventional2005-02-28Completed
An Open Label Trial of Ziprasidone as an Adjuvant for Clozapine- or Olanzapine-Associated Diabetes Mellitus or Impaired Fasting Glucose in Chronic Schizophrenia [NCT00351000]Phase 424 participants (Actual)Interventional2005-01-31Completed
Pharmacovigilance in Gerontopsychiatric Patients [NCT02374567]Phase 3407 participants (Actual)Interventional2015-01-31Terminated
A Three-phase Study Designed to Test the Efficacy, Tolerability and Safety of the Combination of Ziprasidone With Selective Serotonin Reuptake Inhibitors (SSRI) for Patients With Major Depressive Disorder (MDD) That do Not Sufficiently Respond to Treatmen [NCT00633399]Phase 2458 participants (Actual)Interventional2008-07-31Completed
Gene-by-Stress Interactions in Intervention Studies Significance [NCT03011645]Phase 17 participants (Actual)Interventional2018-05-24Terminated(stopped due to Lack of participants)
Improving Diabetes Risk Factors in Persons With Schizophrenia or Bipolar Disorder by Switching to Ziprasidone [NCT00538642]24 participants (Actual)Interventional2007-08-31Completed
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)
Improving Metabolic Parameters of Antipsychotic Child Treatment (IMPACT) [NCT00806234]Phase 4127 participants (Actual)Interventional2009-01-31Completed
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
A PHASE 3, MULTICENTER, FOUR-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP EFFICACY AND SAFETY TRIAL OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPOLAR I DISORDER (CURRENT OR MOST RECENT EPISODE MANIC) [NCT02075047]Phase 3171 participants (Actual)Interventional2014-05-23Terminated(stopped due to Based on recent input from FDA, the pre-specified final analysis will be performed at the current enrollment using a re-estimation of the sample size.)
Effectiveness of Switching Antipsychotic Medications [NCT00044655]Phase 4219 participants (Actual)Interventional2001-07-31Completed
[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
NCT00139737 (1) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00141271 (38) [back to overview]Change in Hamilton Depression (HAM-D 17) Total Score
NCT00141271 (38) [back to overview]Change in Hamilton Anxiety Rating (HAM-A)
NCT00141271 (38) [back to overview]Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
NCT00141271 (38) [back to overview]Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7
NCT00141271 (38) [back to overview]Change in Total Score of Young Mania Rating Scale (YMRS)
NCT00141271 (38) [back to overview]Change in Sleep Disturbance Factor Score
NCT00141271 (38) [back to overview]Change in Tower of London Test at Endpoint
NCT00141271 (38) [back to overview]Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF)
NCT00141271 (38) [back to overview]Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)
NCT00141271 (38) [back to overview]Change in Global Clinical Improvement of Symptoms (CGI -I)
NCT00141271 (38) [back to overview]Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint
NCT00141271 (38) [back to overview]Change in Token Motor Task at Endpoint
NCT00141271 (38) [back to overview]Change in Retardation Factor Scores
NCT00141271 (38) [back to overview]Change in Verbal Fluency Controlled Word Association at Endpoint
NCT00141271 (38) [back to overview]Change in Verbal Fluency in Naming Categories at Endpoint
NCT00141271 (38) [back to overview]Change in Bech Melancholia Score
NCT00141271 (38) [back to overview]Change in Verbal Memory Trial Performance Total Score at Endpoint
NCT00141271 (38) [back to overview]Change in Anxiety/Somatizations Factor Total Score
NCT00141271 (38) [back to overview]Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint
NCT00141271 (38) [back to overview]Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint
NCT00141271 (38) [back to overview]Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint
NCT00141271 (38) [back to overview]Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint
NCT00141271 (38) [back to overview]Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint
NCT00141271 (38) [back to overview]Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint
NCT00141271 (38) [back to overview]Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint
NCT00141271 (38) [back to overview]Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint
NCT00141271 (38) [back to overview]Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint
NCT00141271 (38) [back to overview]Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint
NCT00141271 (38) [back to overview]Change in Digit Sequencing Task at Endpoint
NCT00141271 (38) [back to overview]Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint
NCT00141271 (38) [back to overview]Change in Sheehan Disability Scale (SDS) Total Score at Endpoint
NCT00141271 (38) [back to overview]Change in Symbol Coding at Endpoint
NCT00141271 (38) [back to overview]Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint
NCT00141271 (38) [back to overview]Change in Total Score in Hamilton Depression (HAM-D 25)
NCT00141271 (38) [back to overview]Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
NCT00141271 (38) [back to overview]Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
NCT00141271 (38) [back to overview]Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score
NCT00141271 (38) [back to overview]Response as Measured by CGI-I Score Less Than or Equal to 2
NCT00174447 (6) [back to overview]Change From Baseline in CGI-S at End of Study (up to 5 Years)
NCT00174447 (6) [back to overview]Change From Baseline in CGI-I at End of Study (up to 5 Years)
NCT00174447 (6) [back to overview]Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
NCT00174447 (6) [back to overview]Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
NCT00174447 (6) [back to overview]Number of Participants With Scores on Patient Preference Scale (PPS)
NCT00174447 (6) [back to overview]Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years)
NCT00177164 (4) [back to overview]BMI
NCT00177164 (4) [back to overview]Number of Participants With Treatment Emergent Hyperlipidemia
NCT00177164 (4) [back to overview]Number of Participants With Treatment - Emergent Hyperglycemia
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.
NCT00215150 (1) [back to overview]Brief Social Phobia Scale(BSPS)
NCT00225498 (1) [back to overview]Working Memory
NCT00237666 (7) [back to overview]Mean Change From Baseline in the Total Score of the Beck Depression Inventory (BDI)
NCT00237666 (7) [back to overview]Mean Change From Baseline in the CGI-Severity of Illness (CGI-S) Score at Study Endpoint
NCT00237666 (7) [back to overview]Mean Change From Baseline in the Hamilton Anxiety Scale (HAM-A)
NCT00237666 (7) [back to overview]Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale
NCT00237666 (7) [back to overview]Mean Change From Baseline in the Total Score of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
NCT00237666 (7) [back to overview]The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores
NCT00237666 (7) [back to overview]Percentage of Subjects With Clinical Global Inventory (CGI) Global Improvement Score of 1 or 2
NCT00257166 (4) [back to overview]Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4
NCT00257166 (4) [back to overview]Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3
NCT00257166 (4) [back to overview]Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4
NCT00257166 (4) [back to overview]Clinical Global Impression - Improvement (CGI-I) Score
NCT00257192 (19) [back to overview]Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item
NCT00257192 (19) [back to overview]Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score
NCT00257192 (19) [back to overview]Clinical Global Impression of Improvement (CGI-I) Score at Week 6
NCT00257192 (19) [back to overview]Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13
NCT00257192 (19) [back to overview]Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6
NCT00257192 (19) [back to overview]Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1
NCT00257192 (19) [back to overview]Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6
NCT00257192 (19) [back to overview]Number of Subjects Per Response on the School Placement Questionnaire: School Situation
NCT00257192 (19) [back to overview]Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
NCT00257192 (19) [back to overview]Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
NCT00257192 (19) [back to overview]Change From Baseline in PANSS: Positive and Negative Subscales at Week 6
NCT00257192 (19) [back to overview]Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS)
NCT00257192 (19) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6
NCT00257192 (19) [back to overview]Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score
NCT00257192 (19) [back to overview]Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index
NCT00257192 (19) [back to overview]Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
NCT00257192 (19) [back to overview]Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score
NCT00257192 (19) [back to overview]Change From Baseline in Children's Global Assessment Scale (CGAS)
NCT00257192 (19) [back to overview]Change From Baseline in Child Health Questionnaire (CHQ)
NCT00265330 (19) [back to overview]Body Mass Index (BMI) Z-score Frequency
NCT00265330 (19) [back to overview]Young Mania Rating Scale (YMRS) Total Score Change From Baseline
NCT00265330 (19) [back to overview]Mean Change From Baseline for Body Weight
NCT00265330 (19) [back to overview]Body Mass Index (BMI) Z-score Frequency
NCT00265330 (19) [back to overview]Frequency of Largest Categorical Increases in QTcF for Males
NCT00265330 (19) [back to overview]Change in Hormones
NCT00265330 (19) [back to overview]Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol
NCT00265330 (19) [back to overview]Clinical Global Impression of Severity (CGI-S) Change From Baseline
NCT00265330 (19) [back to overview]Frequency of Largest Categorical Increases in QTcF - All Subjects
NCT00265330 (19) [back to overview]Frequency of Largest Categorical Increases in QTcF for Females
NCT00265330 (19) [back to overview]Mean Change From Baseline in Supine Diastolic Blood Pressure
NCT00265330 (19) [back to overview]Incidence of Lab Abnormalities
NCT00265330 (19) [back to overview]Mean Change From Baseline for Body Mass Index (BMI) Z-Score
NCT00265330 (19) [back to overview]Mean Change From Baseline for QTcF Intervals
NCT00265330 (19) [back to overview]Mean Change From Baseline in Standing Diastolic Blood Pressure
NCT00265330 (19) [back to overview]Mean Change From Baseline in Standing Pulse Rates
NCT00265330 (19) [back to overview]Mean Change From Baseline in Standing Systolic Blood Pressure
NCT00265330 (19) [back to overview]Mean Change From Baseline in Supine Pulse Rates
NCT00265330 (19) [back to overview]Mean Change From Baseline in Supine Systolic Blood Pressure
NCT00265382 (15) [back to overview]Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score
NCT00265382 (15) [back to overview]Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score
NCT00265382 (15) [back to overview]Change From Baseline in Children's Global Assessment Scale (CGAS)
NCT00265382 (15) [back to overview]Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00265382 (15) [back to overview]Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
NCT00265382 (15) [back to overview]Change From Baseline in Child Health Questionnaire (CHQ)
NCT00265382 (15) [back to overview]Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score
NCT00265382 (15) [back to overview]Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score
NCT00265382 (15) [back to overview]Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item
NCT00265382 (15) [back to overview]Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment
NCT00265382 (15) [back to overview]Number of Subjects Per Response on the School Placement Questionnaire: School Situation
NCT00265382 (15) [back to overview]Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
NCT00265382 (15) [back to overview]Change From Baseline in Simpson-Angus Rating Scale (SARS)
NCT00265382 (15) [back to overview]Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index
NCT00265382 (15) [back to overview]Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
NCT00280566 (10) [back to overview]Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period
NCT00280566 (10) [back to overview]Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period
NCT00280566 (10) [back to overview]Time to Intervention for a Mood Episode During Double Blind Period
NCT00280566 (10) [back to overview]Modified Time to Intervention for a Mood Episode (TIME)
NCT00280566 (10) [back to overview]Time to Discontinuation for Any Reason During Double Blind Period 2
NCT00280566 (10) [back to overview]Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period
NCT00280566 (10) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period
NCT00280566 (10) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period
NCT00280566 (10) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale by Visit During Double Blind Period
NCT00280566 (10) [back to overview]Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period
NCT00282464 (22) [back to overview]Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint
NCT00282464 (22) [back to overview]Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject
NCT00282464 (22) [back to overview]Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating
NCT00282464 (22) [back to overview]Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer
NCT00282464 (22) [back to overview]Change in Hamilton Anxiety Rating (HAM-A)
NCT00282464 (22) [back to overview]Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
NCT00282464 (22) [back to overview]Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score
NCT00282464 (22) [back to overview]Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
NCT00282464 (22) [back to overview]Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7
NCT00282464 (22) [back to overview]Change in Total Score of Young Mania Rating Scale (YMRS)
NCT00282464 (22) [back to overview]Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25)
NCT00282464 (22) [back to overview]Change in Sleep Disturbance Factor Score
NCT00282464 (22) [back to overview]Change in Retardation Factor Scores
NCT00282464 (22) [back to overview]Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
NCT00282464 (22) [back to overview]Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score
NCT00282464 (22) [back to overview]Change in Global Clinical Severity of Symptoms (CGI-S)
NCT00282464 (22) [back to overview]Change in Global Clinical Improvement of Symptoms (CGI -I)
NCT00282464 (22) [back to overview]Change in Bech Melancholia Score
NCT00282464 (22) [back to overview]Change in Anxiety/Somatizations Factor Total Score
NCT00282464 (22) [back to overview]Change in Sheehan Disability Scale (SDS) Total Score
NCT00282464 (22) [back to overview]Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score
NCT00282464 (22) [back to overview]Change in Global Assessment of Functioning (GAF)
NCT00288366 (1) [back to overview]HDL Ratio
NCT00312494 (8) [back to overview]Change From Baseline in Global Assessment of Functioning (GAF) Score
NCT00312494 (8) [back to overview]Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score
NCT00312494 (8) [back to overview]Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores
NCT00312494 (8) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score
NCT00312494 (8) [back to overview]Change From Baseline to Week 1 and Week 2 in YMRS
NCT00312494 (8) [back to overview]Clinical Global Impression - Improvement (CGI-I) Scale Scores
NCT00312494 (8) [back to overview]Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS)
NCT00312494 (8) [back to overview]Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score
NCT00330863 (3) [back to overview]Substantial Clinical Deterioration Measured by Psychotic Symptoms
NCT00330863 (3) [back to overview]Number of Patients Discontinuing From the Study
NCT00330863 (3) [back to overview]Side Effects and Metabolic Measures
NCT00338949 (2) [back to overview]Change in Visceral Fat Mass From Baseline to Week 26
NCT00338949 (2) [back to overview]Change in Insulin Sensitivity Index From Baseline to Week 26 ((1/mU/L) x 1/Min)
NCT00340379 (3) [back to overview]21 Item Hamilton Depression Rating Scale
NCT00340379 (3) [back to overview]Brief Psychiatric Rating Scale at 12 Weeks
NCT00340379 (3) [back to overview]Clinical Global Impression Improvement Scale
NCT00351000 (2) [back to overview]Change From Baseline on Fasting Insulin
NCT00351000 (2) [back to overview]Change From Baseline in Fasting Glucose
NCT00403546 (17) [back to overview]Number of Events Recorded Based on Ziprasidone Side Effects Checklist During Randomized Trial
NCT00403546 (17) [back to overview]Change From Baseline in Positive Subscale Score of PANSS
NCT00403546 (17) [back to overview]Change From Baseline in the Calgary Depression Rating Scale (CDRS) Total Score
NCT00403546 (17) [back to overview]Change From Baseline in the Barnes Akathisia Scale (BAS)
NCT00403546 (17) [back to overview]Number of Participants With High and Low Levels in Serum Prolactin Concentration
NCT00403546 (17) [back to overview]Number of Treatment-emergent Adverse Events During Randomized Trial
NCT00403546 (17) [back to overview]Percentage of Participants With Response
NCT00403546 (17) [back to overview]Vital Signs: Systolic and Diastolic Blood Pressure Levels
NCT00403546 (17) [back to overview]Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS)
NCT00403546 (17) [back to overview]Change in Schizophrenia Cognition Rating Scale (SCoRS) Score
NCT00403546 (17) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
NCT00403546 (17) [back to overview]Change From Baseline in PANSS Negative Subscale Score
NCT00403546 (17) [back to overview]Change From Baseline in Global Assessment of Functioning (GAF) Score
NCT00403546 (17) [back to overview]Change From Baseline in Clinical Global Impression- Severity (CGI-S) Score
NCT00403546 (17) [back to overview]Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score
NCT00403546 (17) [back to overview]Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score
NCT00403546 (17) [back to overview]Electrocardiogram (EKG): Number of Participants With an Increase From Baseline to Corrected QT (QTc) Interval >/= 500 Milliseconds (Msec)
NCT00406315 (15) [back to overview]Change From Baseline in Weight at Week 16
NCT00406315 (15) [back to overview]Change From Baseline in Waist and Hip Circumference at Week 16
NCT00406315 (15) [back to overview]Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16
NCT00406315 (15) [back to overview]Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16
NCT00406315 (15) [back to overview]Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16
NCT00406315 (15) [back to overview]Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16
NCT00406315 (15) [back to overview]Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16
NCT00406315 (15) [back to overview]Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16
NCT00406315 (15) [back to overview]Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16
NCT00406315 (15) [back to overview]Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16
NCT00406315 (15) [back to overview]Change From Baseline in Fasting Insulin at Week 16
NCT00406315 (15) [back to overview]Change From Baseline in Fasting Glucose at Week 16
NCT00406315 (15) [back to overview]Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16
NCT00406315 (15) [back to overview]Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16
NCT00406315 (15) [back to overview]Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16
NCT00458211 (15) [back to overview]Clinical Global Impression (CGI) Scores the Evaluator's Overall Impression of Severity (CGI-S) or Change (CGI-I) in Illness.
NCT00458211 (15) [back to overview]Cholesterol
NCT00458211 (15) [back to overview]Calgary Depression Scale for Schizophrenia
NCT00458211 (15) [back to overview]Fasting Glucose
NCT00458211 (15) [back to overview]Insulin Level
NCT00458211 (15) [back to overview]Medical Outcomes Study Cognitive Functioning Scale (MOS-COG)
NCT00458211 (15) [back to overview]Brief Assessment of Cognition in Schizophrenia (BACS)
NCT00458211 (15) [back to overview]Barnes Akathisia Scale
NCT00458211 (15) [back to overview]Corrected QT Interval (QTc)
NCT00458211 (15) [back to overview]Abnormal Involuntary Movement Scale (AIMS) Measures Tardive Dyskinesia
NCT00458211 (15) [back to overview]Personal Evaluation of Transitions in Treatment Scale (PETiTP
NCT00458211 (15) [back to overview]Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia
NCT00458211 (15) [back to overview]Simpson-Angus Scale Measures Drug Induced Parkinsonism
NCT00458211 (15) [back to overview]HbA1c
NCT00458211 (15) [back to overview]Weight
NCT00472641 (2) [back to overview]The Primary Outcome Measure Was Weight Change From Baseline to Endpoint.
NCT00472641 (2) [back to overview]Changes From Baseline to Endpoint in Body Mass Index (BMI)
NCT00483548 (17) [back to overview]Change From Baseline in Young Mania Rating Scale (YMRS) Total Score
NCT00483548 (17) [back to overview]Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 4 and 5)
NCT00483548 (17) [back to overview]Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S)
NCT00483548 (17) [back to overview]Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
NCT00483548 (17) [back to overview]Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6
NCT00483548 (17) [back to overview]MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6
NCT00483548 (17) [back to overview]MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6
NCT00483548 (17) [back to overview]CGI-Improvement Score
NCT00483548 (17) [back to overview]Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Scores
NCT00483548 (17) [back to overview]Change From Baseline in Barnes Akathisia Rating Scale (BARS or BAS)
NCT00483548 (17) [back to overview]Change From Baseline in CGI-Severity Score (Post-baseline Excluding Week 6)
NCT00483548 (17) [back to overview]Change From Baseline in Global Assessment of Functioning (GAF) Scale at Week 6
NCT00483548 (17) [back to overview]Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score
NCT00483548 (17) [back to overview]Change From Baseline in MADRS Total Score (Post-baseline Excluding Week 6)
NCT00483548 (17) [back to overview]Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Scores at Week 6
NCT00483548 (17) [back to overview]Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 1 Through 3)
NCT00483548 (17) [back to overview]Change From Baseline in Simpson Angus Scale (SAS) Score
NCT00490542 (1) [back to overview]The Primary Outcome Measure Was Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores Over Weeks Between Groups.
NCT00509067 (3) [back to overview]MATRICS Verbal Learning and Memory
NCT00509067 (3) [back to overview]Clinical Global Impression
NCT00509067 (3) [back to overview]Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS)
NCT00515723 (2) [back to overview]DEXA Total Fat
NCT00515723 (2) [back to overview]Clamp Derived Insulin Sensitivity (mg/kg/Min)
NCT00538642 (18) [back to overview]Insulin Sensitivity
NCT00538642 (18) [back to overview]Triglycerides
NCT00538642 (18) [back to overview]Systolic Blood Pressure
NCT00538642 (18) [back to overview]Systolic Blood Pressure
NCT00538642 (18) [back to overview]LDL Cholesterol
NCT00538642 (18) [back to overview]LDL Cholesterol
NCT00538642 (18) [back to overview]Insulin Sensitivity
NCT00538642 (18) [back to overview]Cholesterol
NCT00538642 (18) [back to overview]HDL Cholesterol
NCT00538642 (18) [back to overview]HDL Cholesterol
NCT00538642 (18) [back to overview]Diastolic Blood Pressure
NCT00538642 (18) [back to overview]Cholesterol
NCT00538642 (18) [back to overview]Body Mass Index
NCT00538642 (18) [back to overview]Body Mass Index
NCT00538642 (18) [back to overview]Abdominal Circumference
NCT00538642 (18) [back to overview]Abdominal Circumference
NCT00538642 (18) [back to overview]Triglycerides
NCT00538642 (18) [back to overview]Diastolic Blood Pressure
NCT00555997 (2) [back to overview]Hamilton Depression Rating Scale (HAM-D-17) Scores
NCT00555997 (2) [back to overview]Responder/Non-responder
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?: Within SmPC"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question As a Result of Taking This Medication, do You Experience Any Side Effects at All?"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question As a Result of Taking This Medication, do You Experience Any Side Effects at All?: Within SmPC"
NCT00579670 (45) [back to overview]Percent Change From Baseline to Final Visit in Body Weight: Within SmPC
NCT00579670 (45) [back to overview]Percent Change From Baseline to Final Visit in Body Weight
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?: Within SmPC"
NCT00579670 (45) [back to overview]Summary of Schizophrenia
NCT00579670 (45) [back to overview]Summary of Most Frequently Used Concomitant Drug Treatments
NCT00579670 (45) [back to overview]Summary of Metabolic Risk Factors
NCT00579670 (45) [back to overview]Positive and Negative Syndrome Scale (PANSS) - Positive Subscale: Within SmPC
NCT00579670 (45) [back to overview]Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
NCT00579670 (45) [back to overview]PANSS - Negative Subscale: Within SmPC
NCT00579670 (45) [back to overview]PANSS - Negative Subscale
NCT00579670 (45) [back to overview]PANSS - Composite Subscale: Within SmPC
NCT00579670 (45) [back to overview]PANSS - Composite Subscale
NCT00579670 (45) [back to overview]Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC
NCT00579670 (45) [back to overview]Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
NCT00579670 (45) [back to overview]Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I): Within Summary of Product Characteristics Population (SmPC)
NCT00579670 (45) [back to overview]Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
NCT00579670 (45) [back to overview]Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period: Within SmPC
NCT00579670 (45) [back to overview]Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?: Within SmPC"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?: Within SmPC"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?: Within SmPC"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question Overall, How Confident Are You That Taking This Medication is a Good Thing?"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question Overall, How Confident Are You That Taking This Medication is a Good Thing?: Within SmPC"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?: Within SmPC"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?: Within SmPC"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?: Within SmPC"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question How Easy or Difficult is it to Use the Medication in Its Current Form?"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question How Easy or Difficult is it to Use the Medication in Its Current Form?: Within SmPC"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?: Within SmPC"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question How Convenient or Inconvenient is it to Take the Medication as Instructed?"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question How Convenient or Inconvenient is it to Take the Medication as Instructed?: Within SmPC"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?"
NCT00579670 (45) [back to overview]"Number of Participants Answering the Question How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?: Within SmPC"
NCT00622739 (6) [back to overview]Barnes Akathisia Rating Scale (BARS)
NCT00622739 (6) [back to overview]Children's Depression Rating Scale
NCT00622739 (6) [back to overview]Clinical Global Impressions-Severity (CGI-S) Scale
NCT00622739 (6) [back to overview]SAFTEE (Side Effects Rating Scale)
NCT00622739 (6) [back to overview]AIMS (Abnormal Involuntary Movement Scale)
NCT00622739 (6) [back to overview]Young Mania Rating Scale (YMRS)
NCT00633399 (3) [back to overview]Remission Rates (HAM-D 17 Scores of Less Than 8) After Treatment Phase 2.
NCT00633399 (3) [back to overview]Comparing Scores on HAM-D 17 Baseline Visit to Phase 2 Final Visit at Week 8
NCT00633399 (3) [back to overview]The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2
NCT00635700 (2) [back to overview]Change in Scale of Psychosis-risk Symptoms Total Score
NCT00635700 (2) [back to overview]Conversion to Psychosis
NCT00723606 (6) [back to overview]Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours
NCT00723606 (6) [back to overview]Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours
NCT00723606 (6) [back to overview]Change From Baseline in BPRS Agitation Subscale Score at 72 Hours
NCT00723606 (6) [back to overview]Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours
NCT00723606 (6) [back to overview]Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours
NCT00723606 (6) [back to overview]BPRS Agitation Subscale Response at 72 Hours
NCT00748566 (24) [back to overview]Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52
NCT00748566 (24) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52
NCT00748566 (24) [back to overview]Change From Baseline in Insulin Level at Week 4, 12, 28 and 52
NCT00748566 (24) [back to overview]Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52
NCT00748566 (24) [back to overview]Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52
NCT00748566 (24) [back to overview]Change From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Index (EQ-I) Score at Week 28 and 52
NCT00748566 (24) [back to overview]Change From Baseline in Drug-Attitude Inventory-30-Item Scale (DAI-30) Score at Week 28 and 52
NCT00748566 (24) [back to overview]Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52
NCT00748566 (24) [back to overview]Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52
NCT00748566 (24) [back to overview]Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52
NCT00748566 (24) [back to overview]Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)
NCT00748566 (24) [back to overview]Clinical Global Impression-Improvement (CGI-I) Scale Score
NCT00748566 (24) [back to overview]Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52
NCT00748566 (24) [back to overview]Percentage of Participants With Metabolic Syndrome (MS)
NCT00748566 (24) [back to overview]Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS)
NCT00748566 (24) [back to overview]Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52
NCT00748566 (24) [back to overview]Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52
NCT00748566 (24) [back to overview]Changes From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52
NCT00748566 (24) [back to overview]Change From Baseline in Weight at Week 4,12, 28 and 52
NCT00748566 (24) [back to overview]Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52
NCT00748566 (24) [back to overview]Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52
NCT00748566 (24) [back to overview]Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52
NCT00748566 (24) [back to overview]Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52
NCT00748566 (24) [back to overview]Change From Baseline in the Physical Activity Index Score at Week 28 and 52
NCT00806234 (4) [back to overview]Change in Whole Body Insulin Sensitivity Index
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
NCT00910988 (4) [back to overview]Peripheral Insulin Sensitivity
NCT00910988 (4) [back to overview]Whole Body Insulin Sensitivity
NCT00910988 (4) [back to overview]Adipose Tissue Insulin Sensitivity
NCT00910988 (4) [back to overview]Hepatic Insulin Sensitivity
NCT01053429 (4) [back to overview]Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT
NCT01053429 (4) [back to overview]Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP
NCT01053429 (4) [back to overview]Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population
NCT01053429 (4) [back to overview]Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population
NCT01113541 (5) [back to overview]Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels
NCT01113541 (5) [back to overview]Change From Baseline in Weight
NCT01113541 (5) [back to overview]Percentage of Participants Who Achieved a Reduction From Baseline of at Least 1 Risk Factor for Metabolic Syndrome (MS) at Week 52 or Premature Discontinuation
NCT01113541 (5) [back to overview]Change From Baseline in Glycosylated Hemoglobin (HbA1c)
NCT01113541 (5) [back to overview]Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF)
NCT01168674 (2) [back to overview]MADRS Improvement Over 6 Weeks
NCT01168674 (2) [back to overview]Predictors of Bipolarity to Define the Study Population
NCT01211522 (10) [back to overview]Time to Hospital Discharge
NCT01211522 (10) [back to overview]Time to ICU Readmission
NCT01211522 (10) [back to overview]Time to Liberation From Mechanical Ventilation
NCT01211522 (10) [back to overview]Delirium Duration
NCT01211522 (10) [back to overview]Delirium/Coma-free Days (DCFDs)
NCT01211522 (10) [back to overview]Number of Participants With Extrapyramidal Symptoms
NCT01211522 (10) [back to overview]Number of Participants With Neuroleptic Malignant Syndrome
NCT01211522 (10) [back to overview]Mortality
NCT01211522 (10) [back to overview]Number of Participants With Torsades de Pointes
NCT01211522 (10) [back to overview]Time to Final ICU Discharge
NCT01293825 (9) [back to overview]Global Psychopathology Score as Measured by Clinical Global Impressions
NCT01293825 (9) [back to overview]Montgomery Asberg Depression Rating Scale
NCT01293825 (9) [back to overview]Social and Occupational Functioning Scale
NCT01293825 (9) [back to overview]Treatment Adherence Score as Measured by the Morisky Rating Scale
NCT01293825 (9) [back to overview]Young Mania Rating Scale
NCT01293825 (9) [back to overview]Quality of Life Score as Measured by 12-item Short Form Health Survey
NCT01293825 (9) [back to overview]Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ)
NCT01293825 (9) [back to overview]Body Weight
NCT01293825 (9) [back to overview]Attitude Toward Medication Score as Measured by the Drug Attitude Inventory
NCT01844700 (4) [back to overview]BMI Percentile
NCT01844700 (4) [back to overview]BMI Z-scores
NCT01844700 (4) [back to overview]Weight Change
NCT01844700 (4) [back to overview]Percent Weight Change Compared to Baseline Weight
NCT02075047 (20) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT02075047 (20) [back to overview]Number of Participants Who Took at Least 1 Concomitant Medication and Concomitant Non-Drug Treatments/Procedures
NCT02075047 (20) [back to overview]Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 1, 2, and 3
NCT02075047 (20) [back to overview]Change From Baseline in Simpson-Angus Rating Scale (SARS) Total Score at Weeks 1, 2, 3, and 4
NCT02075047 (20) [back to overview]Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, Early Termination Visit and Follow-up Visit
NCT02075047 (20) [back to overview]Clinical Global Impression of Improvement (CGI-I) Scores at Weeks 1, 2, 3, and 4
NCT02075047 (20) [back to overview]Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) - Movement Cluster Score at Weeks 1, 2, 3, and 4
NCT02075047 (20) [back to overview]Number of Participants With Physical Examination Abnormalities
NCT02075047 (20) [back to overview]Number of Participants With Laboratory Abnormalities
NCT02075047 (20) [back to overview]Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 4
NCT02075047 (20) [back to overview]Change From Baseline in Height and Waist Circumference at Week 4 and Early Termination Visit
NCT02075047 (20) [back to overview]Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4
NCT02075047 (20) [back to overview]Change From Baseline in Body Weight at Week 4 and Early Termination Visit
NCT02075047 (20) [back to overview]Change From Baseline in Body Mass Index (BMI) Z-score at Week 4 and Early Termination Visit
NCT02075047 (20) [back to overview]Change From Baseline in Body Mass Index (BMI) at Week 4 and Early Termination Visit
NCT02075047 (20) [back to overview]Change From Baseline in Blood Pressure at Week 1, 2, 3, 4, Early Termination Visit and Follow-up Visit
NCT02075047 (20) [back to overview]Change From Baseline in Barnes Akathisia Rating Scale (BAS): Global Clinical Assessment of Akathisia Subscale Score at Weeks 1, 2, 3, and 4
NCT02075047 (20) [back to overview]Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS)
NCT02075047 (20) [back to overview]Number of Participants With Pre-defined Categories of Electrocardiogram (ECG) Findings
NCT02075047 (20) [back to overview]Change From Baseline in Children's Depression Rating Scale (CDRS-R) Total Score at Weeks 1, 2, 3, and 4 and Early Termination Visit
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 Adverse Event (AE)
NCT03557931 (8) [back to overview]Number of Participants With Clinically Significant Differences in Abnormal Involuntary Movement Scale (AIMS) Values
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]Number of Participants With Clinically Significant Differences in Simpson Angus Scale (SAS) 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
NCT03768726 (19) [back to overview]Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS)
NCT03768726 (19) [back to overview]Change From Baseline in Body Weight at Week 6, 26 and Follow-up Visit
NCT03768726 (19) [back to overview]Change From Baseline in Body Mass Index (BMI) Z-score at Week 6, 26 and Follow-up Visit
NCT03768726 (19) [back to overview]Change From Baseline in Body Mass Index (BMI) at Week 6, 26 and Follow-up Visit
NCT03768726 (19) [back to overview]Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit
NCT03768726 (19) [back to overview]Number of Participants With Laboratory Abnormalities
NCT03768726 (19) [back to overview]Change From Baseline in Children's Global Assessment Scale (CGAS) Total Score at Week 26
NCT03768726 (19) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT03768726 (19) [back to overview]Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26
NCT03768726 (19) [back to overview]Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit
NCT03768726 (19) [back to overview]Change From Baseline in Children's Depression Rating Scale (CDRS-R) Total Score at Week 26
NCT03768726 (19) [back to overview]Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit
NCT03768726 (19) [back to overview]Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit
NCT03768726 (19) [back to overview]Change From Baseline in Simpson-Angus Rating Scale (SARS) Total Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit
NCT03768726 (19) [back to overview]Change From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit
NCT03768726 (19) [back to overview]Change From Baseline in Global Clinical Assessment of Akathisia Subscale Score of Barnes Akathisia Rating Scale (BAS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit
NCT03768726 (19) [back to overview]Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26
NCT03768726 (19) [back to overview]Number of Participants With Physical Examination Abnormalities at Baseline and Week 26
NCT03768726 (19) [back to overview]Change From Baseline in Movement Cluster Subscale Score of Abnormal Involuntary Movement Scale (AIMS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit

