Compounds > lurasidone hydrochloride
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lurasidone hydrochloride

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Description

Lurasidone Hydrochloride: A thiazole derivative and atypical ANTIPSYCHOTIC AGENT that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST; SEROTONIN 5-HT2 RECEPTOR ANTAGONIST, serotonin 5-HT7 receptor antagonist, and antagonist of the adrenergic α2A and α2C receptors, as well as a partial SEROTONIN 5-HT1A RECEPTOR AGONIST. It is used in the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

lurasidone hydrochloride : A hydrochloride obtained by reaction of lurasidone with one equivalent of hydrochloric acid. An atypical antipsychotic agent used for the treatment of schizophrenia. [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 CID11237860
CHEMBL ID1615372
CHEBI ID70732
SCHEMBL ID1534132
MeSH IDM000604584

Synonyms (53)

Synonym
latuda (tn)
sm 13496
367514-88-3
lurasidone hydrochloride (jan/usan)
D04820
mk-3756
smp-13496
lurasidone hydrochloride
latuda
sm-13496
lurasidone-d8 hydrochloride
EX-3125
lurasidone hcl
chebi:70732 ,
CHEMBL1615372
unii-o0p4i5851i
lurasidone hydrochloride [usan]
o0p4i5851i ,
4,7-methano-1h-isoindole-1,3(2h)-dione, 2-(((1r,2r)-2-((4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)methyl)cyclohexyl)methyl)hexahydro-, monohydrochloride, (3ar,4s,7r,7as)-
lurasidone hydrochloride [mart.]
lurasidone hydrochloride [who-dd]
lurasidone hydrochloride [mi]
lurasidone hydrochloride [orange book]
(3ar,4s,7r,7as)-2-((1r,2r)-2-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl)cyclohexylmethyl)hexahydro-4,7-methano-2h-isoindole-1,3-dione, hydrochloride
lurasidone hydrochloride [vandf]
lurasidone hydrochloride [jan]
4-(1,2-benzothiazol-3-yl)-1-{[(1r,2r)-2-{[(3ar,4s,7r,7as)-1,3-dioxooctahydro-2h-4,7-methanoisoindol-2-yl]methyl}cyclohexyl]methyl}piperazin-1-ium chloride
(3ar,4s,7r,7as)-2-{[(1r,2r)-2-{[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl}cyclohexyl]methyl}hexahydro-1h-4,7-methanoisoindole-1,3(2h)-dione hydrochloride
lurasidone monohydrochloride
S3044
AKOS022185856
SCHEMBL1534132
(3ar,4s,7r,7as)-2-{(1r,2r)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl}hexahydro-4,7-methano-2h-isoindole-1,3-dione hydrochloride
NEKCRUIRPWNMLK-SCIYSFAVSA-N
(3ar,4s,7r,7as)-2-[(1r,2r)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl]hexahydro-1h-4,7-methanoisoindole-1,3-dione hydrochloride
(3ar,4s,7r,7as)-2-(((1r,2r)-2-((4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)methyl)cyclohexyl)methyl)hexahydro-1h-4,7-methanoisoindole-1,3(2h)-dione hydrochloride
lurasidonhydrochloride
hcl, lurasidone
hydrochloride, lurasidone
sm-13496 (hydrochloride)
lurasidone hydrochloride, >=98% (hplc)
(1r,2s,6r,7s)-4-{[(1r,2r)-2-{[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl}cyclohexyl]methyl}-4-azatricyclo[5.2.1.0^{2,6}]decane-3,5-dione hydrochloride
Q27882070
AS-35074
(1s,2r,6s,7r)-4-[[(1r,2r)-2-[[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl]cyclohexyl]methyl]-4-azatricyclo[5.2.1.02,6]decane-3,5-dione;hydrochloride
DTXSID401027714
lurasidone hydrochloride (mart.)
4-(1,2-benzothiazol-3-yl)-1-(((1r,2r)-2-(((3ar,4s,7r,7as)-1,3-dioxooctahydro-2h-4,7-methanoisoindol-2-yl)methyl)cyclohexyl)methyl)piperazin-1-ium chloride
(3ar,4s,7r,7as)-2-(((1r,2r)-2-((4-(1,2-benzothiazol-3-yl)piperazin-1-yl)methyl)cyclohexyl)methyl)hexahydro-1h-4,7-methanoisoindole-1,3(2h)-dione hydrochloride
(3ar,4s,7r,7as)-2-((1r,2r)-2-(4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl)cyclohexylmethyl)hexahydro-4,7-methano-2h-isoindole-1,3-dione monohydrochloride
Z3241270511
EN300-7409921
(1r,2s,6r,7s)-4-{[(1r,2r)-2-{[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl}cyclohexyl]methyl}-4-azatricyclo[5.2.1.0,2,6]decane-3,5-dione hydrochloride

Research Excerpts

Overview

Lurasidone hydrochloride is an atypical antipsychotic. It is approved for the treatment of schizophrenia.

ExcerptReferenceRelevance
"Lurasidone hydrochloride is an atypical antipsychotic that is approved for the treatment of schizophrenia. "( Lurasidone: an atypical antipsychotic for schizophrenia.
Fuller, MA; Lee, JR; Risbood, V; Roche-Desilets, J, )		1.57

Toxicity

ExcerptReferenceRelevance
" The most common adverse events in the clinical trials were somnolence (broadly defined), akathisia, nausea, parkinsonism and agitation."( Lurasidone for schizophrenia: a review of the efficacy and safety profile for this newly approved second-generation antipsychotic.
Citrome, L, 2011)		0.37
" Doses above 80 mg/day do not appear to confer added benefit and may be associated with a dose-related increase in certain adverse reactions."( Lurasidone for schizophrenia: a review of the efficacy and safety profile for this newly approved second-generation antipsychotic.
Citrome, L, 2011)		0.37
"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)		0.37
" Outcome measures included adverse events (AEs), vital signs, ECG, and laboratory tests."( Long-term safety and tolerability of lurasidone in schizophrenia: a 12-month, double-blind, active-controlled study.
Citrome, L; Cucchiaro, J; Loebel, A; Phillips, D; Sarma, K; Silva, R; Tsuchiya, S, 2012)		0.38
" In this context, newer SGAs were developed to further improve the adverse effect burden of available agents."( Body weight and metabolic adverse effects of asenapine, iloperidone, lurasidone and paliperidone in the treatment of schizophrenia and bipolar disorder: a systematic review and exploratory meta-analysis.
Correll, CU; De Hert, M; Detraux, J; Sweers, K; van Winkel, R; Yu, W, 2012)		0.38
"Lurasidone 80 mg and 160 mg doses administered once-daily in the evening, were safe and effective treatments for subjects with acute schizophrenia, with increased response rates observed at the higher dose."( Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial.
Cucchiaro, J; Hsu, C; Kalali, AH; Loebel, A; Pikalov, A; Potkin, SG; Sarma, K; Xu, L, 2013)		0.39
"7%) discontinued due to an adverse event (AE) during OL treatment."( Long-term safety and effectiveness of lurasidone in schizophrenia: a 22-month, open-label extension study.
Correll, CU; Cucchiaro, J; Hsu, J; Loebel, A; Pikalov, A; Silva, R, 2016)		0.43
" The most common adverse events (incidence ≥5% in either lurasidone dose group and at least twice the rate of placebo) for lurasidone 40 mg/day, 80 mg/day, and placebo, respectively, were nausea (12."( Efficacy and Safety of Lurasidone in Adolescents with Schizophrenia: A 6-Week, Randomized Placebo-Controlled Study.
Cucchiaro, J; Deng, L; Findling, RL; Goldman, R; Loebel, A, 2017)		0.46
"7% in the placebo group; discontinuation rates due to adverse events were the same for the 2 groups (1."( Efficacy and Safety of Lurasidone in Children and Adolescents With Bipolar I Depression: A Double-Blind, Placebo-Controlled Study.
Cucchiaro, J; DelBello, MP; Deng, L; Goldman, R; Loebel, A; Phillips, D, 2017)		0.46
"3% due to adverse events."( Safety and effectiveness of lurasidone for the treatment of schizophrenia in Asian patients: Results of a 26-week open-label extension study.
Hagi, K; Higuchi, T; Ishigooka, J; Iyo, M, 2020)		0.56
" Key words: Bipolar I depression; Lurasidone; Meta-analysis; Remission rates; Adverse effect."( Efficacy and safety of lurasidone versus placebo as adjunctive to mood stabilizers in bipolar I depression: A meta-analysis.
Wang, GH; Wang, H; Wang, HL; Xiao, L, 2020)		0.56
" Other outcomes were discontinuation rates and incidence of individual adverse events."( Efficacy, tolerability, and safety of lurasidone for acute schizophrenia: A systematic review and network meta-analysis of phase 3 trials in Japan.
Iwata, N; Kishi, T; Nosaka, T; Okuya, M; Sakuma, K, 2020)		0.56
"7% due to adverse events."( Safety and effectiveness of lurasidone in adolescents with schizophrenia: results of a 2-year, open-label extension study.
Correll, CU; Deng, L; Findling, RL; Goldman, R; Pikalov, A; Tocco, M, 2022)		0.72
" For lurasidone (combined doses), three adverse events occurred with a frequency of ≥5% (nausea: 13."( Efficacy and safety of lurasidone in adolescents and young adults with schizophrenia: A pooled post hoc analysis of double-blind, placebo-controlled 6-week studies.
Calisti, F; Cattaneo, A; Costamagna, I; Goldman, R; Hsu, J; Pikalov, A; Tocco, M, 2021)		0.62
" Available safety outcomes included discontinuations (all-cause, lack of efficacy, adverse events), metabolic parameters (weight change, cholesterol, triglycerides, glucose), changes in prolactin, and somnolence."( Systematic Review and Network Meta-analysis: Efficacy and Safety of Second-Generation Antipsychotics in Youths With Bipolar Depression.
DelBello, MP; Hagi, K; Heller, V; Kadakia, A; Loebel, A; Nosaka, T; Singh, R, 2022)		0.72
"We conducted a meta-analysis of double-blind, randomized placebo-controlled trials of lurasidone (LUR) to examine the difference in the risk ratios (RRs) for adverse events (AEs) between depressive disorders (bipolar depression and major depressive disorders) and schizophrenia."( Differences in the incidence of lurasidone adverse events between depressive disorders and schizophrenia in double-blind, randomized, placebo-controlled trials: a meta-analysis.
Iwata, N; Kishi, T; Nakamura, H, 2021)		0.62
" The three most common adverse events for TN and TP patients, respectively, were headache (26."( Long-term safety and effectiveness of open-label lurasidone in antipsychotic-Naïve versus previously treated adolescents with Schizophrenia: A post-hoc analysis.
Correll, CU; Goldman, R; Hsu, J; Pikalov, A; Tocco, M, 2022)		0.72
" These data indicate that lurasidone is a safe and efficacious treatment option for treatment-naïve youth with schizophrenia, who are generally most sensitive to antipsychotic adverse effects."( Long-term safety and effectiveness of open-label lurasidone in antipsychotic-Naïve versus previously treated adolescents with Schizophrenia: A post-hoc analysis.
Correll, CU; Goldman, R; Hsu, J; Pikalov, A; Tocco, M, 2022)		0.72
" Adverse events with a frequency ≥5% (and were greater than for combined lurasidone) were insomnia (11."( Efficacy and safety of lurasidone in schizophrenia: pooled analysis of European results from double-blind, placebo-controlled 6-week studies.
Calabrese, M; Calisti, F; Cattaneo, A; Goldman, R; Mao, Y; Pikalov, A; Tocco, M, 2022)		0.72
" Our study investigated the FDA Adverse Event Reporting System and the pharmacodynamic CHEMBL database to further characterize TGA-induced ICDs."( Impulse Control Disorders by Dopamine Partial Agonists: A Pharmacovigilance-Pharmacodynamic Assessment Through the FDA Adverse Event Reporting System.
De Ponti, F; Fusaroli, M; Giunchi, V; Menchetti, M; Poluzzi, E; Raschi, E; Rimondini Giorgini, R, 2022)		0.72
"We downloaded and pre-processed the FDA Adverse Event Reporting System up to December 2020."( Impulse Control Disorders by Dopamine Partial Agonists: A Pharmacovigilance-Pharmacodynamic Assessment Through the FDA Adverse Event Reporting System.
De Ponti, F; Fusaroli, M; Giunchi, V; Menchetti, M; Poluzzi, E; Raschi, E; Rimondini Giorgini, R, 2022)		0.72
" The changes in the depressive rating scale, remission/response rates, nervous system adverse events (NSAEs), gastrointestinal adverse events (GIAEs), metabolic parameters, and prolactin were compared between medication and placebo or among medications with the Cohen's d or number needed to treat/harm."( Efficacy and safety profiles of mood stabilizers and antipsychotics for bipolar depression: a systematic review.
Bai, Y; Cai, L; Chen, G; Yang, H, 2023)		0.91
" Safety assessments included the number of treatment-emergent adverse events (TEAEs) and laboratory assessments."( The efficacy and safety of lurasidone in bipolar I depression with and without rapid cycling: A pooled post-hoc analysis of two randomized, placebo-controlled trials.
Kato, M; Kato, T; Masuda, T; Sano, F, 2023)		0.91