Number Who Discontinued Medication Within First 6 Study Months

(NCT00044655)
Timeframe: Measured at Six Months

Interventionparticipants (Number)
Stay11
Switch23

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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported. (NCT00139737)
Timeframe: Baseline up to 72 months

InterventionParticipants (Number)
AEsSAEs
Ziprasidone17732

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Change in Hamilton Depression (HAM-D 17) Total Score

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Total score is first 17 items of the HAM-D 25, which measures the range of depressive symptoms patient currently experiencing; scale 0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score 0 - 52. (NCT00141271)
Timeframe: Baseline to 6 weeks

,,
Interventionscore on scale (Least Squares Mean)
Week 3 (n= 147, 149, 148)Week 6 (n= 104,117,125)Endpoint (n= 151,150,153)
120-160mg Ziprasidone-9.56-12.37-10.48
40-80 mg Ziprasidone-10.58-12.82-11.48
Placebo-10.13-11.30-10.60

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Change in Hamilton Anxiety Rating (HAM-A)

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. HAM-A is a 14-item scale: rates intensity of psychic anxiety and somatic anxiety on a 5-point severity scale (range: 0=not present to 4=very severe). Total possible score is 0 - 56. (NCT00141271)
Timeframe: Baseline to 6 weeks

,,
Interventionscore on scale (Least Squares Mean)
Week 3 (n= 147, 148, 147)Week 6 (n= 104, 117, 124)Endpoint (n= 151, 150, 152)
120-160mg Ziprasidone-5.54-7.63-6.40
40-80 mg Ziprasidone-6.46-7.46-6.75
Placebo-6.79-6.73-6.82

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Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score

Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. MADRS is 10-item instrument measuring depression; scale 0(Normal) and 6(most abnormal). Total possible score is 0 - 60. (NCT00141271)
Timeframe: Baseline to 6 weeks

,,
Interventionscore on scale (Least Squares Mean)
Week 1 (n=161, 153, 159)Week 2 (n=135, 142, 146)Week 3 (n=120, 131, 138)Week 4 (n=106, 126, 131)Week 5 (n=99, 115, 123)Week 6 (n=95, 107, 115)Overall (n=166, 158, 162)
120-160mg Ziprasidone-6.07-10.12-11.61-12.54-14.25-13.81-11.40
40-80 mg Ziprasidone-7.66-10.20-12.93-13.87-14.53-14.77-12.33
Placebo-5.75-9.47-11.37-12.49-12.99-13.25-10.89

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Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7

Response was yes when HAM-D 17 total score was less than or equal to 7 , if not, response was no. Endpoint is LOCF endpoint among Week 1 through Week 6. Total score is first 17 items of the HAM-D 25,which measures the range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe. Total possible score 0 - 52. (NCT00141271)
Timeframe: Baseline to 6 weeks

,,
InterventionParticipants (Number)
Week 3; YesWeek 3; NoWeek 6; YesWeek 6; NoEndpoint: YesEndpoint: No
120-160mg Ziprasidone27120416345106
40-80 mg Ziprasidone30119437444106
Placebo35113438247106

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Change in Total Score of Young Mania Rating Scale (YMRS)

Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. YMRS: 11 item instrument with scale 0 to 4 for 7 items and 0 to 8 for 4 items; 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60. (NCT00141271)
Timeframe: Baseline to 6 weeks

,,
Interventionscore on scale (Least Squares Mean)
Week 1 (n = 140,131, 132)Week 2 (n = 114,124,123)Week 3 (n = 120, 130, 138)Week 4 (n = 93, 116, 116)Week 5 (n = 87, 105, 109)Week 6 (n = 95, 107, 115)Overall (n = 161, 158, 161)
120-160mg Ziprasidone0.050.16-0.03-0.09-0.89-0.86-0.27
40-80 mg Ziprasidone0.640.640.110.19-0.82-0.030.12
Placebo-0.080.510.05-0.73-0.28-1.00-0.26

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Change in Sleep Disturbance Factor Score

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument = sum of Scores of 3 items on sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible is 0 - 12. (NCT00141271)
Timeframe: Baseline to 6 weeks

,,
Interventionscore on scale (Least Squares Mean)
Week 3 (n = 147, 149, 148)Week 6 (n = 104, 117, 125)Endpoint (n = 151, 150 153)
120-160mg Ziprasidone-1.92-2.20-1.90
40-80 mg Ziprasidone-2.07-2.19-1.98
Placebo-1.96-2.06-1.96

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Change in Tower of London Test at Endpoint

Change is observed value at each visit minus baseline value. Endpoint: LOCF endpoint among Week 1 through Week 6. Brief Assessment of Cognition: subjects asked to arrange balls in 2 pictures so they are identical and give the total number of ball movements to reach this arrangment. Range: 0-22; more correct = better cognition. (NCT00141271)
Timeframe: Baseline to 6 Weeks LOCF

InterventionNumber Correct (Least Squares Mean)
120-160mg Ziprasidone0.31
40-80 mg Ziprasidone0.68
Placebo0.91

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Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF)

Change is observed value at endpoint minus baseline value. Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 - 6; GAF is used to assess global psychological, social, & occupational functioning; 100=normal and 0=greatest abnormality (NCT00141271)
Timeframe: Baseline, 6 Weeks LOCF

Interventionscore on scale (Least Squares Mean)
120-160mg Ziprasidone10.11
40-80 mg Ziprasidone11.72
Placebo11.19

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Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)

Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. CGI-S measures severity of patient's mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill (NCT00141271)
Timeframe: Baseline to 6 weeks

,,
Interventionscore on scale (Least Squares Mean)
Week 1 (n=161, 152, 158)Week 2 (n=133, 142, 147)Week 3 (n=119, 131, 137)Week 4 (n=105, 126, 130)Week 5 (n=98, 115, 123)Week 6 (n=94, 107, 115)Overall (n=165, 158, 162)
120-160mg Ziprasidone-0.05-0.84-0.90-1.14-1.33-1.38-1.02
40-80 mg Ziprasidone-0.47-0.82-1.15-1.23-1.35-1.38-1.07
Placebo-0.42-0.75-0.93-1.14-1.23-1.35-0.97

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Change in Global Clinical Improvement of Symptoms (CGI -I)

Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. CGI-I is an instrument for Global assessment of improvement in patient's condition. Scale range: 0=not assessed, 1=very much improved, 7=very much worse (NCT00141271)
Timeframe: Baseline to 6 weeks

,,
Interventionscore on scale (Least Squares Mean)
Week 1 (n=162, 152, 158)Week 2 (n=134, 142, 147)Week 3 (n=120,131,137)Week 4 (n=106,126,130)Week 5 (n=99, 115, 123)Week 6 (n=95,107, 115)Overall (n=166, 158, 162)
120-160mg Ziprasidone3.342.862.902.542.472.492.77
40-80 mg Ziprasidone3.172.822.622.532.482.432.67
Placebo3.383.012.832.552.592.522.81

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Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition measuring immediate recall of 15 emotional words; higher number of words is better recall. (NCT00141271)
Timeframe: Baseline to 6 Weeks LOCF

Interventionwords (Least Squares Mean)
120-160mg Ziprasidone-0.28
40-80 mg Ziprasidone-0.30
Placebo-0.06

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Change in Token Motor Task at Endpoint

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition in which a patient places as many of 100 tokens (2 at a time) into a container as they can within 60 seconds. The higher number of tokens placed = patient is better at motor tasks (NCT00141271)
Timeframe: Baseline to 6 Weeks LOCF

InterventionNumber of Tokens (Least Squares Mean)
120-160mg Ziprasidone0.28
40-80 mg Ziprasidone-0.00
Placebo2.02

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Change in Retardation Factor Scores

Change is observed value at each visit minus baseline value. This instrument = sum of Scores of 4 items on retardation within Hamilton Depression Rating Scale (HAM-D). Scale range is 0 to 4 with higher scores reflecting greater severity. Total possible is 0 - 16. (NCT00141271)
Timeframe: Baseline to 6 Weeks

,,
Interventionscore on scale (Least Squares Mean)
Week 3 (n = 147,149,148)Week 6 (n = 104,117,125)Endpoint (n = 151,150,153)
120-160mg Ziprasidone-3.50-4.44-3.89
40-80 mg Ziprasidone-3.64-4.40-3.99
Placebo-3.59-3.79-3.62

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Change in Verbal Fluency Controlled Word Association at Endpoint

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition. Patients given 60 seconds to generate as many words as possible that begin with a given letter; better verbal fluency = more words (NCT00141271)
Timeframe: Baseline to 6 Weeks LOCF

InterventionNumber Correct (Least Squares Mean)
120-160mg Ziprasidone1.09
40-80 mg Ziprasidone-0.15
Placebo1.54

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Change in Verbal Fluency in Naming Categories at Endpoint

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition.Patients are given 60 seconds to name as many words as possible within a given category. The more words named=better cognition. (NCT00141271)
Timeframe: Baseline to 6 Weeks LOCF

InterventionNumber Correct (Least Squares Mean)
120-160mg Ziprasidone0.19
40-80 mg Ziprasidone-0.11
Placebo-0.28

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Change in Bech Melancholia Score

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Bech Melancholia is the sum of Scores on 6 Items pertaining to melancholia within Hamilton Depression Rating Scale (HAM-D). Scale 0 to 4, higher scores reflecting greater severity;Total possible 0 - 24. (NCT00141271)
Timeframe: Baseline to 6 Weeks

,,
Interventionscore on scale (Least Squares Mean)
Week 3 (n = 147, 149, 148)Week 6 (n = 104, 117, 125)Endpoint (n =151, 150, 153)
120-160mg Ziprasidone-5.12-6.91-5.85
40-80 mg Ziprasidone-5.61-6.93-6.23
Placebo-5.22-6.23-5.70

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Change in Verbal Memory Trial Performance Total Score at Endpoint

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This test is part of Brief Assessment of Cognition and measures recall of 15 words repeated 5 times. Range 0-75 words, higher number reflects better recall. (NCT00141271)
Timeframe: Baseline to 6 Weeks LOCF

Interventionwords (Least Squares Mean)
120-160mg Ziprasidone1.31
40-80 mg Ziprasidone0.85
Placebo1.22

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Change in Anxiety/Somatizations Factor Total Score

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument = sum of Scores on 6 Items measuring anxiety/somatization within Hamilton Depression Rating Scale (HAM-D). Scale range is 0 to 4, higher scores reflecting greater severity. Total possible 0 - 24. (NCT00141271)
Timeframe: Baseline to 6 Weeks

,,
Interventionscore on scale (Least Squares Mean)
Week 3 (n = 147,149,148)Week 6 (n = 104,117,125)Endpoint (n = 151,150,153)
120-160mg Ziprasidone-2.69-3.67-3.04
40-80 mg Ziprasidone-2.92-3.88-3.39
Placebo-2.98-3.62-3.32

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Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument measures immediate recall of 15 non-emotional words (List 1); higher number of words is better recall. (NCT00141271)
Timeframe: Baseline to 6 Weeks LOCF

Interventionwords (Least Squares Mean)
120-160mg Ziprasidone-0.02
40-80 mg Ziprasidone0.14
Placebo-0.00

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Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition in which the number of correct emotional words in delayed recognition is measured. Range 0-75 with higher numbers showing better cognition. (NCT00141271)
Timeframe: Baseline to 6 Weeks LOCF

InterventionWords (Least Squares Mean)
120-160mg Ziprasidone-0.37
40-80 mg Ziprasidone0.15
Placebo0.23

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Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition which measures number of correct emotional word's false alarms (during delayed recognition). Higher number = better cognition (NCT00141271)
Timeframe: Baseline to 6 Weeks LOCF

InterventionNumber Correct (Least Squares Mean)
120-160mg Ziprasidone0.09
40-80 mg Ziprasidone0.01
Placebo-0.03

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Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures number of Non-Emotional Words (Delayed Recognition); higher number of words = better cognition (NCT00141271)
Timeframe: Baseline to Week 6 LOCF

InterventionNumber Correct (Least Squares Mean)
120-160mg Ziprasidone-0.18
40-80 mg Ziprasidone-0.24
Placebo-0.02

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Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures number of correct non-eEmotional word's false alarms(at delayed recognition). Higher number of words = greater cognition (NCT00141271)
Timeframe: Baseline to Week 6 LOCF

InterventionNumber Correct (Least Squares Mean)
120-160mg Ziprasidone0.06
40-80 mg Ziprasidone0.19
Placebo0.14

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Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 emotional words; higher number of words is better recall (NCT00141271)
Timeframe: Baseline to 6 Weeks LOCF

Interventionwords (Least Squares Mean)
120-160mg Ziprasidone-0.06
40-80 mg Ziprasidone-0.07
Placebo0.08

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Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 non-emotional words; higher number of words is better recall (NCT00141271)
Timeframe: Baseline to 6 Weeks LOCF

Interventionwords (Least Squares Mean)
120-160mg Ziprasidone-0.39
40-80 mg Ziprasidone-0.01
Placebo-0.32

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Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This test is in Brief Assessment of Cognition and measures immediate recall of 15 emotional words (List 2); higher number of words is better recall (NCT00141271)
Timeframe: Baseline to 6 Weeks LOCF

Interventionwords (Least Squares Mean)
120-160mg Ziprasidone-0.09
40-80 mg Ziprasidone-0.05
Placebo0.05

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Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 emotional words (List 3); higher number of words is better recall (NCT00141271)
Timeframe: Baseline to Week 6 LOCF

Interventionwords (Least Squares Mean)
120-160mg Ziprasidone-0.18
40-80 mg Ziprasidone-0.30
Placebo-0.03

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Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 3); higher number of words is better recall (NCT00141271)
Timeframe: Baseline to Week 6 LOCF

Interventionwords (Least Squares Mean)
120-160mg Ziprasidone-0.52
40-80 mg Ziprasidone-0.15
Placebo-0.24

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Change in Digit Sequencing Task at Endpoint

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition in which patient sequences digits from lowest to highest. Range of number of correct responses (0-28); higher numbers show better digit sequencing and greater cognition. (NCT00141271)
Timeframe: Baseline to 6 Weeks LOCF

InterventionNumber Correct (Least Squares Mean)
120-160mg Ziprasidone0.76
40-80 mg Ziprasidone0.09
Placebo0.46

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Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint

Change is observed value at each visit minus baseline value. LOCF endpoint among Week 1 through Week 6. Q-LES-Q: 16-item instrument for patients assessment of his/her quality of life; overall level of satisfaction scale 1=very poor to 5=Very good (1 item re medication can be blank). Total possible score 15 - 80 (NCT00141271)
Timeframe: Baseline to 6 Weeks

Interventionscore on scale (Least Squares Mean)
120-160mg Ziprasidone0.08
40-80 mg Ziprasidone0.09
Placebo0.09

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Change in Sheehan Disability Scale (SDS) Total Score at Endpoint

Observed value each visit minus baseline value. Endpoint is LOCF Week 1 through Week 6. SDS: patient rated measure of disability and impairment in 3 items: work/school, social life, family life/home responsibilities:0(no disruption)- 10(extreme disruption). Total possible is 30. (NCT00141271)
Timeframe: Baseline to Week 6

Interventionscore on scale (Least Squares Mean)
120-160mg Ziprasidone-5.78
40-80 mg Ziprasidone-5.43
Placebo-6.79

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Change in Symbol Coding at Endpoint

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition. For 90 seconds, Patient writes numerals 1-9 as matched to symbols. Range 0 to 110 with higher totals = better cognition. (NCT00141271)
Timeframe: Baseline to 6 Weeks LOCF

InterventionTotal Correct (Least Squares Mean)
120-160mg Ziprasidone1.34
40-80 mg Ziprasidone1.07
Placebo2.66

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Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint

Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 2); higher number of words is better recall (NCT00141271)
Timeframe: Baseline to 6 Weeks LOCF

Interventionwords (Least Squares Mean)
120-160mg Ziprasidone-0.16
40-80 mg Ziprasidone0.07
Placebo0.13

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Change in Total Score in Hamilton Depression (HAM-D 25)

Change: observed value at each visit minus baseline value. Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 through Week 6. HAM-D 25: measures the range of depressive symptoms experienced. 25 Items with Scale range:0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme.Total possible score is 0 - 72. (NCT00141271)
Timeframe: Baseline to 6 Weeks

,,
Interventionscore on scale (Least Squares Mean)
Week 3 (n= 147, 149, 147)Week 6 (n= 104, 117, 125)Endpoint (n= 151, 150, 153)
120-160mg Ziprasidone-11.02-14.59-12.25
40-80 mg Ziprasidone-12.16-15.08-13.36
Placebo-12.25-13.74-12.78

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Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12

Response was Yes if MADRS Total Score was less than, equal to 12, if not, response was no. Endpoint is LOCF endpoint among Week 1 through 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6(most abnormal) (NCT00141271)
Timeframe: Baseline to 6 weeks

,,
Interventionparticipants (Number)
Week 1; YesWeek 1; NoWeek 2; YesWeek 2; NoWeek 3; YesWeek 3; NoWeek 4; YesWeek 4; NoWeek 5; YesWeek 5; NoWeek 6; YesWeek 6; NoEndpoint; YesEndpoint; No
120-160mg Ziprasidone18143488756645551653458377393
40-80 mg Ziprasidone271264110161706561664963447286
Placebo251344410255836665665761547389

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Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score

Participants with MADRS Total Score greater or equal to 50 percent decrease from baseline responded yes; others responded no. Endpoint is last observation carried forward (LOCF) among Week 1 - Week 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6 (most abnormal). Total possible score is 0 - 60 (NCT00141271)
Timeframe: Baseline to 6 weeks

,,
InterventionParticipants (Number)
Week 1: YesWeek 1: NoWeek 2 : YesWeek 2: NoWeek 3: YesWeek 3: NoWeek 4: YesWeek 4: NoWeek 5: YesWeek 5: NoWeek 6: YesWeek 6: NoEndpoint: YesEndpoint: No
120-160mg Ziprasidone19142518457635650673258377690
40-80 mg Ziprasidone32121509267647056744169388375
Placebo26133519560786863715267488082

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Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score

Participants with greater than or equal to 50 percent decrease from baseline in HAMD-17 total score responded yes; others responded no. Endpoint is LOCF endpoint among Week 1 - 6; Total score is first 17 items of HAM-D 25: measures range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe. Total possible score 0 - 52. (NCT00141271)
Timeframe: Baseline to 6 weeks

,,
Interventionparticipants (Number)
Week 3: YesWeek 3: NoWeek 6: YesWeek 6: NoEndpoint: YesEndpoint: No
120-160mg Ziprasidone608764407477
40-80 mg Ziprasidone678273448268
Placebo618773528172

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Response as Measured by CGI-I Score Less Than or Equal to 2

Response each week was yes if CGI-I score less than or equal to 2 (much or very much improved), if not, response was no; Endpoint is LOCF endpoint among Week 1 through Week 6. CGI-I is a Global assessment of improvement in patient's condition. Scale range: 0=not assessed, 1=very much improved, 7=very much worse (NCT00141271)
Timeframe: Week 1 through Week 6 (endpoint)

,,
InterventionParticipants (Number)
Week 1; YesWeek 1; NoWeek 2; YesWeek 2; NoWeek 3; YesWeek 3; NoWeek 4; YesWeek 4; NoWeek 5; YesWeek 5; NoWeek 6; YesWeek 6; NoEndpoint; YesEndpoint; No
120-160mg Ziprasidone20142528251696838693060357492
40-80 mg Ziprasidone34118548871607650744176318375
Placebo28130509758797060735066497785

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Change From Baseline in CGI-S at End of Study (up to 5 Years)

CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill). Change: score at observation minus score at baseline. (NCT00174447)
Timeframe: Baseline, up to 5 years (End of Study [LOCF])

Interventionscore on a scale (Mean)
Ziprasidone0.9

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Change From Baseline in CGI-I at End of Study (up to 5 Years)

CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Change from baseline is score at observation minus score at baseline. (NCT00174447)
Timeframe: Baseline, up to 5 years (End of Study [LOCF])

Interventionscore on a scale (Mean)
Ziprasidone1.4

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Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)

CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assessed investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). (NCT00174447)
Timeframe: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]

Interventionparticipants (Number)
Baseline (n=43): normal, not ill at allBaseline (n=43): borderlineBaseline (n=43): mildly illBaseline (n=43): moderately illBaseline (n=43): markedly ill3 months (n=35): normal, not ill at all3 months (n=35): borderline3 months (n=35): mildly ill3 months (n=35): moderately ill6 months (n=34): normal, not ill at all6 months (n=34): borderline6 months (n=34): mildly ill6 months (n=34): moderately ill1 year (n=27): normal, not ill at all1 year (n=27): borderline1 year (n=27): mildly ill1 year (n=27): moderately ill3 years (n=10): normal, not ill at all3 years (n=10): borderline3 years (n=10): mildly ill3 years (n=10): moderately ill5 years (n=7): normal, not ill at all5 years (n=7): borderline5 years (n=7): mildly illEnd of Study [LOCF] (n=43): normal, not ill at allEnd of Study [LOCF] (n=43): borderlineEnd of Study [LOCF] (n=43): mildly illEnd of Study [LOCF] (n=43): moderately illEnd of Study [LOCF] (n=43):markedly illEnd of Study [LOCF] (n=43): severely ill
Ziprasidone42014416131068101156109215221424991083

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Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)

CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. (NCT00174447)
Timeframe: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]

Interventionparticipants (Number)
Baseline (n=43): very much improvedBaseline (n=43): much improved3 months (n=35): very much improved3 months (n=35): much improved3 months (n=35): minimally improved3 months (n=35): no change6 months (n=34): very much improved6 months (n=34): much improved6 months (n=34): minimally improved6 months (n=34): no change6 months (n=34): minimally worsened1 year (n=27): very much improved1 year (n=27): much improved1 year (n=27): minimally improved1 year (n=27): no change3 years (n=10): very much improved3 years (n=10): much improved3 years (n=10): no change3 years (n=10): minimally worsened5 years (n=7): very much improved5 years (n=7): much improved5 years (n=7): minimally improvedEnd of Study [LOCF] (n=43): very much improvedEnd of Study [LOCF] (n=43): much improvedEnd of Study [LOCF] (n=43): minimally improvedEnd of Study [LOCF] (n=43): no changeEnd of Study [LOCF] (n=43): minimally worsenedEnd of Study [LOCF] (n=43): much worsened
Ziprasidone133010202311182217161325212415175646

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Number of Participants With Scores on Patient Preference Scale (PPS)

Patient rated satisfaction scale with responses: Much better, I prefer this medication, Slightly better, About the same, Slightly worse, and Much worse, I much preferred my previous medication. (NCT00174447)
Timeframe: Baseline, up to 5 years (End of Study)

Interventionparticipants (Number)
Baseline (n=43): much betterBaseline (n=43): slightly betterBaseline (n=43): about the sameEnd of study (n=28): much betterEnd of study (n=28): slightly betterEnd of study (n=28): about the sameEnd of study (n=28): slightly worseEnd of study (n=28): much worse
Ziprasidone2813248835

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Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years)

DAI, a 10-item scale to assess how the attitude of schizophrenia patients toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicated a positive subjective response (compliant), whilst a negative score indicated non-compliance. Change: score at observation minus score at baseline. (NCT00174447)
Timeframe: Baseline, up to 5 years (End of Study)

Interventionscore on a scale (Mean)
Ziprasidone-3.3

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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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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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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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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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Brief Social Phobia Scale(BSPS)

An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items. (NCT00215150)
Timeframe: Baseline, 8 and 16 weeks

,,
Interventionunits on a scale (Mean)
Beginning of Study PhaseEnd of Study Phase
Open Label Phase44.031.2
Randomization Phase for Placebo Group31.824.6
Randomization Phase for Ziprasidone Group31.821.0

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Working Memory

"California Verbal Learning Test (CVLT) trials 1 through 5 is a well established neuropsychological test of working memory. The maximum score is 80 which reflects a better outcome and the minimum score is 0 which reflects a worse outcome.~The only meaningful analyses with adequate statistical power that could be reported were of the 10 schizophrenia patients who met nonresponse criteria to ziprasidone. The overall enrollment of 35 subjects was insufficient to perform the originally planned analyses in a statistically valid manner." (NCT00225498)
Timeframe: 3 months

Interventionunits on a scale (Mean)
Ziprasidone44.8

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Mean Change From Baseline in the Total Score of the Beck Depression Inventory (BDI)

Beck Depression Inventory, self-rated scale measuring depression symptoms; possible total scores ranging from 0-63, with higher scores indicating greater severity of depression. (NCT00237666)
Timeframe: Week 8

InterventionScores on a scale (Mean)
Baseline BDIWeek 8 BDI
Ziprasidone27.915.0

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Mean Change From Baseline in the CGI-Severity of Illness (CGI-S) Score at Study Endpoint

Clinical Global Impression of Severity scale: one item, measuring overall severity of illness; possible scores range from 1-7, with higher scores representing greater severity of illness. (NCT00237666)
Timeframe: Week 8

InterventionScore on a scale (Mean)
Baseline CGI-SWeek 8 CGI-S
Ziprasidone4.272.33

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Mean Change From Baseline in the Hamilton Anxiety Scale (HAM-A)

Hamilton Anxiety Rating Scale, measuring anxiety symptoms; possible total scores ranging from 0-30, with higher scores indicating greater severity of anxiety. (NCT00237666)
Timeframe: Week 8

InterventionScores on a scale (Mean)
Baseline HAM-AWeek 8 HAM-A
Ziprasidone19.4710.69

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Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale

Montgomery-Åsberg Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-60, with higher scores indicating greater severity of depression. (NCT00237666)
Timeframe: Week 8

InterventionScores on a scale (Mean)
Baseline MADRSWeek 8 MADRS
Ziprasidone28.4713.21

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Mean Change From Baseline in the Total Score of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scale consists of 14 items; possible scores range from 14-70 with higher scores indicating greater quality of life and satisfaction. (NCT00237666)
Timeframe: Week 8

InterventionScores on a scale (Mean)
Baseline Q-LES-QWeek 8 Q-LES-Q
Ziprasidone35.0748.25

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The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores

Hamilton Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-54, with higher scores indicating greater severity of symptoms. (NCT00237666)
Timeframe: Week 8

InterventionScores on a scale (Mean)
Baseline HAM-DWeek 8 HAM-D
Ziprasidone23.110.57

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Percentage of Subjects With Clinical Global Inventory (CGI) Global Improvement Score of 1 or 2

"Clinical Global Impression of Improvement scale: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement.~18 subjects (60%) were responders (defined as having a CGI-I scores of 1 or 2 at Week 8/study endpoint) by the end of the trial." (NCT00237666)
Timeframe: Week 8

Interventionpercentage of subjects with CGI-I
Ziprasidone60

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Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill). (NCT00257166)
Timeframe: Baseline, Week 1, 2, 3, 4

,
Interventionunits on a scale (Mean)
Baseline (n=143,86)Change at Week 1 (n=131,85)Change at Week 2 (n=120,82)Change at Week 3 (n=108,65)Change at Week 4 (n=96,51)
Placebo4.5-0.5-0.6-0.7-0.9
Ziprasidone4.5-0.9-1.1-1.3-1.4

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Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3

YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania. (NCT00257166)
Timeframe: Baseline, Week 1, 2, 3

,
Interventionunits on a scale (Mean)
Change at Week 1 (n=131,85)Change at Week 2 (n=120,81)Change at Week 3 (n=108,65)
Placebo-6.3-8.1-9.0
Ziprasidone-9.3-11.5-13.0

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Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4

YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania. (NCT00257166)
Timeframe: Baseline, Week 4

,
Interventionunits on a scale (Mean)
Baseline (n=143,86)Change at Week 4 (n=97,51)
Placebo27.0-9.9
Ziprasidone26.2-13.8

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Clinical Global Impression - Improvement (CGI-I) Score

CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. (NCT00257166)
Timeframe: Week 1, 2, 3, 4

,
Interventionunits on a scale (Mean)
Week 1 (n=132,85)Week 2 (n=120,82)Week 3 (n=108,65)Week 4 (n=96,51)
Placebo3.43.23.12.8
Ziprasidone2.82.52.42.3

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Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item

BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6-point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed. (NCT00257192)
Timeframe: Baseline, Week 1 through Week 6

,
Interventionscores on a scale (Mean)
Week 1 (n=190, 86)Week 2 (n=183, 86)Week 3 (n=166, 74)Week 4 (n=155, 63)Week 5 (n=142, 54)Week 6 (n=135, 52)Week 6 [LOCF] (n=190, 87)
Placebo0.10.00.0-0.00.00.00.0
Ziprasidone0.10.10.10.10.10.00.0

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Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score

CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. (NCT00257192)
Timeframe: Baseline, Week 1 through Week 6

,
Interventionscores on a scale (Mean)
Week 1 (n=179, 82)Week 2 (n=174, 80)Week 3 (n=157, 69)Week 4 (n=148, 59)Week 5 (n=135, 49)Week 6 (n=126, 47)Week 6 [LOCF] (n=178, 82)
Placebo-1.4-2.5-3.2-4.9-5.6-6.5-4.0
Ziprasidone-2.8-4.2-5.5-6.0-7.0-7.9-5.8

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Clinical Global Impression of Improvement (CGI-I) Score at Week 6

CGI-I: single-item clinician rated scale used to assess the subject's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected. (NCT00257192)
Timeframe: Baseline, Week 6

Interventionscores on a scale (Least Squares Mean)
Ziprasidone2.66
Placebo2.85

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Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13

CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Suicide Ideation (Item 13) detects changes in suicidality over time. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). (NCT00257192)
Timeframe: Baseline, Week 1 through Week 6

,
Interventionscores on a scale (Mean)
Week 1 (n=188, 86)Week 2 (n=182, 86)Week 3 (n=165, 74)Week 4 (n=154, 63)Week 5 (n=141, 54)Week 6 (n=134, 52)Week 6 [LOCF] (n=189, 87)
Placebo-0.0-0.1-0.1-0.1-0.1-0.1-0.0
Ziprasidone-0.1-0.0-0.10.00.0-0.00.0

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Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6

CGI-S: single-item clinician rated scale to rate the severity of a subject's illness over time. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score indicates more affected. (NCT00257192)
Timeframe: Baseline, Week 6

Interventionscores on a scale (Least Squares Mean)
Ziprasidone-1.05
Placebo-0.84

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Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1

Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses resolved by using most impaired rating given by valid informant. Impaired Schoolwork (Item 1) assesses school function for the subgroup of subjects reported to be in school. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). (NCT00257192)
Timeframe: Baseline, Week 2, Week 6

,
Interventionscores on a scale (Mean)
Week 2 (n=38, 15)Week 6 (n=30, 8)Week 6 [LOCF] (n=39, 15)
Placebo-0.2-0.1-0.1
Ziprasidone-0.3-0.6-0.6

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Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6

BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology. (NCT00257192)
Timeframe: Baseline, Week 6

Interventionscores on a scale (Least Squares Mean)
Ziprasidone-14.16
Placebo-12.35

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Number of Subjects Per Response on the School Placement Questionnaire: School Situation

School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school. (NCT00257192)
Timeframe: Baseline, Week 2, Week 6, ET

,
Interventionparticipants (Number)
Baseline: Enrolled or attend (n=185, 85)Baseline: Not attend or mental illness (n=185, 85)Baseline: Not attend or other (n=185, 85)Baseline: Enrolled or vacation (n=185, 85)Baseline: Not enrolled or mental illnessBaseline: Not enrolled or other (n=185, 85)Week 2: Enrolled or attend (n=179, 84)Week 2: Not attend or mental illness (n=179, 84)Week 2: Not attend or other (n=179, 84)Week 2: Enrolled or vacation (n=179, 84)Week 2: Not enrolled or mental illness (n=179, 84)Week 2: Not enrolled or other (n=179, 84)Week 6: Enrolled or attend (n=134, 51)Week 6: Not attend or mental illness (n=134, 51)Week 6: Not attend or other (n=134, 51)Week 6: Enrolled or vacation (n=134, 51)Week 6: Not enrolled or mental illness (n=134, 51)Week 6: Not enrolled or other (n=134, 51)ET: Enrolled or attend (n=32, 25)ET: Not attend or mental illness (n=32, 25)ET: Not attend or other (n=32, 25)ET: Enrolled or vacation (n=32, 25)ET: Not enrolled or mental illness (n=32, 25)ET: Not enrolled or other (n=32, 25)Week 6 [LOCF]: Enrolled or attend (n=183, 86)Week 6 [LOCF]: Not attend or mental illnessWeek 6 [LOCF]: Not attend or other (n=183, 86)Week 6 [LOCF]: Enrolled or vacation (n=183, 86)Week 6 [LOCF]: Not enrolled or mental illnessWeek 6 [LOCF]: Not enrolled or other (n=183, 86)
Placebo1526019121320242111512187051110314043123861101712
Ziprasidone406222036253859320362338363142320580510447503213626

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Number of Subjects Per Response on the School Placement Questionnaire: School Attendance

School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school. (NCT00257192)
Timeframe: Baseline, Week 2, Week 6, ET

,
Interventionparticipants (Number)
Baseline: No absences (n=88, 42)Baseline: Only a few absences (n=88, 42)Baseline: Frequent absences (n=88, 42)Baseline: Did not attend (n=88, 42)Baseline: Not applicable or vacation (n=88, 42)Week 2: No absences (n=82, 36)Week 2: Only a few absences (n=82, 36)Week 2: Frequent absences (n=82, 36)Week 2: Did not attend (n=82, 36)Week 2: Not applicable or vacation (n=82, 36)Week 6: No absences (n=67, 24)Week 6: Only a few absences (n=67, 24)Week 6: Frequent absences (n=67, 24)Week 6: Did not attend (n=67, 24)Week 6: Not applicable or vacation (n=67, 24)ET: No absences (n=12, 12)ET: Only a few absences (n=12, 12)ET: Frequent absences (n=12, 12)ET: Did not attend (n=12, 12)ET: Not applicable or vacation (n=12, 12)Week 6 [LOCF]: No absences (n=89, 37)Week 6 [LOCF]: Only a few absences (n=89, 37)Week 6 [LOCF]: Frequent absences (n=89, 37)Week 6 [LOCF]: Did not attend (n=89, 37)Week 6[LOCF]: Not applicable or vacation(n=89,37)
Placebo71527118948781200400543813448
Ziprasidone20161326131914112513162251311142411826112113

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Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance

School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school. (NCT00257192)
Timeframe: Baseline, Week 2, Week 6, ET

,
Interventionparticipants (Number)
Baseline: Excellent (n=64, 29)Baseline: Good (n=64, 29)Baseline: Fair (n=64, 29)Baseline: Poor (n=64, 29)Baseline: Very poor (n=64, 29)Week 2: Excellent (n=60, 26)Week 2: Good (n=60, 26)Week 2: Fair (n=60, 26)Week 2: Poor (n=60, 26)Week 2: Very poor (n=60, 26)Week 6: Excellent (n=52, 21)Week 6: Good (n=52, 21)Week 6: Fair (n=52, 21)Week 6: Poor (n=52, 21)Week 6: Very poor (n=52, 21)ET: Excellent (n=8, 7)ET: Good (n=8, 7)ET: Fair (n=8, 7)ET: Poor (n=8, 7)ET: Very poor (n=8, 7)Week 6 [LOCF]: Excellent (n=68, 28)Week 6 [LOCF]: Good (n=68, 28)Week 6 [LOCF]: Fair (n=68, 28)Week 6 [LOCF]: Poor (n=68, 28)Week 6 [LOCF]: Very poor (n=68, 28)
Placebo26143418105218111001312191422
Ziprasidone4102519651220176416171230052141824166

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Change From Baseline in PANSS: Positive and Negative Subscales at Week 6

PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity. (NCT00257192)
Timeframe: Baseline, Week 6

,
Interventionscores on a scale (Least Squares Mean)
Positive scoreNegative score
Placebo-5.88-5.09
Ziprasidone-7.22-5.51

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Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS)

SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected. (NCT00257192)
Timeframe: Baseline, Week 1 through Week 6

,
Interventionscores on a scale (Mean)
Week 1 (n=189, 85)Week 2 (n=182, 85)Week 3 (n=165, 74)Week 4 (n=154, 62)Week 5 (n=141, 54)Week 6 (n=134, 52)Week 6 [LOCF] (n=189, 86)
Placebo0.1-0.00.3-0.0-0.0-0.2-0.1
Ziprasidone0.50.50.70.40.20.20.3

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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6

PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity. (NCT00257192)
Timeframe: Baseline, Week 6

Interventionscores on a scale (Least Squares Mean)
Ziprasidone-23.58
Placebo-21.01

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Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score

AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity. (NCT00257192)
Timeframe: Baseline, Week 1 through Week 6

,
Interventionscores on a scale (Mean)
Week 1 (n=190, 86)Week 2 (n=183, 86)Week 3 (n=166, 74)Week 4 (n=155, 63)Week 5 (n=142, 54)Week 6 (n=135, 52)Week 6 [LOCF] (n=190, 87)
Placebo-0.00.00.1-0.00.00.0-0.0
Ziprasidone0.20.10.10.1-0.10.00.0

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Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index

A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79). (NCT00257192)
Timeframe: Baseline, Week 6, ET

,
Interventionscores on a scale (Mean)
Neurocognitive Index: Week 6 (n=120, 45)Neurocognitive Index: ET (n=23, 23)Neurocognitive Index: Week 6 [LOCF] (n=143, 67)
Placebo0.82.21.1
Ziprasidone1.8-2.71.0

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Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales

A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79). (NCT00257192)
Timeframe: Baseline, Week 6, ET

,
Interventionscores on a scale (Mean)
Sedation: Week 6 (n=124, 47)Sedation: ET (n=23, 26)Sedation: Week 6 [LOCF] (n=147, 72)Verbal Memory: Week 6 (n=124, 47)Verbal Memory: ET (n=24, 25)Verbal Memory: Week 6 [LOCF] (n=148, 71)Visual Memory: Week 6 (n=124, 46)Visual Memory: ET (n=24, 26)Visual Memory: Week 6 [LOCF] (n=148, 71)Processing Speed: Week 6 (n=124, 46)Processing Speed: ET (n=24, 25)Processing Speed: Week 6 [LOCF] (n=148, 70)Reasoning: Week 6 (n=122, 46)Reasoning: ET (n=23, 25)Reasoning: Week 6 [LOCF] (n=145, 70)Executive Functioning: Week 6 (n=123, 46)Executive Functioning: ET (n=23, 26)Executive Functioning: Week 6 [LOCF] (n=146, 71)Working Memory: Week 6 (n=120, 45)Working Memory: ET (n=23, 24)Working Memory: Week 6 [LOCF] (n=143, 68)Sustained Attention: Week 6 (n=120, 45)Sustained Attention: ET (n=23, 24)Sustained Attention: Week 6 [LOCF] (n=143, 68)
Placebo-0.40.2-0.20.5-2.6-0.52.00.41.21.00.50.6-0.73.30.72.74.63.20.53.71.3-1.61.5-0.9
Ziprasidone0.00.00.01.3-2.30.70.5-3.8-0.21.3-10.6-0.62.21.31.92.9-6.71.41.93.22.02.00.51.7

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Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score

CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression. (NCT00257192)
Timeframe: Baseline, Week 1 through Week 6

,
Interventionscores on a scale (Mean)
Week 1 (n=165, 69)Week 2 (n=161, 71)Week 3 (n=146, 64)Week 4 (n=138, 51)Week 5 (n=126, 44)Week 6 (n=119, 42)Week 6 [LOCF] (n=167, 71)
Placebo-1.3-1.0-0.7-1.0-0.8-1.9-0.3
Ziprasidone-2.4-2.5-3.0-2.7-3.1-3.0-2.3

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Change From Baseline in Children's Global Assessment Scale (CGAS)

"CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the normal range; lower score indicates need for increased supervision." (NCT00257192)
Timeframe: Baseline, Week 2, Week 4, Week 6, Early termination (ET)

,
Interventionscores on a scale (Mean)
Week 2 (n=183, 86)Week 4 (n=155, 63)Week 6 (n=135, 52)ET (n=20, 15)Week 6 [LOCF] (n=185, 87)
Placebo2.66.210.81.76.4
Ziprasidone4.77.910.91.38.4

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Change From Baseline in Child Health Questionnaire (CHQ)

CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status. (NCT00257192)
Timeframe: Baseline, Week 6, ET

,
Interventionscores on a scale (Mean)
Global health: Week 6Global health: ETGlobal health: Week 6 [LOCF]Global behavior: Week 6Global behavior: ETGlobal behavior: Week 6 [LOCF]Family cohesion: Week 6Family cohesion: ETFamily cohesion: Week 6 [LOCF]Physical health: Week 6Physical health: ETPhysical health: Week 6 [LOCF]Bodily pain: Week 6Bodily pain: ETBodily pain: Week 6 [LOCF]Emotion, behavior: Week 6Emotion, behavior: ETEmotion, behavior: Week 6 [LOCF]Time impact on parent: Week 6Time impact on parent: ETTime impact on parent: Week 6 [LOCF]Emotional impact on parent: Week 6Emotional impact on parent: ETEmotional impact on parent: Week 6 [LOCF]Mental health: Week 6Mental health: ETMental health: Week 6 [LOCF]Physical function: Week 6Physical function: ETPhysical function: Week 6 [LOCF]Behavior scale: Week 6Behavior scale: ETBehavior scale: Week 6 [LOCF]Self-esteem: Week 6Self-esteem: ETSelf-esteem: Week 6 [LOCF]General health perception: Week 6General health perception: ETGeneral health perception: Week 6 [LOCF]Family activities: Week 6Family activities: ETFamily activities: Week 6 [LOCF]Change in health: Week 6Change in health: ETChange in health: Week 6 [LOCF]Physical health global subscale: Week 6Physical health global subscale: ETPhysical health global subscale: Week 6 [LOCF]Psychosocial health global subscale: Week 6Psychosocial health global subscale: ETPsychosocial health global subscale: Week 6 [LOCF]
Placebo8.5-9.11.410.9-0.56.5-0.8-2.6-1.15.03.24.88.00.04.913.8-2.57.811.81.88.010.02.77.412.6-0.87.55.9-0.23.79.00.65.89.01.36.43.3-0.61.814.6-4.67.80.6-0.10.32.40.11.67.70.04.8
Ziprasidone5.0-5.42.89.46.48.81.9-1.81.23.5-6.51.44.44.74.516.24.013.68.82.07.48.93.57.78.11.36.75.6-5.43.39.07.68.76.01.05.01.1-2.20.49.21.37.50.5-0.40.31.8-2.80.96.63.15.9

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Body Mass Index (BMI) Z-score Frequency

change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change (NCT00265330)
Timeframe: Week 26

Interventionparticipants (Number)
<-4≥-4 to <-3≥-3 to <-2≥-2 to <-1≥-1 to <0≥0 to <1≥1 to <2≥2 to <3≥3 to <4≥4
Ziprasidone000127391000

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Young Mania Rating Scale (YMRS) Total Score Change From Baseline

YMRS: 11-item instrument with scales 0 (normal) to 4 (highest abnormal)for 7 items and 0 (normal) to 8 (highest abnormal) for 4 items. Total possible 0 - 60. Baseline is from parent study A1281132. (NCT00265330)
Timeframe: baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF)

Interventionscore on scale (Mean)
Week 2 (n=153)Week 6 (n=122)Week 18 (n=76)Week 26 (n=69)Early Termination (n=59)Week 26-LOCF (n=153)
Ziprasidone-3.8-4.0-6.3-6.11.5-3.3

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Mean Change From Baseline for Body Weight

Mean change; body weight value at observation minus body weight value at baseline. (NCT00265330)
Timeframe: Week 6, Week 26

Interventionkilogram (Mean)
Week 6 (n=119)Week 26 (n=68)Early Termination (n=74)
Ziprasidone1.33.91.4

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Body Mass Index (BMI) Z-score Frequency

change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change (NCT00265330)
Timeframe: Week 6

Interventionparticipants (Number)
<-4≥-4 to <-3≥-3 to <-2≥-2 to <-1≥-1 to <0≥0 to <1≥1 to <2≥2 to <3≥3 to <4≥4
Ziprasidone000053611000

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Frequency of Largest Categorical Increases in QTcF for Males

QT intervals (observed in an electrocardiogram) corrected with Fridericia's Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF. (NCT00265330)
Timeframe: Week 26 (end of study)

Interventionparticipants (Number)
≥450 msec (millisecond )≥460 msec≥480 msec≥30 msec increase≥60 msec increase
Ziprasidone000280

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Change in Hormones

Mean Change: lab value at observation minus lab value at baseline (NCT00265330)
Timeframe: Week 6, Week 26

Interventionnanogram/deciliter (ng/dL) (Mean)
Testosterone Week 6 (n=80)Testosterone Week 26 (n=38)Testosterone Early Termination (n=32)Prolactin Week 6 (n=110)Prolactin Week 26 (n=59)Prolactin Early Termination (n=40)Insulin-like growth factor Week 6 (n=95)Insulin-like growth factor Week 26 (n=47)Insulin-like growth factor Early Term (n=34)
Ziprasidone0.9-23.4-0.42.71.91.0-19.9-9.2-8.4

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Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol

Mean Change: lab value at observation minus lab value at baseline. (NCT00265330)
Timeframe: Week 6, Week 26

Interventionmilligram /deciliter (mg/dL) (Mean)
LDL cholesterol Week 6 (n=113)LDL cholesterol Week 26 (n=59)LDL cholesterol Early Termination (n=44)Fasting cholesterol Week 6 (n=113)Fasting cholesterol Week 26 (n=59)Fasting cholesterol Early Termination (n=44)
Ziprasidone-7.5-8.9-7.6-7.7-10.3-8.6

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Clinical Global Impression of Severity (CGI-S) Change From Baseline

CGI-S Scale:standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Change: score at observation minus score at baseline. Score: 1 (not ill at all) to 7 (among most extremely ill). Baseline = last available observation from parent double-blind study(A1281132). (NCT00265330)
Timeframe: baseline and 26 Weeks; 26 Weeks LOCF

Interventionscore on scale (Mean)
Week 1 (n=159)Week 2 (n=150)Week 6 (n=122)Week 10 (n=99)Week 14 (n=85)Week 18 (n=76)Week 22 (n=70)Week 26 (n=69)Early Termination (n=48)Week 26-LOCF (n=160)
Ziprasidone-0.2-0.5-0.4-0.7-0.7-0.7-0.8-1.10.4-0.4

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Frequency of Largest Categorical Increases in QTcF - All Subjects

QT intervals (observed in an electrocardiogram)corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF. (NCT00265330)
Timeframe: Week 26 (end of study)

Interventionparticipants (Number)
≥450 msec (millisecond)≥460 msec≥480 msec≥30 msec increase≥60 msec increase
Ziprasidone300382

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Frequency of Largest Categorical Increases in QTcF for Females

QT interval (observed in an electrocardiogram) corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF. (NCT00265330)
Timeframe: Week 26 (end of study)

Interventionparticipants (Number)
≥450 msec (millisecond)≥460 msec≥480 msec≥30 msec increase≥60 msec increase
Ziprasidone300102

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Mean Change From Baseline in Supine Diastolic Blood Pressure

Mean Change: vital sign value at observation minus vital sign value at baseline (NCT00265330)
Timeframe: Week 1 through Week 26

Interventionmillimeters mercury (mm Hg) (Mean)
Week 1 (n=155)Week 2 (n=142)Week 6/pre-dose (n=115)Week 6/5-7 hours post dose (n=108)Week 10 (n=93)Week 14 (n=82)Week 18 (n=74)Week 22 (n=69)Week 26 (n=68)Early Termination (n=75)
Ziprasidone-0.50.50.60.5-0.4-2.4-0.6-0.71.51.3

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Incidence of Lab Abnormalities

number of subjects with an abnormal lab value for those parameters with 5% or greater incidence of abnormality. (NCT00265330)
Timeframe: Week 26

Interventionparticipants (Number)
Bicarbonate (N=136)Urine blood/Hemoglobin (N=136)Urine ketones (N=136)Testosterone (N=134)Urine specific gravity (N=136)Urine red blood cells (N=136)Monocytes (N=134)Triglycerides (N=136)Urine white blood cells (N=136)Insulin (N=115)
Ziprasidone443432221313910108

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Mean Change From Baseline for Body Mass Index (BMI) Z-Score

mean change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change (NCT00265330)
Timeframe: Week 6, 26, early termination

Interventionscore on scale (Mean)
Week 6 (n=119)Week 26 (n=68)Early Termination (n=74)
Ziprasidone0.00.10.0

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Mean Change From Baseline for QTcF Intervals

QT intervals (observed in an electrocardiogram)corrected using Fridericia's formula (QTcF). Mean change: mean change of observation minus baseline. Baseline: last available observation in the parent double-blind study. (NCT00265330)
Timeframe: Baseline to Week 26 (end of study)

Interventionmillisecond (Mean)
Week 1 (n=152)Week 2 (n=137)Week 6/pre-dose (n=111)Week 6/5-7 hours post dose (n=107)Week 10 (n=91)Week 14 (n=81)Week 18 (n=73)Week 22 (n=68)Week 26 (n=64)Early Termination (n=45)
Ziprasidone4.83.57.67.04.36.27.48.17.12.7

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Mean Change From Baseline in Standing Diastolic Blood Pressure

Mean Change: vital sign value at observation minus vital sign value at baseline (NCT00265330)
Timeframe: Week 1 through Week 26

Interventionmm Hg (Mean)
Week 1 (n=154)Week 2 (n=141)Week 6/pre-dose (n=115)Week 6/5-7 hours post dose (n=108)Week 10 (n=93)Week 14 (n=82)Week 18 (n=74)Week 22 (n=70)Week 26 (n=68)Early Termination (n=75)
Ziprasidone0.72.01.41.21.6-0.11.10.52.83.4

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Mean Change From Baseline in Standing Pulse Rates

Mean Change: vital sign value at observation minus vital sign value at baseline (NCT00265330)
Timeframe: Week 1 through Week 26

Interventionbeats per minute (Mean)
Week 1 (n=154)Week 2 (n=140)Week 6/pre-dose (n=115)Week 6/5-7 hours post dose (n=108)Week 10 (n=93)Week 14 (n=82)Week 18 (n=74)Week 22 (n=70)Week 26 (n=68)Early Termination (n=75)
Ziprasidone3.52.90.33.82.60.5-0.31.2-0.94.8

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Mean Change From Baseline in Standing Systolic Blood Pressure

Mean Change: vital sign value at observation minus vital sign value at baseline (NCT00265330)
Timeframe: Week 1 through Week 26

Interventionmm Hg (Mean)
Week 1 (n=154)Week 2 (n=141)Week 6/pre-dose (n=115)Week 6/5-7 hours post dose (n=108)Week 10 (n=93)Week 14 (n=82)Week 18 (n=74)Week 22 (n=70)Week 26 (n=68)Early Termination (n=75)
Ziprasidone1.43.71.62.02.40.53.13.23.63.0

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Mean Change From Baseline in Supine Pulse Rates

Mean Change: vital sign value at observation minus vital sign value at baseline (NCT00265330)
Timeframe: Week 1 through Week 26

Interventionbeats per minute (Mean)
Week 1 (n=155)Week 2 (n=142)Week 6/pre-dose (n=115)Week 6/5-7 hours post dose (n=108)Week 10 (n=93)Week 14 (n=82)Week 18 (n=74)Week 22 (n=69)Week 26 (n=68)Early Termination (n=75)
Ziprasidone1.42.0-1.81.01.4-3.0-3.5-2.1-3.03.9

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Mean Change From Baseline in Supine Systolic Blood Pressure

Mean Change: vital sign value at observation minus vital sign value at baseline (NCT00265330)
Timeframe: Week 1 through Week 26

Interventionmillimeters of mercury (mm Hg) (Mean)
Week 1 (n=155)Week 2 (n=142)Week 6/pre-dose (n=115)Week 6/5-7 hours post dose (n=108)Week 10 (n=93)Week 14 (n=82)Week 18 (n=74)Week 22 (n=69)Week 26 (n=68)Early Termination (n=75)
Ziprasidone0.41.11.21.21.4-0.70.41.72.91.3

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Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score

AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity. (NCT00265382)
Timeframe: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET

Interventionscores on a scale (Mean)
Week 1 (n=206)Week 2 (n=197)Week 6 (n=168)Week 10 (n=135)Week 14 (n=110)Week 18 (n=99)Week 22 (n=82)Week 26 (n=76)ET (n=127)Week 26 LOCF (n=206)
Ziprasidone0.06-0.05-0.040.020.010.010.100.08-0.120.00

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Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score

CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression. (NCT00265382)
Timeframe: Baseline, Weeks 2, 6, 18, 26, ET

Interventionscores on a scale (Mean)
Week 2 (n=178)Week 6 (n=153)Week 18 (n=93)Week 26 (n=68)ET (n=113)Week 26 LOCF (n=177)
Ziprasidone-0.3-0.8-0.50.70.5-0.5

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Change From Baseline in Children's Global Assessment Scale (CGAS)

"CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the normal range; lower score indicates need for increased supervision." (NCT00265382)
Timeframe: Baseline, Weeks 2, 6, 18, 26, ET

Interventionscores on a scale (Mean)
Week 2 (n=197)Week 6 (n=168)Week 18 (n=99)Week 26 (n=76)ET (n=127)Week 26 LOCF (n=197)
Ziprasidone55.559.262.365.656.660.5

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Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported. (NCT00265382)
Timeframe: 26 weeks

Interventionparticipants (Number)
AEsSAEs
Ziprasidone13716

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Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales

Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79). (NCT00265382)
Timeframe: Baseline, Weeks 6 and 26, ET

Interventionscores on a scale (Mean)
Sedation: Week 6 (n=149)Sedation: Week 26 (n=70)Sedation: ET (n=102)Sedation: Week 26 LOCF (n=153)Verbal Memory: Week 6 (n=150)Verbal Memory: Week 26 (n=71)Verbal Memory: ET (n=103)Verbal Memory: Week 26 LOCF (n=155)Visual Memory: Week 6 (n=148)Visual Memory: Week 26 (n=71)Visual Memory: ET (n=103)Visual Memory: Week 26 LOCF (n=154)Processing Speed: Week 6 (n=148)Processing Speed: Week 26 (n=71)Processing Speed: ET (n=103)Processing Speed: Week 26 LOCF (n=153)Reasoning: Week 6 (n=145)Reasoning: Week 26 (n=71)Reasoning: ET (n=100)Reasoning: Week 26 LOCF (n=151)Executive Functioning: Week 6 (n=145)Executive Functioning: Week 26 (n=71)Executive Functioning: ET (n=100)Executive Functioning: Week 26 LOCF (n=151)Working Memory: Week 6 (n=145)Working Memory: Week 26 (n=68)Working Memory: ET (n=99)Working Memory: Week 26 LOCF (n=150)Sustained Attention: Week 6 (n=145)Sustained Attention: Week 26 (n=68)Sustained Attention: ET (n=99)Sustained Attention: Week 26 LOCF (n=150)
Ziprasidone0.1-0.2-0.1-0.2-1.30.6-0.70.3-3.6-2.1-1.9-1.5-1.22.1-1.40.5-0.33.01.91.52.02.02.42.4-0.50.80.30.70.21.9-0.61.2

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Change From Baseline in Child Health Questionnaire (CHQ)

CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status. (NCT00265382)
Timeframe: Baseline, Weeks 6 and 26, ET

Interventionscores on a scale (Mean)
Global Health: Week 6 (n=163)Global Health: Week 26 (n=75)Global Health: ET (n=124)Global Health: Week 26 LOCF (n=164)Global Behavior: Week 6 (n=163)Global Behavior: Week 26 (n=75)Global Behavior: ET (n=124)Global Behavior: Week 26 LOCF (n=164)Family Cohesion: Week 6 (n=163)Family Cohesion: Week 26 (n=75)Family Cohesion: ET (n=124)Family Cohesion: Week 26 LOCF (n=164)Physical Health: Week 6 (n=163)Physical Health: Week 26 (n=74)Physical Health: ET (n=123)Physical Health: Week 26 LOCF (n=163)Bodily Pain: Week 6 (n=163)Bodily Pain: Week 26 (n=75)Bodily Pain: ET (n=124)Bodily Pain: Week 26 LOCF (n=164)Emotion, Behavior: Week 6 (n=163)Emotion, Behavior: Week 26 (n=74)Emotion, Behavior: ET (n=123)Emotion, Behavior: Week 26 LOCF (n=163)Time Impact on Parent: Week 6 (n=163)Time Impact on Parent: Week 26 (n=75)Time Impact on Parent: ET (n=124)Time Impact on Parent: Week 26 LOCF (n=164)Emotional Impact on Parent: Week 6 (n=163)Emotional Impact on Parent: Week 26 (n=75)Emotional Impact on Parent: ET (n=124)Emotional Impact on Parent: Week 26 LOCF (n=164)Mental Health: Week 6 (n=163)Mental Health: Week 26 (n=75)Mental Health: ET (n=124)Mental Health: Week 26 LOCF (n=164)Physical Function: Week 6 (n=163)Physical Function: Week 26 (n=75)Physical Function: ET (n=124)Physical Function: Week 26 LOCF (n=164)Behavior Scale: Week 6 (n=163)Behavior Scale: Week 26 (n=75)Behavior Scale: ET (n=124)Behavior Scale: Week 26 LOCF (n=164)Self-Esteem: Week 6 (n=163)Self-Esteem: Week 26 (n=74)Self-Esteem: ET (n=124)Self-Esteem: Week 26 LOCF (n=163)General Health Perception: Week 6 (n=163)General Health Perception: Week 26 (n=75)General Health Perception: ET (n=124)General Health Perception: Week 26 LOCF (n=164)Family Activities: Week 6 (n=163)Family Activities: Week 26 (n=75)Family Activities: ET (n=124)Family Activities: Week 26 LOCF (n=164)Physical Health Global Subscale: Week 6 (n=163)Physical Health Global Subscale: Week 26 (n=74)Physical Health Global: ET (n=123)Physical Health Global: Week 26 LOCF (n=163)Psychosocial Health Global: Week 6 (n=163)Psychosocial Health Global: Week 26 (n=74)Psychosocial Health Global: ET (n=123)Psychosocial Health Global: Week 26 LOCF (n=163)
Ziprasidone44.250.340.544.944.947.038.743.853.054.450.053.476.480.275.577.880.884.481.082.553.360.149.554.862.069.959.965.149.557.243.452.263.666.760.865.180.484.979.581.462.764.560.263.052.755.352.654.550.351.849.750.360.163.956.361.644.146.643.844.835.738.533.736.8

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Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score

CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. (NCT00265382)
Timeframe: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET

Interventionscores on a scale (Mean)
Week 1 (n=198)Week 2 (n=188)Week 6 (n=160)Week 10 (n=129)Week 14 (n=105)Week 18 (n=94)Week 22 (n=78)Week 26 (n=72)ET (n=122)Week 26 LOCF (n=197)
Ziprasidone-1.4-2.2-3.5-4.6-5.0-4.9-5.1-5.3-2.7-4.5

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Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score

BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement. Ratings anchored to improve consistency for single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology. (NCT00265382)
Timeframe: Baseline, Weeks 2, 6, 18, 26, ET

Interventionscores on a scale (Mean)
Week 2 (n=196)Week 6 (n=167)Week 18 (n=98)Week 26 (n=75)ET (n=127)Week 26 LOCF (n=196)
Ziprasidone-3.8-6.1-7.8-8.5-4.0-6.9

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Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item

BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6- point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed. (NCT00265382)
Timeframe: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET

Interventionscores on a scale (Mean)
Week 1 (n=206)Week 2 (n=197)Week 6 (n=168)Week 10 (n=135)Week 14 (n=110)Week 18 (n=99)Week 22 (n=82)Week 26 (n=76)ET (n=127)Week 26 LOCF (n=206)
Ziprasidone0.00.00.00.00.10.00.00.00.00.1

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Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment

Tanner Adolescent Pubertal Staging Questionnaire: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). (NCT00265382)
Timeframe: Baseline, Week 26, Early Termination (ET)

Interventionparticipants (Number)
Pubic Hair, Week 26 (Stage 1)Pubic Hair, Week 26 (Stage 2)Pubic Hair, Week 26 (Stage 3)Pubic Hair, Week 26 (Stage 4)Pubic Hair, Week 26 (Stage 5)Pubic Hair, ET (Stage 1)Pubic Hair, ET (Stage 2)Pubic Hair, ET (Stage 3)Pubic Hair, ET (Stage 4)Pubic Hair, ET (Stage 5)
Ziprasidone11113921010225930

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Number of Subjects Per Response on the School Placement Questionnaire: School Situation

School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school. (NCT00265382)
Timeframe: Baseline, Weeks 6 and 26, ET

Interventionparticipants (Number)
Baseline: Enrolled or Attend (n=221)Baseline: Not Attend or Mental Illness (n=221)Baseline: Not Attend or Other (n=221)Baseline: Enrolled or Vacation (n=221)Baseline: Not Enrolled or Mental Illness (n=221)Baseline: Not Enrolled or Other (n=221)Week 6: Enrolled or Attend (n=166)Week 6: Not Attend or Mental Illness (n=166)Week 6: Not Attend or Other (n=166)Week 6: Enrolled or Vacation (n=166)Week 6: Not Enrolled or Mental Illness (n=166)Week 6: Not Enrolled or Other (n=166)Week 26: Enrolled or Attend (n=75)Week 26: Not Attend or Mental Illness (n=75)Week 26: Not Attend or Other (n=75)Week 26: Enrolled or Vacation (n=75)Week 26: Not Enrolled or Mental Illness (n=75)Week 26: Not Enrolled or Other (n=75)ET: Enrolled or Attend (n=125)ET: Not Attend or Mental Illness (n=125)ET: Not Attend or Other (n=125)ET: Enrolled or Vacation (n=125)ET: Not Enrolled or Mental Illness (n=125)ET: Not Enrolled or Other (n=125)Week 26 LOCF: Enrolled or Attend (n=166)Week 26 LOCF: Not Attend or Mental Illness (n=166)Week 26 LOCF: Not Attend or Other (n=166)Week 26 LOCF: Enrolled or Vacation (n=166)Wk 26 LOCF: Not Enrolled or Mental Illness (n=166)Week 26 LOCF: Not Enrolled or Other (n=166)
Ziprasidone635942642276832114292235905131342351921177530182824