Pharmacokinetics

ExcerptReferenceRelevance
" The author provides the reader with knowledge of the fundamental pharmacokinetic characteristics and metabolic pathways of these new antipsychotics, emphasizing the clinically important common features and differences compared to other older agents."( Pharmacokinetics and metabolism update for some recent antipsychotics.
Caccia, S, 2011)		0.37
"Aripiprazole, perospirone, lurasidone and cariprazine share some of the pharmacokinetic characteristics of older, lipophilic antipsychotics and, like these, each has some distinct pharmacokinetic features that are clinically beneficial and some that are not."( Pharmacokinetics and metabolism update for some recent antipsychotics.
Caccia, S, 2011)		0.37
" 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
"In Study 1, the geometric mean Cmax in the fasted state was 56."( Effect of food on the pharmacokinetics of lurasidone: results of two randomized, open-label, crossover studies.
Chiu, YY; Ereshefsky, L; Loebel, A; Poola, N; Preskorn, S, 2013)		0.39
" The current study investigated whether the pharmacodynamic properties of lurasidone fit to a previously developed model which was the first to be derived on the basis of the strict combination of clinical and preclinical data with no input from theory or opinion."( The pharmacodynamic properties of lurasidone and their role in its antidepressant efficacy in bipolar disorder.
Akiskal, H; Fountoulakis, KN; Gazouli, M; Kelsoe, J, 2015)		0.42
"This paper reviews the pharmacokinetic and safety profile of lurasidone from the perspective of clinical pharmacology and helps the clinician compare this drug with others from the same therapeutic class to aid in drug selection and use in specific situations."( How the pharmacokinetics and receptor-binding profile of lurasidone affect the clinical utility and safety of the drug in the treatment of schizophrenia.
Kazanchi, H; Macaluso, M; Preskorn, SH, 2015)		0.42
"' In our review, particular attention was paid to those articles that reviewed the pharmacokinetic characteristics of the drug and its efficacy and safety/tolerability based on data from registration trials."( How the pharmacokinetics and receptor-binding profile of lurasidone affect the clinical utility and safety of the drug in the treatment of schizophrenia.
Kazanchi, H; Macaluso, M; Preskorn, SH, 2015)		0.42
" Additionally, this method was successfully used to estimate the in vivo plasma concentrations of lurasidone and ID-14283 obtained from a pharmacokinetic study in south Indian male subjects and the results were authenticated by conducting incurred samples reanalysis."( LC-MS/MS assay for the determination of lurasidone and its active metabolite, ID-14283 in human plasma and its application to a clinical pharmacokinetic study.
Katteboina, MY; Mullangi, R; Pilli, NR; Satla, SR; Seelam, RR, 2016)		0.43
"The aim of this study was to evaluate the pharmacokinetic (PK) profile and tolerability of lurasidone in children and adolescents with a range of psychiatric disorders."( Pharmacokinetics and Tolerability of Lurasidone in Children and Adolescents With Psychiatric Disorders.
Chiu, YY; Findling, RL; Goldman, R; Jin, F; Loebel, A; Pikalov, A; Silva, R, 2015)		0.42
"87) for Cmax on day 10 or 12."( Pharmacokinetics and Tolerability of Lurasidone in Children and Adolescents With Psychiatric Disorders.
Chiu, YY; Findling, RL; Goldman, R; Jin, F; Loebel, A; Pikalov, A; Silva, R, 2015)		0.42
" Our study investigated the FDA Adverse Event Reporting System and the pharmacodynamic CHEMBL database to further characterize TGA-induced ICDs."( Impulse Control Disorders by Dopamine Partial Agonists: A Pharmacovigilance-Pharmacodynamic Assessment Through the FDA Adverse Event Reporting System.
De Ponti, F; Fusaroli, M; Giunchi, V; Menchetti, M; Poluzzi, E; Raschi, E; Rimondini Giorgini, R, 2022)		0.72
" The current study investigated whether the pharmacodynamic properties of cariprazine fit into a previously developed model which was the first to be derived based on the strict combination of clinical and preclinical data."( Antidepressant efficacy of cariprazine in bipolar disorder and the role of its pharmacodynamic properties: A hypothesis based on data.
Fountoulakis, KN; Haarman, BCM; Ioannou, M; Tohen, M; Zarate, CA, 2023)		0.91

Compound-Compound Interactions

ExcerptReferenceRelevance
"To evaluate potential drug-drug interactions with the atypical antipsychotic lurasidone."( Lurasidone drug-drug interaction studies: a comprehensive review.
Chiu, YY; Ereshefsky, L; Loebel, A; Poola, N; Preskorn, SH, 2014)		0.4
" No dose adjustment for lurasidone is needed when administered with lithium or valproate."( Lurasidone drug-drug interaction studies: a comprehensive review.
Chiu, YY; Ereshefsky, L; Loebel, A; Poola, N; Preskorn, SH, 2014)		0.4
"Auditory processing cognitive remediation combined with lurasidone did not lead to differential improvement over nonspecific video games."( A Multicenter, Rater-Blinded, Randomized Controlled Study of Auditory Processing-Focused Cognitive Remediation Combined With Open-Label Lurasidone in Patients With Schizophrenia and Schizoaffective Disorder.
Barch, DM; Bruder, G; Choo, T; Harvey, P; Kantrowitz, JT; Keefe, RS; Lee, S; Lieberman, JA; Medalia, A; Sharif, Z, 2016)		0.43
" We report a case of an atazanavir-precipitated drug-drug interaction that led to elevated serum concentrations of lurasidone and associated clinical symptoms of drug toxicity."( A case of a probable drug interaction between lurasidone and atazanavir-based antiretroviral therapy.
Carvalhal, A; Hall, E; Naccarato, M; Ostrowski, M; Wai, A, 2016)		0.43
" To evaluate the recurrence prevention efficacy of lurasidone for the maintenance treatment of bipolar I disorder, patients received up to 20 weeks of open-label lurasidone (20-80mg/d) combined with lithium or valproate during an initial stabilization phase."( Lurasidone in combination with lithium or valproate for the maintenance treatment of bipolar I disorder.
Calabrese, JR; Cucchiaro, J; Loebel, A; Mao, Y; Pikalov, A; Streicher, C, 2017)		0.46
"Antipsychotics are often used in combination with other psychotropic drugs to treat a variety of psychiatric disorders, as well as in combination with other drugs taken by patients with co-morbidities."( Asenapine and iloperidone decrease the expression of major cytochrome P450 enzymes CYP1A2 and CYP3A4 in human hepatocytes. A significance for drug-drug interactions during combined therapy.
Danek, PJ; Daniel, WA; Wójcikowski, J, 2020)		0.56
" Then, we constructed rat liver microsomes (RLM) and human liver microsomes (HLM) incubation system to screen potential anti-tumor drugs that could interact with lurasidone and studied its inhibitory mechanism."( The impacts of CYP3A4 genetic polymorphism and drug interactions on the metabolism of lurasidone.
Cai, JP; Hu, GX; Li, Q; Liu, YN; Shen, Y; Wang, J; Wang, ZL; Xu, RA; Zhou, Q, 2023)		0.91

Bioavailability

The aim of this study is to test the efficiency of phospholipid based self-nanoemulsifying self-nanosuspension (p-SNESNS) formulation as a powerful tool to diminish the food effect on bioavailability.

ExcerptReferenceRelevance
" 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 bioavailability of lurasidone is enhanced three-fold by administration with food."( Comment on the potential utility of the new atypical antipsychotic lurasidone in the geriatric population.
Guay, DR, 2011)		0.37
" Study 1 (n = 16) evaluated the effect of fasting and three meal types (100 kcal/medium fat, 200 kcal/medium fat, and 800-1000 kcal/high fat), and Study 2 (n = 26) evaluated the effect of fasting and five meal types (350 kcal/high fat, 500 kcal/low fat, 500 kcal/high fat, 800-1000 kcal/low fat, and 800-1000 kcal/high fat) on the bioavailability of lurasidone."( Effect of food on the pharmacokinetics of lurasidone: results of two randomized, open-label, crossover studies.
Chiu, YY; Ereshefsky, L; Loebel, A; Poola, N; Preskorn, S, 2013)		0.39
"The purpose of this work was to develop a new formulation to enhance the bioavailability and reduce the food effect of lurasidone using self-nanoemulsifying drug delivery systems (SNEDDSs)."( Enhanced oral bioavailability of lurasidone by self-nanoemulsifying drug delivery system in fasted state.
Chen, G; Lili, R; Miao, Y; Ouyang, P; Sun, J, 2016)		0.43
"It was concluded that enhanced bioavailability and no food effect of lurasidone had been achieved by using SNEDDS."( Enhanced oral bioavailability of lurasidone by self-nanoemulsifying drug delivery system in fasted state.
Chen, G; Lili, R; Miao, Y; Ouyang, P; Sun, J, 2016)		0.43
" The aim of this study is to test the efficiency of phospholipid based self-nanoemulsifying self-nanosuspension (p-SNESNS) formulation as a powerful tool to diminish the food effect on bioavailability of lurasidone hydrochloride as BCS Class II model drug."( Phospholipid based self-nanoemulsifying self-nanosuspension (p-SNESNS) as a dual solubilization approach for development of formulation with diminished food effect: Fast/fed in vivo pharmacokinetics study in human.
Abdallah Ahmed, M; Basalious, EB, 2017)		0.64
"The global aim of this research was to develop and evaluate self-microemulsifying drug delivery system (SMEDDS) to improve oral bioavailability of Lurasidone Hydrochloride (LH)."( Self microemulsifying drug delivery system of lurasidone hydrochloride for enhanced oral bioavailability by lymphatic targeting: In vitro, Caco-2 cell line and in vivo evaluation.
Patel, MH; Sawant, KK, 2019)		0.97
"3 mg/kg acute oral), respectively, and relative bioavailability comparing these two routes of administration was of 19."( Antipsychotic lurasidone: Behavioural and pharmacokinetic data in C57BL/6 mice.
Bouet, V; Boulouard, M; Freret, T; Lagadu, S; Percelay, S; Since, M, 2020)		0.56
"Lurasidone is an important antipsychotic drug indicated for the treatment of schizophrenia and bipolar disorder, with an oral bioavailability of 9-19% owing to its poor aqueous solubility."( Harnessing the potential of nanostructured formulations to mimic the food effect of lurasidone.
Bremmell, KE; Joyce, P; Meola, TR; Prestidge, CA; Wignall, A, 2021)		0.62