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Number of Subjects Per Response on the School Placement Questionnaire: School Attendance

School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school. (NCT00265382)
Timeframe: Baseline, Weeks 6 and 26, ET

Interventionparticipants (Number)
Baseline: No Absences (n=133)Baseline: Only a Few Absences (n=133)Baseline: Frequent Absences (n=133)Baseline: Did Not Attend (n=133)Baseline: Not Applicable or Vacation (n=133)Week 6: No Absences (n=95)Week 6: Only a Few Absences (n=95)Week 6: Frequent Absences (n=95)Week 6: Did Not Attend (n=95)Week 6: Not Applicable or Vacation (n=95)Week 26: No Absences (n=42)Week 26: Only a Few Absences (n=42)Week 26: Frequent Absences (n=42)Week 26: Did Not Attend (n=42)Week 26: Not Applicable or Vacation (n=42)ET: No Absences (n=62)ET: Only a Few Absences (n=62)ET: Frequent Absences (n=62)ET: Did Not Attend (n=62)ET: Not Applicable or Vacation (n=62)Week 26 LOCF: No Absences (n=93)Week 26 LOCF: Only a Few Absences (n=93)Week 26 LOCF: Frequent Absences (n=93)Week 26 LOCF: Did Not Attend (n=93)Week 26 LOCF: Not Applicable or Vacation (n=93)
Ziprasidone2537123623312911101414167051623511732321478

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Change From Baseline in Simpson-Angus Rating Scale (SARS)

SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected. (NCT00265382)
Timeframe: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET

Interventionscores on a scale (Mean)
Week 1 (n=206)Week 2 (n=197)Week 6 (n=168)Week 10 (n=135)Week 14 (n=110)Week 18 (n=99)Week 22 (n=82)Week 26 (n=76)ET (n=127)Week 26 LOCF (n=206)
Ziprasidone-0.05-0.11-0.04-0.10-0.020.02-0.04-0.32-0.31-0.15

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Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index

Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79). (NCT00265382)
Timeframe: Baseline, Weeks 6 and 26, ET

Interventionscores on a scale (Mean)
Neurocognitive Index: Week 6 (n=144)Neurocognitive Index: Week 26 (n=68)Neurocognitive Index: ET (n=99)Neurocognitive Index: Week 26 LOCF (n=150)
Ziprasidone-0.61.30.50.7

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Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance

School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school. (NCT00265382)
Timeframe: Baseline, Weeks 6 and 26, ET

Interventionparticipants (Number)
Baseline: Excellent (n=103)Baseline: Good (n=103)Baseline: Fair (n=103)Baseline: Poor (n=103)Baseline: Very Poor (n=103)Week 6: Excellent (n=73)Week 6: Good (n=73)Week 6: Fair (n=73)Week 6: Poor (n=73)Week 6: Very Poor (n=73)Week 26: Excellent (n=37)Week 26: Good (n=37)Week 26: Fair (n=37)Week 26: Poor (n=37)Week 26: Very Poor (n=37)ET: Excellent (n=48)ET: Good (n=48)ET: Fair (n=48)ET: Poor (n=48)ET: Very Poor (n=48)Week 26 LOCF: Excellent (n=80)Week 26 LOCF: Good (n=80)Week 26 LOCF: Fair (n=80)Week 26 LOCF: Poor (n=80)Week 26 LOCF: Very Poor (n=80)
Ziprasidone525402310223341401101853015236412239153

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Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period

Period 2 Baseline = last observation in Period 1 to the start of Period 2. MRS is 11-item scale to measure mania; derived from Schedule for Affective Disorders and Schizophrenia-Change Behavior (SADS-CB). Subscales: Manic Syndrome (elevated mood, less need for sleep, excessive energy and activity, grandiosity), Behavior and Ideation (irritability, motor hyperactivity, accelerated speech, racing thoughts, poor judgment), and Impaired Insight. Racing thoughts range=0 to 2 (highest level of abnormal=2); all other items 0 to 5 (highest level of abnormal=5). Higher score = greater abnormality. (NCT00280566)
Timeframe: Period 2: Weeks 1 - 24 or time of early termination

,
Interventionscores on scale (Mean)
Week 1 (n=121, 106)Week 2 (n=116, 95)Week 4 (n=117,95)Week 8 (n=107, 79)Week 12 (n=98, 70)Week 16 (n=94,65)Week 20 (n=84, 58)Week 24 (n=85,53)
Placebo0.8-0.10.20.81.21.20.20.3
Ziprasidone-0.2-0.4-0.6-0.3-1.0-1.4-1.1-1.1

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Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period

Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Clinical Global Impression Severity Score is 7-item scale rates severity of illness from 0=not assessed, 1= normal to 7=most extremely ill. (NCT00280566)
Timeframe: Period 2: Weeks 1 - 24 or time of early termination

,
Interventionscores on scale (Mean)
Week 1 (n=122, 106)Week 2 (n=117, 95)Week 4 (n=117, 95)Week 8 (n=107, 79)Week 12 (n=98, 70)Week 16 (n=94, 65)Week 20 (n=83, 58)Week 24 (n=85, 53)
Placebo0.30.20.1-0.10.00.0-0.2-0.2
Ziprasidone0.10.2-0.0-0.0-0.1-0.1-0.1-0.2

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Time to Intervention for a Mood Episode During Double Blind Period

Time to Intervention for Mood Episode (TIME) while on randomized drug after at least 8 weeks of symptom reduction on open-label ziprasidone plus mood stabilizer. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart. (NCT00280566)
Timeframe: Period 2: 24 weeks or time of early termination

InterventionDays (Mean)
Ziprasidone172.159
Placebo143.133

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Modified Time to Intervention for a Mood Episode (TIME)

Time to intervention for a mood episode or time to discontinuation for treatment related adverse events, or death due to drug, or death due to disease. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart. (NCT00280566)
Timeframe: Period 2: Week 24 or time of early termination

InterventionDays (Mean)
Ziprasidone168.145
Placebo140.325

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Time to Discontinuation for Any Reason During Double Blind Period 2

Key Secondary endpoint is time to discontinuation for any reason. Profile of patients remaining in the trial over time. (NCT00280566)
Timeframe: Period 2: 24 weeks or time of early termination

Interventiondays (Mean)
Ziprasidone153.526
Placebo123.313

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Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period

Clinical Global Impression measures 7 items in Global assessment of improvement in patient's condition; 0=not assessed, 1= very much improved to 7= very much worse. (NCT00280566)
Timeframe: Period 2: Weeks 1 - 24 or time of early termination

,
Interventionscores on scale (Mean)
Week 1 (n=122, 106)Week 2 (n=117, 95)Week 4 (n=117, 95Week 8 (n=107, 79)Week 12 (n=98, 70)Week 16 (n=94, 65)Week 20 (n=83, 58)Week 24 (n=85, 53)
Placebo2.82.62.52.22.22.52.12.2
Ziprasidone2.32.42.32.32.22.32.12.2

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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period

Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive and Negative Syndrome Scale Total Score is 30-item scale measuring severity of psychopathology (16 items), positive symptoms (7 items) and negative symptoms (7 items); scale from 1 (absent) to 7 (extreme) (NCT00280566)
Timeframe: Period 2: Weeks 4 - 24 or time of early termination

,
Interventionscores on scale (Mean)
Week 4 (n=123, 98)Week 8 (n=107, 79)Week 12 (n=98, 70)Week 16 (n=94, 65)Week 20 (n=84, 58)Week 24 (n=85, 53)
Placebo1.5-0.80.30.7-1.0-0.9
Ziprasidone0.4-0.1-0.1-0.0-0.2-0.6

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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period

Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive Scale is 7-items derived from PANSS; 1 (absent), 2 (minimal) to 7 (extreme). (NCT00280566)
Timeframe: Period 2: Weeks 4 - 24 or time of early termination

,
Interventionscores on scale (Mean)
Week 4 (n=123, 98)Week 8 (n=107, 79)Week 12 (n=98, 70)Week 16 (n=94, 65)Week 20 (n=84, 58)Week 24 (n=85, 53)
Placebo0.1-0.20.30.0-0.1-0.1
Ziprasidone0.0-0.2-0.3-0.4-0.2-0.2

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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale by Visit During Double Blind Period

Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Negative Scale is 7 items derived from PANSS; scale is 1 (absent) to 7 (extreme). (NCT00280566)
Timeframe: Period 2: Weeks 4 - 24 or time of early termination

,
Interventionscores on scale (Mean)
Week 4 (n=123, 98)Week 8 (n=107, 79)Week 12 (n=98, 70)Week 16 (n=94, 65)Week 20 (n=84, 58)Week 24 (n=85, 53)
Placebo0.4-0.10.10.4-0.4-0.1
Ziprasidone0.20.20.10.3-0.0-0.1

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Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period

Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. MADRS is 10-item instrument measuring depression: scales from 0=Normal to 6 = most abnormal. (NCT00280566)
Timeframe: Period 2: Weeks 1 - 24 or time of early termination

,
Interventionscores on scale (Mean)
Week 1 (n=121, 106)Week 2 (n=117, 95)Week 4 (n=117, 95)Week 8 (n=107, 79)Week 12 (n=98, 70)Week 16 (n=94,65)Week 20 (n=84, 58)Week 24 (n=85, 53)
Placebo2.72.71.60.40.60.4-0.21.0
Ziprasidone-0.21.1-0.30.41.11.20.50.4

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Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint

Change is observed value at each visit minus baseline value. Subject Rating: Subject's perceived change in status using a 20-item instrument measuring cognitive deficits and degree of affect on funtioning. Scale 0 to 4, higher numbers reflecting greater impairment. Total possible score is 0 - 80. Endpoint is last observation carried forward. (NCT00282464)
Timeframe: Baseline to Week 6 (endpoint)

Interventionscore on scale (Least Squares Mean)
Ziprasidone 20-80mg Bid4.69
Placebo4.81

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Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject

Change is observed value at each visit minus baseline value. BPCoRs: Subject interview with 20-items measuring cognitive deficits & degree of affect on functioning. Scale range:0 to 4, higher numbers, greater impairment. Total possible score is 0 - 80. Endpoint=last observation carried forward (LOCF) (NCT00282464)
Timeframe: Baseline to week 6 (endpoint)

Interventionscore on scale (Least Squares Mean)
Ziprasidone 20-80mg Bid-0.65
Placebo-0.73

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Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating

Change is observed value at each visit minus baseline value. Informant Global Rating is interview with informant of subject using BPCoRS, a 20-item instrument measuring cognitive deficits & degree of affect on functioning. Scale: 0 to 4, higher numbers = greater impairment. Total possible score is 0 - 80. Endpoint is LOCF. (NCT00282464)
Timeframe: Baseline to week 6 (endpoint)

Interventionscore on scale (Least Squares Mean)
Ziprasidone 20-80mg Bid4.66
Placebo4.68

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Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer

Change in Rating by interviewer, using BPCoRS, 20-item instrument measuring cognitive deficits and the degree of affect on functioning; 4 point scale with higher numbers reflecting greater impairment.Total possible score is 0 - 80. (NCT00282464)
Timeframe: Baseline to week 6 (endpoint)

Interventionscore on scale (Least Squares Mean)
Ziprasidone 20-80mg Bid4.72
Placebo4.63

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Change in Hamilton Anxiety Rating (HAM-A)

Change is observed value at each visit minus baseline value. HAM-A:14-item scale to rate the intensity of psychic anxiety (items 1- 6, 14) and somatic anxiety (items 7-13) on a 5-point severity scale (0=not present to 4=very severe). Total possible score is 0 - 56. (NCT00282464)
Timeframe: Baseline to Weeks 3, 6

,
Interventionscore on scale (Least Squares Mean)
Week 3 (n=167, 177)Week 6 (n=126, 150)Endpoint (n=168, 181)
Placebo-4.18-6.64-3.26
Ziprasidone 20-80mg Bid-4.63-6.84-3.05

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Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score

Participants with MADRS Total Score greater than or equal to 50 percent decrease from baseline responded yes; others responded no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6 (most abnormal)for each item. Total possible score is 0 - 60. Endpoint is last observation carried forward (LOCF) (NCT00282464)
Timeframe: Baseline to Week 6

,
Interventionparticipants (Number)
Week 1: YesWeek 1: NoWeek 2: YesWeek 2: NoWeek 3: YesWeek 3: NoWeek 4: YesWeek 4: NoWeek 5: YesWeek 5: NoWeek 6: YesWeek 6: NoEndpoint: YesEndpoint: No
Placebo2416848128601056687776983589793
Ziprasidone 20-80mg Bid401375510571787659814076409585

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Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score

Participants with greater than or equal to 50 percent decrease from baseline in HAM-D 17 total score responded yes; others responded no. Total score is first 17 items of the HAM-D 25: measures range of depressive symptoms. Scale: 8 items 0-2 & 9 items 0-4, higher scores being more severe. Total possible score is 0 - 52. Endpoint is LOCF. (NCT00282464)
Timeframe: Baseline to Week 3, Week 6

,
InterventionParticipants (Number)
Week 3: YesWeek 3: NoWeek 6: YesWeek 6: NoEndpoint: YesEndpoint: No
Placebo6511291599784
Ziprasidone 20-80mg Bid729585419573

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Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12

Remission response is yes if MADRS total score less than or equal to 12; if not, response is no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6(most abnormal).Total possible score is 0 - 60. Endpoint is LOCF. (NCT00282464)
Timeframe: Week 1 to Week 6

,
InterventionParticipants (Number)
Week 1: YesWeek 1: NoWeek 2: YesWeek 2: NoWeek 3: YesWeek 3: NoWeek 4: YesWeek 4: NoWeek 5: YesWeek 5: NoWeek 6: YesWeek 6: NoEndpoint: YesEndpoint: No
Placebo21168411355810560936680726981109
Ziprasidone 20-80mg Bid411365410670796669705170468793

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Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7

Remission response is yes when HAM-D 17 total score is less than or equal to 7; if not, response is no. Total score is first 17 items of HAM-D 25, measures range of depressive symptoms. Scale: 8 items 0-2 and 9 items 0-4, higher scores more severe. Total possible score is 0 - 52. Endpoint is LOCF. (NCT00282464)
Timeframe: Week 3, Week 6

,
InterventionParticipants (Number)
Week 3: YesWeek 3: NoWeek 6: YesWeek 6: NoEndpoint: YesEndpoint: No
Placebo33144519955126
Ziprasidone 20-80mg Bid32135567059109

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Change in Total Score of Young Mania Rating Scale (YMRS)

Change is observed value at each visit minus baseline value. YMRS: 11 item instrument with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60. Overall is average response Week 1 - 6. (NCT00282464)
Timeframe: Baseline to week 6

,
Interventionscore on scale (Least Squares Mean)
Week 1 (n=177, 189)Week 2 (n=160, 176)Week 3 (n=149, 163)Week 4 (n=135, 153)Week 5 (n=121, 146)Week 6 (n=116, 141)Overall (n=180, 190)
Placebo0.69-0.130.00-0.77-0.77-0.66-0.27
Ziprasidone 20-80mg Bid0.400.49-0.13-0.60-0.94-0.45-0.20

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Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25)

Change is observed value at each visit minus baseline value. HAM-D: 25-item instrument measuring the range of depressive symptoms patient currently experiencing. Scale: 14 items 0-2 & 11 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 72. Endpoint is LOCF. (NCT00282464)
Timeframe: Baseline to Weeks 3, 6

,
Interventionscore on scale (Least Squares Mean)
Week 3 (n=167, 177)Week 6 (n=126, 150)Endpoint (n=168, 181)
Placebo-10.76-14.80-8.58
Ziprasidone 20-80mg Bid-11.68-15.48-8.06

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Change in Sleep Disturbance Factor Score

Change is observed value at each visit minus baseline value. Sleep Disturbance is the sum of scores of 3 items which pertain to sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 12. (NCT00282464)
Timeframe: Baseline to Weeks 3, 6

,
Interventionscore on scale (Least Squares Mean)
Week 3 (n =167, 177)Week 6 (n =126, 150)Endpoint (n=168, 181)
Placebo-1.48-2.31-1.26
Ziprasidone 20-80mg Bid-1.51-2.38-1.19

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Change in Retardation Factor Scores

Change is observed value at each visit minus baseline value. Retardation Factor is the sum of scores of 4 items which pertain to retardation within HAM-D. Scores 0 to 4, higher scores reflecting greater severity.Total possible score is 0 - 16. Endpoint is LOCF. (NCT00282464)
Timeframe: Baseline to Weeks 3, 6

,
Interventionscore on scale (Least Squares Mean)
Week 3 (n =167, 177)Week 6 (n =126, 150)Endpoint (n =168, 181)
Placebo-2.68-3.66-1.88
Ziprasidone 20-80mg Bid-3.22-4.38-2.24

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Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

Change is observed value at each visit minus baseline value. MADRS:10-item instrument measuring depression; scale range between 0(Normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. Overall is average response Week 1 - Week 6. (NCT00282464)
Timeframe: Baseline to Week 6

,
Interventionscore on scale (Least Squares Mean)
Week 1 (n= 177, 189)Week 2 (n=160, 176)Week 3 (n=149, 163)Week 4 (n=135, 153)Week 5 (n=121, 146)Week 6 (n=116, 141)Overall (n= 180, 190)
Placebo-5.02-8.13-10.04-11.53-12.55-13.24-10.09
Ziprasidone 20-80mg Bid-7.23-9.99-11.88-13.29-14.53-14.88-11.97

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Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score

Change is observed value at each visit minus baseline value. HAM-D 17 Total score is first 17 items of HAM-D 25; measures range of depressive symptoms patient currently experiencing. Scale: 8 items 0-2 & 9 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 52.Endpoint is LOCF (NCT00282464)
Timeframe: Baseline to Weeks 3, 6

,
Interventionscore on scale (Least Squares Mean)
Week 3 (n=167, 177)Week 6 (n=126, 150)Endpoint (n=168, 181)
Placebo-8.73-12.07-7.11
Ziprasidone 20-80mg Bid-9.91-12.91-6.92

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Change in Global Clinical Severity of Symptoms (CGI-S)

Change is observed value at each visit minus baseline value. CGI-S is an instrument to measure severity of mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill (NCT00282464)
Timeframe: Baseline to week 6

,
Interventionscore on scale (Least Squares Mean)
Week 1 (n=177, 188)Week 2 (n=160, 176)Week 3 (n=149, 163)Week 4 (n=135, 152)Week 5 (n=121, 146)Week 6 (n=116, 140)Overall (n=180, 190)
Placebo-0.25-0.51-0.84-0.98-1.15-1.28-0.84
Ziprasidone 20-80mg Bid-0.39-0.66-0.88-1.03-1.27-1.34-0.93

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Change in Global Clinical Improvement of Symptoms (CGI -I)

Change is observed value at each visit minus baseline value. CGI-I is an instrument for Global assessment of improvement in patient's condition. Scale range:0=not assessed, 1=very much improved, 7=very much worse (NCT00282464)
Timeframe: Baseline to Week 6

,
Interventionscore on scale (Least Squares Mean)
Week 1 (n=177, 188)Week 2 (n=160, 176)Week 3 (n=149, 163)Week 4 (n=135, 152)Week 5 (n=121, 146)Week 6 (n=116, 140)Overall (n=180, 190)
Placebo3.613.293.042.942.842.643.06
Ziprasidone 20-80mg Bid3.373.092.892.742.612.522.87

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Change in Bech Melancholia Score

Change is observed value at each visit minus baseline value. Bech Melancholia is sum of scores on 6 Items pertaining to melancholia within HAM-D. Scale range 0 to 4; higher scores, greater severity. Total possible score is 0 - 24. Endpoint is LOCF. (NCT00282464)
Timeframe: Baseline to Weeks 3, 6

,
Interventionscore on scale (Least Squares Mean)
Week 3 (n =167, 177)Week 6 (n =126, 150)Endpoint (n =168, 181)
Placebo-4.28-6.20-3.61
Ziprasidone 20-80mg Bid-5.22-6.82-3.73

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Change in Anxiety/Somatizations Factor Total Score

Change is observed value at each visit minus baseline value. This test is sum of Scores on 6 Items pertaining to anxiety/somatization within HAM-D. Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 24. Endpoint is LOCF. (NCT00282464)
Timeframe: Baseline to Weeks 3, 6

,
Interventionscore on scale (Least Squares Mean)
Week 3 (n =167, 177)Week 6 (n =126, 150)Endpoint (n =168, 181)
Placebo-2.61-3.96-2.57
Ziprasidone 20-80mg Bid-2.84-4.09-2.18

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Change in Sheehan Disability Scale (SDS) Total Score

Change is observed value at each visit minus baseline value. SDS is a patient rated measure of disability and impairment in work/school, social life, family life/home responsibilities. Scale range: 0-10 with 0=no disruption,10=extreme disruption. Total possible score is 0 - 30. (NCT00282464)
Timeframe: Baseline to week 6 (endpoint)

Interventionscore on scale (Least Squares Mean)
Ziprasidone 20-80mg Bid-3.69
Placebo-3.05

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Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score

Change is observed value at each visit minus baseline value. Q-LES-Q: 16- item instrument for a patient's assessment of his/her quality of life. Scale range: overall level of satisfaction 1=very poor to 5=Very good. 1 item (medication)can be left blank. Total possible score 15 - 80. (NCT00282464)
Timeframe: Baseline to week 6 (endpoint)

Interventionscore on scale (Least Squares Mean)
Ziprasidone 20-80mg Bid0.06
Placebo0.06

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Change in Global Assessment of Functioning (GAF)

Change is observed value at each visit minus baseline value. GAF is an instrument used to assess global psychological, social, & occupational functioning. Scale range: 100 = normal and 0 = greatest abnormality. (NCT00282464)
Timeframe: Baseline to week 6 (Endpoint)

Interventionscore on scale (Least Squares Mean)
Ziprasidone 20-80mg Bid9.59
Placebo9.53

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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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Change From Baseline in Global Assessment of Functioning (GAF) Score

GAF measures the severity of illness-related impairment in psychological, social, and occupational functioning; rated on a 100-point scale (single score of 1 to 100) with 100 indicating superior functioning. Change calculated as mean of (value of GAF score at observation minus baseline value). (NCT00312494)
Timeframe: Baseline, Week 3

Interventionscores on scale (Least Squares Mean)
Ziprasidone (Higher Dose)8.79
Ziprasidone (Lower Dose)9.62
Placebo7.79

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Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score

CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Rating ranges from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score = more affected. Change calculated as mean of (value of CGI-S score at observation minus baseline value). (NCT00312494)
Timeframe: Baseline, Week 1, Week 2, Week 3

,,
Interventionscores on scale (Least Squares Mean)
Week 1 (n=202, 206, 200)Week 2 (n=178, 188, 186)Week 3 (n=163, 172, 171)
Placebo-0.39-0.73-1.00
Ziprasidone (Higher Dose)-0.35-0.70-0.94
Ziprasidone (Lower Dose)-0.43-0.74-1.13

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Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores

MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal) with anchors at 2-point intervals; total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as mean of (value of MADRS score at observation minus baseline value). (NCT00312494)
Timeframe: Baseline, Week 1, Week 2, Week 3

,,
Interventionscores on scale (Least Squares Mean)
Week 1 (n=202, 205, 200)Week 2 (n=178, 188, 186)Week 3 (n=163, 172, 170)
Placebo-1.11-1.71-2.90
Ziprasidone (Higher Dose)-2.16-3.27-4.20
Ziprasidone (Lower Dose)-2.47-3.24-3.79

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

PANSS is a 30-item scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Scores rated 1 (absent symptoms) to 7 (extreme); total score range 30 to 210: higher score indicates greater severity. Change calculated as mean of (value of PANSS score at observation minus baseline value). (NCT00312494)
Timeframe: Baseline, Week 3

,,
Interventionscores on scale (Least Squares Mean)
Week 3 total score (n=198, 199, 189)Week 3 positive score (n=198, 199, 189)Week 3 negative score (n=198, 199, 189)
Placebo-3.44-1.56-0.20
Ziprasidone (Higher Dose)-4.87-1.94-0.58
Ziprasidone (Lower Dose)-5.34-2.26-0.43

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Change From Baseline to Week 1 and Week 2 in YMRS

YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value). (NCT00312494)
Timeframe: Baseline, Week 1, Week 2

,,
Interventionscores on scale (Least Squares Mean)
Week 1 (n=202, 205, 200)Week 2 (n=178, 188, 186)
Placebo-5.10-8.24
Ziprasidone (Higher Dose)-4.38-7.10
Ziprasidone (Lower Dose)-4.56-7.56

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Clinical Global Impression - Improvement (CGI-I) Scale Scores

CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score = more affected. (NCT00312494)
Timeframe: Week 1, Week 2, Week 3

,,
Interventionscores on scale (Least Squares Mean)
Week 1 (n=202, 206, 200)Week 2 (n=178, 188, 186)Week 3 (n=163, 172, 171)
Placebo3.382.982.72
Ziprasidone (Higher Dose)3.343.022.65
Ziprasidone (Lower Dose)3.342.912.57

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Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS)

YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value). (NCT00312494)
Timeframe: Baseline, Week 3

Interventionscores on scale (Least Squares Mean)
Ziprasidone (Higher Dose)-10.19
Ziprasidone (Lower Dose)-10.95
Placebo-9.47

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Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score

LIFE-RIFT measures severity of illness-related impairment in 4 domains: work, interpersonal relations, recreation, and global satisfaction; has a total score and individual domain scores. Domain scores range from 1 to 5 (scores ≥ 2 reflect impaired functioning). Total score is sum of the 4 domains with range of 4 (very good) to 20 (very poor): higher scores indicate greater impairment. Change calculated as mean of (value of LIFE-RIFT score at observation minus baseline value). (NCT00312494)
Timeframe: Baseline, Week 3

Interventionscores on scale (Least Squares Mean)
Ziprasidone (Higher Dose)-1.68
Ziprasidone (Lower Dose)-1.58
Placebo-1.27

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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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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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Change in Visceral Fat Mass From Baseline to Week 26

CT measured change in visceral fat mass from baseline to week 26 (mm^3) (NCT00338949)
Timeframe: Baseline and Week 26

Interventionmm^3 (Mean)
Control315
Switch392

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Change in Insulin Sensitivity Index From Baseline to Week 26 ((1/mU/L) x 1/Min)

As measured by frequently sampled intravenous glucose tolerance testing (units: 1/mU/L) x 1/Min) (NCT00338949)
Timeframe: Measured at Baseline and Week 26

Intervention(1/mU/L) x 1/Min (Mean)
Control0.072
Switch0.407

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21 Item Hamilton Depression Rating Scale

The scale rates 21 symptoms related to major depression. A total score of 0-7 is considered to be normal, scores of 20 or higher indicate moderately severe depression. Total scores range from a minimum of 0(not ill) to a maximum of 64 (severely ill). (NCT00340379)
Timeframe: 12 week

InterventionUnits on Hamilton Depression Scale (Mean)
Ziprasidone13.6
Sertraline/Haloperidol11.0

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Brief Psychiatric Rating Scale at 12 Weeks

A rating scale used to measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behaviour. Each symptom is rated 1-7 and in this version a total of 24 symptoms are scored. Thus the total range of scores is from a minimum of 24 to a maximum of 168. Lower scores are considered better, so the minimum total score of 24 indicates someone with no psychiatric symptoms, while any score over 40 is considered at least moderately severe, with only the most severely ill patients scoring over 60. (NCT00340379)
Timeframe: 12 weeks

Interventionunits on a Psychiatric Rating scale (Mean)
Ziprasidone28.7
Sertraline/Haloperidol25.8

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Clinical Global Impression Improvement Scale

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, very much worse. Overall the scale goes from a minimum of 1(very much improved) to a maximum of 7(very much worse). (NCT00340379)
Timeframe: 12 weeks

Interventionunits on a Clinical Impressions Scale (Mean)
Ziprasidone3.1
Sertraline/Haloperidol2.5

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Change From Baseline on Fasting Insulin

Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting insulin levels from baseline to study endpoint (week 6 - baseline) (NCT00351000)
Timeframe: baseline, week 6

InterventionmicroIU/L (Mean)
Clozapine Treatment With Adjunctive Ziprasidone1
Olanzapine Treatment With Adjunctive Ziprasidone-0.9

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Change From Baseline in Fasting Glucose

Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting glucose levels from baseline to study endpoint (week 6 - baseline) (NCT00351000)
Timeframe: baseline, week 6

Interventionmg/dL (Mean)
Clozapine Treatment With Adjunctive Ziprasidone5
Olanzapine Treatment With Adjunctive Ziprasidone-4.5

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Number of Events Recorded Based on Ziprasidone Side Effects Checklist During Randomized Trial

Side effects were tracked using the Side Effect Checklist for ziprasidone, which is a well-validated 17 item scale that records the presence or absence of side effects. Total number of side effect events is reported here. (NCT00403546)
Timeframe: From Baseline up to Week 8

Interventionside effect events (Number)
High-Dose Ziprasidone633
Placebo, Standard Treatment Ziprasidone588

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Change From Baseline in Positive Subscale Score of PANSS

The PANSS is a medical scale and was used for measuring symptom severity of participants with schizophrenia in this study. Positive symptoms as defined by the American Psychiatric Association refer to an excess or distortion of normal functions and include the following 7 items: delusions, conceptual disorganization, hallucinations, excitement, grandiosity, suspiciousness/persecution and hostility. Score ranges from 7 to 49 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement. (NCT00403546)
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8
High-Dose Ziprasidone19.6-1.30-2.08-3.09-3.24
Placebo, Standard Treatment Ziprasidone18.2-0.90-1.57-0.91-1.52

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Change From Baseline in the Calgary Depression Rating Scale (CDRS) Total Score

The CDRS was used to assess the level of depression in participants with schizophrenia. The questionnaire consists of 9 questions rated on a 4-point scale from 0 to 3. Total range is 0 to 27 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement. (NCT00403546)
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8
High-Dose Ziprasidone3.8-0.720.19-0.32-0.62
Placebo, Standard Treatment Ziprasidone4.9-1.61-1.83-2.45-2.14

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Change From Baseline in the Barnes Akathisia Scale (BAS)

BAS is a rating scale that is administered by physicians to assess the severity of drug-induced akathisia, which is a movement disorder characterized by a feeling of inner restlessness and a compelling need to be in constant motion, as well as by actions such as rocking while standing or sitting, lifting the feet as if marching on the spot, and crossing and uncrossing the legs while sitting. The following subcategories are scored: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness and are rated on a 4-point scale from 0 - 3. In addition, the global clinical assessment of akathisia uses a 6-point scale ranging from 0 - 5. Total score ranges from 0 to 14 with a higher score indicating increased severity. A positive change from baseline indicates a worse outcome. (NCT00403546)
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8
High-Dose Ziprasidone1.20.00-0.27-0.95-0.62
Placebo, Standard Treatment Ziprasidone1.40.13-0.48-0.45-0.29

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Number of Participants With High and Low Levels in Serum Prolactin Concentration

Blood samples were taken at baseline and Week 8 to measure serum prolactin concentrations. Normal range for females (non-pregnant) is 2-29 nanograms per deciliter (ng/dL) and for males 2-18 ng/dL. Values above the normal range were reported as High and values below the normal range were reported as Low. Reported here is the number of participants with high prolactin concentration and the number of participants with low prolactin concentration. (NCT00403546)
Timeframe: Baseline, Week 8

,
Interventionparticipants (Number)
High Prolactin at BaselineHigh Prolactin up to Week 8Low Prolactin at BaselineLow Prolactin up to Week 8
High-Dose Ziprasidone9711
Placebo, Standard Treatment Ziprasidone10610

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Number of Treatment-emergent Adverse Events During Randomized Trial

Adverse event: any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Serious adverse event (SAE): significant hazard, contraindication, side effect, or precaution, which fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. (NCT00403546)
Timeframe: From Baseline up to Week 8

,
Interventionadverse events (Number)
Serious Adverse EventsNon-serious Adverse Events
High Dose Ziprasidone485
Placebo, Standard Treatment Ziprasidone395

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Percentage of Participants With Response

Response was defined as a reduction in the PANSS total score from baseline by 20% or greater, calculated by first subtracting 30 (the PANSS minimum possible total score). Response rate is the percentage of participants with a response. (NCT00403546)
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

,
Interventionpercentage of participants (Number)
Week 2Week 4Week 6Week 8
High-Dose Ziprasidone24.223.136.433.3
Placebo, Standard Treatment Ziprasidone38.760.931.842.9

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Vital Signs: Systolic and Diastolic Blood Pressure Levels

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at regular times during the study. Normal SBP is defined as 120 millimeters of mercury (mmHg) or below and normal DBP is defined as 80 mmHg or below. Change from baseline is indicated for each time point. A positive change from baseline indicates and increase in blood pressure and a negative change from baseline indicates a decrease. (NCT00403546)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8

,
InterventionmmHg (Mean)
SBP BaselineSBP Week 1SBP Week 2SBP Week 4SBP Week 6SBP Week 8DBP BaselineDBP Week 1DBP Week 2DBP Week 4DBP Week 6DBP Week 8
High-Dose Ziprasidone123.2123.9124.5124.8122.5125.177.6377.1879.2478.0877.7379.24
Placebo, Standard Treatment Ziprasidone125.0122.3124.9124.3127.3121.378.4376.5677.8179.1782.1875.67

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Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS)

The SAS is a 10-item testing instrument used to evaluate drug-related extrapyramidal syndromes. The following items are included in the SAS: gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella reflex, tremor, and salivation. Total score ranges from 0 to 40 with a higher score indicating increased severity. A positive change from baseline indicates a worse outcome. (NCT00403546)
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8
High-Dose Ziprasidone1.50.440.460.59-0.10
Placebo, Standard Treatment Ziprasidone1.5-0.65-0.35-0.09-0.10

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Change in Schizophrenia Cognition Rating Scale (SCoRS) Score

SCoRS is a 20 item interview-based clinical assessment that evaluates cognitive deficits and the degree to which these deficits impair participants' day-to-day functioning. The following cognitive domains are assessed: attention, memory, working memory, language production, reasoning, problem solving, motor skills, and social cognition. Score ranges from 1 to 10 with a higher score indicating a greater degree of impairment. A negative change from baseline indicates an improvement. (NCT00403546)
Timeframe: Baseline, Week 8

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline at Week 8
High-Dose Ziprasidone4.9-0.75
Placebo, Standard Treatment Ziprasidone4.30.25

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

The PANSS is a medical scale and was used for measuring symptom severity of participants with schizophrenia in this study. Total PANSS score consists of 7 items in the Negative subscale, 7 items in the Positive subscale and 16 items in the General Psychopathology scale. Total PANSS score ranges from 30 to 210. A higher score indicates a worse outcome. A negative change from baseline indicates an improvement. (NCT00403546)
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8
High-Dose Ziprasidone74.7-4.03-5.08-8.73-8.62
Placebo, Standard Treatment Ziprasidone71.9-4.16-6.87-4.32-5.48

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Change From Baseline in PANSS Negative Subscale Score

The PANSS is a medical scale and was used for measuring symptom severity of participants with schizophrenia in this study. Negative symptoms as defined by the American Psychiatric Association represent a diminution or loss of normal functions and include the following 7 items: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. Score ranges from 7 to 49 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement. (NCT00403546)
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8
High-Dose Ziprasidone18.1-0.30-1.04-1.59-1.90
Placebo, Standard Treatment Ziprasidone17.9-1.16-2.04-1.68-1.52

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Change From Baseline in Global Assessment of Functioning (GAF) Score

GAF is a numeric scale used to rate social, occupational, and psychological functioning of participants. Scores range from 100 (extremely high functioning) to 1 (severely impaired). A positive change from baseline indicates an improvement. (NCT00403546)
Timeframe: Baseline, Week 8

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline at Week 8
High-Dose Ziprasidone44.43.24
Placebo, Standard Treatment Ziprasidone49.04.86

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Change From Baseline in Clinical Global Impression- Severity (CGI-S) Score

CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with subjects who have the same diagnosis. Score ranges from 1 to 7 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement. (NCT00403546)
Timeframe: Baseline, Week 8

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline at Week 8
High-Dose Ziprasidone4.1-0.25
Placebo, Standard Treatment Ziprasidone4.3-0.05

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Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score

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 baseline. Score ranges from 1 to 7 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement. (NCT00403546)
Timeframe: Baseline, Week 8

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline at Week 8
High-Dose Ziprasidone3.8-0.57
Placebo, Standard Treatment Ziprasidone3.9-0.43

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

AIMS is a rating scale measuring involuntary movements known as tardive dyskinesia, that sometimes develop as a side effect of long-term treatment with antipsychotic medications. The AIMS score was calculated as the sum of questions 1 through 7 of the AIMS instrument, which includes assessments of involuntary movements in the face, lips, jaw, tongue, upper and lower extremities, and neck/shoulders/hips. Each item is rated on a five-point scale of severity from 0-4 with 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Total scores range from 0 to 28. A negative change from baseline indicates an improvement. (NCT00403546)
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8
High-Dose Ziprasidone0.60.000.460.550.90
Placebo, Standard Treatment Ziprasidone1.3-0.53-0.430.180.10

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Electrocardiogram (EKG): Number of Participants With an Increase From Baseline to Corrected QT (QTc) Interval >/= 500 Milliseconds (Msec)

QT interval is a measure of the time between the start of the Q wave and the end of the T wave as determined by electrocardiogram (EKG). The corrected QT Interval (QTc) adjusts the QT interval for heart rate. The number of participants with an increase to QTc interval >/= 500 msec was reported. (NCT00403546)
Timeframe: 6 hours after dosing of Weeks 1, 2 and 8

,
Interventionparticipants (Number)
Week 1Week 2Week 8
High-Dose Ziprasidone000
Placebo, Standard Treatment Ziprasidone100

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Change From Baseline in Weight at Week 16

Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline. (NCT00406315)
Timeframe: Baseline, Week 16, Week 16 LOCF

Interventionkilogram (Mean)
Week 16 (n=133)Week 16 LOCF (n=231)
Ziprasidone-1.09-0.73

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Change From Baseline in Waist and Hip Circumference at Week 16

Waist and hip circumference value: Change = value at Week 16 minus value at Baseline. (NCT00406315)
Timeframe: Baseline, Week 16

Interventioncentimeter (Mean)
Waist (n=132)Hip (n=131)
Ziprasidone-2.9-3.0

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Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16

The TSQM is a 13-item subject-rated scale that evaluates the effectiveness, side effects and convenience of the medication over the past 2-3 weeks. Likert scale: 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 0 and best value is 100. TSQM Effectivenss, Side Effect, Convenience, and Global Satisfaction scores: Change: score at Week 16 or Week 16 LOCF minus score at Baseline. (NCT00406315)
Timeframe: Baseline, Week 16, Week 16 LOCF

Interventionscores on a scale (Mean)
Effectiveness, Week 16 (n=178)Effectiveness, Week 16 LOCF (n=178)Side Effect, Week 16 (n=167)Side Effect, Week 16 LOCF (n=167)Convenience, Week 16 (n=180)Convenience, Week 16 LOCF (n=180)Global Satisfaction, Week 16 (n=179)Global Satisfaction, Week 16 LOCF (n=179)
Ziprasidone10.4910.4918.4918.496.456.4515.3215.32

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Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16

The SCoRS is a 20-question rating scale completed via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. Each question was completed using a 4-point scale (ranging from 1=none to 4=severe). Total possible score ranged from 20 to 80. At the end of the 20 questions, the interviewer completed a Global Scale of 1-10, rating subject's overall difficulty. Higher scores on both indicated greater cognitive impairment. SCoRS total score and global rating: Change: score at Week 16 or Week 16 LOCF minus score at Baseline. (NCT00406315)
Timeframe: Baseline, Week 16, Week 16 LOCF

Interventionscores on a scale (Mean)
Total Score, Week 16 (n=137)Total Score, Week 16 LOCF (n=169)Global Rating, Week 16 (n=137)Global Rating, Week 16 LOCF (n=169)
Ziprasidone-4.61-4.21-1.02-0.88

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Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16

PANSS measures severity of psychopathology in subjects with schizophrenia, schizoaffective disorder and other psychotic disorders. It includes 3 scales and a total of 30 items: 7 items comprise the positive scale, 7 comprise the negative scale, and 16 items measure general psychopathology. 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. PANSS total score and positive and negative scores: Change = score at Week 16 or Week 16 LOCF minus score at Baseline. (NCT00406315)
Timeframe: Baseline, Week 16, Week 16 LOCF

Interventionscores on a scale (Mean)
Total Score, Week 16 (n=144)Total Score, Week 16 LOCF (n=231)Positive Subscale Score, Week 16 (n=144)Positive Subscale Score, Week 16 LOCF (n=231)Negative Subscale Score, Week 16 (n=144)Negative Subscale Score, Week 16 LOCF (n=231)
Ziprasidone-10.22-6.61-3.30-2.43-1.67-0.92

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Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16

GAF Scale measures the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale. Total possible score ranges from 0 (not enough information available to provide GAF) to 100 (Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many qualities. No symptoms). The assessment was done by a trained assessor. GAF scale score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline. (NCT00406315)
Timeframe: Baseline, Week 16, Week 16 LOCF

Interventionscores on a scale (Mean)
Week 16 (n=145)Week 16 LOCF (n=230)
Ziprasidone7.885.27

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Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16

The CGI-S is a single item, clinician-rated scale that assesses the global severity of the subject's overall illness. The CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). CGI-S score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline. (NCT00406315)
Timeframe: Baseline, Week 16, Week 16 LOCF

Interventionscores on a scale (Mean)
Week 16 (n=135)Week 16 LOCF (n=231)
Ziprasidone-0.76-0.47

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Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16

The CDSS is a 9-item, clinician-rated scale validated for rating the severity of depressive symptoms in subjects diagnosed with schizophrenia, and independent of confounding negative and extrapyramidal symptoms. The CDSS rates the severity of depressive symptoms on a 4-point scale ranging from 0 (absent) to 3 (severe). The CDSS depression total score is obtained by adding each of the item scores. Total possible score ranges from 0 to 27. CDSS possible total score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline. (NCT00406315)
Timeframe: Baseline, Week 16, Week 16 LOCF

Interventionscores on a scale (Mean)
Week 16 (n=144)Week 16 LOCF (n=231)
Ziprasidone-2.55-1.58

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Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16

AIMS: a 12-item clinician administered instrument assessing observed abnormal movements in different parts of body. Ten items scored on a 5-point scale (0 = none/normal, 4 = severe) evaluate abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42. Item 8 indicates severity, item 9 indicates Incapacitation. AIMS total, global severity, or global incapacitation score: Change = score at Week 16 minus score at Baseline. (NCT00406315)
Timeframe: Baseline, Week 16

Interventionscores on a scale (Mean)
AIMS Total ScoreAIMS Global Severity ScoreAIMS Global Incapacitation Score
Ziprasidone0.050.030.01

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Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16

Total cholesterol value: Change = value at Week 16 minus value at Baseline. (NCT00406315)
Timeframe: Baseline, Week 16

Interventionmilligram (mg)/deciliter (dL) (Mean)
Ziprasidone-3.0

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Change From Baseline in Fasting Insulin at Week 16

Fasting insulin value: Change = value at Week 16 minus value at Baseline. (NCT00406315)
Timeframe: Baseline, Week 16

Interventionmicrointernational (mciu)/milliliter(mL) (Mean)
Ziprasidone134.8

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Change From Baseline in Fasting Glucose at Week 16

Fasting glucose value: Change = value at Week 16 minus value at Baseline. (NCT00406315)
Timeframe: Baseline, Week 16

Interventionmg/dL (Mean)
Ziprasidone3.0

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Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16

HDL, LDL, and triglyceride value: Change = value at Week 16 minus value at Baseline. (NCT00406315)
Timeframe: Baseline, Week 16

Interventionmg/dL (Mean)
HDL (n=128)LDL (n=123)Triglycerides (n=128)
Ziprasidone-0.2-2.5-1.6

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Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16

The CGI-I is a 7-point, single-item, clinician-rated scale that assesses global improvement in the subject's clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). (NCT00406315)
Timeframe: Week 16, Week 16 LOCF

Interventionscores on a scale (Mean)
Week 16 (n=135)Week 16 LOCF (n=231)
Ziprasidone2.73.2

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Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16

HbAlc value: Change = value at Week 16 minus value at Baseline. (NCT00406315)
Timeframe: Baseline, Week 16

Interventionpercent (Mean)
Ziprasidone0.1

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Clinical Global Impression (CGI) Scores the Evaluator's Overall Impression of Severity (CGI-S) or Change (CGI-I) in Illness.

CGI-S scores from 1 = normal to 7 = most extremely ill (NCT00458211)
Timeframe: 8 weeks

Interventionscore on scale (Mean)
Bronx baselineBronx endBuffalo baselineBuffalo end
Experimental4.64.93.52.8

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Cholesterol

(NCT00458211)
Timeframe: 8 weeks

Interventionmg/dL (Mean)
Bronx baselineBronx endBuffalo baselineBuffalo end
Experimental185160186179

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Calgary Depression Scale for Schizophrenia

Score on scale, from 0 to 27, above 6 considered indicative of depression, higher scores mean worse outcome, (NCT00458211)
Timeframe: 8 weeks

Interventionscore on a scale (Mean)
Bronx baselineBronx endBuffalo baselineBuffalo end
Experimental5.45.33.41.3

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Fasting Glucose

Amount of glucose in the blood in mg/dl (NCT00458211)
Timeframe: 8 weeks

Interventionmg/dl (Mean)
Bronx baselineBronx endBuffalo baselineBuffalo end
Experimental91829493

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Insulin Level

Measure of the amount of insulin in the blood, in uIU/ml. No minimum or maximum but fasting levels are usually below 25 uIU/ml. After a dose of glucose they may be 30 to 230 uIU/ml. (NCT00458211)
Timeframe: 8 weeks

InterventionuIU/ml (Mean)
Bronx baselineBronx endBuffalo baselineBuffalo end
Experimental10131217

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Medical Outcomes Study Cognitive Functioning Scale (MOS-COG)

MOS-COG measures day to day problems in six aspects of cognitive functioning. The scores are converted to 0-100 and so can range from 0 to 100 with 100 being the best. Population means are 70 to 80. (NCT00458211)
Timeframe: 8 weeks

Interventionscore on a scale (Mean)
Bronx baselineBronx endBuffalo baselineBuffalo end
Experimental17161819

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Brief Assessment of Cognition in Schizophrenia (BACS)

Scores on the BACS scale, which measures cognition, were changed to Z-scores based on normal controls from Keefe (2008) A Z-score of zero would indicate cognition the same as the normal controls. Negative scores indicate cognition worse than the normal. Theoretically there are no maximum or minimum scores. (NCT00458211)
Timeframe: 8 weeks

InterventionZ-score from score on scale (Mean)
Bronx baselineBronx endBuffalo baselineBuffalo end
Experimental-14-13-12-11

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Barnes Akathisia Scale

Barnes Akathisia Scale measures akathisia: a score of zero is none (good) maximum score is 12 (NCT00458211)
Timeframe: 8 weeks

Interventionscore on a scale (Mean)
Bronx baselineBronx endBuffalo baselineBuffalo end
Experimental0.60.81.41.1

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Corrected QT Interval (QTc)

Time interval between Q and T waves on EKG corrected for pulse rate. Over 500 msec may be dangerous (NCT00458211)
Timeframe: 8 weeks

Interventionmsec (Mean)
Bronx baselineBronx endBuffalo baelineBuffalo end
Experimental396411412427

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Abnormal Involuntary Movement Scale (AIMS) Measures Tardive Dyskinesia

Scores 0 (none) to 4 (severe) choreo-athetoid and dystonic movements of seven parts of the body with a maximum score 28 (NCT00458211)
Timeframe: 8 weeks

Interventionscore on scale (Mean)
Bronx baselineBronx endBuffalo baselineBuffalo end
Experimental0.30.32.91.6

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Personal Evaluation of Transitions in Treatment Scale (PETiTP

PETiT is a 30 item self administered scale measuring response to and tolerability and adherence to antipsychotic medication in people with schizophrenia. The range is 30 to 100. Higher scores are better. Although different features are assessed there is a single total score - no subscales. (NCT00458211)
Timeframe: 8 weeks

Interventionscore on a scale (Mean)
Bronx baselineBronx endBuffalo baselineBuffalo end
Experimental43454648

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Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia

Minimum score 32 (best) maximum 210 (worst) (NCT00458211)
Timeframe: Baseline to 8 weeks

Interventionscore on scale (Mean)
Bronx baselineBronx endBuffalo baselineBuffalo end
Experimental95997262

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Simpson-Angus Scale Measures Drug Induced Parkinsonism

Measures 10 signs, (not all of which are now considered Parkinsonism), minimum score 0 (no Parkinsonism) maximum 40. (NCT00458211)
Timeframe: 8 weeks

Interventionscore on scale (Mean)
Bronx baselineBronx endBuffalo baselineBuffalo end
Experimental0.20.13.62.5

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HbA1c

Lab measure of glycated hemoglobin indicative of blood glucose over the last three months. At that time in the US measured as a percentage (of glucose attached to hemoglobin). No maximum or minimum but over 6.5% is generally considered indicative of diabetes. (NCT00458211)
Timeframe: 8 weeks

InterventionHbA1c (Mean)
Bronx baselineBronx endBuffalo baselineBuffalo end
Experimental5.35.46.05.7

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Weight

(NCT00458211)
Timeframe: 8 weeks

Interventionpounds (Mean)
Bronx baselineBronx endBuffalo baselineBuffalo end
Experimental195193213204

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The Primary Outcome Measure Was Weight Change From Baseline to Endpoint.

The primary outcome measure will be the change in weight from baseline to endpoint using a random regression mixed effects model. (NCT00472641)
Timeframe: Baseline, 12 weeks

InterventionPounds (Mean)
Ziprasidone/Geodon-9.8

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Changes From Baseline to Endpoint in Body Mass Index (BMI)

Secondary outcome measures will include the change from baseline to endpoint in Body Mass Index (BMI). (NCT00472641)
Timeframe: Baseline, 12 weeks

Interventionkg/m^2 (Mean)
Ziprasidone/Geodon1.6

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Change From Baseline in Young Mania Rating Scale (YMRS) Total Score

YMRS is clinician rated 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Higher scores indicate greater severity. Change calculated as a difference between post-baseline observation and baseline YMRS score values. Week 6 is the primary timepoint. (NCT00483548)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

,
Interventionscores on scale (Mean)
Week 1 (n=142, 141)Week 2 (n=121, 139)Week 3 (n=115, 130)Week 4 (n=106, 122)Week 5 (n=103, 112)Week 6 (n=92, 108)
Placebo-0.2-0.2-0.2-1.1-1.3-0.9
Ziprasidone0.70.5-0.0-0.9-0.9-1.0

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Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 4 and 5)

SDS is a 5-item subject rated scale to measure the extent to which work and or school, social life and or leisure activities, and home life and or family responsibilities were impaired by psychiatric illness. Items 1 to 3 rated on 11-point scale ranging 0 (not at all) to 10 (extremely affected). Total score 0 to 30; higher score indicates greater impairment; items 4 and 5 report number of days in the last month (0 to 31) subject missed work or school or was unproductive and are rated separately. Change calculated as a difference between post-baseline observation and baseline SDS score values. (NCT00483548)
Timeframe: Baseline, Week 6

,
Interventiondays (Mean)
Days lost: Week 6 (n=85, 93)Days lost: ET (n=29, 21)Days unproductive: Week 6 (n=87, 89)Days unproductive: ET (n=29, 21)
Placebo-0.70.0-1.3-0.1
Ziprasidone-1.20.5-1.6-0.2

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Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S)

CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Scored from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). Higher score = more affected. Change calculated as a difference between post-baseline observation and baseline CGI-S score values. (NCT00483548)
Timeframe: Baseline, Week 6

Interventionscores on scale (Mean)
Ziprasidone-1.5
Placebo-1.5

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Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values. (NCT00483548)
Timeframe: Baseline, Week 6

Interventionscores on scale (Mean)
Ziprasidone-14.7
Placebo-13.2

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Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6

Number of subjects with improvement defined as CGI-I response of 1 (very much improved) or 2 (much improved). CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). Higher score = more affected. (NCT00483548)
Timeframe: Baseline, Week 6

Interventionparticipants (Number)
Ziprasidone66
Placebo69

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MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6

Number of subjects with MADRS total score ≤ 12 (indicates remission). MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). (NCT00483548)
Timeframe: Week 6

Interventionparticipants (Number)
Ziprasidone48
Placebo54

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MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6

Number of subjects with reduction of ≥50 percent (%) in MADRS total score (indicates response). MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Reduction calculated as ([A-B]/B*100): A=value at observation; B=baseline value. (NCT00483548)
Timeframe: Week 6

Interventionparticipants (Number)
Ziprasidone62
Placebo65

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CGI-Improvement Score

CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). Higher score = more affected. Week 6 is the primary timepoint. (NCT00483548)
Timeframe: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

,
Interventionscores on scale (Mean)
Week 1 (n=142, 141)Week 2 (n=120, 138)Week 3 (n=115, 130)Week 4 (n=106, 122)Week 5 (n=103, 112)Week 6 (n=92, 108)
Placebo3.43.12.92.82.62.4
Ziprasidone3.22.92.72.62.52.4

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Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Scores

AIMS is a clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe); items 11 to 14 are No or Yes response to dental status and sleep movements and are assessed separately. AIMS total score is sum of first 7 items. Change calculated as a difference between post-baseline observation and baseline AIMS score values. (NCT00483548)
Timeframe: Baseline, Week 2, Week 4, Week 6

,
Interventionscores on scale (Mean)
Total score: Week 2 (n=136, 142)Total score: Week 4 (n=111, 127)Total score: Week 6 (n=100, 111)Global severity score: Week 2 (n=136, 142)Global severity score: Week 4 (n=111, 127)Global severity score: Week 6 (n=100, 111)Incapacitation score: Week 2 (n=136, 142)Incapacitation score: Week 4 (n=111, 127)Incapacitation score: Week 6 (n=100, 111)
Placebo-0.1-0.0-0.0-0.00.00.0-0.0-0.00.0
Ziprasidone0.1-0.0-0.00.00.00.00.00.00.0

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Change From Baseline in Barnes Akathisia Rating Scale (BARS or BAS)

BARS is a clinician rated scale to evaluate akathisia associated with use of antipsychotic medications: objective motor restlessness, range 0 to 3; subjective complaints of restlessness and associated distress, range 0 to 3; global clinical assessment of akathisia, range 0 to 5. Higher scores indicate more affected. Change calculated as a difference between post-baseline observation and baseline BARS score values. (NCT00483548)
Timeframe: Baseline, Week 2, Week 4, Week 6

,
Interventionscores on scale (Mean)
Week 2 (n=135, 139)Week 4 (n=111, 125)Week 6 (n=100, 110)
Placebo-0.00.0-0.0
Ziprasidone0.10.00.0

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Change From Baseline in CGI-Severity Score (Post-baseline Excluding Week 6)

CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). Higher score = more affected. Change calculated as a difference between post-baseline observation and baseline CGI-S score values. (NCT00483548)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5

,
Interventionscores on scale (Mean)
Week 1 (n=142, 141)Week 2 (n=120, 139)Week 3 (n=115, 130)Week 4 (n=106, 122)Week 5 (n=103, 112)
Placebo-0.4-0.7-0.9-1.1-1.3
Ziprasidone-0.5-0.9-0.9-1.1-1.3

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Change From Baseline in Global Assessment of Functioning (GAF) Scale at Week 6

GAF is a clinician rated scale to measure the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale (single score of 1 to 100) with 100 indicating a superior level of function. Change calculated as a difference between post-baseline observation and baseline GAF score values. (NCT00483548)
Timeframe: Baseline, Week 6

,
Interventionscores on scale (Mean)
Week 6 (n=100, 110)ET (n=34, 27)
Placebo11.22.8
Ziprasidone14.70.0

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Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score

HAM-A is a clinician rated 14-item scale that rates the intensity of psychic anxiety (items 1 to 6 and item 14) and somatic anxiety (items 7 to 13) on a 5-point severity scale; scores range from 0 (not present) to 4 (very severe); lower score indicates less affected. Change calculated as a difference between post-baseline observation and baseline HAM-A score values. Week 6 is the primary timepoint. (NCT00483548)
Timeframe: Baseline, Week 2, Week 4, Week 6

,
Interventionscores on scale (Mean)
Week 2 (n=136, 141)Week 4 (n=111, 127)Week 6 (n=100, 111)
Placebo-5.9-7.4-8.6
Ziprasidone-5.6-7.1-8.5

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Change From Baseline in MADRS Total Score (Post-baseline Excluding Week 6)

MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values. (NCT00483548)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5

,
Interventionscores on scale (Mean)
Week 1 (n=142, 141)Week 2 (n=121, 139)Week 3 (n=115, 130)Week 4 (n=106, 122)Week 5 (n=103, 112)
Placebo-6.1-9.0-11.0-11.8-13.3
Ziprasidone-8.1-11.7-13.0-14.1-14.9

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Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Scores at Week 6

Q-LES-Q is a 16-item subject rated scale to measure satisfaction with areas of daily functioning (physical health, social relationships, medication, and overall life satisfaction); rated on a 5-point Likert scale: higher scores indicate greater enjoyment and satisfaction with general life activities. Scores for items 1 to 14 are summed for a total score and converted to 0 to 100 range. Items 15 and 16 measure satisfaction with medication and overall satisfaction and are analyzed separately. Change calculated as a difference between post-baseline observation and baseline Q-LES-Q score values. (NCT00483548)
Timeframe: Baseline, Week 6

,
Interventionscores on scale (Mean)
Total Q-LES-Q: Week 6 (n=82, 94)Total Q-LES-Q: ET (n=27, 17)Medications: Week 6 (n=91, 93)Medications: ET (n=27, 20)Overall life satisfaction: Week 6 (n=94, 103)Overall life satisfaction: ET (n=31, 23)
Placebo11.61.60.3-0.40.50.0
Ziprasidone15.2-0.10.4-0.30.80.1

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Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 1 Through 3)

SDS is a 5-item subject rated scale to measure the extent to which work and or school, social life and or leisure activities, and home life and or family responsibilities were impaired by psychiatric illness. Items 1 to 3 rated on 11-point scale ranging 0 (not at all) to 10 (extremely affected). Total score 0 to 30; higher score indicates greater impairment; items 4 and 5 report number of days in the last month (0 to 31) subject missed work or school or was unproductive and are rated separately. Change calculated as a difference between post-baseline observation and baseline SDS score values. (NCT00483548)
Timeframe: Baseline, Week 6

,
Interventionscores on scale (Mean)
Total SDS: Week 6 (n=58, 63)Total SDS: ET (n=19, 14)Work/School: Week 6 (n=58, 64)Work/School: ET (n=19, 14)Social life: Week 6 (n=94, 102)Social life: ET (n=31, 23)Family/Home: Week 6 (n=94, 102)Family/Home: ET (n=31, 23)
Placebo-3.7-1.4-1.6-0.1-1.70.1-1.7-0.6
Ziprasidone-8.50.2-2.10.4-2.5-0.5-2.60.2

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Change From Baseline in Simpson Angus Scale (SAS) Score

SAS is a clinician rated 10-item scale to measure extrapyramidal side effects (Parkinsonism or Parkinsonian side effects induced with antipsychotics); rated on a 5-point scale with range 0 (absence of condition) to 4 (presence of condition in extreme form). Global score is sum of all scores divided by the total number of items. Change calculated as a difference between post-baseline observation and baseline SAS score values. (NCT00483548)
Timeframe: Baseline, Week 2, Week 4, Week 6

,
Interventionscores on scale (Mean)
Week 2 (n=136, 141)Week 4 (n=111, 126)Week 6 (n=100, 110)
Placebo-0.10.0-0.1
Ziprasidone0.10.00.0

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The Primary Outcome Measure Was Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores Over Weeks Between Groups.

Change in Montgomery-Asberg Depression Rating Scale score was compared between placebo and ziprasidone arms. The MADRS measures severity of depressive symptoms. The MADRS scale is from 0 (min) to 40 (max) with 0 being not depressed at all and 40 being the most severely depressed. 0 is the best outcome and 40 is the worst outcome. (NCT00490542)
Timeframe: Baseline to 6 weeks

InterventionScores on a scale (Mean)
Ziprasidone Arm11.4
Placebo Arm5.9

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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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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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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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DEXA Total Fat

This study hypothesized that antipsychotic treatment would increase total body fat, as measured by whole body dual energy x-ray absorptiometry (DEXA), with larger adverse effects for olanzapine. (NCT00515723)
Timeframe: The relevant time points include baseline, week 6 and week 12.

,,,,
Interventionkilograms of body fat (Mean)
Baseline6 Weeks12 Weeks
Olanzapine32.2434.3835.45
Quetiapine28.8329.6030.10
Risperidone27.6628.2929.23
Total30.2531.0531.52
Ziprasidone31.6031.1830.66

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Clamp Derived Insulin Sensitivity (mg/kg/Min)

This study hypothesized that antipsychotic treatment would decrease insulin sensitivity, with larger adverse effects for olanzapine. Insulin sensitivity describes how sensitive the body is to the effects of insulin. (NCT00515723)
Timeframe: The relevant time points include baseline and week 12.