Dosage Studied

ExcerptRelevanceReference
" Principal advantages over some other second-generation antipsychotics are lurasidone's highly favourable metabolic profile and once-daily dosing regimen."( Lurasidone for schizophrenia: a review of the efficacy and safety profile for this newly approved second-generation antipsychotic.
Citrome, L, 2011)		0.37
" Iloperidone and asenapine are dosed twice daily, in contrast to lurasidone, which is dosed once daily with food."( Iloperidone, asenapine, and lurasidone: a brief overview of 3 new second-generation antipsychotics.
Citrome, L, 2011)		0.37
"Participants, who were recently admitted inpatients with schizophrenia with an acute exacerbation of psychotic symptoms, were randomly assigned to 6 weeks of double-blind treatment with 40 mg of lurasidone, 120 mg of lurasidone, 15 mg of olanzapine (included to test for assay sensitivity), or placebo, dosed once daily."( Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo- and olanzapine-controlled study.
Cucchiaro, J; Kalali, AH; Loebel, A; Meltzer, HY; Ogasa, M; Phillips, D; Pikalov, A; Schweizer, E; Silva, R; Xu, J, 2011)		0.37
" Lurasidone will be a difficult drug to use in the elder patient population because of the virtual absence of elder-specific information, limitations of existing formulations (40 and 80 mg nonscored tablets) in enabling precise dosage adjustment, and the substantial difference in bioavailability with food versus fasting, with attendant risks for over- and underdosing depending on when the drug is ingested."( Comment on the potential utility of the new atypical antipsychotic lurasidone in the geriatric population.
Guay, DR, 2011)		0.37
" Further study is needed to determine whether these results concerning mechanism and dosage can be the basis for prevention of the development of CIS in at risk populations."( Prevention of the phencyclidine-induced impairment in novel object recognition in female rats by co-administration of lurasidone or tandospirone, a 5-HT(1A) partial agonist.
Adelekun, AE; Hannaway, KE; Horiguchi, M; Jayathilake, K; Meltzer, HY, 2012)		0.38
" Principal advantages over some other second-generation antipsychotics are lurasidone's highly favorable metabolic profile and once-daily dosing regimen."( Lurasidone in schizophrenia: new information about dosage and place in therapy.
Citrome, L, 2012)		0.38
" However, these agents differ from one another in terms of formulations, pharmacokinetics, and dosing and nonmetabolic adverse effect profile."( Asenapine, iloperidone and lurasidone: critical appraisal of the most recently approved pharmacotherapies for schizophrenia in adults.
Bobo, WV, 2013)		0.39
"Participants, who were recently admitted inpatients with schizophrenia with an acute exacerbation of psychotic symptoms, were randomly assigned to 6 weeks of fixed-dose, double-blind treatment with lurasidone 80 mg (n=125), lurasidone 160 mg (n=121), quetiapine XR 600 mg (QXR-600 mg; n=119; active control included to test for assay sensitivity), or placebo (n=121), all dosed once daily in the evening."( Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial.
Cucchiaro, J; Hsu, C; Kalali, AH; Loebel, A; Pikalov, A; Potkin, SG; Sarma, K; Xu, L, 2013)		0.39
"To examine the effectiveness of switching patients to lurasidone using 3 different dosing strategies."( Effectiveness of lurasidone in patients with schizophrenia or schizoaffective disorder switched from other antipsychotics: a randomized, 6-week, open-label study.
Citrome, L; Cucchiaro, J; Hernandez, D; Hsu, J; Loebel, A; McEvoy, JP; Pikalov, A, 2013)		0.39
"Adults with DSM-IV-defined schizophrenia or schizoaffective disorder in a nonacute phase of illness were randomized to 1 of 3 lurasidone dosing regimens for the initial 2 weeks of the study: (1) 40 mg/d for 2 weeks; (2) 40 mg/d for 1 week, increased to 80 mg/d on day 8 for week 2 (up-titration group); and (3) 80 mg/d for 2 weeks."( Effectiveness of lurasidone in patients with schizophrenia or schizoaffective disorder switched from other antipsychotics: a randomized, 6-week, open-label study.
Citrome, L; Cucchiaro, J; Hernandez, D; Hsu, J; Loebel, A; McEvoy, JP; Pikalov, A, 2013)		0.39
"Patients who completed a 6-week, double-blind, placebo-controlled study evaluating the efficacy of fixed doses of once-daily lurasidone (40 or 120 mg) or olanzapine 15 mg (to confirm assay sensitivity) were eligible to receive flexibly dosed lurasidone 40 to 120 mg/d in this 6-month, open-label extension study (conducted from March 2008 to December 2009)."( Effectiveness of lurasidone for patients with schizophrenia following 6 weeks of acute treatment with lurasidone, olanzapine, or placebo: a 6-month, open-label, extension study.
Cucchiaro, J; Hsu, J; Loebel, A; Pikalov, A; Simonelli, D; Stahl, SM, 2013)		0.39
"Open-label treatment with flexibly dosed lurasidone (40-120 mg/d) was generally safe, well tolerated, and effective over a 6-month period in patients who had completed a preceding 6-week, double-blind study."( Effectiveness of lurasidone for patients with schizophrenia following 6 weeks of acute treatment with lurasidone, olanzapine, or placebo: a 6-month, open-label, extension study.
Cucchiaro, J; Hsu, J; Loebel, A; Pikalov, A; Simonelli, D; Stahl, SM, 2013)		0.39
"Clinical pharmacology as an interdisciplinary science is unique in its capacity and the diversity of the methods and approaches it can provide to derive dosing recommendations in various subpopulations."( An integrated clinical pharmacology approach for deriving dosing recommendations in a regulatory setting: review of recent cases in psychiatry drugs.
Mehta, MU; Rogers, H; Uppoor, RS; Younis, IR; Zhang, H; Zhu, H, 2013)		0.39
" Maximum serum concentration (Cmax ) and area under the serum concentration-time curve over the dosing interval (AUC0-tau ) were determined on Day 5 for each meal type."( Effect of food on the pharmacokinetics of lurasidone: results of two randomized, open-label, crossover studies.
Chiu, YY; Ereshefsky, L; Loebel, A; Poola, N; Preskorn, S, 2013)		0.39
"Monotherapy with lurasidone in the dosage range of 20-120 mg/day significantly reduced depressive symptoms in patients with bipolar I depression."( Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study.
Cucchiaro, J; Hsu, J; Kroger, H; Loebel, A; Sachs, G; Sarma, K; Silva, R, 2014)		0.4
" The time to development of Pisa syndrome, patient demographics, dosing and titration of causative medications, approach to treatment, and resolution of Pisa syndrome varied widely in these reports."( Risperidone-induced Pisa syndrome in MS: resolution with lurasidone and recurrence with Chlorpromazine.
Diefenderfer, LA; Iuppa, CA, 2013)		0.39
"Patients who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for schizophrenia were randomized to 6 weeks of double-blind treatment with fixed doses of lurasidone 80 mg/d (n = 125), lurasidone 160 mg/d (n = 121), quetiapine XR 600 mg/d (n = 119), or placebo (n = 121), all dosed once daily in the evening, with food."( Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia.
Cucchiaro, JB; Harvey, PD; Loebel, AD; Pikalov, AA; Siu, CO, 2014)		0.4
" Patients started the extension study on treatment with the same dose of lurasidone taken at study endpoint of the 6-week core study; following this, lurasidone was flexibly dosed (40-120 mg/day), if clinically indicated, starting on Day 7 of the extension study."( Effectiveness of lurasidone in schizophrenia or schizoaffective patients switched from other antipsychotics: a 6-month, open-label, extension study.
Citrome, L; Correll, CU; Cucchiaro, J; Hsu, J; Loebel, A; McEvoy, JP; Weiden, PJ, 2014)		0.4
"Seven phase I studies were conducted to investigate the effects of repeated dosing of ketoconazole, diltiazem, rifampin, or lithium on the pharmacokinetics (PK) of single oral doses of lurasidone, or the effects of repeated dosing of lurasidone on the PK of digoxin, midazolam, or the oral contraceptive norgestimate/ethinyl estradiol."( Lurasidone drug-drug interaction studies: a comprehensive review.
Chiu, YY; Ereshefsky, L; Loebel, A; Poola, N; Preskorn, SH, 2014)		0.4
" Steady-state dosing with lurasidone increased Cmax and AUC0-24 (AUC from time 0 to 24 h postdose) of digoxin by 9% and 13%, respectively, and of midazolam by 21% and 44%, respectively."( Lurasidone drug-drug interaction studies: a comprehensive review.
Chiu, YY; Ereshefsky, L; Loebel, A; Poola, N; Preskorn, SH, 2014)		0.4
"Lurasidone PK is altered by strong cytochrome P450 (CYP) 3A4 inhibitors or inducers, and coadministration is contraindicated; whereas moderate CYP3A4 inhibitors have less effect, and lurasidone dosage restrictions are recommended."( Lurasidone drug-drug interaction studies: a comprehensive review.
Chiu, YY; Ereshefsky, L; Loebel, A; Poola, N; Preskorn, SH, 2014)		0.4
" Available only in an oral formulation, it is effective in once-daily dosing (40 - 160 mg/day) and its absorption is affected by food."( Lurasidone in the treatment of schizophrenia: a critical evaluation.
Bruijnzeel, D; Suryadevara, U; Tandon, R; Yazdanpanah, M, 2015)		0.42
" The purpose of this report is to describe the background, rationale and design of this study that included a novel method for the assessment of the potential for dose-response in early non-responding patients with schizophrenia."( Treatment of early non-response in patients with schizophrenia: assessing the efficacy of antipsychotic dose escalation.
Citrome, L; Correll, CU; Cucchiaro, J; Kane, JM; Loebel, A; Xu, J, 2015)		0.42
"Characterization of dose-response relationships for psychotropic agents may be difficult to determine based on results of individual clinical studies, particularly those with a flexible dose design."( Lurasidone Dose Response in Bipolar Depression: A Population Dose-response Analysis.
Chapel, S; Chiu, YY; Cucchiaro, J; Hsu, J; Loebel, A, 2016)		0.43
" A linear dose-response model best described the effect of lurasidone."( Lurasidone Dose Response in Bipolar Depression: A Population Dose-response Analysis.
Chapel, S; Chiu, YY; Cucchiaro, J; Hsu, J; Loebel, A, 2016)		0.43
"This population dose-response modeling analysis indicates that higher doses of lurasidone are likely to produce greater therapeutic effects in patients with bipolar depression."( Lurasidone Dose Response in Bipolar Depression: A Population Dose-response Analysis.
Chapel, S; Chiu, YY; Cucchiaro, J; Hsu, J; Loebel, A, 2016)		0.43
" In bipolar depression broader dosage ranges (20-120mg/day) were found to be effective."( Lurasidone: The 2016 update on the pharmacology, efficacy and safety profile.
Datka, W; Jaeschke, RR; Misztak, P; Pańczyszyn-Trzewik, P; Sowa-Kućma, M; Styczeń, K, 2016)		0.43
" We recommend requiring normal-weight and obese patients to limit the dosage of lurasidone, or undergo a washout period, for two and three weeks, respectively, after discontinuation of posaconazole."( Sustained Impairment of Lurasidone Clearance After Discontinuation of Posaconazole: Impact of Obesity, and Implications for Patient Safety.
Chow, CR; Greenblatt, DJ; Harmatz, JS; Ryan, MJ, 2018)		0.48
"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
" Patients 10-17 years of age with a DSM-5 diagnosis of bipolar I depression were randomized to 6 weeks of double-blind treatment with flexibly dosed lurasidone (20-80 mg/day) (n = 173) or placebo (n = 170)."( C-reactive protein and response to lurasidone treatment in children and adolescents with bipolar I depression: Results from a placebo-controlled trial.
Loebel, A; Pikalov, A; Raison, CL; Siu, C; Tocco, M, 2020)		0.56
" This study brings tools to improve pharmacological validity of preclinical models of psychiatric diseases, and to adapt dosage of antipsychotics according to the route used."( Antipsychotic lurasidone: Behavioural and pharmacokinetic data in C57BL/6 mice.
Bouet, V; Boulouard, M; Freret, T; Lagadu, S; Percelay, S; Since, M, 2020)		0.56
" In the extension study, lurasidone was flexibly dosed (20 to 120 mg/day)."( Lurasidone in the Long-Term Treatment of Bipolar I Depression: A 28-week Open Label Extension Study.
Hagi, K; Higuchi, T; Ishigooka, J; Kato, T; Masuda, T; Miyajima, M; Watabe, K, 2021)		0.62
"We compared the efficacy, safety, and acceptability of lurasidone at different doses to establish the dose-response relationships of lurasidone therapeutic and adverse effects in acute schizophrenia."( A network meta-analysis of the dose-response effects of lurasidone on acute schizophrenia.
Likhitsathian, S; Maneeton, B; Maneeton, N; Srisurapanont, M; Suttajit, S, 2021)		0.62
" Data to guide dosing in pregnancy that maximizes efficacy and minimizes adverse effects are lacking."( Perinatal use of lurasidone for the treatment of bipolar disorder.
Clark, CT; Montiel, C; Newmark, RL, 2022)		0.72
" For lurasidone, the combination of lipid-based nanostructure and porous silica nanostructure (SLH) led to optimal fasted state bioavailability which can ultimately result in enhanced treatment efficacy, easier dosing regimens and improved patient outcomes."( Harnessing the potential of nanostructured formulations to mimic the food effect of lurasidone.
Bremmell, KE; Joyce, P; Meola, TR; Prestidge, CA; Wignall, A, 2021)		0.62
"The moderating effects of these bridge symptoms on the response to flexibly dosed lurasidone 20-80 mg/d compared to placebo treatment was analyzed in children and adolescents with bipolar I depression in a six-week, placebo-controlled, double-blind study followed by a 2-year, openlabel extension study of lurasidone."( Sleep Disturbance, Irritability, and Response to Lurasidone Treatment in Children and Adolescents with Bipolar Depression.
Loebel, A; Pikalov, A; Singh, MK; Siu, C; Tocco, M, 2023)		0.91
" This finding supports once-daily dosing regimen of antipsychotics and abrupt antipsychotic discontinuation when switching to another antipsychotic."( Does short-term antipsychotic discontinuation of up to 3 weeks worsen symptoms in acute schizophrenia? A pooled analysis of placebo washout data.
Takeuchi, H; Watabe, K, 2023)		0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (4)

RoleDescription
dopaminergic antagonistA drug that binds to but does not activate dopamine receptors, thereby blocking the actions of dopamine or exogenous agonists.
serotonergic antagonistDrugs that bind to but do not activate serotonin receptors, thereby blocking the actions of serotonin or serotonergic agonists.
adrenergic antagonistAn agent that binds to but does not activate adrenergic receptors thereby blocking the actions of endogenous or exogenous adrenergic agonists.
second generation antipsychoticAntipsychotic drugs which can have different modes of action but which tend to be less likely than first generation antipsychotics to cause extrapyramidal motor control disabilities such as body rigidity or Parkinson's disease-type movements.
[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 (1)

ClassDescription
hydrochlorideA salt formally resulting from the reaction of hydrochloric acid with an organic base.
[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]

Research

Studies (343)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's4 (1.17)29.6817
2010's231 (67.35)24.3611
2020's108 (31.49)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 61.00