,,,,
Interventionmg/kg/min (Mean)
BaselineWeek 12
Olanzapine4.393.62
Quetiapine5.285.08
Risperidone5.535.01
Total4.824.50
Ziprasidone4.334.45

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Insulin Sensitivity

Euglycemic clamp method (NCT00538642)
Timeframe: 4-5 months

Interventionmg glucose/kg.min/μIU insulin (Mean)
Stay on Current Antipsychotic6.01
Ziprasidone Treatment2.07

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Triglycerides

(NCT00538642)
Timeframe: 4-5 months

Interventionmg/dL (Mean)
Stay on Current Antipsychotic154
Ziprasidone Treatment252

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Systolic Blood Pressure

(NCT00538642)
Timeframe: Baseline

Interventionmm Hg (Mean)
Stay on Current Antipsychotic118
Ziprasidone Treatment121

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Systolic Blood Pressure

(NCT00538642)
Timeframe: 4-5 months

Interventionmm Hg (Mean)
Stay on Current Antipsychotic123
Ziprasidone Treatment128

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LDL Cholesterol

(NCT00538642)
Timeframe: Baseline

Interventionmg/dL (Mean)
Stay on Current Antipsychotic108
Ziprasidone Treatment106

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LDL Cholesterol

(NCT00538642)
Timeframe: 4-5 months

Interventionmg/dL (Mean)
Stay on Current Antipsychotic106
Ziprasidone Treatment109

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Insulin Sensitivity

Euglycemic clamp method (NCT00538642)
Timeframe: Baseline

Interventionmg glucose/kg.min/μIU insulin (Mean)
Stay on Current Antipsychotic5.55
Ziprasidone Treatment1.88

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Cholesterol

(NCT00538642)
Timeframe: Baseline

Interventionmg/dL (Mean)
Stay on Current Antipsychotic176
Ziprasidone Treatment176

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HDL Cholesterol

(NCT00538642)
Timeframe: Baseline

Interventionmg/dL (Mean)
Stay on Current Antipsychotic34
Ziprasidone Treatment35

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HDL Cholesterol

(NCT00538642)
Timeframe: 4-5 months

Interventionmg/dL (Mean)
Stay on Current Antipsychotic40
Ziprasidone Treatment38

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Diastolic Blood Pressure

(NCT00538642)
Timeframe: Baseline

Interventionmm Hg (Mean)
Stay on Current Antipsychotic81
Ziprasidone Treatment80

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Cholesterol

(NCT00538642)
Timeframe: 4-5 months

Interventionmg/dL (Mean)
Stay on Current Antipsychotic177
Ziprasidone Treatment186

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Body Mass Index

(NCT00538642)
Timeframe: Baseline

InterventionKg/m2 (Mean)
Stay on Current Antipsychotic38.4
Ziprasidone Treatment39.0

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Body Mass Index

(NCT00538642)
Timeframe: 4-5 months

InterventionKg/m2 (Mean)
Stay on Current Antipsychotic36.0
Ziprasidone Treatment38.8

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Abdominal Circumference

(NCT00538642)
Timeframe: Baseline

Interventioncm (Mean)
Stay on Current Antipsychotic115
Ziprasidone Treatment126

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Abdominal Circumference

(NCT00538642)
Timeframe: 4-5 months

Interventioncm (Mean)
Stay on Current Antipsychotic115
Ziprasidone Treatment122

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Triglycerides

(NCT00538642)
Timeframe: Baseline

Interventionmg/dL (Mean)
Stay on Current Antipsychotic183
Ziprasidone Treatment227

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Diastolic Blood Pressure

(NCT00538642)
Timeframe: 4-5 months

Interventionmm Hg (Mean)
Stay on Current Antipsychotic82
Ziprasidone Treatment81

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Hamilton Depression Rating Scale (HAM-D-17) Scores

Higher numbers represent more symptoms of a major depressive episode. Minimum is 0. Maximum is 52. (NCT00555997)
Timeframe: 6 weeks

,,,
Interventionpoints (Mean)
Mean phase baseline scoreMean phase score reduction
Placebo Phase I19.9-7.1
Placebo Phase II15.6-4.3
Ziprasidone Phase I20.1-8.8
Ziprasidone Phase II14.7-2.1

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Responder/Non-responder

A responder during phase 1 or phase 2 is someone who demonstrated a 50% or greater decrease in HAMD-17 scores during phase 1 or phase 2 (corresponding). (NCT00555997)
Timeframe: 6 weeks

Interventionpercentage of patients (Number)
Ziprasidone Phase I44.8
Placebo Phase I31.8
Ziprasidone Phase II23.8
Placebo Phase II28.0

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"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?: Within SmPC"

(NCT00579670)
Timeframe: Week 12

,,,
InterventionParticipants (Number)
A great dealQuite a bitSomewhatMinimallyNot at all
Ziprasidone < 80 mg00120
Ziprasidone = 160 mg1718123
Ziprasidone 120 mg to < 160 mg11371
Ziprasidone 80 mg to < 120 mg01433

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"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?"

(NCT00579670)
Timeframe: Week 12

,,,,
InterventionParticipants (Number)
Extremely DissatisfiedVery DissatisfiedDissatisfiedSomewhat SatisfiedSatisfiedVery SatisfiedExtremely Satisfied
Ziprasidone < 80 mg0013640
Ziprasidone >= 160 mg1522691024827
Ziprasidone 120 mg to < 160 mg0132340153
Ziprasidone 80 mg to < 120 mg0051525110
Ziprasidone Unknown0001130

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"Number of Participants Answering the Question As a Result of Taking This Medication, do You Experience Any Side Effects at All?"

(NCT00579670)
Timeframe: Week 12

,,,,
InterventionParticipant (Number)
YesNo
Ziprasidone < 80 mg311
Ziprasidone >= 160 mg84189
Ziprasidone 120 mg to < 160 mg1372
Ziprasidone 80 mg to < 120 mg1145
Ziprasidone Unknown14

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"Number of Participants Answering the Question As a Result of Taking This Medication, do You Experience Any Side Effects at All?: Within SmPC"

(NCT00579670)
Timeframe: Week 12

,,,
InterventionParticipant (Number)
YesNo
Ziprasidone < 80 mg311
Ziprasidone = 160 mg41111
Ziprasidone 120 mg to < 160 mg1367
Ziprasidone 80 mg to < 120 mg1144

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Percent Change From Baseline to Final Visit in Body Weight: Within SmPC

(NCT00579670)
Timeframe: Baseline, Week 12

Interventionpercent change (Mean)
Ziprasidone < 80 mg1.2
Ziprasidone 80 mg to < 120 mg-0.2
Ziprasidone 120 mg to < 160 mg-1.1
Ziprasidone = 160 mg-0.0

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Percent Change From Baseline to Final Visit in Body Weight

(NCT00579670)
Timeframe: Baseline, Week 12

Interventionpercent change (Mean)
Ziprasidone < 80 mg1.2
Ziprasidone 80 mg to < 120 mg-0.2
Ziprasidone 120 mg to < 160 mg-1.0
Ziprasidone >= 160 mg0.1
Ziprasidone Unknown-1.0

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"Number of Participants Answering the Question How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?"

(NCT00579670)
Timeframe: Week 12

,,,,
InterventionParticipants (Number)
Extremely BothersomeVery BothersomeSomewhat BothersomeA Little BothersomeNot At All Bothersome
Ziprasidone < 80 mg00030
Ziprasidone >= 160 mg1929414
Ziprasidone 120 mg to < 160 mg01372
Ziprasidone 80 mg to < 120 mg00830
Ziprasidone Unknown00010

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"Number of Participants Answering the Question How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?: Within SmPC"

(NCT00579670)
Timeframe: Week 12

,,,
InterventionParticipants (Number)
Extremely BothersomeVery BothersomeSomewhat BothersomeA Little BothersomeNot At All Bothersome
Ziprasidone < 80 mg00030
Ziprasidone = 160 mg0418181
Ziprasidone 120 mg to < 160 mg01372
Ziprasidone 80 mg to < 120 mg00830

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Summary of Schizophrenia

Stage, symptoms and type of schizophrenia were recorded in addition to demographic and other clinical history data at the Baseline visit. The primary outcome was to assess the participants profile. Some assessments have been included in the Baseline demographics. This outcome presents results for the Summary of Schizophrenia. (NCT00579670)
Timeframe: Baseline

,,,,
InterventionParticipants (Number)
Stage: First episodeStage: Acute exacerbationStage: Chronic, stableStage: RefractorySymptoms: PositiveSymptoms: NegativeSymptoms: DepressiveSymptoms: No predominant symptomatologyType: CatatonicType: DisorganizedType: ParanoidType: ResidualType: UndifferentiatedType: Schizoaffective disorderType: Schizophrenia not otherwise specified (NOS)
Ziprasidone < 80 mg1112126161027230
Ziprasidone >= 160 mg3989117401914912327301483030355
Ziprasidone 120 mg to < 160 mg9125413471691605431410142
Ziprasidone 80 mg to < 120 mg524642913960022135152
Ziprasidone Unknown023030020031010

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Summary of Most Frequently Used Concomitant Drug Treatments

Most frequently concomitant drug treatments used by >15 participants. (NCT00579670)
Timeframe: Baseline

,,,,
InterventionParticipants (Number)
AkinetonAloperidineBiperidenClozapineHaloperidolLorazepamOlanzapineQuetiapineRisperidoneTavor
Ziprasidone < 80 mg6003100031
Ziprasidone >= 160 mg241338445332010319
Ziprasidone 120 mg to < 160 mg12755786174
Ziprasidone 80 mg to < 120 mg11624431472
Ziprasidone Unknown0000110111

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Summary of Metabolic Risk Factors

(NCT00579670)
Timeframe: Baseline

InterventionParticipants (Number)
No metabolic risk factors at Baseline≥1 metabolic risk factors at Baseline1 metabolic risk factor at Baseline2 metabolic risk factors at Baseline≥3 metabolic risk factors at BaselineFasting glucose level (≥110 mg/dL)Triglycerides (≥150 mg/dL)HDL (men <40 mg/dL; women <50 mg/dL)Blood pressure (≥130/85 mm Hg)Centrally distributed obesity
Ziprasidone Total205245133644848767754182

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Positive and Negative Syndrome Scale (PANSS) - Positive Subscale: Within SmPC

Modified positive subscale: clinician-rated measurement that consists of 30 items, each rated from 1 (absent) to 7 (extreme). Positive subscale (ranging from 4 to 28) taking the sum of the following 4 items: P1, delusions; P2, conceptual disorganization; P3, hallucinatory behavior; and P6, suspiciousness/persecution. Higher scores indicated greater severity of symptoms. The positive subscale total was calculated as the sum of the 4 items in the positive subscale. (NCT00579670)
Timeframe: Baseline, Week 12

,,,
InterventionScores on a scale (Mean)
BaselineFinal
Ziprasidone < 80 mg12.910.2
Ziprasidone = 160 mg15.310.0
Ziprasidone 120 mg to < 160 mg14.810.7
Ziprasidone 80 mg to < 120 mg14.511.3

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Positive and Negative Syndrome Scale (PANSS) - Positive Subscale

Modified positive subscale: clinician-rated measurement that consists of 30 items, each rated from 1 (absent) to 7 (extreme). Positive subscale (ranging from 4 to 28) taking the sum of the following 4 items: P1, delusions; P2, conceptual disorganization; P3, hallucinatory behavior; and P6, suspiciousness/persecution. Higher scores indicated greater severity of symptoms. The positive subscale total was calculated as the sum of the 4 items in the positive subscale. (NCT00579670)
Timeframe: Baseline, Week 12

,,,,
InterventionScores on a scale (Mean)
BaselineFinal
Ziprasidone < 80 mg12.910.2
Ziprasidone >= 160 mg16.610.4
Ziprasidone 120 mg to < 160 mg14.610.5
Ziprasidone 80 mg to < 120 mg14.411.2
Ziprasidone Unknown12.67.8

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PANSS - Negative Subscale: Within SmPC

Modified negative subscale: assesses negative symptoms associated with schizophrenia. 7 items make up the Negative scale (eg, blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Negative Subscale scores range from 7 to 49. This negative subscale total was calculated as the sum of 4 items in the negative subscale. (NCT00579670)
Timeframe: Baseline, Week 12

,,,
InterventionScores on a scale (Mean)
BaselineFinal
Ziprasidone < 80 mg16.714.1
Ziprasidone = 160 mg14.511.1
Ziprasidone 120 mg to < 160 mg14.811.4
Ziprasidone 80 mg to < 120 mg16.012.7

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PANSS - Negative Subscale

Modified negative subscale: assesses negative symptoms associated with schizophrenia. 7 items make up the Negative scale (eg, blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Negative Subscale scores range from 7 to 49. This negative subscale total was calculated as the sum of 4 items in the negative subscale. (NCT00579670)
Timeframe: Baseline, Week 12

,,,,
InterventionScores on a scale (Mean)
BaselineFinal
Ziprasidone < 80 mg16.714.1
Ziprasidone >= 160 mg14.710.6
Ziprasidone 120 mg to < 160 mg14.611.3
Ziprasidone 80 mg to < 120 mg16.112.8
Ziprasidone Unknown12.88.6

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PANSS - Composite Subscale: Within SmPC

The modified composite subscale total was calculated as the difference of the positive subscale total (7 items; total possible score of 49) and the negative subscale total (7 items; total possible score of 49). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The composite subscale total provided an indication of the level of dominance of the symptoms of one subscale over the symptoms of the other subscale. Higher scores indicated greater severity of symptoms. (NCT00579670)
Timeframe: Baseline, Week 12

,,,
InterventionScores on a scale (Mean)
BaselineFinal
Ziprasidone < 80 mg-3.8-3.9
Ziprasidone = 160 mg0.7-1.1
Ziprasidone 120 mg to < 160 mg0.0-0.6
Ziprasidone 80 mg to < 120 mg-1.5-1.5

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PANSS - Composite Subscale

The modified composite subscale total was calculated as the difference of the positive subscale total (7 items; total possible score of 49) and the negative subscale total (7 items; total possible score of 49). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The composite subscale total provided an indication of the level of dominance of the symptoms of one subscale over the symptoms of the other subscale. Higher scores indicated greater severity of symptoms. (NCT00579670)
Timeframe: Baseline, Week 12

,,,,
InterventionScores on a scale (Mean)
BaselineFinal
Ziprasidone < 80 mg-3.8-3.9
Ziprasidone >= 160 mg1.9-0.2
Ziprasidone 120 mg to < 160 mg0.0-0.7
Ziprasidone 80 mg to < 120 mg-1.7-1.5
Ziprasidone Unknown-0.2-0.8

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Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC

CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 0 (not assessed) to 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. B = Baseline; F = Final Visit (Week 12) (NCT00579670)
Timeframe: Baseline, Week 12

,,,
InterventionParticipants (Number)
B - Not assessedF - Not assessedF (only) - Normal, not at all illB - Borderline mentally illF - Borderline mentally illB - Mildly illF - Mildly illB - Moderately illF - Moderately illB - Markedly illF - Markedly illB - Severely illF - Severely illB - Among the most extremely illF - Among the most extremely ill
Ziprasidone < 80 mg001434763100000
Ziprasidone = 160 mg06612410535338592233822
Ziprasidone 120 mg to < 160 mg1212145314116241710100
Ziprasidone 80 mg to < 120 mg01007112425171654200

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Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)

CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 0 (not assessed) to 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. B = Baseline; F = Final Visit (Week 12) (NCT00579670)
Timeframe: Baseline, Week 12

,,,,
InterventionParticipants (Number)
B - Not assessedF - Not assessedF (only) - Normal, not at all illB - Borderline mentally illF - Borderline mentally illB - Mildly illF - Mildly illB - Moderately illF - Moderately illB - Markedly illF - Markedly illB - Severely illF - Severely illB - Among the most extremely illF - Among the most extremely ill
Ziprasidone < 80 mg001434763100000
Ziprasidone >= 160 mg012182471790806210840711363
Ziprasidone 120 mg to < 160 mg1212166334517241710100
Ziprasidone 80 mg to < 120 mg01007112526171654200
Ziprasodone Unknown000142000101100

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Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I): Within Summary of Product Characteristics Population (SmPC)

CGI-I: 7-point clinician rated scale ranging from 0 (not assessed) to 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. (NCT00579670)
Timeframe: Week 12

,,,
InterventionParticipants (Number)
Not assessedVery much improvedMuch improvedMinimally improvedNo changeMinimally worse
Ziprasidone < 80 mg017330
Ziprasidone = 160 mg6226252143
Ziprasidone 120 mg to < 160 mg26393230
Ziprasidone 80 mg to < 120 mg12173330

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Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)

CGI-I: 7-point clinician rated scale ranging from 0 (not assessed) to 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. (NCT00579670)
Timeframe: Week 12

,,,,
InterventionParticipants (Number)
Not assessedVery much improvedMuch improvedMinimally improvedNo changeMinimally worse
Ziprasidone < 80 mg017330
Ziprasidone >= 160 mg126010579236
Ziprasidone 120 mg to < 160 mg27393630
Ziprasidone 80 mg to < 120 mg12183330
Ziprasidone Unknown012110

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Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period: Within SmPC

(NCT00579670)
Timeframe: Week 12

,,,
InterventionParticipants (Number)
YesNo
Ziprasidone < 80 mg132
Ziprasidone = 160 mg13623
Ziprasidone 120 mg to < 160 mg784
Ziprasidone 80 mg to < 120 mg551

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Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period

(NCT00579670)
Timeframe: Week 12

,,,,
InterventionParticipants (Number)
YesNo
Ziprasidone < 80 mg132
Ziprasidone >= 160 mg24538
Ziprasidone 120 mg to < 160 mg834
Ziprasidone 80 mg to < 120 mg561
Ziprasidone Unknown40

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"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?"

(NCT00579670)
Timeframe: Week 12

,,,,
InterventionParticipants (Number)
A great dealQuite a bitSomewhatMinimallyNot at all
Ziprasidone < 80 mg00120
Ziprasidone >= 160 mg61131288
Ziprasidone 120 mg to < 160 mg11371
Ziprasidone 80 mg to < 120 mg01433
Ziprasidone Unknown00010

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"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?"

(NCT00579670)
Timeframe: Week 12

,,,,
InterventionParticipants (Number)
A great dealQuite a bitSomewhatMinimallyNot at all
Ziprasidone < 80 mg30000
Ziprasidone >= 160 mg840000
Ziprasidone 120 mg to < 160 mg130000
Ziprasidone 80 mg to < 120 mg110000
Ziprasidone Unknown10000

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"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?: Within SmPC"

(NCT00579670)
Timeframe: Week 12

,,,
InterventionParticipants (Number)
A great dealQuite a bitSomewhatMinimallyNot at all
Ziprasidone < 80 mg30000
Ziprasidone = 160 mg410000
Ziprasidone 120 mg to < 160 mg130000
Ziprasidone 80 mg to < 120 mg110000

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"Number of Participants Answering the Question To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?"

(NCT00579670)
Timeframe: Week 12

,,,,
InterventionParticipants (Number)
A great dealQuite a bitSomewhatMinimallyNot at all
Ziprasidone < 80 mg00111
Ziprasidone >= 160 mg218262710
Ziprasidone 120 mg to < 160 mg11245
Ziprasidone 80 mg to < 120 mg00524
Ziprasidone Unknown00010

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"Number of Participants Answering the Question To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?: Within SmPC"

(NCT00579670)
Timeframe: Week 12

,,,
InterventionParticipants (Number)
A great dealQuite a bitSomewhatMinimallyNot at all
Ziprasidone < 80 mg00111
Ziprasidone = 160 mg2815124
Ziprasidone 120 mg to < 160 mg11245
Ziprasidone 80 mg to < 120 mg00524

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"Number of Participants Answering the Question Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?"

(NCT00579670)
Timeframe: Week 12

,,,,
InterventionParticipants (Number)
Extremely dissatisfiedVery dissatisfiedDissatisfiedSomewhat satisfiedSatisfiedVery satisfiedExtremely satisfied
Ziprasidone < 80 mg0011750
Ziprasidone >= 160 mg261764896132
Ziprasidone 120 mg to < 160 mg0031637235
Ziprasidone 80 mg to < 120 mg0051917150
Ziprasidone Unknown0001121

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"Number of Participants Answering the Question Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?: Within SmPC"

(NCT00579670)
Timeframe: Week 12

,,,
InterventionParticipants (Number)
Extremely dissatisfiedVery dissatisfiedDissatisfiedSomewhat satisfiedSatisfiedVery satisfiedExtremely satisfied
Ziprasidone < 80 mg0011750
Ziprasidone = 160 mg121043473712
Ziprasidone 120 mg to < 160 mg0031633225
Ziprasidone 80 mg to < 120 mg0051916150

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"Number of Participants Answering the Question Overall, How Confident Are You That Taking This Medication is a Good Thing?"

(NCT00579670)
Timeframe: Week 12

,,,,
InterventionParticipants (Number)
Not at all confidentA little confidentSomewhat confidentVery confidentExtremely confident
Ziprasidone < 80 mg02660
Ziprasidone >= 160 mg13338810036
Ziprasidone 120 mg to < 160 mg2933347
Ziprasidone 80 mg to < 120 mg21021221
Ziprasidone Unknown01301

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"Number of Participants Answering the Question Overall, How Confident Are You That Taking This Medication is a Good Thing?: Within SmPC"

(NCT00579670)
Timeframe: Week 12

,,,
InterventionParticipants (Number)
Not at all confidentA little confidentSomewhat confidentVery confidentExtremely confident
Ziprasidone < 80 mg02660
Ziprasidone = 160 mg723495716
Ziprasidone 120 mg to < 160 mg2932307
Ziprasidone 80 mg to < 120 mg21020221

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"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?"

(NCT00579670)
Timeframe: Week 12

,,,,
InterventionParticipants (Number)
Extremely DissatisfiedVery DissatisfiedDissatisfiedSomewhat SatisfiedSatisfiedVery SatisfiedExtremely Satisfied
Ziprasidone < 80 mg0012740
Ziprasidone >= 160 mg161880865429
Ziprasidone 120 mg to < 160 mg0212438164
Ziprasidone 80 mg to < 120 mg0051422141
Ziprasidone Unknown0001022

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"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?: Within SmPC"

(NCT00579670)
Timeframe: Week 12

,,,
InterventionParticipants (Number)
Extremely DissatisfiedVery DissatisfiedDissatisfiedSomewhat SatisfiedSatisfiedVery SatisfiedExtremely Satisfied
Ziprasidone < 80 mg0012740
Ziprasidone = 160 mg03114848349
Ziprasidone 120 mg to < 160 mg0212434154
Ziprasidone 80 mg to < 120 mg0051421141

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"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?"

(NCT00579670)
Timeframe: Week 12

,,,,
InterventionParticipants (Number)
Extremely DissatisfiedVery DissatisfiedDissatisfiedSomewhat SatisfiedSatisfiedVery satisfiedExtremely satisfied
Ziprasidone < 80 mg0015620
Ziprasidone >= 160 mg242979964123
Ziprasidone 120 mg to < 160 mg0163132123
Ziprasidone 80 mg to < 120 mg016212170
Ziprasidone Unknown0000230

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"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?: Within SmPC"

(NCT00579670)
Timeframe: Week 12

,,,
InterventionParticipants (Number)
Extremely DissatisfiedVery DissatisfiedDissatisfiedSomewhat SatisfiedSatisfiedVery satisfiedExtremely satisfied
Ziprasidone < 80 mg0015620
Ziprasidone = 160 mg03174258267
Ziprasidone 120 mg to < 160 mg0163028123
Ziprasidone 80 mg to < 120 mg016202170

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"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?: Within SmPC"

(NCT00579670)
Timeframe: Week 12

,,,
InterventionParticipants (Number)
Extremely DissatisfiedVery DissatisfiedDissatisfiedSomewhat SatisfiedSatisfiedVery SatisfiedExtremely Satisfied
Ziprasidone < 80 mg0013640
Ziprasidone = 160 mg03124356309
Ziprasidone 120 mg to < 160 mg0132336143
Ziprasidone 80 mg to < 120 mg0051524110

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"Number of Participants Answering the Question How Easy or Difficult is it to Use the Medication in Its Current Form?"

(NCT00579670)
Timeframe: Week 12

,,,,
InterventionParticipants (Number)
Extremely difficultVery difficultDifficultSomewhat easyEasyVery easyExtremely easy
Ziprasidone < 80 mg0000842
Ziprasidone >= 160 mg2213451177122
Ziprasidone 120 mg to < 160 mg0131839168
Ziprasidone 80 mg to < 120 mg001925156
Ziprasidone Unknown0000320

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"Number of Participants Answering the Question How Easy or Difficult is it to Use the Medication in Its Current Form?: Within SmPC"

(NCT00579670)
Timeframe: Week 12

,,,
InterventionParticipants (Number)
Extremely difficultVery difficultDifficultSomewhat easyEasyVery easyExtremely easy
Ziprasidone < 80 mg0000842
Ziprasidone = 160 mg2192265449
Ziprasidone 120 mg to < 160 mg0131736158
Ziprasidone 80 mg to < 120 mg001924156

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"Number of Participants Answering the Question How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?"

(NCT00579670)
Timeframe: Week 12

,,,,
InterventionParticipants (Number)
Extremely difficultVery difficultDifficultSomewhat easyEasyVery easyExtremely easy
Ziprasidone < 80 mg0013712
Ziprasidone >= 160 mg0425571085424
Ziprasidone 120 mg to < 160 mg0172137154
Ziprasidone 80 mg to < 120 mg001142579
Ziprasidone Unknown0001130

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"Number of Participants Answering the Question How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?: Within SmPC"

(NCT00579670)
Timeframe: Week 12

,,,
InterventionParticipants (Number)
Extremely difficultVery difficultDifficultSomewhat easyEasyVery easyExtremely easy
Ziprasidone < 80 mg0013712
Ziprasidone = 160 mg031632603011
Ziprasidone 120 mg to < 160 mg0162035144
Ziprasidone 80 mg to < 120 mg001142479

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"Number of Participants Answering the Question How Convenient or Inconvenient is it to Take the Medication as Instructed?"

(NCT00579670)
Timeframe: Week 12

,,,,
InterventionParticipants (Number)
Extremely inconvenientVery inconvenientInconvenientSomewhat convenientConvenientVery convenientExtremely convenient
Ziprasidone < 80 mg0012722
Ziprasidone >= 160 mg1425711113921
Ziprasidone 120 mg to < 160 mg016303576
Ziprasidone 80 mg to < 120 mg004122668
Ziprasidone Unknown0001130

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"Number of Participants Answering the Question How Convenient or Inconvenient is it to Take the Medication as Instructed?: Within SmPC"

(NCT00579670)
Timeframe: Week 12

,,,
InterventionParticipants (Number)
Extremely inconvenientVery inconvenientInconvenientSomewhat convenientConvenientVery convenientExtremely convenient
Ziprasidone < 80 mg0012722
Ziprasidone = 160 mg121338672011
Ziprasidone 120 mg to < 160 mg016283366
Ziprasidone 80 mg to < 120 mg004122568

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"Number of Participants Answering the Question How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?"

(NCT00579670)
Timeframe: Week 12

,,,,
InterventionParticipants (Number)
Not at all certainA little certainSomewhat certainVery certainExtremely certain
Ziprasidone < 80 mg03650
Ziprasidone >= 160 mg15368110139
Ziprasidone 120 mg to < 160 mg2726446
Ziprasidone 80 mg to < 120 mg11321201
Ziprasidone Unknown00230

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"Number of Participants Answering the Question How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?: Within SmPC"

(NCT00579670)
Timeframe: Week 12

,,,
InterventionParticipants (Number)
Not at all certainA little certainSomewhat certainVery certainExtremely certain
Ziprasidone < 80 mg03650
Ziprasidone = 160 mg823475618
Ziprasidone 120 mg to < 160 mg2726396
Ziprasidone 80 mg to < 120 mg11321191

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Barnes Akathisia Rating Scale (BARS)

"The BARS measures drug-induced akathisia occurring specifically with use of neuroleptic agents. It is a four-item fully anchored scale. Three items (objective akathisia, subjective awareness of restlessness, and subjective distress related to restlessness) are rated on a 4-point scale (0= normal and 9= most severe) and, the global clinical assessment of akathisia uses a 5-point scale (0= normal and 4= most severe).~Total scores ranged from 0-13 with higher scores reflecting more akathisia." (NCT00622739)
Timeframe: 6 weeks of treatment

Interventionunits on a scale (Least Squares Mean)
Ziprasidone Rapid Dose Group0.11
Ziprasidone Slow Dose Group0.06

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Children's Depression Rating Scale

The CDRS-R is a 17 item clinician-rated instrument used to measure severity of depressive symptoms in youth (ages 6-18). Each item is rated on a 1 to 5 or 1 to 7 point scale, with a 1 describing absence of the given symptom. The CDRS-R yields a total score from 17 to 113 with a score of 40 or greater considered to symptomatic of depression. Scores of 35-40 indicate mild depression, 29-34 is borderline and <28 is no depression. (NCT00622739)
Timeframe: 6 weeks of treatment

Interventionscore on a scale (Least Squares Mean)
Ziprasidone Rapid Dose32.56
Ziprasidone Slow Dose29.22

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Clinical Global Impressions-Severity (CGI-S) Scale

"The CGI-S assesses clinical severity. The CGI-S is a seven point scale where 1 is the minimum value and 7 is the maximum value. Lower scores mean a better outcome.~The CGI-Severity scale scores are: 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." (NCT00622739)
Timeframe: 6 weeks of treatment

Interventionunits on a scale (Least Squares Mean)
Ziprasidone Rapid Dose3.63
Ziprasidone Slow Dose3.36

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SAFTEE (Side Effects Rating Scale)

The Systematic Assessment for Treatment of Emergent Events (SAFTEE) is one of the first comprehensive Adverse effects-elicitation instruments developed specifically for use in psychiatric clinical trials. The SAFTEE is a standardized method, which increases consistency of Adverse Effects data, both within and across clinical trials.It allows ratings of five levels of severity and collects information about the onset, duration, pattern, judgement of attribution of cause, and action taken by the clinician. Suggested probe questions are also provided, which the clinician can use to elicit detailed information about the AE. Furthermore, the SAFTEE requires the clinician to determine a time interval of inquiry to be used in the trial. Adverse Effects are graded as None=0, Mild=1, Moderate=2, Severe=3. (NCT00622739)
Timeframe: 6 weeks of treatment

Interventionunits on a scale (Least Squares Mean)
Ziprasidone Rapid Dose Group0.32
Ziprasidone Slow Dose Group0.46

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AIMS (Abnormal Involuntary Movement Scale)

AIMS is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs, such as tardive dystonia and chronic akathisia, as well as 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in three main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). (NCT00622739)
Timeframe: 6 weeks of treatment

Interventionunits on a scale (Least Squares Mean)
Ziprasidone Rapid Dose Group0.20
Ziprasidone Slow Dose Group0.32

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Young Mania Rating Scale (YMRS)

The Young Mania Rating Scale (YMRS) is a measure of the severity of manic symptoms. The scores on the scale range from 0-56. A score of more than or equal to 14 was the cut off for inclusion into this study. A higher score denotes increased severity of manic symptoms. (NCT00622739)
Timeframe: 6 weeks of treatment

Interventionunits on a scale (Least Squares Mean)
Ziprasidone Rapid Dose Group12.70
Ziprasidone Slow Dose Group12.57

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Remission Rates (HAM-D 17 Scores of Less Than 8) After Treatment Phase 2.