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 Index61.00 (24.57)
Research Supply Index6.10 (2.92)
Research Growth Index6.91 (4.65)
Search Engine Demand Index98.52 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (61.00)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials76 (20.71%)5.53%
Reviews89 (24.25%)6.00%
Case Studies44 (11.99%)4.05%
Observational3 (0.82%)0.25%
Other155 (42.23%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (77)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Comparison of NRX-101 to Standard of Care (Lurasidone) for Treatment-resistant Bipolar Depression With Suicidal Ideation and Behavior [NCT03395392]Phase 270 participants (Anticipated)Interventional2022-05-12Recruiting
Chinese Longitudinal and Systematic Study of Bioplar Disorder [NCT05480150]10,000 participants (Anticipated)Interventional2021-11-01Recruiting
Sequential Therapy (NRX-100 Followed by NRX-101) for the Treatment of Acute Suicidal Ideation and Behavior in Bipolar Depression: the STABIL-B Study [NCT02974010]Phase 222 participants (Actual)Interventional2018-01-15Completed
An Observational Drug Utilization Study of SYCREST^® (Asenapine) in the United Kingdom [NCT01498770]42 participants (Actual)Observational2013-04-01Completed
A Randomized, Double Blind, Placebo Controlled, Single Ascending Dose Study With Lurasidone Injectable Suspension to Evaluate Safety, Tolerability and Pharmacokinetics in Subjects With Schizophrenia [NCT03627195]Phase 140 participants (Actual)Interventional2018-06-07Completed
The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine: An Open-label, Single-arm And Multi-center Study for 16 Weeks [NCT05213143]Phase 4162 participants (Anticipated)Interventional2021-12-30Active, not recruiting
The Safety and Effectiveness of Latuda® Post-marketing Surveillance in the Treatment of Chinese Schizophrenia Patients [NCT04432688]3,000 participants (Anticipated)Observational [Patient Registry]2020-12-01Enrolling by invitation
AN OPEN-LABEL, RANDOMIZED, THREE-PERIOD, TWO-SEQUENCE CROSSOVER, REPEATED-DOSE, REPLICATE DESIGN STUDY TO DETERMINE THE BIOEQUIVALENCE OF TWO DIFFERENT LURASIDONE FORMULATIONS IN PATIENTS WITH SCHIZOPHRENIA, SCHIZOAFFECTIVE, OR SCHIZOPHRENIFORM DISORDER [NCT01082250]Phase 152 participants (Anticipated)Interventional2008-07-31Completed
[NCT01082276]Phase 120 participants (Actual)Interventional2008-08-31Completed
A Phase 1, Open-Label, Drug-Drug Interaction Study to Determine the Effect of Repeated Dose Lurasidone 120 mg Administration on the Pharmacokinetics of Orally Administered Digoxin 0.25 mg in Patients With Schizophrenia or Schizoaffective Disorder. [NCT01082289]Phase 124 participants (Actual)Interventional2008-09-30Completed
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
A 6-Week Randomised, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy of Lurasidone Adjunctive Therapy in Improving Cognitive Functioning in Euthymic Bipolar Disorder Patients (ELICE-BD) [NCT02731612]Phase 3150 participants (Anticipated)Interventional2017-05-08Recruiting
A Multi-Center, Open-Label, Single Arm and Flexible Dose Study of the Effectiveness and Safety of Oral Use Lurasidone HCl Tablet (LATUDA®) for 40-160 mg/Day in Subjects With Schizophrenia [NCT03393026]Phase 454 participants (Actual)Interventional2018-01-03Completed
Changes in Cognitive Functioning in Euthymic Bipolar Patients Treated With Lurasidone Versus Treatment as Usual; A Randomized, Open-Label Study. [NCT02147379]Phase 353 participants (Actual)Interventional2014-05-31Completed
An Open Label Study of NRX-101 for Patients With Acute Complicated Urinary Tract Infection Including Pyelonephritis [NCT06128213]Phase 213 participants (Anticipated)Interventional2024-03-31Not yet recruiting
18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder [NCT03902613]Phase 41 participants (Actual)Interventional2019-02-07Completed
A Randomized, Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Prevention of Recurrence in Subjects With Bipolar I Disorder [NCT01358357]Phase 3965 participants (Actual)Interventional2011-06-30Completed
High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia [NCT01569659]Phase 4101 participants (Actual)Interventional2011-10-31Completed
[NCT01082263]Phase 124 participants (Anticipated)Interventional2008-10-31Completed
A Phase 1, Open-Label Study to Determine the Effect of Calories and Fat Content on the Pharmacokinetics of Repeated Dose Lurasidone 120 mg in Subjects With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder. [NCT01074632]Phase 126 participants (Actual)Interventional2009-05-31Completed
Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia [NCT01614912]Phase 3284 participants (Actual)Interventional2012-08-31Completed
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-group Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication [NCT03557931]Phase 2233 participants (Actual)Interventional2018-07-13Completed
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression. [NCT01986101]Phase 3525 participants (Actual)Interventional2014-02-19Completed
Randomized, Double-blind, Parallel- Group, Placebo-controlled, Confirmatory Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia [NCT01614899]Phase 3457 participants (Actual)Interventional2012-07-02Completed
Randomized, Placebo-controlled, Double-blind, Parallel-group, Confirmatory Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia [NCT00711269]Phase 3460 participants (Actual)Interventional2008-06-27Completed
A Phase 3 Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Lurasidone in Subjects With Schizophrenia (PEARL 3 Extension Study) [NCT00789698]Phase 3240 participants (Actual)Interventional2008-12-31Completed
A Randomized, 6-week, Open-Label, Study Evaluating The Safety, Tolerability, and Efficacy of Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents [NCT01143077]Phase 3244 participants (Actual)Interventional2010-06-30Completed
A Phase 3 Randomized, Placebo-Controlled, CLinical Trial to Study the Safety and Efficacy of Three Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia [NCT00549718]Phase 3489 participants (Actual)Interventional2007-10-31Completed
A Phase 1, Open-Label, 2-Period, Sequential, Drug-Drug Interaction Study To Determine The Effect Of Lithium 600 Mg BID On The Safety And Pharmacokinetics Of Lurasidone 120 Mg QD In Patients With Schizophrenia Or Schizoaffective Disorder [NCT01074073]Phase 124 participants (Actual)Interventional2008-08-31Completed
A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects [NCT00549666]Phase 123 participants (Actual)Interventional2007-08-31Completed
Open-Label Study of Latuda for the Treatment of Mania in Children and Adolescents 6-17 Years Old With Bipolar I, Bipolar II and Bipolar Spectrum Disorder [NCT01932541]Phase 40 participants (Actual)Interventional2017-01-31Withdrawn(stopped due to On hold due to competing departmental studies)
A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [Issthiazolyl-3-14C]-Lurasidone Following Postprandial Single Oral Dose Administration in Health Male Subjects [NCT01082146]Phase 16 participants (Actual)Interventional2008-08-31Completed
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
A D2 Receptor Occupancy and fMRI Study in Schizophrenic Subjects Treated With Lurasidone [NCT01979679]Phase 328 participants (Actual)Interventional2008-12-31Completed
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies [NCT02893371]1,037,352 participants (Actual)Observational2016-09-30Completed
Impact of Structural and Myelin Abnormalities on Cognitive Impairments in Recent-onset Schizophrenia - Before and After Lurasidone Treatment (MARYLU) [NCT05351736]Phase 410 participants (Anticipated)Interventional2022-01-26Recruiting
A 24-Week, Flexible-Dose, Open-label Extension Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder (Protocol No. D1050290) [NCT01143090]Phase 3149 participants (Actual)Interventional2010-08-31Completed
A Randomized, 6-week, Double-blind, Placebo-controlled, Fixed-dose, Parallel Group Study of Lurasidone for the Treatment of Major Depressive Disorder With Mixed Features [NCT01423240]Phase 30 participants (Actual)Interventional2012-01-31Withdrawn
A Randomized, 6-Week, Multicenter, Double-Blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression [NCT04383691]Phase 3124 participants (Actual)Interventional2020-12-11Terminated(stopped due to Company's business decision)
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care [NCT01431326]3,520 participants (Actual)Observational2011-11-30Completed
A 12-Week, Open-Label Extension Study For the Treatment of Major Depressive Disorder With Mixed Features [NCT01423253]Phase 348 participants (Actual)Interventional2011-09-30Completed
A 24-Week, Flexible-Dose, Open-Label Extension Study of Lurasidone for the Treatment of Bipolar I Depression [NCT00868959]Phase 3817 participants (Actual)Interventional2009-04-30Completed
A Randomized, 6-Week, Double-Blind, Placebo- Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression [NCT00868452]Phase 3348 participants (Actual)Interventional2009-04-30Completed
A Twelve Week, Multicenter, Open Label Extension Study in Subjects With Schizophrenia [NCT01566162]Phase 3191 participants (Actual)Interventional2012-04-30Completed
A Phase 3 Randomized, Placebo-and Active Comparator Controlled, Clinical Trial to Study the Safety and Efficacy of Two Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia. [NCT00615433]Phase 3478 participants (Actual)Interventional2008-01-31Completed
Validation of the Glx Biomarker for Treatment of Moderate Bipolar Depression With NRX-101 [NCT03402152]Phase 2/Phase 38 participants (Actual)Interventional2018-11-01Completed
NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Acute Suicidal Ideation and Behavior: The SBD-ASIB Study [NCT03396068]Phase 372 participants (Anticipated)Interventional2019-12-01Active, not recruiting
A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression [NCT00868699]Phase 3505 participants (Actual)Interventional2009-04-30Completed
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Low-dose Lurasidone in Acutely Psychotic Subjects With Schizophrenia [NCT01821378]Phase 3412 participants (Actual)Interventional2013-05-31Completed
Lurasidone Effects on Tissue Glutamate in Schizophrenia [NCT02199743]Phase 435 participants (Actual)Interventional2013-02-28Completed
An Open-Label Pilot Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents [NCT01731119]Phase 29 participants (Actual)Interventional2012-12-31Completed
A Double-blind Fixed-dose Study of Lurasidone (SM-13496) and Placebo in the Treatment of Schizophrenia [NCT00088634]Phase 2180 participants (Actual)Interventional2004-05-31Completed
A Randomized, 6-week Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression in Subjects Demonstrating Non-response to Treatment With Lithium or Diva [NCT01284517]Phase 3356 participants (Actual)Interventional2010-11-30Completed
An Open-Label, Multicenter, Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia [NCT00088621]Phase 261 participants (Actual)Interventional2004-07-31Completed
A Randomized, Open-Label, Dose-Blinded, Multicenter, 6-Month Study of Safety and Tolerability of 3 Dose Levels of SM-13496 (Lurasidone) in Patients With Schizophrenia [NCT00044005]Phase 298 participants (Actual)Interventional2002-09-30Completed
A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study Of Lurasidone For The Maintenance Treatment Of Subjects With Schizophrenia [NCT01435928]Phase 3676 participants (Actual)Interventional2011-09-30Completed
"Observational Study on the Effect of Switch to Lurasidone or Other Antipsychothics on Metabolic and Weight Changes in Subjects With Schizophrenia" [NCT04312503]95 participants (Actual)Observational2020-07-13Completed
A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder. [NCT01986114]Phase 3495 participants (Actual)Interventional2014-01-29Completed
A Randomized, Double-blind, Double-dummy, Parallel-group and Multicenter Study to Investigate Lurasidone in Treatment of Schizophrenia Compared With Risperidone [NCT02002832]Phase 3388 participants (Actual)Interventional2013-12-31Completed
A Phase 3 Randomized, Double-Blind, Active-controlled Study to Evaluate the Efficacy and Safety of Lurasidone in Acutely Psychotic Patients With Schizophrenia [NCT03465787]Phase 3210 participants (Actual)Interventional2018-04-09Completed
Effect of Lurasidone Vs Olanzapine on Neurotrophic Biomarkers and Cardiometabolic Parameters in First Episode Untreated Schizophrenia: A Randomized, Open Label, Active Controlled Study [NCT03304457]Phase 4100 participants (Actual)Interventional2017-08-25Completed
The Safety and Efficacy of Lurasidone With Different Initiation Dose in Chinese Acute Phase Patients With Schizophrenia: A Multi-Center, Prospective, Open-Label Study for 6 Weeks [NCT05011669]Phase 4200 participants (Anticipated)Interventional2021-08-16Enrolling by invitation
Long-Term Safety, Tolerability, and Effectiveness of Lurasidone in Subjects With Schizophrenia or Schizoaffective Disorder: A Randomized, Active Comparator-Controlled Trial [NCT00641745]Phase 3629 participants (Actual)Interventional2008-03-31Completed
A Pharmacokinetic Study of Lurasidone After Single Oral Administration in Healthy Subjects [NCT02174510]Phase 137 participants (Actual)Interventional2014-03-31Completed
A Multi-center, Open Label, Flexible Dose, Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects With Bipolar I Disorder [NCT01575561]Phase 3377 participants (Actual)Interventional2012-06-30Completed
A 6-Week, Double-Blind, Randomized, Fixed-Dose, Parallel-Group Study of the Efficacy and Safety of Three Dose Levels of SM-13496 Compared to Placebo and Haloperidol in Patients With Schizophrenia Who Are Experiencing an Acute Exacerbation of Symptoms [NCT00044044]Phase 2356 participants (Actual)Interventional2002-07-31Completed
Pharmacokinetic Study of Lurasidone After Multiple Oral Administration in Healthy Human Subjects [NCT02174523]Phase 114 participants (Actual)Interventional2014-04-30Completed
A Phase 3 Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Two Doses of Lurasidone in Acutely Psychotic Subjects With Schizophrenia (PEARL 3) [NCT00790192]Phase 3488 participants (Actual)Interventional2008-10-31Completed
A Phase 1 Open-Label, Multicenter, Single and Multiple Ascending Dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Lurasidone in Subjects 6 to 17 Years Old With Schizophrenia Spectrum, Bipolar Spectrum, Autistic Spectrum Disorder, or Ot [NCT01620060]Phase 1105 participants (Actual)Interventional2012-06-30Completed
Improving Metabolic Parameters of Antipsychotic Child Treatment (IMPACT) [NCT00806234]Phase 4127 participants (Actual)Interventional2009-01-31Completed
A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone for the Treatment of Major Depressive Disorder With Mixed Features [NCT01421134]Phase 3211 participants (Actual)Interventional2011-09-30Completed
A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study [NCT01485640]Phase 3162 participants (Actual)Interventional2011-06-30Completed
A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects [NCT01914393]Phase 3702 participants (Actual)Interventional2013-09-30Completed
A Randomized, 6-Week, Double-blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Bipolar I Depression [NCT02046369]Phase 3350 participants (Actual)Interventional2014-03-31Completed
A 6-Week, Randomized, Parallel, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Irritability Associated With Autistic Disorder [NCT01911442]Phase 3150 participants (Actual)Interventional2013-08-31Completed
A 6-Week Randomized, Parallel, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study To Evaluate The Efficacy and Safety of Lurasidone in Adolescent Subjects With Schizophrenia [NCT01911429]Phase 3327 participants (Actual)Interventional2013-08-31Completed
Identification of Biosignatures for Lurasidone (Latuda) Response in Bipolar Depression [NCT02239094]20 participants (Actual)Interventional2015-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00044005 (1) [back to overview]Number of Participants With Adverse Events
NCT00044044 (4) [back to overview]Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores
NCT00044044 (4) [back to overview]Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores
NCT00044044 (4) [back to overview]Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score
NCT00044044 (4) [back to overview]Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores
NCT00088621 (1) [back to overview]Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study
NCT00088634 (4) [back to overview]Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores
NCT00088634 (4) [back to overview]Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores
NCT00088634 (4) [back to overview]Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score
NCT00088634 (4) [back to overview]Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores
NCT00549718 (2) [back to overview]Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
NCT00549718 (2) [back to overview]CGI-S From Baseline to the End of the Double-blind Treatment
NCT00615433 (2) [back to overview]Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.
NCT00615433 (2) [back to overview]CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.
NCT00641745 (1) [back to overview]Number of Participants With Adverse Events.
NCT00711269 (7) [back to overview]Change From Baseline in the PANSS General Psychopathology Subscales at Week 6 (LOCF)
NCT00711269 (7) [back to overview]Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)
NCT00711269 (7) [back to overview]Proportion of Participants With Treatment-emergent Adverse Events (TEAEs)
NCT00711269 (7) [back to overview]Proportion of Participants With TEAEs Leading to Discontinuation
NCT00711269 (7) [back to overview]Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (LOCF)
NCT00711269 (7) [back to overview]Change From Baseline in the PANSS Positive Subscales at Week 6 (LOCF)
NCT00711269 (7) [back to overview]Change From Baseline in the PANSS Negative Subscales at Week 6
NCT00789698 (4) [back to overview]Relapse of Psychotic Symptoms
NCT00789698 (4) [back to overview]Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores
NCT00789698 (4) [back to overview]Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.
NCT00789698 (4) [back to overview]Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)
NCT00790192 (2) [back to overview]Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
NCT00790192 (2) [back to overview]Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment
NCT00806234 (4) [back to overview]Triglyceride Levels
NCT00806234 (4) [back to overview]Body Mass Index (BMI) Z-score Change
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
NCT00868452 (3) [back to overview]Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
NCT00868452 (3) [back to overview]Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)
NCT00868452 (3) [back to overview]Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
NCT00868699 (3) [back to overview]Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
NCT00868699 (3) [back to overview]Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
NCT00868699 (3) [back to overview]Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)
NCT00868959 (3) [back to overview]Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
NCT00868959 (3) [back to overview]Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
NCT00868959 (3) [back to overview]Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment
NCT01143077 (2) [back to overview]Tolerability and Safety
NCT01143077 (2) [back to overview]Time to Relapse of Psychotic Symptoms During 6 Weeks
NCT01143090 (1) [back to overview]Adverse Events
NCT01284517 (3) [back to overview]Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)
NCT01284517 (3) [back to overview]Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
NCT01284517 (3) [back to overview]Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
NCT01358357 (14) [back to overview]Change From Double-blind Baseline to Week 28 (LOF) in PANSS Positive Symptom (PANNS-P) Subscale Score
NCT01358357 (14) [back to overview]Percentage of Subjects Who Experience a Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode
NCT01358357 (14) [back to overview]Time to All-cause Discontinuation
NCT01358357 (14) [back to overview]Time to Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode
NCT01358357 (14) [back to overview]Time to Recurrence of Mood Event During the Double Blind Treatment Phase
NCT01358357 (14) [back to overview]Change From Double-blind Baseline to Week 28 (LOCF) in MADRS Total Score
NCT01358357 (14) [back to overview]Change Fro Double-blind Baseline to Week 28 (LOCF) in QIDS-SR(16) Total Score
NCT01358357 (14) [back to overview]Change From Double -Blind Baseline to Week 28 (LOCF) in CGI-BP-S Mania Score
NCT01358357 (14) [back to overview]Change From Double-blind Baseline to Week 28 (LOCF) in CGI-BP-S Overall Score
NCT01358357 (14) [back to overview]Change From Double-blind Baseline to Week 28 (LOCF) in CGI+-BP-S Depression Score
NCT01358357 (14) [back to overview]Change From Double-blind Baseline to Week 28 (LOCF) in PIRS-2 Total Score
NCT01358357 (14) [back to overview]Change From Double-blind Baseline to Week 28 (LOCF) in Q-LES-Q-SF Percent Maximum Possible Score
NCT01358357 (14) [back to overview]Change From Double-blind Baseline to Week 28 (LOCF) in SDS Total Score
NCT01358357 (14) [back to overview]Change From Double-blind Baseline to Week 28 (LOCF) in YMRS Total Score
NCT01421134 (7) [back to overview]Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score
NCT01421134 (7) [back to overview]Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score
NCT01421134 (7) [back to overview]Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF)
NCT01421134 (7) [back to overview]Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF).
NCT01421134 (7) [back to overview]Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores
NCT01421134 (7) [back to overview]Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score
NCT01421134 (7) [back to overview]Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score
NCT01423253 (8) [back to overview]Change From Baseline to Week 12 (LOCF) in CGI-S Score
NCT01423253 (8) [back to overview]Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score
NCT01423253 (8) [back to overview]Change From Baseline to Week 12 (LOCF) in the YMRS Total Score
NCT01423253 (8) [back to overview]Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores
NCT01423253 (8) [back to overview]Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)
NCT01423253 (8) [back to overview]Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)
NCT01423253 (8) [back to overview]Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)
NCT01423253 (8) [back to overview]Change From Baseline to Week 12 (LOCF) in the SDS Total Score
NCT01435928 (11) [back to overview]Time to First Relapse Event During Double-blind Phase
NCT01435928 (11) [back to overview]Smoking Questionnaire (Average Number of Cigarettes Per Day) at Week 28 (LOCF)
NCT01435928 (11) [back to overview]Intent to Attend (ITA) Assessment at Open-label Baseline
NCT01435928 (11) [back to overview]Brief Adherence Rating Scale
NCT01435928 (11) [back to overview]Change From Double-blind Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
NCT01435928 (11) [back to overview]EuroQol (EQ-5D): EQ-VAS Score
NCT01435928 (11) [back to overview]Change From Double-blind Baseline in Short Form-12v2 Health Survey (SF-12v2) Physical Component Score
NCT01435928 (11) [back to overview]Change From Double-blind Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score
NCT01435928 (11) [back to overview]Change From Double-blind Baseline in Modified Specific Levels of Functioning (SLOF) Total Score
NCT01435928 (11) [back to overview]Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
NCT01435928 (11) [back to overview]Time to All-cause Discontinuation
NCT01485640 (2) [back to overview]Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs
NCT01485640 (2) [back to overview]Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S
NCT01566162 (9) [back to overview]Brief Adherence Rating Scale (BARS)
NCT01566162 (9) [back to overview]Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score.
NCT01566162 (9) [back to overview]Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score
NCT01566162 (9) [back to overview]Modified Specific Levels of Functioning (SLOF) Total Score.
NCT01566162 (9) [back to overview]Short Form-12 Health Survey (SF-12)
NCT01566162 (9) [back to overview]Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs)
NCT01566162 (9) [back to overview]Intent to Attend Assessment
NCT01566162 (9) [back to overview]Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score
NCT01566162 (9) [back to overview]Smoking Questionnaire
NCT01575561 (9) [back to overview]Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Depression Scale
NCT01575561 (9) [back to overview]Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Mania Score
NCT01575561 (9) [back to overview]Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Overall Score- Severity of Illness as Assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S)
NCT01575561 (9) [back to overview]Change From Baseline to Week 12 (LOCF) in the MADRS Total Score- Depression as Assessed by Montgomery-Asberg Depression Rating Scale (MADRS)
NCT01575561 (9) [back to overview]Change From Baseline to Week 12 (LOCF) in the Positive and Negative Syndrome Scale Positive Subscale (PANSS P) Score
NCT01575561 (9) [back to overview]Change From Baseline to Week 12 (LOCF) in the YMRS Total Score -Mania as Assessed by Young Mania Rating Scale (YMRS)
NCT01575561 (9) [back to overview]Change From Baseline to Week 12 (LOCF) in the SDS Total Score
NCT01575561 (9) [back to overview]Change From Baseline to Week 12 (LOCF) in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) Total Score
NCT01575561 (9) [back to overview]Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events
NCT01614899 (8) [back to overview]Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)
NCT01614899 (8) [back to overview]Proportion of Participants With Treatment-emergent Adverse Events (TEAEs)
NCT01614899 (8) [back to overview]Proportion of Participants With TEAEs Leading to Discontinuation
NCT01614899 (8) [back to overview]Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
NCT01614899 (8) [back to overview]Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 6
NCT01614899 (8) [back to overview]Change From Baseline in PANSS Positive Subscale Scores at Week 6
NCT01614899 (8) [back to overview]Change From Baseline in PANSS Negative Subscale Scores at Week 6
NCT01614899 (8) [back to overview]Change From Baseline in PANSS General Psychopathology Subscale Scores at Week 6
NCT01614912 (8) [back to overview]Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)
NCT01614912 (8) [back to overview]Proportion of Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT01614912 (8) [back to overview]Proportion of Participants With TEAEs Leading to Discontinuation
NCT01614912 (8) [back to overview]Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at LOCF Endpoint
NCT01614912 (8) [back to overview]Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score at LOCF Endpoint
NCT01614912 (8) [back to overview]Change From Baseline in PANSS Positive Subscale Score at LOCF Endpoint
NCT01614912 (8) [back to overview]Change From Baseline in PANSS Negative Subscale Score at LOCF Endpoint
NCT01614912 (8) [back to overview]Change From Baseline in PANSS General Psychopathology Subscale Score at LOCF Endpoint
NCT01620060 (3) [back to overview]Number of Participants With Serious Adverse Events and Non-serious Adverse Events
NCT01620060 (3) [back to overview]Lurasidone Peak Serum Concentration (Cmax)
NCT01620060 (3) [back to overview]Lurasidone Primary Pharmacokinetic Parameters
NCT01731119 (5) [back to overview]Overall Clinical Improvement
NCT01731119 (5) [back to overview]Number of Participants Experiencing Side Effects
NCT01731119 (5) [back to overview]Changes in Efficacy Measures
NCT01731119 (5) [back to overview]Change in Weight
NCT01731119 (5) [back to overview]Proportion of Participants Completing Treatment
NCT01821378 (11) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 for Lurasidone 20 mg and 80-160 mg Versus Placebo.
NCT01821378 (11) [back to overview]Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the MADRS Total Score
NCT01821378 (11) [back to overview]Change From Baseline to Week 6 for the Lurasidone 20 mg and Lurasidone 80 - 160 mg Groups Compared to the Placebo Group in the Euroqol (EQ-5D) Index Score
NCT01821378 (11) [back to overview]Change From Baseline to Week 6 for the Lurasidone 20 mg and Lurasidone 80 - 160 mg Groups Compared to the Placebo Group in the GAF Score
NCT01821378 (11) [back to overview]Change From Baseline to Week 6 for the Lurasidone 20 mg, and Lurasidone 80 - 160 mg Groups Versus the Placebo Group in the Montgomery-Asberg Depression Rating Scale Total Score
NCT01821378 (11) [back to overview]Change From Week 2 to Week 6 for ENR Lurasidone 80 mg vs. ENR Lurasidone 160 mg in CGI-S Score
NCT01821378 (11) [back to overview]Change From Week 2 to Week 6 for the ENR (Early Non-responders) Lurasidone 160mg Group vs the ENR (Early Non-responders) Lurasidone 80 mg Group in the Following: PANSS Total Score
NCT01821378 (11) [back to overview]Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the CGI-S Score
NCT01821378 (11) [back to overview]Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the PANSS Total Score
NCT01821378 (11) [back to overview]Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Score (PANSS) Total Score at Week 6
NCT01821378 (11) [back to overview]Change in Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 6 for Lurasidone 20 mg and 80-160 mg Versus Placebo.
NCT01911429 (9) [back to overview]Proportion of Responders, Where Response is Based on ≥ 20% Improvement From Baseline in PANSS Total Score at Week 6
NCT01911429 (9) [back to overview]Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale
NCT01911429 (9) [back to overview]Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS)
NCT01911429 (9) [back to overview]Change From Baseline in PANSS Excitability Subscale Scores
NCT01911429 (9) [back to overview]Change From Baseline in PANSS General Psychopathology Subscale Scores
NCT01911429 (9) [back to overview]Change From Baseline in PANSS Positive Subscale Scores
NCT01911429 (9) [back to overview]Change From Baseline in PANSS Positive, Negative Subscale Scores
NCT01911429 (9) [back to overview]Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q)
NCT01911429 (9) [back to overview]Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6.
NCT01911442 (7) [back to overview]Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score at Week 6
NCT01911442 (7) [back to overview]Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) Modified for Pervasive Developmental Disorders (PDDs)
NCT01911442 (7) [back to overview]Change From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 6
NCT01911442 (7) [back to overview]Change From Baseline in the Caregiver Strain Questionnaire (CGSQ)
NCT01911442 (7) [back to overview]Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6
NCT01911442 (7) [back to overview]Proportion of Subjects Who Have at Least 25% Reduction From Baseline to Week 6 in the ABC Irritability Subscale Score.
NCT01911442 (7) [back to overview]Proportion of Subjects Who Have CGI-I Score of 1 (Very Much Improved) or 2 (Much Improved) at Week 6
NCT01914393 (23) [back to overview]Change From Baseline in PANSS Negative Subscale Score
NCT01914393 (23) [back to overview]Change From Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score
NCT01914393 (23) [back to overview]Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score
NCT01914393 (23) [back to overview]Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score
NCT01914393 (23) [back to overview]Change From Baseline in the Clinical Global Impression -Severity Score
NCT01914393 (23) [back to overview]Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score
NCT01914393 (23) [back to overview]Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs)
NCT01914393 (23) [back to overview]Change From Baseline in PANSS Positive Subscale Score
NCT01914393 (23) [back to overview]Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score
NCT01914393 (23) [back to overview]Change From Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score
NCT01914393 (23) [back to overview]Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score
NCT01914393 (23) [back to overview]Change From Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score
NCT01914393 (23) [back to overview]Change From Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score
NCT01914393 (23) [back to overview]Change From Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score
NCT01914393 (23) [back to overview]Change From Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score
NCT01914393 (23) [back to overview]Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score
NCT01914393 (23) [back to overview]Change From Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS)
NCT01914393 (23) [back to overview]Change From Baseline in Clinical Global Impression (CGI) - Severity Score
NCT01914393 (23) [back to overview]Change From Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score
NCT01914393 (23) [back to overview]Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score
NCT01914393 (23) [back to overview]Change From Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score
NCT01914393 (23) [back to overview]Change From Baseline in PANSS Excitability Subscale Score
NCT01914393 (23) [back to overview]Change From Baseline in PANSS General Psychopathology Subscale Score
NCT01986101 (5) [back to overview]Change From Baseline in the YMRS Total Score at Week 6
NCT01986101 (5) [back to overview]Change From Baseline in the SDS Total Score at Week 6 (LOCF)
NCT01986101 (5) [back to overview]Change From Baseline in the HAM-A Total Score at Week 6 (LOCF)
NCT01986101 (5) [back to overview]Change From Baseline in the CGI-BP-S (Depression) Score at Week 6
NCT01986101 (5) [back to overview]Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6
NCT01986114 (4) [back to overview]Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR)
NCT01986114 (4) [back to overview]Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
NCT01986114 (4) [back to overview]Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score.
NCT01986114 (4) [back to overview]Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder.
NCT02002832 (2) [back to overview]Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores.
NCT02002832 (2) [back to overview]Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6.
NCT02046369 (6) [back to overview]Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) Score as Compared to Placebo.
NCT02046369 (6) [back to overview]Change in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score as Compared to Placebo From Double-Blind Baseline to Week 6 (Day 43) Baseline
NCT02046369 (6) [back to overview]Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Score as Compared to Placebo.
NCT02046369 (6) [back to overview]Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Score as Compared to Placebo.
NCT02046369 (6) [back to overview]Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score as Compared to Placebo.
NCT02046369 (6) [back to overview]Change From Baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) Depression Score
NCT02174510 (8) [back to overview]Lurasidone Tmax
NCT02174510 (8) [back to overview]Lurasidone CL/F
NCT02174510 (8) [back to overview]Lurasidone Cmax
NCT02174510 (8) [back to overview]Lurasidone MRT
NCT02174510 (8) [back to overview]Lurasidone t1/2
NCT02174510 (8) [back to overview]Lurasidone VZ/F
NCT02174510 (8) [back to overview]Lurasidone λZ
NCT02174510 (8) [back to overview]Lurasidone AUC
NCT02174523 (23) [back to overview]Lurasidone Vzss/F
NCT02174523 (23) [back to overview]Lurasidone λz
NCT02174523 (23) [back to overview]Lurasidone λz
NCT02174523 (23) [back to overview]Accumulation Ratios Lurasidone,Ratio of Cmax,Ratio of AUC0-∞,Ratio of AUC0-τ,
NCT02174523 (23) [back to overview]Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 4 and Day 5
NCT02174523 (23) [back to overview]Lurasidone AUC0-∞
NCT02174523 (23) [back to overview]Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 6 and Day 7
NCT02174523 (23) [back to overview]Lurasidone Vz/F
NCT02174523 (23) [back to overview]CLss/F
NCT02174523 (23) [back to overview]Lurasidone AUC 0-24
NCT02174523 (23) [back to overview]Lurasidone AUC 0-24
NCT02174523 (23) [back to overview]Lurasidone AUC 0-τ
NCT02174523 (23) [back to overview]Lurasidone AUC 0-τ
NCT02174523 (23) [back to overview]Lurasidone AUC0-∞
NCT02174523 (23) [back to overview]Lurasidone CL/F
NCT02174523 (23) [back to overview]Lurasidone Cmax
NCT02174523 (23) [back to overview]Lurasidone Cmax
NCT02174523 (23) [back to overview]Lurasidone MRT
NCT02174523 (23) [back to overview]Lurasidone MRT
NCT02174523 (23) [back to overview]Lurasidone t1/2
NCT02174523 (23) [back to overview]Lurasidone t1/2
NCT02174523 (23) [back to overview]Lurasidone Tmax
NCT02174523 (23) [back to overview]Lurasidone Tmax
NCT02199743 (2) [back to overview]Brief Assessments of Cognition in Schizophrenia Scores (BACS)
NCT02199743 (2) [back to overview]Cerebral Glutamate Levels
NCT02239094 (2) [back to overview]Montgomery-Asberg Rating Scale for Depression (MADRS)
NCT02239094 (2) [back to overview]Montgomery-Asberg Rating Scale for Depression (MADRS) at Week8
NCT02974010 (1) [back to overview]BDM Score (BISS-derived MADRS) Change From Baseline at Day 42
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 Simpson Angus Scale (SAS) Values
NCT03557931 (8) [back to overview]Number of Participants With Clinically Significant Differences in Barnes Akathisia Rating Scale (BARS) Values
NCT03557931 (8) [back to overview]Number of Participants With Clinically Significant Differences in Abnormal Involuntary Movement Scale (AIMS) Values
NCT03557931 (8) [back to overview]Number of Participants With Clinically Significant Differences in Columbia-Suicide Severity Rating Scale (C-SSRS) Values
NCT03557931 (8) [back to overview]Change From Baseline to Week 12/EoT in University of California San Diego Performance-based Skills Assessment-2 Extended Range (UPSA-2-ER) Total Score
NCT03557931 (8) [back to overview]Number of Participants With Adverse Event (AE)
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
NCT03627195 (3) [back to overview]Area Under the Curve From Time 0 to Time of Last Quantifiable Concentration [AUC0-last] for Lurasidone After Lurasidone Injectable Suspension Administration
NCT03627195 (3) [back to overview]Maximum Serum Concentration [Cmax] for Lurasidone After Lurasidone Injectable Suspension Administration
NCT03627195 (3) [back to overview]Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs ) Leading to Study Discontinuation
NCT03902613 (1) [back to overview]Montgomery Asberg Depression Rating Scale

Number of Participants With Adverse Events

The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone. (NCT00044005)
Timeframe: 6-months

Interventionparticipants (Number)
Lurasidone 20 mg19
Lurasidone 40 mg22
Lurasidone 80mg18

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Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores

The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. (NCT00044044)
Timeframe: Baseline and 6 weeks

Interventionunits on scale (Least Squares Mean)
20 mg-1.3
40 mg-1.1
80 mg-2.5
10 mg Haloperidol-2.7
Placebo-1.9

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Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores

The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). (NCT00044044)
Timeframe: Baseline and 6 weeks

Interventionunits on a scale (Least Squares Mean)
20 mg-0.5
40 mg-0.4
80 mg-0.8
10 mg Haloperidol-0.8
Placebo-0.7

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Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score

"The BPRS consists of 18 ordered categorical items (from not present to extremely severe, on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia." (NCT00044044)
Timeframe: Baseline and 6 weeks

Interventionunits on a scale (Least Squares Mean)
20 mg-5.0
40 mg-5.2
80 mg-8.0
10 mg Haloperidol-9.8
Placebo-7.9

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Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores

The PANSS Positive and Negative Syndrome Scale)is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia. (NCT00044044)
Timeframe: Baseline and 6 weeks

Interventionunits on a scale (Least Squares Mean)
20 mg-7.1
40 mg-7.2
80 mg-13.6
10 mg Haloperidol-16.0
Placebo-12.3

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Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study

(NCT00088621)
Timeframe: 1 year

Interventionparticipants (Number)
Lurasidone 80 mg59

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Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores

The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. (NCT00088634)
Timeframe: Baseline and 6 weeks

Interventionunits on scale (Least Squares Mean)
Lurasidone 80 mg-2.9
Placebo-0.1

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Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores

The PANSS is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia. (NCT00088634)
Timeframe: Baseline and 6 weeks

Interventionunits on a scale (Least Squares Mean)
Lurasidone 80 mg-14.1
Placebo-5.5

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Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score

"The BPRS consists of 18 ordered categorical items (from not present to extremely severe, on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately." (NCT00088634)
Timeframe: Baseline and 6 weeks

Interventionunits on a scale (Least Squares Mean)
Lurasidone 80 mg-8.9
Placebo-4.2

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Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores

The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). (NCT00088634)
Timeframe: Baseline and 6 weeks

Interventionunits on a scale (Least Squares Mean)
Lurasidone 80 mg-0.6
Placebo-0.2

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Change in Total PANSS Score From Baseline to the End of the Double Blind Phase

The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening. (NCT00549718)
Timeframe: 6 weeks

Interventionscores on a scale (Least Squares Mean)
Lurasidone 40mg-19.2
Lurasidone 80mg-23.4
Lurasidone 120mg-20.5
Placebo-17.0

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CGI-S From Baseline to the End of the Double-blind Treatment

Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill). (NCT00549718)
Timeframe: 6 weeks

Interventionscores on a scale (Least Squares Mean)
Lurasidone 40mg-1.1
Lurasidone 80mg-1.4
Lurasidone 120mg-1.2
Placebo-1.0

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Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.