A secondary outcome measure will be remission rates (HAM-D 17 scores of less than 8) after treatment phase 2.. A remitted will be a patient with a final score of 7 or less on the HAMD-17 during phase 2. (NCT00633399)
Timeframe: 8 weeks

InterventionPercentage of patients (Number)
Ziprasidone + Escitalopram38
Placebo + Escitalopram30

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Comparing Scores on HAM-D 17 Baseline Visit to Phase 2 Final Visit at Week 8

This will involve looking at the change in HAM-D 17 scores during phase 2. For HAMD-17 the minimum is 0, the maximum is 52, and greater scores represent more symptoms. (NCT00633399)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
Ziprasidone + Escitalopram-6.4
Placebo + Escitalopram-3.3

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The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2

The primary outcome measure will be response rates (50% decrease in HAM-D-17 scores) during phase 2. A responder will be a patient who experiences a 50% or greater decrease in symptoms according to the HAM-D-17 during phase 2. (NCT00633399)
Timeframe: 8 Weeks

InterventionPercentage of patients (Number)
Ziprasidone + Escitalopram35.2
Placebo + Escitalopram20.5

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Change in Scale of Psychosis-risk Symptoms Total Score

The Scale of Psychosis-risk Symptoms, a 19-item scale with items scored 0-6. Positive Symptom scores on the SOPS in the 1 to 2 range are considered non-prodromal. Scores of 6 are considered psychotic. Scores in the 3 to 5 range are considered at the clinical high risk level. Minimum value 0. Maximum value 114. Higher score means worse outcome. (NCT00635700)
Timeframe: baseline and 8 weeks

Interventionscores on a scale (Mean)
Ziprasidone-0.271
Placebo0

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Conversion to Psychosis

Conversion to psychosis according to the Structured Interview for Psychosis-risk Syndromes (SIPS) require psychotic symptom severity ratings in the frankly psychotic range, along with meeting persistence or urgency criteria. (NCT00635700)
Timeframe: 6 months

Interventionparticipants (Number)
Ziprasidone1
Placebo2

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Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours

CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. (NCT00723606)
Timeframe: 72 hours

Interventionscores on a scale (Least Squares Mean)
Ziprasidone2.52
Haloperidol2.55

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Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours

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. Change: score at final visit minus score at baseline. (NCT00723606)
Timeframe: Baseline, 72 hours

Interventionscores on a scale (Least Squares Mean)
Ziprasidone-17.32
Haloperidol-18.44

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Change From Baseline in BPRS Agitation Subscale Score at 72 Hours

The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. Change: score at final visit minus score at baseline. (NCT00723606)
Timeframe: Baseline, 72 hours

Interventionscores on a scale (Least Squares Mean)
Ziprasidone-6.97
Haloperidol-7.45

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Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours

BARS measures the degree of agitated behavior using a 7-point scale describing increasing levels of activity (1 =difficult or unable to rouse; 2 = asleep but responds normally to verbal or physical contact; 3 = drowsy, appears sedated; 4 = quiet and awake [normal level of activity]; 5 = signs of overt [physical or verbal] activity, calms down with instructions; 6 = extremely or continuously active, not requiring restraint; 7 = violent, requires restraint. (NCT00723606)
Timeframe: Baseline, 72 hours

Interventionscores on a scale (Least Squares Mean)
Ziprasidone-0.93
Haloperidol-1.06

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Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours

CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. (NCT00723606)
Timeframe: Baseline, 72 hours

Interventionscores on a scale (Least Squares Mean)
Ziprasidone-1.18
Haloperidol-1.21

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BPRS Agitation Subscale Response at 72 Hours

The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. A response was defined as a > 30 percent reduction from baseline in BPRS agitation subscale score. (NCT00723606)
Timeframe: 72 hours

,
Interventionparticipants (Number)
ResponseNo Response
Haloperidol15529
Ziprasidone14939

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Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52

QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds (60 divided by heart rate). (NCT00748566)
Timeframe: Baseline, Week 4, 12, 28, 52

Interventionmilliseconds (Mean)
Baseline (n=56)Change at Week 4 (n=4)Change at Week 12 (n=14)Change at Week 28 (n=38)Change at Week 52 (n=56)
Ziprasidone413.20.93.46.67.6

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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52

Assesses positive and negative symptoms, general psychopathology specifically associated with schizophrenia. Scale consists of 30 items, each rated on scale from 1 (symptom not present) - 7 (symptoms extremely severe). Sum of 30 items is defined as PANSS total score, range:30-210. 7 items make up positive scale (delusions, conceptual disorganization, hallucinatory behavior); total range: 7-49. 7 items make up negative scale (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); total range: 7-49. For each subscale, total score: higher score=greater severity. (NCT00748566)
Timeframe: Baseline, Week 12, 28, 52

Interventionunits on a scale (Mean)
Baseline: Total Score (n=112)Baseline: Positive Subscale Score (n=113)Baseline: Negative Subscale Score (n=112)Change at Week 12: Total Score (n=110)Change at Week 12: Positive Subscale Score (n=112)Change at Week 12: Negative Subscale Score (n=111)Change at Week 28: Total Score (n=98)Change at Week 28: Positive Subscale Score (n=100)Change at Week 28: Negative Subscale Score (n=98)Change at Week 52: Total Score (n=112)Change at Week 52: Positive Subscale Score (n=113)Change at Week 52: Negative Subscale Score (n=112)
Ziprasidone64.113.617.9-5.7-1.0-1.9-4.4-0.9-1.6-3.2-0.2-1.7

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Change From Baseline in Insulin Level at Week 4, 12, 28 and 52

(NCT00748566)
Timeframe: Baseline, Week 4, 12, 28, 52

Interventioninternational unit per liter (IU/L) (Mean)
Baseline (n=107)Change at Week 4 (n=102)Change at Week 12 (n=104)Change at Week 28 (n=92)Change at Week 52 (n=107)
Ziprasidone22.4-0.3-4.6-7.8-5.6

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Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. (NCT00748566)
Timeframe: Baseline, Week 4, 12, 28, 52

Interventionpercentage of total hemoglobin (Mean)
Baseline (n=114)Change at Week 4 (n=111)Change at Week 12 (n=112)Change at Week 28 (n=99)Change at Week 52 (n=114)
Ziprasidone5.7-0.0-0.0-0.1-0.1

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Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52

(NCT00748566)
Timeframe: Baseline, Week 4, 12, 28, 52

Interventionmg/dL (Mean)
Baseline (n=114)Change at Week 4 (n=113)Change at Week 12 (n=112)Change at Week 28 (n=99)Change at Week 52 (n=114)
Ziprasidone104.5-0.8-4.0-5.0-3.0

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Change From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Index (EQ-I) Score at Week 28 and 52

"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state." (NCT00748566)
Timeframe: Baseline, Week 28, 52

Interventionunits on a scale (Mean)
BaselineChange at Week 28Change at Week 52
Ziprasidone0.80.00.0

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Change From Baseline in Drug-Attitude Inventory-30-Item Scale (DAI-30) Score at Week 28 and 52

DAI, a 30-item scale measuring subjective responses to medication (including acceptability and tolerability which aims to understand the factors influencing treatment adherence). Scale has 15 items (statements) scored as true and 15 items scored as false. An overall calculated score ranged from -15 to 15, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. (NCT00748566)
Timeframe: Baseline, Week 28, 52

Interventionunits on a scale (Mean)
Baseline (n=105)Change at Week 28 (n=104)Change at Week 52 (n=105)
Ziprasidone-1.30.4-0.1

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Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52

CGI-S is a single-item, clinician-rated scale that assesses the global severity of the participants overall illness. CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill participants). (NCT00748566)
Timeframe: Baseline, Week 12, 28, 52

Interventionunits on a scale (Mean)
Baseline (n=113)Change at Week 12 (n=112)Change at Week 28 (n=100)Change at Week 52 (n=113)
Ziprasidone3.3-0.3-0.2-0.2

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Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52

Body mass index calculated as weight in kilograms (kg) divided by height in (meters) squared (m)^2 . (NCT00748566)
Timeframe: Baseline, Week 4, 12, 28, 52

Interventionkg/m^2 (Mean)
Baseline (n=114)Change at Week 4 (n=113)Change at Week 12 (n=112)Change at Week 28 (n=100)Change at Week 52 (n=114)
Ziprasidone32.4-0.3-0.8-1.2-1.5

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Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52

Framingham scoring system risk factors: age (risk points range: -9 to 16), cholesterol (risk points range: 0 to 13), HDL cholesterol (risk points range: -1 to 2), smoking (risk points range: 0 to 9), and systolic blood pressure (risk points range: 0 to 6); total risk points range <0 to >=25, higher score indicates higher CHD risk. The risk points are transformed to 10-year risk percentage for CHD which ranges from <1% to >=30%, where higher percent indicates greater risk for CHD. (NCT00748566)
Timeframe: Baseline, Week 4, 12, 28, 52

Interventionpercent of 10-year CHD risk (Mean)
Baseline (n=113)Change at Week 4 (n=112)Change at Week 12 (n=111)Change at Week 28 (n=97)Change at Week 52 (n=113)
Ziprasidone9.3-0.7-0.9-1.2-1.3

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Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)

MS risks factors: elevated (el) waist, men:>=102 centimeters(cm), women:>=88 cm (Asian origin:>=90 cm in men, >=80 cm in women); el triglycerides: >=1.7 millimoles per liter (mmol/L) (>=150 milligram per deciliter [mg/dL]); reduced high-density lipoprotein cholesterol (HDL-C), men:<1.03 mmol/L (<40 mg/dL), women:<1.3 mmol/L (<50 mg/dL); el fasting glucose: >=5.6 mmol/L (>=100 mg/dL); el systolic/diastolic blood pressure (SBP/DBP): SBP>=130 millimeters of mercury (mmHg) and/or DBP>=85 mmHg. Responder=at least 1 less risk factor at endpoint (premature discontinuation or Week 52) than baseline. (NCT00748566)
Timeframe: Endpoint (premature discontinuation or Week 52)

Interventionpercentage of participants (Number)
Ziprasidone58.77

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Clinical Global Impression-Improvement (CGI-I) Scale Score

CGI-I is a single-item, clinician-rated scale that assesses global improvement in the participants clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 to 7, where 1=very much improved, 4=no change and 7=very much worse. (NCT00748566)
Timeframe: Endpoint (premature discontinuation or Week 52)

Interventionunits on a scale (Mean)
Ziprasidone3.2

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Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52

BP measurement is recorded as systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). (NCT00748566)
Timeframe: Baseline, Week 4, 12, 28, 52

InterventionmmHg (Mean)
Baseline: SBP (n=114)Baseline: DBP (n=114)Change at Week 4: SBP (n=113)Change at Week 4: DBP (n=113)Change at Week 12: SBP (n=112)Change at Week 12: DBP (n=112)Change at Week 28: SBP (n=100)Change at Week 28: DBP (n=100)Change at Week 52: SBP (n=114)Change at Week 52: DBP (n=114)
Ziprasidone124.380.7-1.0-0.4-1.0-0.1-1.00.0-1.0-1.1

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Percentage of Participants With Metabolic Syndrome (MS)

According to the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATPIII), metabolic syndrome is defined as a condition that includes 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose. (NCT00748566)
Timeframe: Baseline, Week 4, 12, 28, 52

Interventionpercentage of participants (Number)
Baseline (n=114)Week 4 (n=113)Week 12 (n=112)Week 28 (n=98)Week 52 (n=114)
Ziprasidone79.8270.8072.3258.1652.63

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Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS)

MS risks factors: elevated waist circumference: >=102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg. (NCT00748566)
Timeframe: Baseline, Week 4, 12, 28, 52

Interventionpercentage of participants (Number)
Baseline: Elevated waist circumference (n=114)Baseline: Elevated triglycerides (n=114)Baseline: Reduced HDL-C (n=114)Baseline: Elevated SBP (n=114)Baseline: Elevated DBP (n=114)Baseline: Elevated fasting glucose (n=114)Week 4: Elevated waist circumference (n=113)Week 4: Elevated triglycerides (n=111)Week 4: Reduced HDL-C (n=113)Week 4: Elevated SBP (n=113)Week 4: Elevated DBP (n=113)Week 4: Elevated fasting glucose (n=113)Week 12: Elevated waist circumference (n=112)Week 12: Elevated triglycerides (n=112)Week 12: Reduced HDL-C (n=112)Week 12: Elevated SBP (n=112)Week 12: Elevated DBP (n=112)Week 12: Elevated fasting glucose (n=112)Week 28: Elevated waist circumference (n=100)Week 28: Elevated triglycerides (n=99)Week 28: Reduced HDL-C (n=99)Week 28: Elevated SBP (n=100)Week 28: Elevated DBP (n=100)Week 28: Elevated fasting glucose (n=99)Week 52: Elevated waist circumference (n=114)Week 52: Elevated triglycerides (n=114)Week 52: Reduced HDL-C (n=114)Week 52: Elevated SBP (n=114)Week 52: Elevated DBP (n=114)Week 52: Elevated fasting glucose (n=114)
Ziprasidone93.8683.3378.0732.4626.3244.7488.5060.3671.6831.8629.2046.0283.9361.6172.3229.4631.2536.6176.0056.5761.6229.0035.0037.3772.8152.6363.1628.9528.9532.46

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Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52

MS risks factors: elevated waist circumference: >=102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg. (NCT00748566)
Timeframe: Week 4, 12, 28, 52

Interventionparticipants (Number)
Week 4: Decrease by at least 1 risk factor (n=113)Week 4: No change in risk factor (n=113)Week 4: Increase by at least 1 risk factor (n=113)Week 12:Decrease by at least 1 risk factor (n=112)Week 12: No change in risk factor (n=112)Week 12:Increase by at least 1 risk factor (n=112)Week 28: Decrease by at least 1 risk factor (n=98)Week 28: No change in risk factor (n=98)Week 28: Increase by at least 1 risk factor (n=98)Week 52:Decrease by at least 1 risk factor (n=114)Week 52: No change in risk factor (n=114)Week 52:Increase by at least 1 risk factor (n=114)
Ziprasidone464621445117453914673512

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Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52

MS risks factors: elevated waist circumference: greater than or equal to (>=)102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): less than (<)1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg. (NCT00748566)
Timeframe: Baseline, Week 4, 12, 28, 52

Interventionrisk factors (Mean)
Baseline (n=114)Change at Week 4 (n=113)Change at Week 12 (n=112)Change at Week 28 (n=98)Change at Week 52 (n=114)
Ziprasidone3.4-0.3-0.4-0.7-0.8

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Changes From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. (NCT00748566)
Timeframe: Baseline, Week 28, 52

Interventionunits on a scale (Mean)
Baseline (n=112)Change at Week 28 (n=111)Change at Week 52 (n=112)
Ziprasidone58.84.75.7

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Change From Baseline in Weight at Week 4,12, 28 and 52

(NCT00748566)
Timeframe: Baseline, Week 4, 12, 28, 52

Interventionkilogram (kg) (Mean)
Baseline (n=114)Change at Week 4 (n=113)Change at Week 12 (n=112)Change at Week 28 (n=100)Change at Week 52 (n=114)
Ziprasidone96.5-0.9-2.4-3.8-4.4

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Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52

Waist circumference data is reported separately for male and female participants. (NCT00748566)
Timeframe: Baseline, Week 4, 12, 28, 52

Interventioncm (Mean)
Baseline: Male (n=79)Baseline: Female (n=35)Change at Week 4: Male (n=78)Change at Week 4: Female (n=35)Change at Week 12: Male (n=77)Change at Week 12: Female (n=35)Change at Week 28: Male (n=70)Change at Week 28: Female (n=30)Change at Week 52: Male (n=79)Change at Week 52: Female (n=35)
Ziprasidone110.8108.9-1.00.4-2.1-2.4-3.7-2.5-3.6-4.0

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Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52

Triglyceride data is reported for whole study population whereas HDL-C data is reported separately for male and female participants. (NCT00748566)
Timeframe: Baseline, Week 4, 12, 28, 52

Interventionmg/dL (Mean)
Baseline: Triglyceride (n=114)Baseline: HDL-C, Male (n=79)Baseline: HDL-C, Female (n=35)Change at Week 4: Triglyceride (n=111)Change at Week 4: HDL-C, Male (n=78)Change at Week 4: HDL-C, Female (n=35)Change at Week 12: Triglyceride (n=112)Change at Week 12: HDL-C, Male (n=77)Change at Week 12: HDL-C, Female (n=35)Change at Week 28: Triglyceride (n=99)Change at Week 28: HDL-C, Male (n=69)Change at Week 28: HDL-C, Female (n=30)Change at Week 52: Triglyceride (n=114)Change at Week 52: HDL-C, Male (n=79)Change at Week 52: HDL-C, Female (n=35)
Ziprasidone242.835.841.9-37.31.22.1-39.52.11.8-52.33.14.5-60.03.95.0

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Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52

(NCT00748566)
Timeframe: Baseline, Week 4, 12, 28, 52

Interventionmmol/L (Mean)
Baseline: TC (n=114)Baseline: LDL-C (n=114)Change at Week 4: TC (n=113)Change at Week 4: LDL-C (n=110)Change at Week 12: TC (n=112)Change at Week 12: LDL-C (n=112)Change at Week 28: TC (n=99)Change at Week 28: LDL-C (n=97)Change at Week 52: TC (n=114)Change at Week 52: LDL-C (n=114)
Ziprasidone5.53.3-0.3-0.1-0.4-0.2-0.4-0.2-0.5-0.3

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Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52

SOFAS: a 0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning. (NCT00748566)
Timeframe: Baseline, Week 28, 52

Interventionunits on a scale (Mean)
BaselineChange at Week 28Change at Week 52
Ziprasidone57.21.61.1

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Change From Baseline in the Physical Activity Index Score at Week 28 and 52

Physical activity (exercise) score derived for each participant based on the frequency and intensity of physical activities: regular walking, recreational activity, cycling, and sporting activity. Six categories of total score: inactive (range: 0-2), occasional (range: 3-5), light (range: 6-8), moderate (range: 9-12), moderately vigorous (range: 13-20), and vigorous (>=21). Higher total score = higher frequency and intensity of physical activity. (NCT00748566)
Timeframe: Baseline, Week 28, 52

Interventionunits on a scale (Mean)
BaselineChange at Week 28Change at Week 52
Ziprasidone7.30.60.5

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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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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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Peripheral Insulin Sensitivity

To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as primarily muscle glucose utilization (glucose rate of disappearance [Rd]). (NCT00910988)
Timeframe: approximately 3 hours

Intervention% change from basal to insulin phase (Mean)
Olanzapine, to be Followed by Normal Saline152.2
Normal Saline, Following Olanzapine183.5
Normal Saline, to be Followed by Olanzapine157.0
Olanzapine, Following Normal Saline83.7
Normal Saline, to be Followed by Ziprasidone208.2
Ziprasidone, Following Normal Saline161.0
Ziprasidone, to be Followed by Normal Saline135.6
Normal Saline, Following Ziprasidone185.3

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Whole Body Insulin Sensitivity

To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min). (NCT00910988)
Timeframe: approximately 3 hours

Interventionmg/kg/min (Mean)
Olanzapine (Drug/Placebo)-Drug4.9
Olanzapine (Drug/Placebo)-Placebo5.4
Olanzapine (Placebo/Drug)-Placebo4.1
Olanzapine (Placebo/Drug)-Drug2.9
Ziprasidone (Placebo/Drug)-Placebo5.8
Ziprasidone (Placebo/Drug)-Drug4.7
Ziprasidone (Drug/Placebo)-Drug4.5
Ziprasidone (Drug/Placebo)-Placebo5.3

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Adipose Tissue Insulin Sensitivity

To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as free fatty acid release (glycerol rate of appearance [Ra]). (NCT00910988)
Timeframe: approximately 3 hours

Intervention% change from basal to insulin phase (Mean)
Olanzapine, to be Followed by Normal Saline43.3
Normal Saline, Following Olanzapine45.2
Normal Saline, to be Followed by Olanzapine52.8
Olanzapine, Following Normal Saline53.1
Normal Saline, to be Followed by Ziprasidone39.5
Ziprasidone, Following Normal Saline37.6
Ziprasidone, to be Followed by Normal Saline47.8
Normal Saline, Following Ziprasidone44.4

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Hepatic Insulin Sensitivity

To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as hepatic glucose production (glucose rate of appearance [Ra]). (NCT00910988)
Timeframe: approximately 3 hours

Intervention% change from basal to insulin phase (Mean)
Olanzapine, to be Followed by Normal Saline81.0
Normal Saline, Following Olanzapine79.1
Normal Saline, to be Followed by Olanzapine73.1
Olanzapine, Following Normal Saline78.5
Normal Saline, to be Followed by Ziprasidone84.0
Ziprasidone, Following Normal Saline80.7
Ziprasidone, to be Followed by Normal Saline82.1
Normal Saline, Following Ziprasidone83.4

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Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT

CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected. (NCT01053429)
Timeframe: Baseline up to Week 8

Interventionparticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Ziprasidone HCl (Zeldox)3681026136151271130

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Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP

CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected. (NCT01053429)
Timeframe: Baseline up to Week 8

Interventionparticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Ziprasidone HCl (Zeldox)2717518892993680

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Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population

CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected. (NCT01053429)
Timeframe: Baseline up to Week 8

Interventionparticpants (Number)
Normal, not ill at allBorderline mentally illMildly illModerately illMarkedly illSeverely illAmong the most extremely ill
Ziprasidone HCl (Zeldox)19011251325506156463

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Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population

CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected. (NCT01053429)
Timeframe: Baseline up to Week 8

Interventionparticipants (Number)
Normal, not ill at allBorderline mentally illMildly illModerately illMarkedly illSeverely illAmong the most extremely ill
Ziprasidone HCl (Zeldox)13081588932077212

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Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels

(NCT01113541)
Timeframe: Baseline, Week 52 or Early Termination

Interventionmilligrams per deciliter (Median)
Total cholesterol: BaselineTotal cholesterol: Change at Last ObservationLDL cholesterol: BaselineLDL cholesterol: Change at Last Observation
Ziprasidone206.0-20.0131.0-8.0

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Change From Baseline in Weight

(NCT01113541)
Timeframe: Baseline, Week 4, Week 12, Week 52 or Early Termination

Interventionkilograms (Mean)
Baseline (n=13)Value at Week 4 (n=9)Value at Week 12 (n=5)Value at Week 52 (n=10)
Ziprasidone93.592.997.387.5

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Percentage of Participants Who Achieved a Reduction From Baseline of at Least 1 Risk Factor for Metabolic Syndrome (MS) at Week 52 or Premature Discontinuation

MS risks factors: elevated (el) waist circumference: ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); el triglycerides: ≥1.7 millimoles per liter (mmol/L) (1≥50 milligrams per deciliter [mg/dL]); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; el fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and el systolic/diastolic blood pressure: systolic ≥130 millimeters of mercury (mmHg) and/or diastolic ≥85 mmHg. Responder = at least 1 less risk factor at endpoint than baseline. (NCT01113541)
Timeframe: Week 52 or Early Termination

Interventionpercentage of participants (Number)
Ziprasidone50.00

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Change From Baseline in Glycosylated Hemoglobin (HbA1c)

(NCT01113541)
Timeframe: Baseline, Week 52 or Early Termination

Interventionpercent HbA1c (Median)
BaselineMedian change
Ziprasidone5.5-0.2

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Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF)

QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds. (NCT01113541)
Timeframe: Baseline, Week 4, Week 52 or Early Termination

Interventionmilliseconds (Mean)
Baseline (n=13)Week 4 (n=9)Week 52 or or Early Termination (n=9)
Ziprasidone421.0434.0428.8

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MADRS Improvement Over 6 Weeks

"Montgomery Asberg Depression scale improvement was assessed in two 6 week crossover periods.~Minimum score on MADRS is 0, the maximum is 60. Higher scores represent a worse outcome, i.e., greater severity of depressive symptoms.~Scores of about 20 and above are generally seen as consistent with being in a full major depressive episode.~No subscales were used or combined." (NCT01168674)
Timeframe: 13 weeks (Two 6 week periods plus a one week washout)

Interventionunits on a scale (Mean)
Placebo10.0
Ziprasidone6.7

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Predictors of Bipolarity to Define the Study Population

The specific bipolarity predictors in patients with MDD were assessed. (NCT01168674)
Timeframe: 13 weeks

Interventionpercentage of subjects (Number)
Antidepressant toleranceAntidepressant nonresponseHighly recurrent depressive episodesAtypical depressionFamily history of bipolar disorderEarly age of onsetAntidepressant-induced mania
All Study Participants75.073.572.352.946.047.68.8

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Time to Hospital Discharge

"Days from randomization to successful hospital discharge, where successful indicates that discharge was followed by at least 48 hours alive." (NCT01211522)
Timeframe: 90 days

Interventiondays (Median)
Haloperidol13
Ziprasidone12
Placebo13

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Time to ICU Readmission

Days from first ICU discharge to next ICU readmission. (NCT01211522)
Timeframe: 90 days after first ICU discharge

Interventiondays (Median)
Haloperidol5
Ziprasidone5
Placebo4

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Time to Liberation From Mechanical Ventilation

"Days from randomization to successful liberation from mechanical ventilation, where successful indicates that liberation was followed by at least 48 hours alive and without reinitiation of invasive or noninvasive ventilation." (NCT01211522)
Timeframe: 30 days

Interventiondays (Median)
Haloperidol2
Ziprasidone3
Placebo3

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Delirium Duration

Duration of delirium during the intervention period (NCT01211522)
Timeframe: 14 days

Interventiondays (Median)
Haloperidol4
Ziprasidone4
Placebo4

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Delirium/Coma-free Days (DCFDs)

Defined as the number of days during the 14-day intervention period (beginning on the day of randomization) that the patient was alive and experienced neither delirium nor coma. (NCT01211522)
Timeframe: 14 days

Interventiondays (Median)
Haloperidol8
Ziprasidone8
Placebo7

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Number of Participants With Extrapyramidal Symptoms

(NCT01211522)
Timeframe: 14 days plus 4-day post-study drug period (if longer than 14 days)

InterventionParticipants (Count of Participants)
Haloperidol1
Ziprasidone1
Placebo1

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Number of Participants With Neuroleptic Malignant Syndrome

(NCT01211522)
Timeframe: 14 days plus 4-day post-study drug period (if longer than 14 days)

InterventionParticipants (Count of Participants)
Haloperidol0
Ziprasidone0
Placebo0

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Mortality

Deaths within the specified timeframe (NCT01211522)
Timeframe: 30-day and 90-day

,,
InterventionParticipants (Count of Participants)
30-day mortality90-day mortality
Haloperidol5073
Placebo5063
Ziprasidone5365

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Number of Participants With Torsades de Pointes

(NCT01211522)
Timeframe: 14 days plus 4-day post-study drug period (if longer than 14 days)

InterventionParticipants (Count of Participants)
Haloperidol2
Ziprasidone0
Placebo0

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Time to Final ICU Discharge

"Days from randomization to final, successful ICU discharge, where successful indicates that discharge was followed by at least 48 hours alive. ICU discharge is represented by readiness for ICU discharge indicated by a physician order for transfer to a lower level of care even if a bed availability problems prevent actual discharge from the ICU." (NCT01211522)
Timeframe: 90 days

Interventiondays (Median)
Haloperidol5
Ziprasidone6
Placebo5

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Global Psychopathology Score as Measured by Clinical Global Impressions

Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976). Lower scores indicate improved outcomes. (NCT01293825)
Timeframe: Week 16

Interventionunits on a scale (Mean)
Medication Adherence Bipolar Disorder2.25

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Montgomery Asberg Depression Rating Scale

Scale Range: 0-60. Lower scores indicate better outcomes. (NCT01293825)
Timeframe: Week 16

Interventionunits on a scale (Mean)
Medication Adherence Bipolar Disorder12.35

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Social and Occupational Functioning Scale

Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF (Global Assessment of Functioning). The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes. (NCT01293825)
Timeframe: Week 16

Interventionunits on a scale (Mean)
Medication Adherence Bipolar Disorder54.40

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Treatment Adherence Score as Measured by the Morisky Rating Scale

Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes. (NCT01293825)
Timeframe: Week 16

Interventionunits on a scale (Mean)
Medication Adherence Bipolar Disorder2.90

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Young Mania Rating Scale

Scale Range: 0-60. Lower scores indicate better outcomes. (NCT01293825)
Timeframe: Week 16

Interventionunits on a scale (Mean)
Medication Adherence Bipolar Disorder5.30

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Quality of Life Score as Measured by 12-item Short Form Health Survey

Scale Range: 1-99th percentile score. Higher scores indicate better outcomes. (NCT01293825)
Timeframe: Week 16

Interventionunits on a scale (Mean)
Norm-Based Standardized PCS ScoreNorm-Based Standardized MCS Score
Medication Adherence Bipolar Disorder41.1342.00

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Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ)

Scale Range: 0-100%. The score represents percentage of time that required medication doses were missed. Higher scores indicate lower medication adherence. (NCT01293825)
Timeframe: Week 16

InterventionPercentage of doses (Mean)
Past weekPast month
Medication Adherence Bipolar Disorder16.1113.88

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Body Weight

(NCT01293825)
Timeframe: Week 16

Interventionlbs (Mean)
Medication Adherence Bipolar Disorder210.75

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Attitude Toward Medication Score as Measured by the Drug Attitude Inventory

Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes. (NCT01293825)
Timeframe: Week 16

Interventionunits on a scale (Mean)
Medication Adherence Bipolar Disorder6.10

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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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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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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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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs. (NCT02075047)
Timeframe: Screening (2 Weeks prior to Day 1) up to maximum of 5 Weeks after administration of the final dose of study medication (maximum up to 11 weeks)

,
InterventionParticipants (Count of Participants)
AEsSAEs
Placebo500
Ziprasidone673

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Number of Participants Who Took at Least 1 Concomitant Medication and Concomitant Non-Drug Treatments/Procedures

Concomitant medications or treatments were those prescription and over-the-counter drugs and supplements or non drug treatment/procedures other than the study medication. (NCT02075047)
Timeframe: Screening (2 Weeks prior to Day 1) up to 1 Week after administration of the final dose of study medication (maximum for 7 Weeks)

,
InterventionParticipants (Count of Participants)
Concomitant MedicationConcomitant Non-Drug Treatments/Procedures
Placebo477
Ziprasidone556

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Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 1, 2, and 3

YMRS: an 11-item scale that measured the severity of manic episodes. Four items (irritability, speech, thought content, and disruptive/ aggressive behavior) were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score was sum of score of all 11 items and ranged from 0 (no symptoms) to 60 (extreme severity of symptoms), higher score indicated higher severity of mania. (NCT02075047)
Timeframe: Baseline, Week 1, 2, 3

,
Interventionunits on a scale (Least Squares Mean)
Change at Week 1Change at Week 2Change at Week 3
Placebo-5.58-9.53-11.17
Ziprasidone-11.43-13.70-16.79

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Change From Baseline in Simpson-Angus Rating Scale (SARS) Total Score at Weeks 1, 2, 3, and 4

SARS: 10-item clinician rated instrument to assess parkinsonian symptoms and related extrapyramidal side effects. All 10 items were anchored on a 5-point scale: range 0 (absence of condition, normal) to 4 (the most extreme form of condition). Total SARS score is sum of all individual item scores, and ranged from 0 (normal) to 40 (most extreme symptoms and effects); higher score indicates more affected. (NCT02075047)
Timeframe: Baseline, Week 1, 2, 3, 4

,
Interventionunits on a scale (Least Squares Mean)
Change at Week 1Change at Week 2Change at Week 3Change at Week 4
Placebo-0.01-0.00-0.00-0.00
Ziprasidone0.090.110.110.09

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Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, Early Termination Visit and Follow-up Visit

Change from baseline pulse rate in (beats per minute) was reported in sitting and standing positions. (NCT02075047)
Timeframe: Baseline, Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4), Follow up Visit (anytime from Day 1 up to 5 weeks after last dose of study drug = anytime from Day 1 to Week 9)

,
Interventionbeats per minute (Mean)
Sitting, BaselineSitting, Change at Week 1Sitting, Change at Week 2Sitting, Change at Week 3Sitting, Change at Week 4Early Termination: SittingFollow up: SittingStanding, BaselineStanding, Change at Week 1Standing, Change at Week 2Standing, Change at Week 3Standing, Change at Week 4Early Termination: StandingFollow up: Standing
Placebo75.8-2.01.52.3-0.21.63.183.3-2.21.92.6-0.6-6.24.5
Ziprasidone79.1-0.9-2.4-0.5-2.33.52.084.62.1-0.41.4-0.77.95.4

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Clinical Global Impression of Improvement (CGI-I) Scores at Weeks 1, 2, 3, and 4

CGI-I: 7-point clinician rated scale which rates the participant's improvement or worsening from baseline, ranging from 1 (very much improved) to 7 (very much worse), higher scores indicate less improvement. (NCT02075047)
Timeframe: Baseline, Week 1, 2, 3, 4

,
Interventionunits on a scale (Least Squares Mean)
Change at Week 1Change at Week 2Change at Week 3Change at Week 4
Placebo3.412.892.682.64
Ziprasidone2.892.752.422.30

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Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) - Movement Cluster Score at Weeks 1, 2, 3, and 4

AIMS: clinician rated 12-item scale to document occurrences of dyskinesia in participants, specifically tardive dyskinesia. Items 1 to 10, scored as 0 (none) to 4 (severe); higher score indicates greater severity. Items 11 to 12 are questions with No or Yes response. Only the sum of the first 7 items were calculated to evaluate AIMS movement cluster score, giving a score range of 0 (none) to 28 (maximum severity), higher score indicates greater severity. (NCT02075047)
Timeframe: Baseline, Week 1, 2, 3, 4

,
Interventionunits on a scale (Least Squares Mean)
Change at Week 1Change at Week 2Change at Week 3Change at Week 4
Placebo0.000.000.000.00
Ziprasidone0.030.030.080.05