The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness. (NCT00615433)
Timeframe: Baseline and 6 weeks

InterventionUnits on a scale (Least Squares Mean)
40mg-25.7
120mg-23.6
15mg Olz-28.7
Placebo-16.0

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CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.

The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity. (NCT00615433)
Timeframe: 6 weeks

Interventionscale (Least Squares Mean)
40mg-1.5
120mg-1.4
15mg Olz-1.5
Placebo-1.1

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Number of Participants With Adverse Events.

(NCT00641745)
Timeframe: 12 months

Interventionparticipants (Number)
Lurasidone395
Risperidone189

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Change From Baseline in the PANSS General Psychopathology Subscales at Week 6 (LOCF)

The PANSS is comprised of 30 items and three subscales. The General Psychopathology subscale addresses other 16 symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS General Psychopathology subscale score is the sum of all 16 items and ranges from 16 through 112. A higher score is associated with greater illness severity. (NCT00711269)
Timeframe: Baseline and Week 6 (LOCF)

Interventionunits on a scale (Least Squares Mean)
SM-13496 (Lurasidone HCl) 40-mg Group-2.4
SM-13496 (Lurasidone HCl) 80-mg Group-1.2
Placebo Group-1.0
Risperidone Group-2.6

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Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)

Proportion of participants with treatment-emergent adverse events. An adverse event was considered serious if it met one or more of the following criteria: Resulted in death; Was life-threatening (i.e., a patient was at immediate risk of death at the time of the event, not an event where occurrence in a more severe form might have caused death); Required in-patient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect; Was considered to be an important medical event. (NCT00711269)
Timeframe: From Baseline to up to 8 weeks

InterventionParticipants (Count of Participants)
SM-13496 (Lurasidone HCl) 40-mg Group8
SM-13496 (Lurasidone HCl) 80-mg Group7
Placebo Group10
Risperidone Group2

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Proportion of Participants With Treatment-emergent Adverse Events (TEAEs)

Proportion of participants with treatment-emergent adverse events. An adverse event was defined as any untoward medical occurrence in a study participant who was taking a medicinal (investigational) product. Treatment-emergent adverse events (TEAEs) were defined as adverse events with a start date on or after the date of the first dose through the end of follow-up, or adverse events occurring before the date of first dose and worsening during the treatment or follow-up period. (NCT00711269)
Timeframe: From Baseline to up to 8 weeks

InterventionParticipants (Count of Participants)
SM-13496 (Lurasidone HCl) 40-mg Group105
SM-13496 (Lurasidone HCl) 80-mg Group103
Placebo Group101
Risperidone Group53

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Proportion of Participants With TEAEs Leading to Discontinuation

(NCT00711269)
Timeframe: From Baseline to up to 8 weeks

InterventionParticipants (Count of Participants)
SM-13496 (Lurasidone HCl) 40-mg Group18
SM-13496 (Lurasidone HCl) 80-mg Group18
Placebo Group27
Risperidone Group7

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

The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and three subscales: the Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity. (NCT00711269)
Timeframe: Baseline and Week 6 [Last Observation Carried Forward (LOCF)]

Interventionunits on a scale (Least Squares Mean)
SM-13496 (Lurasidone HCl) 40-mg Group-6.1
SM-13496 (Lurasidone HCl) 80-mg Group-4.3
Placebo Group-2.5
Risperidone Group-7.1

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Change From Baseline in the PANSS Positive Subscales at Week 6 (LOCF)

The PANSS is comprised of 30 items and three subscales. The Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS Positive subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity. (NCT00711269)
Timeframe: Baseline and Week 6 (LOCF)

Interventionunits on a scale (Least Squares Mean)
SM-13496 (Lurasidone HCl) 40-mg Group-2.0
SM-13496 (Lurasidone HCl) 80-mg Group-1.4
Placebo Group-0.6
Risperidone Group-2.9

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Change From Baseline in the PANSS Negative Subscales at Week 6

The PANSS is comprised of 30 items and three subscales. The Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS Negative subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity. (NCT00711269)
Timeframe: Baseline and Week 6 (LOCF)

Interventionunits on a scale (Least Squares Mean)
SM-13496 (Lurasidone HCl) 40-mg Group-1.6
SM-13496 (Lurasidone HCl) 80-mg Group-1.7
Placebo Group-0.9
Risperidone Group-1.7

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Relapse of Psychotic Symptoms

"Time to relapse will be defined as the earliest occurrence of any of the following:~Worsening of >= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale >=3~rehospitalization for worsening of psychosis~emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate." (NCT00789698)
Timeframe: 12 Months

Interventionparticipants (Number)
Lurasidone-Lurasidone29
Quetiapine-Quetiapine21

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Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores

The CGI-S is a clinician-rated assessment of the subject's current illness state on a scale ranging from 1-7, where a higher score is associated with greater illness severity. (NCT00789698)
Timeframe: Baseline and 12 months

Interventionunits on a scale (Least Squares Mean)
Lurasidone-Lurasidone-1.9
Quetiapine-Quetiapine-1.6

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Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.

The battery has seven outcome measures that measure the cognitive constructs. The seven domains are: detection, identification, one back task, international shopping list task, one card learning task, Groton maze learning task and social emotional matching. The standardized scores for each subject at each assessment will then be averaged to yield a composite score. There are no maximum or minimum values, however a higher score indicates improved performance on the cognitive constructs. The change score is change from baseline to month 6. (NCT00789698)
Timeframe: Baseline and 6 Months

Interventionunits on a scale (Least Squares Mean)
Lurasidone-Lurasidone0.22
Quetiapine-Quetiapine-0.03

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Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)

The PANSS is an interview-based measure of psychopathology severity in adults with psychotic disorders. Thirty items are rated using a Likert scale, from 1 - 7. The PANSS total score is the sum of thirty items ranging from 30 to 210 (higher score representing a worsening in psychosis). (NCT00789698)
Timeframe: Baseline and 12 months

Interventionunits on a scale (Least Squares Mean)
Lurasidone-Lurasidone-34.6
Quetiapine-Quetiapine-25.7

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Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase

The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening. (NCT00790192)
Timeframe: Week 6

Interventionscores on a scale (Least Squares Mean)
Lurasidone 80 mg-22.2
Lurasidone 160 mg-26.5
Quetiapine XR 600mg-27.8
Placebo-10.3

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Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment

Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill). (NCT00790192)
Timeframe: 6-Weeks

Interventionscores on a scale (Least Squares Mean)
Lurasidone 80 mg-1.5
Lurasidone 160 mg-1.7
Quetiapine XR 600mg-1.7
Placebo-0.9

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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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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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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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Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)

CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening. (NCT00868452)
Timeframe: Baseline Week 6

Interventionunits on a scale (Least Squares Mean)
Lurasidone-1.96
Placebo-1.51

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Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)

MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening. (NCT00868452)
Timeframe: Baseline, Week 6

Interventionunits on a scale (Least Squares Mean)
Lurasidone-17.1
Placebo-13.5

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Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score

STS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening. (NCT00868452)
Timeframe: Baselin Week 6

Interventionunits on a scale (Least Squares Mean)
Lurasidone-9.5
Placebo-7.0

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Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score

"Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of depression.~The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items." (NCT00868699)
Timeframe: Baseline to Week 6

Interventionunits on a scale (Least Squares Mean)
Placebo-6.3
Lurasidone High Arm-9.8
Lurasidone Low Arm-9.5

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Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)

"Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression.~The CGI depression score ranges from a minimum of 0 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome." (NCT00868699)
Timeframe: Baseline to Week 6

Interventionunits on a scale (Least Squares Mean)
Placebo-1.14
Lurasidone High Arm-1.71
Lurasidone Low Arm-1.83

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Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)

"Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression.~The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items." (NCT00868699)
Timeframe: Baseline to Week 6

Interventionunits on a scale (Least Squares Mean)
Placebo-10.7
Lurasidone High Arm-15.4
Lurasidone Low Arm-15.4

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Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)

"This CGI-BP-S is a clinician-rated assessment of the subjects current severity of depression and ranges from 1=Normal, not ill to 7=Very severly ill. Higher scores are associated with greater severity." (NCT00868959)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Lurasidone-0.58

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Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

"The MADRS is a clinician-rated assessment of the subject's level of depression. Ten items are rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of ten items: reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity." (NCT00868959)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Lurasidone-4.4

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Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment

Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517) (NCT00868959)
Timeframe: 24 weeks

Interventionparticipants (Number)
Lurasidone529

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Tolerability and Safety

Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events (NCT01143077)
Timeframe: 6 Weeks

Interventionparticipants (Number)
Lurasidone Open-Label Arm 40/4072
Lurasidone Open-Label Arm 40/8087
Lurasidone Open-Label Arm 80/8081

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Time to Relapse of Psychotic Symptoms During 6 Weeks

"Relapse is defined as any occurrence of:~Insufficient clinical response~Exacerbation of underlying disease~Discontinuation due to an adverse event" (NCT01143077)
Timeframe: 6 Weeks

Interventiondays (Mean)
Lurasidone Open-Label Arm 40/4023.8
Lurasidone Open-Label Arm 40/8016.9
Lurasidone Open-Label Arm 80/8017.3

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Adverse Events

Proportions of subjects with AEs, SAEs, and discontinuations due to AEs. (NCT01143090)
Timeframe: 6 months

Interventionparticipants (Number)
Any Treatment Emergent Adverse EventAny Severe Treatment Emergent Adverse EventTreatment Emergent AE Leading to Discontinuation
Lurasidone Overall981016

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Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)

MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening. (NCT01284517)
Timeframe: Baseline to week 6

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20-120 mg Flexible Dose+Li/VPA-11.8
Placebo + Li/VPA-10.4

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Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)

CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening. (NCT01284517)
Timeframe: Baseline to week 6

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20-120 mg Flexible Dose+Li/VPA-1.36
Placebo + Li/VPA-1.13

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Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score

SDS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening. (NCT01284517)
Timeframe: Baseline to week 6

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20-120 mg Flexible Dose+Li/VPA-5.4
Placebo + Li/VPA-5.4

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Change From Double-blind Baseline to Week 28 (LOF) in PANSS Positive Symptom (PANNS-P) Subscale Score

The PANSS-P is a subset of items in the PANSS, an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS-P subscale score is the sum of the 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity. (NCT01358357)
Timeframe: Double-blind Baseline to week 28

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20-80 mg Flexible Dose0.2
Placebo0.3

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Percentage of Subjects Who Experience a Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode

(NCT01358357)
Timeframe: 28 weeks

Interventionpercentage of participants (Number)
Lurasidone 20-80 mg Flexible Dose16.7
Placebo21.6

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Time to All-cause Discontinuation

(NCT01358357)
Timeframe: 28 weeks (up to 33 weeks)

InterventionDays (Median)
Lurasidone 20-80 mg Flexible Dose225
Placebo207

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Time to Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode

(NCT01358357)
Timeframe: 28 weeks (up to 33 weeks)

InterventionDays (Median)
Lurasidone 20-80 mg Flexible DoseNA
PlaceboNA

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Time to Recurrence of Mood Event During the Double Blind Treatment Phase

"A mood event is defined as one of the following during the double-blind phase:~(1) Fulfilled Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision (DSM-IV-TR) criteria for manic, mixed manic, hypomanic, or depressive episode. (2) Required treatment intervention for manic, mixed manic, hypomanic, or depressive symptoms with any antipsychotic (other than study drug), antidepressant, mood stabilizer (other than lithium or divalproex), anxiolytic agents, benzodiazepine (beyond dosage allowed for anxiety, agitation, or insomnia). (3) Psychiatric hospitalization for any bipolar mood episode. (4) Young Mania Rating Scale (YMRS) or Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 18 or Clinical Global Impression Bipolar Version, Severity of Illness (CGI BP S) score ≥ 4 at 2 consecutive assessments no more than 10 days apart. (5) Discontinuation from the study because of a mood event (as determined by the Investigator)." (NCT01358357)
Timeframe: 28 weeks (up to 33 weeks)

InterventionDays (Median)
Lurasidone 20-80 mg Flexible DoseNA
Placebo207

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Change From Double-blind Baseline to Week 28 (LOCF) in MADRS Total Score

The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity of depressive symptoms. (NCT01358357)
Timeframe: Double-blind Baseline to week 28

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20-80 mg Flexible Dose3.0
Placebo3.5

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Change Fro Double-blind Baseline to Week 28 (LOCF) in QIDS-SR(16) Total Score

The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms. (NCT01358357)
Timeframe: Double-blind Baseline to week 28

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20-80 mg Flexible Dose0.9
Placebo1.1

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Change From Double -Blind Baseline to Week 28 (LOCF) in CGI-BP-S Mania Score

The CGI-BP-S mania score is a single value, clinician-rated assessment of mania illness severity and ranges from 1=Normal, not at all ill to 7=Among the most extremely ill patients. A high score is associated with greater illness severity (NCT01358357)
Timeframe: Double-blind Baseline to week 28

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20-80 mg Flexible Dose0.10
Placebo0.21

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Change From Double-blind Baseline to Week 28 (LOCF) in CGI-BP-S Overall Score

The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar illness severity and ranges from 1=Normal, not at all ill, to 7=Among the most extremely ill patients. a higher score is associated with greater illness severity. (NCT01358357)
Timeframe: Double-blind Baseline to week 28

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20-80 mg Flexible Dose0.40
Placebo0.49

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Change From Double-blind Baseline to Week 28 (LOCF) in CGI+-BP-S Depression Score

The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and ranges from 1=Normal, not at all ill to 7=Among the most extremely ill patients. A higher score is associated with a greater illness severity. (NCT01358357)
Timeframe: Double-blind Baseline to week 28

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20-80 mg Flexible Dose0.35
Placebo0.42

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Change From Double-blind Baseline to Week 28 (LOCF) in PIRS-2 Total Score

The PIRS-2 is a 2-item self-report of insomnia assessed via a computer interface. Each item is scored from 0-3. The PIRS-2 total score is calculated as the sum of the 2 items. The PIRS total score ranges from 0 to 6. Higher scores are associated with greater severity of insomnia. (NCT01358357)
Timeframe: Double-blind Baseline to week 28

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20-80 mg Flexible Dose0.4
Placebo0.5

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Change From Double-blind Baseline to Week 28 (LOCF) in Q-LES-Q-SF Percent Maximum Possible Score

The Q-LES-Q-SF is a 16-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living. The questionnaire was developed and validated for use in depressed outpatient subjects and has eight summary scales that reflect major areas of functioning: physical health, mood, leisure time activities, social relationships, general activities, work, household duties and school/coursework. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The Q-LES-Q-SF percentage maximum possible score is calculated as 100 × (Raw Score - 14 [Minimum Score]) / (70 [Maximum Score] - 14 [Minimum Score]). Higher percent maximum scores indicate better quality of life. (NCT01358357)
Timeframe: Double-blind Baseline to week 28

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20-80 mg Flexible Dose-1.70
Placebo-2.07

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Change From Double-blind Baseline to Week 28 (LOCF) in SDS Total Score

The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient's life are impaired by depressive symptoms. The SDS total score is calculated as the sum of the 3 items. The SDS total score ranges from 0 to 30. Higher scores are associated with greater severity of global functional impairments. If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing. (NCT01358357)
Timeframe: Double-blind Baseline to week 28

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20-80 mg Flexible Dose0.4
Placebo0.6

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Change From Double-blind Baseline to Week 28 (LOCF) in YMRS Total Score

the YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of maia. (NCT01358357)
Timeframe: Double-blind Baseline to week 28

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20-80 mg Flexible Dose1.0
Placebo1.8

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Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score

The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired). (NCT01421134)
Timeframe: Baseline to Week 6

Interventionunits on a scale (Least Squares Mean)
Lurasidone-11.2
Placebo-6.4

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Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score

The YMRS is an 11-item clinician-rated instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 individual items and ranges from 0 to 60. Higher scores are associated with greater severity of mania. (NCT01421134)
Timeframe: Baseline to Week 6

Interventionunits on a scale (Least Squares Mean)
Lurasidone-7.0
Placebo-4.9

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Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF)

(NCT01421134)
Timeframe: Baseline to Week 6

Interventionpercentage of subjects (Number)
Lurasidone49.1
Placebo23.0

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Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF).