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Number of Participants With Physical Examination Abnormalities

Parameters assessed for physical examination included: oral/tympanic temperature, general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts (if medically indicated), abdomen, external genitalia [if medically indicated], extremities, back/spinal system, lymph nodes or worsening of medical history conditions. Abnormality in physical examination was at the investigator's discretion. (NCT02075047)
Timeframe: Screening (2 Weeks prior to Day 1) up to Week 4

InterventionParticipants (Count of Participants)
Ziprasidone4
Placebo5

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Number of Participants With Laboratory Abnormalities

Criteria: Hematology-hemoglobin(Hg),hematocrit,erythrocytes(ery)<0.8*LLN,ery mean corpuscular volume <0.9*LLN>1.1*ULN,platelets<0.5*LLN>1.75*ULN,leukocytes(leu)<0.6*LLN>1.5*ULN,lymphocytes(lym),lym/leu,neutrophils(neu),neu/leu<0.8*LLN>1.2*ULN,basophils (bas),bas/leu, eosinophils(eos), eos/leu, monocytes(mon),mon/leu>1.2*ULN; Clinical chemistry bilirubin: total, direct, indirect>1.5*ULN, aspartate aminotransferase,alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase,alkaline phosphatase>3.0*ULN,protein,albumin<0.8*LLN>1.2*ULN,blood urea nitrogen,creatinine>1.3*ULN, urate>1.2*ULN,HDL<0.8*LLN;LDL>1.2*ULN cholesterol(CH),sodium<0.95*LLN>1.05*ULN,potassium, chloride,calcium,magnesium,bicarbonate<0.9*LLLN>1.1*ULN,phosphate,free thyroxine,thyroid stimulating hormone<0.8*LLN>1.2*ULN,prolactin>1.1*ULN,glucose<0.6*LLN>1.5*ULN,HgA1C,CH, triglycerides>1.3*ULN,creatine kinase>2.0*ULN; Urinalysis-specific gravity<1.003>1.030,pH<4.5 >8,urine glucose, protein, Hg, ketones:>=1. (NCT02075047)
Timeframe: Screening (2 Weeks prior to Day 1) up to 1 Week after administration of the final dose of study medication (maximum for 7 Weeks)

InterventionParticipants (Count of Participants)
Ziprasidone50
Placebo62

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Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 4

YMRS: an 11-item scale that measured the severity of manic episodes. Four items (irritability, speech, thought content, and disruptive/ aggressive behavior) were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score was sum of score of all 11 items and ranged from 0 (no symptoms) to 60 (extreme severity of symptoms), higher score indicated higher severity of mania. (NCT02075047)
Timeframe: Baseline, Week 4

Interventionunits on a scale (Least Squares Mean)
Ziprasidone-16.51
Placebo-12.29

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Change From Baseline in Height and Waist Circumference at Week 4 and Early Termination Visit

Change from baseline in height and waist circumference in centimeter (cm) was reported. (NCT02075047)
Timeframe: Baseline, Week 4, Early Termination Visit (anytime from Day 1 to Week 4)

,
Interventioncentimeter (Mean)
Height, BaselineHeight, Change at Week 4Height, Change at Early TerminationWaist Circumference, BaselineWaist Circumference, Change at Week 4Waist Circumference, Change at Early Termination
Placebo159.70.70.574.90.31.0
Ziprasidone157.90.40.276.9-0.10.4

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Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill), higher scores indicated more severity of illness. (NCT02075047)
Timeframe: Baseline, Week 1, 2, 3, 4

,
Interventionunits on a scale (Least Squares Mean)
Change at Week 1Change at Week 2Change at Week 3Change at Week 4
Placebo-0.47-0.91-1.14-1.32
Ziprasidone-0.91-1.13-1.53-1.59

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Change From Baseline in Body Weight at Week 4 and Early Termination Visit

Change from baseline in body weight in kilogram (kg) was reported. (NCT02075047)
Timeframe: Baseline, Week 4, Early Termination Visit (anytime from Day 1 to Week 4)

,
Interventionkilogram (Mean)
BaselineChange at Week 4Change at Early Termination
Placebo58.00.81.0
Ziprasidone57.50.3-0.3

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Change From Baseline in Body Mass Index (BMI) Z-score at Week 4 and Early Termination Visit

BMI z-score was reported using the Children's Hospital of Philadelphia z-score calculator. Z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of higher BMI. (NCT02075047)
Timeframe: Baseline, Week 4, Early Termination Visit (anytime from Day 1 to Week 4)

,
Interventionz-score (Mean)
BaselineChange at Week 4Change at Early Termination
Placebo0.7-0.0-0.0
Ziprasidone0.80.0-0.0

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Change From Baseline in Body Mass Index (BMI) at Week 4 and Early Termination Visit

Change from baseline in BMI in kilogram per meter square (kg/m^2) was reported. (NCT02075047)
Timeframe: Baseline, Week 4, Early Termination Visit (anytime from Day 1 to Week 4)

,
Interventionkilogram per meter square (Mean)
BaselineChange at Week 4Change at Early Termination
Placebo22.50.20.3
Ziprasidone22.80.1-0.3

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Change From Baseline in Blood Pressure at Week 1, 2, 3, 4, Early Termination Visit and Follow-up Visit

Change from baseline in sitting and standing systolic blood pressure and diastolic blood pressure in millimeter of mercury (mmHg) was reported. (NCT02075047)
Timeframe: Baseline, Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4), Follow up Visit (anytime from Day 1 up to 5 weeks after last dose of study drug = anytime from Day 1 to Week 9)

,
Interventionmillimeter of mercury (Mean)
Sitting Systolic Blood Pressure, BaselineSitting Systolic Blood Pressure, Change at Week 1Sitting Systolic Blood Pressure, Change at Week 2Sitting Systolic Blood Pressure, Change at Week 3Sitting Systolic Blood Pressure, Change at Week 4Sitting Systolic Blood Pressure, Change at Early TerminationSitting Systolic Blood Pressure, Change at Follow upStanding Systolic Blood Pressure, BaselineStanding Systolic Blood Pressure, Change at Week 1Standing Systolic Blood Pressure, Change at Week 2Standing Systolic Blood Pressure, Change at Week 3Standing Systolic Blood Pressure, Change at Week 4Standing Systolic Blood Pressure, Change at Early TerminationStanding Systolic Blood Pressure, Change at Follow upSitting Diastolic Blood Pressure, BaselineSitting Diastolic Blood Pressure, Change at Week 1Sitting Diastolic Blood Pressure, Change at Week 2Sitting Diastolic Blood Pressure, Change at Week 3Sitting Diastolic Blood Pressure, Change at Week 4Sitting Diastolic Blood Pressure, Change at Early TerminationSitting Diastolic Blood Pressure, Change at Follow upStanding Diastolic Blood Pressure, BaselineStanding Diastolic Blood Pressure, Change at Week 1Standing Diastolic Blood Pressure, Change at Week 2Standing Diastolic Blood Pressure, Change at Week 3Standing Diastolic Blood Pressure, Change at Week 4Standing Diastolic Blood Pressure, Change at Early TerminationStanding Diastolic Blood Pressure, Change at Follow up
Placebo110.90.20.1-0.6-2.26.4-2.2112.0-2.5-1.8-1.8-2.55.6-4.470.3-1.5-0.60.1-0.62.01.772.3-1.6-1.7-1.6-0.51.6-2.1
Ziprasidone110.50.70.2-0.7-0.70.7-1.4110.70.80.1-0.1-0.8-2.1-4.968.80.71.00.21.1-1.82.770.31.5-0.1-1.11.01.31.2

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Change From Baseline in Barnes Akathisia Rating Scale (BAS): Global Clinical Assessment of Akathisia Subscale Score at Weeks 1, 2, 3, and 4

BAS: clinician rated scale to assess akathisia by determining the degree of subjective restlessness and distress associated with restlessness. First 3 items (objective, subjective, and distress related to restlessness) were rated on a 4-point scale with range 0 (no symptoms) to 3 (maximum severity of symptoms). Item 4, global clinical assessment of akathisia subscale, was rated on a 6-point scale, and ranged from 0 (no symptoms) to 5 (maximum severity of symptoms); higher score indicates increased severity. (NCT02075047)
Timeframe: Baseline, Week 1, 2, 3, 4

,
Interventionunits on a scale (Least Squares Mean)
Change at Week 1Change at Week 2Change at Week 3Change at Week 4
Placebo0.020.040.01-0.01
Ziprasidone-0.010.040.010.01

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Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS)

C-SSRS: a measure used to identify and assess participants at risk for suicide. It is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. C-SSRS items were mapped to the following C-CASA categories: completed suicide, attempted suicide (actual attempt; aborted attempt; interrupted attempt), non-suicidal self-injurious behavior, preparatory acts, suicidal ideation (wish to be dead; non-specific active suicidal thoughts; active suicidal ideation with any methods [not plan], without intent to act; active suicidal ideation with some intent to act, without specific plan; active suicidal ideation with specific plan and intent; self-injurious behavior, no suicidal intent). Rows according to C-CASA categories at specified time points are reported in this outcome measure, only when there was non-zero data/values for at least 1 reporting arm. (NCT02075047)
Timeframe: Screening (2 Weeks prior to Day 1), Baseline (Day 1), Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4), Follow up Visit (anytime from Day 1 up to 5 weeks after last dose of study drug = anytime from Day 1 to Week 9)

,
InterventionParticipants (Count of Participants)
Screening: Actual AttemptScreening: Interrupted AttemptScreening: Non-Suicidal Self-Injurious BehaviorScreening: Preparatory ActsScreening: Wish To Be DeadScreening: Non-specific Active Suicidal ThoughtsBaseline: Wish To Be DeadBaseline: Active Suicidal Thoughts With No Plan, IntentBaseline: Active Suicidal Thoughts With No Plan, Some IntentBaseline: Active Suicidal Thoughts With Plan, IntentWeek 1: Wish To Be DeadWeek 4: Non-Suicidal Self-Injurious BehaviorWeek 4: Wish To Be DeadWeek 4: Non-specific Active Suicidal ThoughtsEarly Termination: Wish To Be DeadEarly Termination: Non-specific Active Suicidal ThoughtsEarly Termination: Active Suicidal Thoughts With No Plan, IntentFollow up: Actual AttemptFollow up: Wish To Be Dead
Placebo315125130733100000000
Ziprasidone5010025161424012111112

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Number of Participants With Pre-defined Categories of Electrocardiogram (ECG) Findings

Pre-defined categories for ECG were: heart rate intervals - QT interval corrected using the Fridericia's formula (QTCF) value greater than or equal to (>=450) millisecond (msec), >=460 msec, >=480 msec, >=500 msec, >=30 msec increase, >=60 msec increase, >=75 msec increase, QT interval corrected using the Bazett's correction (QTCB) value >=450 msec, >=460 msec, >=480 msec, >=500 msec, >=30 msec increase, >=60 msec increase, >=75 msec increase, PR value >=25 percentage increase, QRS value >=25 percentage increase, QT value >=25 percentage increase, Respiratory rate (RR) value >=25 percentage increase, and Heart rate (HR) value >=25 percentage increase. Rows according to ECG pre-defined categories are reported in this outcome measure, only when there was non-zero data/values for at least 1 reporting arm. (NCT02075047)
Timeframe: Screening (2 Weeks prior to Day 1) up to 1 Week after administration of the final dose of study medication (maximum for 7 Weeks)

,
InterventionParticipants (Count of Participants)
QTcF at >=450 msecQTcF at >=460 msecQTcF at >=30 msec increaseQTcB at >=450 msecQTcB at >=460 msecQTcB at >=480 msecQTcB at >=30 msec increaseQRS at >=25% increaseRR at >=25% increaseHR at >=25% increase
Placebo10473071149
Ziprasidone31914811631218

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Change From Baseline in Children's Depression Rating Scale (CDRS-R) Total Score at Weeks 1, 2, 3, and 4 and Early Termination Visit

CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (maximum impairment). Higher scores indicated greater impairment. Total score calculated as sum of the 17 items ranged from 17 (no impairment) to 119 (maximum impairment); higher score indicated greater impairment. (NCT02075047)
Timeframe: Baseline, Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4)

,
Interventionunits on a scale (Mean)
BaselineChange at Week 1Change at Week 2Change at Week 3Change at Week 4Change at Early Termination
Placebo28.3-0.8-2.4-3.3-3.8-1.2
Ziprasidone29.0-2.5-2.9-3.7-3.62.3

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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 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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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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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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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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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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Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS)

C-SSRS: a measure used to identify and assess participants at risk for suicide. It is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. C-SSRS items were mapped to the following C-CASA categories: completed suicide, attempted suicide (actual attempt; aborted attempt; interrupted attempt), non-suicidal self-injurious behavior, preparatory acts, suicidal ideation (wish to be dead; non-specific active suicidal thoughts; active suicidal ideation with any methods [not plan], without intent to act; active suicidal ideation with some intent to act, without specific plan; active suicidal ideation with specific plan and intent; self-injurious behavior, no suicidal intent). C-CASA categories with at least 1 participant, for specified time points, for at least 1 reporting arm are reported below. (NCT03768726)
Timeframe: Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

,
InterventionParticipants (Count of Participants)
Week 6: Wish to be deadWeek 10: Wish to be deadWeek 26: Wish to be deadWeek 26: Non-specific Active Suicidal ThoughtsWeek 26: Active Suicidal Thoughts With No Plan, Intent
Placebo in A1281198 Then Ziprasidone in A128120111111
Ziprasidone in A1281198 and A128120100000

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Change From Baseline in Body Weight at Week 6, 26 and Follow-up Visit

Change from baseline in body weight in kilogram (kg) was reported. (NCT03768726)
Timeframe: Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

,
Interventionkg (Mean)
BaselineChange at Week 6Change at Week 26Change at Follow-up Visit
Placebo in A1281198 Then Ziprasidone in A128120162.400.782.334.68
Ziprasidone in A1281198 and A128120157.760.821.621.47

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Change From Baseline in Body Mass Index (BMI) Z-score at Week 6, 26 and Follow-up Visit

BMI z-score was reported using the Children's Hospital of Philadelphia z-score calculator. Z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of higher BMI. (NCT03768726)
Timeframe: Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

,
Interventionz-score (Mean)
BaselineChange at Week 6Change at Week 26Change at Follow-up Visit
Placebo in A1281198 Then Ziprasidone in A12812011.06-0.020.110.26
Ziprasidone in A1281198 and A12812010.580.120.210.01

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Change From Baseline in Body Mass Index (BMI) at Week 6, 26 and Follow-up Visit

Change from baseline in BMI in kilogram per meter square (kg/m^2) was reported. (NCT03768726)
Timeframe: Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

,
Interventionkg/m^2 (Mean)
BaselineChange at Week 6Change at Week 26Change at Follow-up Visit
Placebo in A1281198 Then Ziprasidone in A128120123.370.910.781.54
Ziprasidone in A1281198 and A128120122.310.380.190.35

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Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit

Change from baseline in sitting and standing systolic and diastolic blood pressure in millimeter of mercury (mmHg) was reported. (NCT03768726)
Timeframe: Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

,
InterventionmmHg (Mean)
Sitting Systolic Blood Pressure, BaselineSitting Systolic Blood Pressure, Change at Week 1Sitting Systolic Blood Pressure, Change at Week 2Sitting Systolic Blood Pressure, Change at Week 4Sitting Systolic Blood Pressure, Change at Week 6Sitting Systolic Blood Pressure, Change at Week 10Sitting Systolic Blood Pressure, Change at Week 14Sitting Systolic Blood Pressure, Change at Week 18Sitting Systolic Blood Pressure, Change at Week 22Sitting Systolic Blood Pressure, Change at Week 26Sitting Systolic Blood Pressure, Change at Follow up VisitStanding Systolic Blood Pressure, BaselineStanding Systolic Blood Pressure, Change at Week 1Standing Systolic Blood Pressure, Change at Week 2Standing Systolic Blood Pressure, Change at Week 4Standing Systolic Blood Pressure, Change at Week 6Standing Systolic Blood Pressure, Change at Week 10Standing Systolic Blood Pressure, Change at Week 14Standing Systolic Blood Pressure, Change at Week 18Standing Systolic Blood Pressure, Change at Week 22Standing Systolic Blood Pressure, Change at Week 26Standing Systolic Blood Pressure, Change at Follow up VisitSitting Diastolic Blood Pressure, BaselineSitting Diastolic Blood Pressure, Change at Week 1Sitting Diastolic Blood Pressure, Change at Week 2Sitting Diastolic Blood Pressure, Change at Week 4Sitting Diastolic Blood Pressure, Change at Week 6Sitting Diastolic Blood Pressure, Change at Week 10Sitting Diastolic Blood Pressure, Change at Week 14Sitting Diastolic Blood Pressure, Change at Week 18Sitting Diastolic Blood Pressure, Change at Week 22Sitting Diastolic Blood Pressure, Change at Week 26Sitting Diastolic Blood Pressure, Change at Follow up VisitStanding Diastolic Blood Pressure, BaselineStanding Diastolic Blood Pressure, Change at Week 1Standing Diastolic Blood Pressure, Change at Week 2Standing Diastolic Blood Pressure, Change at Week 4Standing Diastolic Blood Pressure, Change at Week 6Standing Diastolic Blood Pressure, Change at Week 10Standing Diastolic Blood Pressure, Change at Week 14Standing Diastolic Blood Pressure, Change at Week 18Standing Diastolic Blood Pressure, Change at Week 22Standing Diastolic Blood Pressure, Change at Week 26Standing Diastolic Blood Pressure, Change at Follow-up Visit
Placebo in A1281198 Then Ziprasidone in A1281201111.38-1.000.08-1.83-3.45-3.09-7.09-0.821.40-2.237.67111.38-1.001.332.17-2.00-2.18-4.55-1.735.40-5.332.5072.00-1.670.17-2.171.00-7.09-3.910.27-1.30-2.46-1.6774.85-4.45-0.33-2.67-2.82-4.36-4.09-0.91-4.30-4.33-3.00
Ziprasidone in A1281198 and A1281201111.702.440.433.293.17-0.80-2.80-2.67-5.00-0.630.75113.40-0.672.86-1.571.67-0.60-0.80-2.67-7.00-3.38-5.5071.000.67-4.140.14-0.83-3.40-6.20-2.67-5.50-2.50-1.7573.90-1.00-4.14-3.14-1.170.40-3.00-5.330.00-0.50-7.75

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Number of Participants With Laboratory Abnormalities

Hemoglobin (Hg), hematocrit, erythrocytes: <0.8*lower limits of normal (LLN); platelets: <0.5*LLN>1.75*upper limits of normal (ULN); leukocytes (leu), glucose-fasting:<0.6*LLN>1.5*ULN; lymphocytes (lym), lym/leu, neutrophils (neu), neu/leu, protein, albumin, phosphate, free thyroxine, thyroid stimulating hormone: <0.8*LLN>1.2*ULN; basophils (bas), bas/leu, eosinophils (eos), eos/leu, monocytes(mon), mon/leu: >1.2*ULN; bilirubin (total, direct, indirect):>1.5*ULN; aspartate aminotransferase(AT), alanine AT, lactate dehydrogenase, alkaline phosphatase:>3.0*ULN; blood urea nitrogen, creatinine, cholesterol (total, LDL, HDL), triglycerides, Hg A1C: >1.3*ULN; sodium: <0.95*LLN>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate: <0.9*LLLN>1.1*ULN; prolactin: >1.1*ULN; creatine kinase: >2.0*ULN; urobilinogen: >=1; Urine-specific gravity: <1.003>1.030, pH: <4.5 >8, glucose, protein, bilirubin, nitrite, leukocyte esterase, ketones: >=1. (NCT03768726)
Timeframe: A1281201: Day 1 up to 1 Week after last dose of study medication (maximum up to 27 Weeks)

InterventionParticipants (Count of Participants)
Ziprasidone in A1281198 and A12812015
Placebo in A1281198 Then Ziprasidone in A128120111

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Change From Baseline in Children's Global Assessment Scale (CGAS) Total Score at Week 26

CGAS: a clinician-rated global assessment item for children, based on symptoms and social functioning in home, school, and community settings. Scores ranged from 1 (extremely impaired) to 100 (doing very well), where higher levels indicate better health. (NCT03768726)
Timeframe: Baseline (last measurement from A1281198), A1281201: Week 26

,
Interventionunits on a scale (Mean)
BaselineChange at Week 26
Placebo in A1281198 Then Ziprasidone in A128120167.77.2
Ziprasidone in A1281198 and A128120168.21.6

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs. (NCT03768726)
Timeframe: A1281201: Day 1 up to 35 days after last dose of study medication (maximum up to 31 Weeks)

,
InterventionParticipants (Count of Participants)
AEsSAEs
Placebo in A1281198 Then Ziprasidone in A1281201121
Ziprasidone in A1281198 and A128120170

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Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state. CGI-S score ranged from 1 (not ill at all) to 7 (among the most extremely ill), higher scores indicated more severity of illness. (NCT03768726)
Timeframe: Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26

,
Interventionunits on a scale (Mean)
BaselineChange at Week 1Chang at Week 2Change at Week 4Change at Week 6Change at Week 10Change at Week 14Change at Week 18Change at Week 22Change at Week 26
Placebo in A1281198 Then Ziprasidone in A12812012.5-0.3-0.3-0.20.0-0.1-0.5-0.4-0.2-0.5
Ziprasidone in A1281198 and A12812012.70.30.10.00.5-0.20.0-0.7-1.0-0.1

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Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit

Change from baseline in PR interval, QT interval corrected using the Bazett's correction (QTcB), QT interval corrected using the Fridericia's formula (QTcF), QT interval, RR interval, QRS duration in millisecond (msec) was reported. (NCT03768726)
Timeframe: Baseline of A1281198, Day 1 (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 14, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

,
Interventionmsec (Mean)
PR interval, BaselinePR interval, Change at Day 1PR interval, Change at Week 1PR interval, Change at Week 2PR interval, Change at Week 4PR interval, Change at Week 6PR interval, Change at Week 14PR interval, Change at Week 22PR interval, Change at Week 26PR interval, Change at Follow-up VisitQTcB interval, BaselineQTcB interval, Change at Day 1QTcB interval, Change at Week 1QTcB interval, Change at Week 2QTcB interval, Change at Week 4QTcB interval, Change at Week 6QTcB interval, Change at Week 14QTcB interval, Change at Week 22QTcB interval, Change at Week 26QTcB interval, Change at Follow-up VisitQTcF interval, BaselineQTcF interval, Change at Day 1QTcF interval, Change at Week 1QTcF interval, Change at Week 2QTcF interval, Change at Week 4QTcF interval, Change at Week 6QTcF interval, Change at Week 14QTcF interval, Change at Week 22QTcF interval, Change at Week 26QTcF interval, Change at Follow-up VisitQT interval, BaselineQT interval, Change at Day 1QT interval, Change at Week 1QT interval, Change at Week 2QT interval, Change at Week 4QT interval, Change at Week 6QT interval, Change at Week 14QT interval, Change at Week 22QT interval, Change at Week 26QT interval, Change at Follow-up VisitRR interval, BaselineRR interval, Change at Day 1RR interval, Change at Week 1RR interval, Change at Week 2RR interval , Change at Week 4RR interval, Change at Week 6RR interval, Change at Week 14RR interval, Change at Week 22RR interval, Change at Week 26RR interval, Change at Follow-up VisitQRS duration, BaselineQRS duration, Change at Day 1QRS duration, Change at Week 1QRS duration, Change at Week 2QRS duration, Change at Week 4QRS duration, Change at Week 6QRS duration, Change at Week 14QRS duration, Change at Week 22QRS duration, Change at Week 26QRS duration, Change at Follow-up Visit
Placebo in A1281198 Then Ziprasidone in A1281201148.50.4-2.62.31.14.0-2.01.7-0.917.0412.42.215.611.42.90.23.98.92.5-5.0401.82.314.05.81.33.26.27.04.36.0382.82.210.8-4.1-2.19.010.64.17.226.0873.6-5.7-17.7-61.2-26.940.633.2-13.720.4134.085.82.83.81.71.52.52.9-0.33.511.0
Ziprasidone in A1281198 and A1281201145.31.03.6-4.63.00.0-6.812.5-0.3-3.0415.81.01.26.4-7.49.0-5.019.03.0-14.0398.53.83.0-0.3-1.312.5-4.623.510.60.0366.39.67.8-11.410.420.5-3.434.024.523.0781.033.630.7-73.370.156.53.669.099.1134.084.42.11.00.12.0-0.8-1.21.03.5-4.0

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Change From Baseline in Children's Depression Rating Scale (CDRS-R) Total Score at Week 26

CDRS-R: clinician-rated interview-based scale to assess 17 distinct symptom areas to derive an index of depression severity. Each symptom area was rated on a 7-point scale; range from 1 (no impairment) to 17 (maximum impairment). Total CDRS-R score was calculated as sum of responses for each 7 symptom areas. Total CDRS-R score ranged from 17 (no impairment) to 119 (maximum impairment); higher score indicated greater impairment. (NCT03768726)
Timeframe: Baseline (last measurement from A1281198), A1281201: Week 26

,
Interventionunits on a scale (Mean)
BaselineChange at Week 26
Placebo in A1281198 Then Ziprasidone in A128120167.77.2
Ziprasidone in A1281198 and A128120168.21.6

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Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit

Change from baseline pulse rate in beats per minute was reported in sitting and standing positions. (NCT03768726)
Timeframe: Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

,
Interventionbeats per minute (Mean)
Sitting, BaselineSitting, Change at Week 1Sitting, Change at Week 2Sitting, Change at Week 4Sitting, Change at Week 6Sitting, Change at Week 10Sitting, Change at Week 14Sitting, Change at Week 18Sitting, Change at Week 22Sitting, Change at Week 26Sitting, Change at Follow-up VisitStanding, BaselineStanding, Change at Week 1Standing, Change at Week 2Standing, Change at Week 4Standing, Change at Week 6Standing, Change at Week 10Standing, Change at Week 14Standing, Change at Week 18Standing, Change at Week 22Standing, Change at Week 26Standing, Change at Follow-up Visit
Placebo in A1281198 Then Ziprasidone in A128120173.382.008.082.002.000.18-0.911.094.30-2.692.6783.081.097.181.270.70-0.20-6.002.302.50-0.33-1.00
Ziprasidone in A1281198 and A128120177.900.780.00-3.29-1.173.40-3.00-0.33-12.00-2.50-2.5080.002.755.332.67-3.006.00-2.20-2.00-10.002.86-3.33

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Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit

Change from baseline in height and waist circumference in centimeter (cm) was reported. (NCT03768726)
Timeframe: Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

,
Interventioncm (Mean)
Height, BaselineHeight, Change at Week 6Height, Change at Week 26Height, Change at Follow-up VisitWaist Circumference, BaselineWaist Circumference, Change at Week 6Waist Circumference, Change at Week 26Waist Circumference, Change at Follow-up Visit
Placebo in A1281198 Then Ziprasidone in A1281201161.690.770.552.4280.232.231.292.01
Ziprasidone in A1281198 and A1281201159.820.272.040.9078.89-0.94-1.02-6.40

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Change From Baseline in Simpson-Angus Rating Scale (SARS) Total Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit

SARS: 10-item clinician rated instrument to assess parkinsonian symptoms and related extrapyramidal side effects. All 10 items were anchored on a 5-point scale: range 0 (absence of condition, normal) to 4 (the most extreme form of condition). Total score is sum of individual item scores, ranged from 0 (normal) to 40 (most extreme symptoms and effects); higher score indicates more affected. Rows with only non-zero data/values for change in SARS total score at specified time points, for at least 1 reporting arm, are reported below. (NCT03768726)
Timeframe: Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

,
Interventionunits on a scale (Mean)
BaselineChange at Week 1Change at Week 2Change at Week 4Change at Week 6Change at Week 26
Placebo in A1281198 Then Ziprasidone in A12812010.00.00.20.20.20.0
Ziprasidone in A1281198 and A12812010.4-0.20.00.00.0-0.5

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Change From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit

Change from baseline in heart rate in beats per minute was reported. (NCT03768726)
Timeframe: Baseline of A1281198, Day 1 (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 14, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

,
Interventionbeats per minute (Mean)
BaselineChange at Day 1Change at Week 1Change at Week 2Change at Week 4Change at Week 6Change at Week 14Change at Week 22Change at Week 26Change at Follow-up Visit
Placebo in A1281198 Then Ziprasidone in A128120171.5-1.20.45.00.4-3.9-2.60.3-3.0-13.0
Ziprasidone in A1281198 and A128120177.8-4.0-2.07.4-7.3-5.0-0.6-5.0-7.8-15.0

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Change From Baseline in Global Clinical Assessment of Akathisia Subscale Score of Barnes Akathisia Rating Scale (BAS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit

BAS: clinician rated scale to assess akathisia by determining the degree of subjective restlessness and distress associated with restlessness. Global clinical assessment of akathisia subscale score of BAS, was rated on a 6-point scale range 0 (no symptoms) to 5 (maximum severity of symptoms); higher score indicates increased severity. (NCT03768726)
Timeframe: Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

,
Interventionunits on a scale (Mean)
BaselineChange at Week 1Change at Week 2Change at Week 4Change at Week 6Change at Week 10Change at Week 14Change at Week 18Change at Week 22Change at Week 26Change at Follow-up Visit
Placebo in A1281198 Then Ziprasidone in A12812010.2-0.10.30.1-0.2-0.2-0.2-0.2-0.2-0.2-0.3
Ziprasidone in A1281198 and A12812010.00.00.00.00.00.00.00.00.00.00.0

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Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26

YMRS: an 11-item scale that measured the severity of manic episodes. Four items (irritability, speech, thought content, and disruptive/ aggressive behavior) were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score was sum of score of all 11 items and ranged from 0 (no symptoms) to 60 (extreme severity of symptoms), higher score indicated higher severity of mania. (NCT03768726)
Timeframe: Baseline (last measurement from A1281198), A1281201: Week 1, 2, 6, 14, 22, 26

,
Interventionunits on a scale (Mean)
BaselineChange at Week 1Change at Week 2Change at Week 6Change at Week 14Change at Week 22Change at Week 26
Placebo in A1281198 Then Ziprasidone in A128120112.0-5.5-3.4-3.7-5.8-4.0-6.4
Ziprasidone in A1281198 and A128120112.70.6-3.11.30.80.5-1.9

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Number of Participants With Physical Examination Abnormalities at Baseline and Week 26

Parameters assessed for physical examination included: oral/tympanic temperature, general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts (if medically indicated), abdomen, external genitalia (if medically indicated), extremities, back/spinal system, lymph nodes or worsening of medical history conditions. Abnormality in physical examination was at the investigator's discretion. (NCT03768726)
Timeframe: Baseline (last measurement from A1281198), Week 26 of A1281201

,
InterventionParticipants (Count of Participants)
BaselineWeek 26
Placebo in A1281198 Then Ziprasidone in A128120100
Ziprasidone in A1281198 and A128120100

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Change From Baseline in Movement Cluster Subscale Score of Abnormal Involuntary Movement Scale (AIMS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit

AIMS: clinician rated 12-item scale to document occurrences of dyskinesia in participants, specifically tardive dyskinesia. Items 1 to 10, scored as 0 (none) to 4 (severe); higher score indicates greater severity. Items 11 to 12 are questions with No or Yes response. Only the sum of the first 7 items were calculated to evaluate AIMS movement cluster subscale score, giving it a possible score range of 0 (none) to 28 (maximum severity), higher scores indicate greater severity. Rows with only non-zero data/values for change in AIMS-movement cluster subscale score at specified time points, for at least 1 reporting arm, are reported below. (NCT03768726)
Timeframe: Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

,
Interventionunits on a scale (Mean)
Change at Week 2Change at Week 6
Placebo in A1281198 Then Ziprasidone in A12812010.30.1
Ziprasidone in A1281198 and A12812010.00.0

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