(NCT01421134)
Timeframe: Baseline to Week 6

Interventionpercentage of subjects (Number)
Lurasidone64.8
Placebo30.0

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Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores

"The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity." (NCT01421134)
Timeframe: Baseline to Week 6

Interventionunits on a scale (Least Squares Mean)
Lurasidone-20.5
Placebo-13.0

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Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score

The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity. (NCT01421134)
Timeframe: Baseline to Week 6

Interventionunits on a scale (Least Squares Mean)
Lurasidone-1.83
Placebo-1.18

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Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score

The HAM-A is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety. (NCT01421134)
Timeframe: Baseline to Week 6

Interventionunits on a scale (Least Squares Mean)
Lurasidone-9.9
Placebo-5.4

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Change From Baseline to Week 12 (LOCF) in CGI-S Score

The Clinical Global Impression - Severity of illness (CGI-S) score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity. (NCT01423253)
Timeframe: baseline to week 12

Interventionunits on a scale (Mean)
Lurasidone 20, 40, 60 mg-0.47

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Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score

The Hamilton Rating Scale for Anxiety (HAM-A) is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety. (NCT01423253)
Timeframe: Baseline to week 12

Interventionunits on a scale (Mean)
Lurasidone 20, 40, 60 mg-1.5

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Change From Baseline to Week 12 (LOCF) in the YMRS Total Score

The Young Mania Rating Scale (YMRS) is an 11-item instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 items and ranges from 0 to 60. Higher scores are associated with greater severity of mania. (NCT01423253)
Timeframe: Baseline to week 12

Interventionunits on a scale (Mean)
Lurasidone 20, 40, 60 mg-1.5

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Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores

"Mean change from baseline to week 12 (LOCF) in Montgomery-Asberg Depression Rating Scale (MADRS) total scores The MADRS is a clinician-rated assessment of the subject's level of depression and consists of 10 items. Each item is rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the ten items and ranges from 0 to 60. Higher scores are associated with greater severity." (NCT01423253)
Timeframe: Baseline to12 Weeks

Interventionunits on a scale (Mean)
Lurasidone 20, 40, 60 mg-5.9

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Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)

Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs) (NCT01423253)
Timeframe: 12 Weeks

Interventionpercentage of subjects (Number)
Lurasidone 20, 40, 60 mg4.2

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Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)

Percentage of subjects with treatment emergent adverse events (TEAEs) (NCT01423253)
Timeframe: 12 Weeks

Interventionpercentage of subjects (Number)
Lurasidone 20, 40, 60 mg66.7

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Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)

Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs) (NCT01423253)
Timeframe: 12 Weeks

Interventionpercentage of subjects (Number)
Lurasidone 20, 40, 60 mg0

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Change From Baseline to Week 12 (LOCF) in the SDS Total Score

The Sheehan Disability Scale (SDS) is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired). (NCT01423253)
Timeframe: Baseline to week 12

Interventionunits on a scale (Mean)
Lurasidone 20, 40, 60 mg-3.6

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Time to First Relapse Event During Double-blind Phase

The Kaplan-Meier method is used for the estimation. (NCT01435928)
Timeframe: Double-blind phase - 28 Weeks

Interventiondays (Median)
LurasidoneNA
Placebo192

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Smoking Questionnaire (Average Number of Cigarettes Per Day) at Week 28 (LOCF)

Smoking history and frequency were assessed during the study by a research staff member. During the study, smoked subjects were asked about the average number of cigarettes per day they smoked over the last week. (NCT01435928)
Timeframe: 28 Weeks - Double Blind Phase

Interventionnumber of cigarettes smoked daily (Mean)
Lurasidone10.0
Placebo8.2

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Intent to Attend (ITA) Assessment at Open-label Baseline

"The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = Not at all and 9 = Extremely. The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the screening visit: How likely is it that you will complete the study?" (NCT01435928)
Timeframe: Open Label Baseline

Interventionunits on a scale (Mean)
Lurasidone7.9
Placebo8.0

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Brief Adherence Rating Scale

The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 - 100%) of doses taken by the subject in the previous month. (NCT01435928)
Timeframe: Double-blind phase - 28 Weeks

Interventionpercentage of monthly doses taken (Mean)
Lurasidone98.8
Placebo98.9

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

The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and three scales: the Positive scale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative scale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity. (NCT01435928)
Timeframe: Double-Blind phase - 28 Weeks

Interventionunits on a scale (Least Squares Mean)
Lurasidone8.3
Placebo12.4

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EuroQol (EQ-5D): EQ-VAS Score

"The EQ-5D is a self-administered, standardized measure of health states consisting of two parts: EQ-5D descriptive system consisting of one question in each of five dimensions (mobility, self-care, pain, usual activities, and anxiety) with three possible response levels per question, classifying patients into one of 243 distinct health states, and a 20-cm visual analogue health status rating.~The 20-cm visual analog scale (VAS) has endpoints labeled best imaginable health state and worst imaginable health state that are anchored at 100 and 0, respectively. Respondents are asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS, which best represents their own health on that day." (NCT01435928)
Timeframe: Double-blind phase - 28 Weeks

Interventionunits on a scale (Mean)
Lurasidone74.5
Placebo68.2

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Change From Double-blind Baseline in Short Form-12v2 Health Survey (SF-12v2) Physical Component Score

"The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales.~Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health." (NCT01435928)
Timeframe: Double-blind phase - 28 Weeks

Interventionunits on a scale (Least Squares Mean)
Lurasidone0.398
Placebo-1.341

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Change From Double-blind Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score

The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity. (NCT01435928)
Timeframe: Double-blind phase - 28 Weeks

Interventionunits on a scale (Least Squares Mean)
Lurasidone0.44
Placebo0.74

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Change From Double-blind Baseline in Modified Specific Levels of Functioning (SLOF) Total Score

The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items divided into two subscales: Social functioning (comprised of 7 items from interpersonal relationships section) and Community Living Skills (comprised of 17 items from activities and work skills sections). Each item is rated on a 5-point scale and mapped to 0 to 4 with a higher score indicating worse condition. The total score will be the sum of all 24 items and ranges from 0 to 96. (NCT01435928)
Timeframe: Double-blind phase - 28 Weeks

Interventionunits on a scale (Least Squares Mean)
Lurasidone0.8
Placebo3.2

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Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

"The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity." (NCT01435928)
Timeframe: Double-blind phase - 28 Weeks

Interventionunits on a scale (Least Squares Mean)
Lurasidone2.5
Placebo3.6

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Time to All-cause Discontinuation

The Kaplan-Meier method was used for estimation. (NCT01435928)
Timeframe: Double-blind phase - 28 weeks

Interventiondays (Median)
Lurasidone148
Placebo115

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Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs

Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring. (NCT01485640)
Timeframe: 18 months

Interventionparticipants (Number)
Subject with at least on treatment emergent AESubject with at least one treatment emergent SAESubjects discontinued due to TEAE
Lurasidone63710

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Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S

The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity. (NCT01485640)
Timeframe: 18 months

Interventionunits on a scale (Mean)
Lurasidone-0.18

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Brief Adherence Rating Scale (BARS)

The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 100%) of doses taken by the subject in the previous month. (NCT01566162)
Timeframe: 12 weeks

Interventionpercentage of monthly doses taken (Mean)
Lurasidone99.0

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Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score.

The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity. (NCT01566162)
Timeframe: Baseline to week 12 LOCF endpoint

Interventionunits on a scale (Mean)
Lurasidone-0.48

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

The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity. (NCT01566162)
Timeframe: Baseline to week 12 LOCF endpoint

Interventionunits on a scale (Mean)
Lurasidone-8.4

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Modified Specific Levels of Functioning (SLOF) Total Score.

The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items, each item is rated on a 5-point scale and mapped to 0 to 4. The total score will be the sum of all 24 items and ranges from 0 to 96. A higher score indicates worse condition. (NCT01566162)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Lurasidone-1.8

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Short Form-12 Health Survey (SF-12)

The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales. Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. (NCT01566162)
Timeframe: Baseline to week 12 LOCF endpoint

Interventionunits on a scale (Mean)
Lurasidone-0.45

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Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs)

Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs) (NCT01566162)
Timeframe: 12 weeks

Interventionparticipants (Number)
Subjects with TEAEsTEASs leading to discontinuationSubjects with TESAEs
Lurasidone72713

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Intent to Attend Assessment

"The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = Not at all and 9 = Extremely. The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the baseline visit: How likely is it that you will complete the study?" (NCT01566162)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Lurasidone8.3

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Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score

"The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity." (NCT01566162)
Timeframe: Baseline to week 12 LOCF endpoint

Interventionunits on a scale (Mean)
Lurasidone-3.3

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Smoking Questionnaire

Smoking questionnaire - average number of cigarettes per day at week 12 (LOCF). (NCT01566162)
Timeframe: 12 weeks

Interventionnumber of cigarettes smoked daily (Mean)
Lurasidone11.1

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Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Depression Scale

The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and range from 1=normal, not at all ill to 7=Among the most extremely ill patients. A higher score is associated with greater illness severity. (NCT01575561)
Timeframe: baseline, week 12 (LOCF)

Interventionunits on a scale (Mean)
Lurasidone-0.27

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Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Mania Score

The CGI-BP-S mania score is a single value, clinician-rated assessment of mania illness severity and ranges from 1=Normal, not at all ill to 7= Among the most extremely ill patients. A higher score is associated with greater illness severity (NCT01575561)
Timeframe: baseline, week 12 (LOCF)

Interventionunits on a scale (Mean)
Lurasidone-0.13

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Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Overall Score- Severity of Illness as Assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S)

Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) -The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity. (NCT01575561)
Timeframe: baseline, week 12 (LOCF)

Interventionunits on a scale (Mean)
Lurasidone-.31

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Change From Baseline to Week 12 (LOCF) in the MADRS Total Score- Depression as Assessed by Montgomery-Asberg Depression Rating Scale (MADRS)

"Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS) -The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity of depression." (NCT01575561)
Timeframe: baseline ,Week 12 (LOCF)

Interventionunits on a scale (Mean)
Lurasidone-1.9

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Change From Baseline to Week 12 (LOCF) in the Positive and Negative Syndrome Scale Positive Subscale (PANSS P) Score

The PANSS-P is a subset of items in the PANSS, an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS-P subscale score is the sum of the 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity. (NCT01575561)
Timeframe: baseline, 12 weeks (LOCF)

Interventionunits on a scale (Mean)
Lurasidone-0.2

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Change From Baseline to Week 12 (LOCF) in the YMRS Total Score -Mania as Assessed by Young Mania Rating Scale (YMRS)

Movement disorders as assessed by Young Mania Rating Scale (YMRS) The YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of mania. (NCT01575561)
Timeframe: Baseline, 12 weeks (LOCF)

Interventionunits on a scale (Mean)
Lurasidone-1.0

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Change From Baseline to Week 12 (LOCF) in the SDS Total Score

The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient's life are impaired by depressive symptoms. The SDS total score is calculated as the sum of the 3 items. The SDS total score ranges from 0 to 30. Higher scores are associated with greater severity of global functional impairments. If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing. (NCT01575561)
Timeframe: baseline, week 12 (LOCF)

Interventionunits on a scale (Mean)
Lurasidone-1.4

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Change From Baseline to Week 12 (LOCF) in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) Total Score

The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms. (NCT01575561)
Timeframe: baseline, 12 weeks (LOCF)

Interventionunits on a scale (Mean)
Lurasidone-1.0

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Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events

Number of subjects with treatment emergent AEs, SAEs, and TEAEs leading to discontinuation (NCT01575561)
Timeframe: 12 weeks

Interventionparticipants (Number)
at Least 1 TEAE potentially related to study drugsubjects with at least one TEAE potentially relateat least 1 treatment emergent SAEat least 1 treatment emergent SAE related to drugat least 1 TEAE leading to discontinuation
Lurasidone155691419

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Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)

Proportion of participants with treatment-emergent adverse events. A serious adverse event was defined as an AE that met one or more of the following criteria: Resulted in death; Was life-threatening (i.e., a patient was at immediate risk of death at the time of the event, not an event where occurrence in a more severe form might have caused death); Required hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability or incapacity; Was a congenital anomaly or birth defect; Was an important medical event that might jeopardize the patient or might require medical intervention to prevent one of the outcomes listed above. (NCT01614899)
Timeframe: From Baseline to 6 weeks

InterventionParticipants (Count of Participants)
SM-13496 (Lurasidone HCl) 40mg4
SM-13496 (Lurasidone HCl) 80mg3
Placebo3

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Proportion of Participants With Treatment-emergent Adverse Events (TEAEs)

Proportion of participants with treatment-emergent adverse events. An adverse event was defined as any untoward medical occurrence in a patient treated with a medicinal (investigational) product and which did not necessarily have a causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as adverse events with a start date on or after the date of the first dose through the end of follow-up, or adverse events occurring before the date of first dose and worsening during the treatment or follow-up period. (NCT01614899)
Timeframe: From Baseline to 6 weeks

InterventionParticipants (Count of Participants)
SM-13496 (Lurasidone HCl) 40mg103
SM-13496 (Lurasidone HCl) 80mg107
Placebo97

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Proportion of Participants With TEAEs Leading to Discontinuation

(NCT01614899)
Timeframe: From Baseline to 6 weeks

InterventionParticipants (Count of Participants)
SM-13496 (Lurasidone HCl) 40mg11
SM-13496 (Lurasidone HCl) 80mg11
Placebo16

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

The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and three subscales: the Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity. (NCT01614899)
Timeframe: Baseline and 6 week

Interventionunits on a scale (Mean)
SM-13496 (Lurasidone HCl) 40mg-17.9
SM-13496 (Lurasidone HCl) 80mg-17.3
Placebo-13.1

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

"CGI-S is a clinician-rated assessment of the participant's current disease state on a 7-point scale, where a higher score is associated with greater severity of the disease.~The change from baseline in CGI-S score (repeated measures) at each visit during the treatment phase is presented for the mITT population" (NCT01614899)
Timeframe: Baseline and 6 weeks

Interventionunits on a scale (Mean)
SM-13496 (Lurasidone HCl) 40mg-0.86
SM-13496 (Lurasidone HCl) 80mg-0.97
Placebo-0.79

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Change From Baseline in PANSS Positive Subscale Scores at Week 6

The PANSS is comprised of 30 items and three subscales. The Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS Positive subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity. (NCT01614899)
Timeframe: Baseline and 6 weeks

Interventionunits on a scale (Mean)
SM-13496 (Lurasidone HCl) 40mg-5.4
SM-13496 (Lurasidone HCl) 80mg-6.2
Placebo-4.2

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Change From Baseline in PANSS Negative Subscale Scores at Week 6

The PANSS is comprised of 30 items and three subscales. The Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS Negative subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity. (NCT01614899)
Timeframe: Baseline and 6 weeks

Interventionunits on a scale (Mean)
SM-13496 (Lurasidone HCl) 40mg-3.9
SM-13496 (Lurasidone HCl) 80mg-3.4
Placebo-2.9

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Change From Baseline in PANSS General Psychopathology Subscale Scores at Week 6

The PANSS is comprised of 30 items and three subscales. The General Psychopathology subscale addresses other 16 symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS General Psychopathology subscale score is the sum of all 16 items and ranges from 16 through 112. A higher score is associated with greater illness severity. (NCT01614899)
Timeframe: Baseline and 6 weeks

Interventionunits on a scale (Mean)
SM-13496 (Lurasidone HCl) 40mg-8.8
SM-13496 (Lurasidone HCl) 80mg-7.9
Placebo-6.3

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Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)

Proportion of participants with treatment-emergent adverse events. A serious adverse event was defined as an AE that met one or more of the following criteria: Resulted in death; Was life-threatening (i.e., a patient was at immediate risk of death at the time of the event, not an event where occurrence in a more severe form might have caused death); Required hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability or incapacity; Was a congenital anomaly or birth defect; Was an important medical event that might jeopardize the patient or might require medical intervention to prevent one of the outcomes listed above. (NCT01614912)
Timeframe: EXT baseline and up to 26 weeks

InterventionParticipants (Count of Participants)
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group31

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Proportion of Participants With Treatment-Emergent Adverse Events (TEAEs)

Proportion of participants with treatment-emergent adverse events. An adverse event was defined as any untoward medical occurrence in a patient treated with a medicinal (investigational) product and which did not necessarily have a causal relationship with this treatment. Treatment-emergent adverse events are defined as adverse events with a start date on or after the date of initial administration of study drug in the present study through the end of follow-up or adverse events occurring before the date of initial administration of study drug in the present study and worsening during the study treatment in the present study. (NCT01614912)
Timeframe: EXT baseline and up to 26 weeks

InterventionParticipants (Count of Participants)
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group215

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Proportion of Participants With TEAEs Leading to Discontinuation

(NCT01614912)
Timeframe: EXT baseline and up to 26 weeks

InterventionParticipants (Count of Participants)
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group39

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Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at LOCF Endpoint

The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and three subscales: the Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity. (NCT01614912)
Timeframe: DB baseline and up to 32 weeks (LOCF endpoint)

Interventionunits on a scale (Mean)
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group-28.4

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Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score at LOCF Endpoint

"CGI-S is a clinician-rated assessment of the participant's current disease state on a 7-point scale, where a higher score is associated with greater severity of the disease.~Baseline in the prior study (D1001056, double-blind [DB] baseline) was defined as baseline of the prior study. Baseline in the present study (D1001057, extension [EXT] baseline) was defined as Week 6 in the prior study.~The last post-baseline visit data collected during the study treatment of the present study were carried forward and defined as the last observation carried forward (LOCF) endpoint." (NCT01614912)
Timeframe: DB baseline and up to 32 weeks (LOCF endpoint)

Interventionunits on a scale (Mean)
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group-1.46

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Change From Baseline in PANSS Positive Subscale Score at LOCF Endpoint

The PANSS is comprised of 30 items and three subscales. The Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS Positive subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity. (NCT01614912)
Timeframe: DB baseline and up to 32 weeks (LOCF endpoint)

Interventionunits on a scale (Mean)
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group-8.4

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Change From Baseline in PANSS Negative Subscale Score at LOCF Endpoint

The PANSS is comprised of 30 items and three subscales. The Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS Negative subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity. (NCT01614912)
Timeframe: DB baseline and up to 32 weeks (LOCF endpoint)

Interventionunits on a scale (Mean)
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group-6.9

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Change From Baseline in PANSS General Psychopathology Subscale Score at LOCF Endpoint

The PANSS is comprised of 30 items and three subscales. The General Psychopathology subscale addresses other 16 symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS General Psychopathology subscale score is the sum of all 16 items and ranges from 16 through 112. A higher score is associated with greater illness severity. (NCT01614912)
Timeframe: DB baseline and up to 32 weeks (LOCF endpoint)

Interventionunits on a scale (Mean)
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group-13.1

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Number of Participants With Serious Adverse Events and Non-serious Adverse Events

Serious adverse event and adverse events data will be listed and summarized as per MedDRA V15.0 (NCT01620060)
Timeframe: 11 Days

Interventionparticipants (Number)
Lurasidone Oral Tablets105

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Lurasidone Peak Serum Concentration (Cmax)

Cmax will be listed and summarized in tabular format (NCT01620060)
Timeframe: Day 1 - pre-dose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, and 48 hours. Day 10/12: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours

Interventionng/mL (Mean)
Cmax (ng/mL)-Day 1 20 mg n=16Cmax (ng/mL)-Day 1 40 mg n=24Cmax (ng/mL)-Day 1 80 mg n=55Cmax (ng/mL)-D10/12 20 mg n=16Cmax (ng/mL)-D10/12 40 mg n=21Cmax (ng/mL)-D10/12 80 mg n=17Cmax (ng/mL)-D10/12 120 mg n=16Cmax (ng/mL)-D10/12 160 mg n=13
Lurasidone Oral Tablets24.438.368.23036.28094.299.7

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Lurasidone Primary Pharmacokinetic Parameters

Lurasidone AUClast (Day 1) and AUC0-∞ (Day 1) AUC0-24 (Day 10 or Day 12) (NCT01620060)
Timeframe: Day 1 - pre-dose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, and 48 hours. Day 10/12: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours

Interventionng.h/mL (Mean)
AUC last (ng.h/mL) -Day 1 20 mg n=16AUC last (ng.h/mL) -Day 1 40 mg n=24AUC last (ng.h/mL) -Day 1 80 mg n=54AUC0-24 (ng.h/mL) -D 10/12 20 mg n=16AUC0-24 (ng.h/mL) -D10/12 40 mg n=21AUC0-24 (ng.h/mL) -D10/12 80 mg n=17AUC0-24 (ng.h/mL) -D10/12 120 mg n=16AUC0-24 (ng.h/mL) -D 10/12 160 mg n=13AUC0-∞(ng.h/mL) -D 1 20 mg n=16AUC0-∞(ng.h/mL) -D 1 40 mg n=19AUC0-∞(ng.h/mL) -D 1 80 mg n=50
Lurasidone Oral Tablets7814030011515438749459083.8153328

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Overall Clinical Improvement

Overall psychiatric functioning will be assessed with the improvement (CGI-I) subscales of the CGI. CGI-I items are rated from 1 (very much improved) to 7 (very much worse). (NCT01731119)
Timeframe: Baseline to 12 weeks

Interventionunits on a scale (Mean)
Flexible Dose Latuda©2.67

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Number of Participants Experiencing Side Effects

Assessment of the medication side effects associated with lurasidone (Latuda©) in children and adolescents. (NCT01731119)
Timeframe: Baseline to12 weeks

InterventionParticipants (Count of Participants)
Flexible Dose Latuda©3

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Changes in Efficacy Measures

Efficacy measures included the Aberrant Behavior Checklist-Community (ABC-C) total score which focuses on problem behaviors in five subdomains, including irritability, attention, repetitive behaviors, unusual speech, and social withdrawal. Differences in subdomains were not assessed. The ABC-C total score is the sum of 58 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC-C total score ranges from 0 to 174. Higher values of ABC-C total scores represent greater severity of illness. (NCT01731119)
Timeframe: Baseline to 12 weeks

Interventionunits on a scale (Mean)
Flexible Dose Latuda©-14

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Change in Weight

Change in weight from Baseline to Week 12 will be assessed as the primary outcome measure. Subjects will be asked to step on a special scale called a tanita which will calculate weight, fat mass at each study visit. (NCT01731119)
Timeframe: Baseline to 12 weeks

Interventionlbs (Mean)
Flexible Dose Latuda©0.70

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Proportion of Participants Completing Treatment

Data will be collected on why participants terminated the study. If terminated early, the specific reason will be collected such as efficacy or tolerability. (NCT01731119)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Flexible Dose Latuda©7

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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 for Lurasidone 20 mg and 80-160 mg Versus Placebo.

The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity. (NCT01821378)
Timeframe: Baseline to 6 Weeks

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20 mg-17.6
Lurasidone 80-160 mg-24.9
Placebo-14.5

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Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the MADRS Total Score

"The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity." (NCT01821378)
Timeframe: baseline to week 6

Interventionunits on a scale (Least Squares Mean)
ENR Lurasidone 80 mg-2.5
ENR Lurasidone 160 mg-3.5
Placebo-1.7

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Change From Baseline to Week 6 for the Lurasidone 20 mg and Lurasidone 80 - 160 mg Groups Compared to the Placebo Group in the Euroqol (EQ-5D) Index Score

The EQ-5D is a standardized measure of health state consisting of two parts: a) EQ-5D measuring mobility, self-care, pain/discomfort, usual activities, and anxiety/depression on a 0 2 scale with lower scores indicating improvement, and b) a 20-cm visual analogue scale (VAS) for health status rating on a 0-100 scale with higher scores indicating improvement. EQ-5D health states, defined by the EQ-5D descriptive system, may be converted into a single summary index (i.e. the EQ-5D index score) by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. The EQ-5D Index scores ranged from -0.429 to 1.000. Generally higher observed EQ-5D Index scores indicate a better degree of health. (NCT01821378)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20 mg0.041
Lurasidone 80-160 mg0.095
Placebo-0.042

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Change From Baseline to Week 6 for the Lurasidone 20 mg and Lurasidone 80 - 160 mg Groups Compared to the Placebo Group in the GAF Score

The GAF is a numeric scale (0 through 100) that measures a patient's overall level of psychological, social, and occupation functioning. It is designed to guide clinicians through a methodical and comprehensive consideration of all aspects of a patient's symptoms and functioning. The scale begins at 100 - superior functioning - to 0 - inadequate information. (NCT01821378)
Timeframe: 6 Weeks

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20 mg11.5
Lurasidone 80-160 mg15.8
Placebo9.2

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Change From Baseline to Week 6 for the Lurasidone 20 mg, and Lurasidone 80 - 160 mg Groups Versus the Placebo Group in the Montgomery-Asberg Depression Rating Scale Total Score

"The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity." (NCT01821378)
Timeframe: Baseline to 6 Weeks

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20 mg-2.0
Lurasidone 80-160 mg-3.7
Placebo-1.7

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Change From Week 2 to Week 6 for ENR Lurasidone 80 mg vs. ENR Lurasidone 160 mg in CGI-S Score

The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale (0-7), where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes. (NCT01821378)
Timeframe: week 2 to week 6

Interventionunits on a scale (Least Squares Mean)
ENR Lurasidone 80 mg-0.61
ENR Lurasidone 160 mg-0.96

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Change From Week 2 to Week 6 for the ENR (Early Non-responders) Lurasidone 160mg Group vs the ENR (Early Non-responders) Lurasidone 80 mg Group in the Following: PANSS Total Score

The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity. (NCT01821378)
Timeframe: week 2 to week 6

Interventionunits on a scale (Least Squares Mean)
ENR Lurasidone 80 mg-8.9
ENR Lurasidone 160 mg-16.6

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Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the CGI-S Score

"The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.~Reason for the discrepancy of the LS mean (SE) for placebo in outcome 2 and outcome 9 is because the different MMRM model used in outcome 2 and outcome 9. The treatment groups included in the MMRM model for outcome 2 are placebo, lurasidone 20 mg, and lurasidone 80-160 mg. The treatment groups included in the MMRM model for outcome 9 are placebo, ENR lurasidone 80 mg, and ENR lurasidone 160 mg." (NCT01821378)
Timeframe: baseline to week 6

Interventionunits on a scale (Least Squares Mean)
ENR Lurasidone 80 mg-0.83
ENR Lurasidone 160 mg-1.31
Placebo-0.73

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Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the PANSS Total Score

The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity. (NCT01821378)
Timeframe: Baseline to week 6

Interventionunits on a scale (Least Squares Mean)
ENR Lurasidone 80 mg-14.4
ENR Lurasidone 160 mg-21.7
Placebo-14.4

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Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Score (PANSS) Total Score at Week 6

The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity. (NCT01821378)
Timeframe: 6 Weeks

Interventionpercentage of participants (Number)
Lurasidone 20 mg44
Lurasidone 80-160 mg53
Placebo73

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Change in Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 6 for Lurasidone 20 mg and 80-160 mg Versus Placebo.

The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale (0-7), where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes. (NCT01821378)
Timeframe: Baseline to 6 Weeks

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20 mg-0.93
Lurasidone 80-160 mg-1.30
Placebo-0.73

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Proportion of Responders, Where Response is Based on ≥ 20% Improvement From Baseline in PANSS Total Score at Week 6

PANSS responder analysis over time: achieving >= 20% reduction from baseline (NCT01911429)
Timeframe: week 6

Interventionnumber of participants (Number)
Lurasidone 40 mg69
Lurasidone 80 mg47
Placebo69

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

"Clinical Global Impression severity (CGI-S): Changes from baseline over time-mixed model for repeated measures- scale from 1-7 - 1=normal, not at all ill; 7=among the most extremely ill patients.~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, CGIS at baseline, and treatment-by-visit interaction." (NCT01911429)
Timeframe: baseline, week 6

,,
Interventionunits on a scale (Mean)
baselineweek 6
Lurasidone 40 mg4.9-0.97
Lurasidone 80 mg4.8-0.92
Placebo4.8-0.50

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

"Clinician-rated Children's Global Assessment Scale (CGAS) score: summary statistics over time - CGAS is a numeric scale (1 through 100) , where 1 represents the most impaired functioning and 100, superior functioning~LS Mean and SE for change from baseline are from an ANCOVA model including factors of treatment, pooled country and age group (stratification factor), and corresponding Baseline score as covariate and LOCF approach." (NCT01911429)
Timeframe: baseline, week 6

,,
Interventionunits on a scale (Mean)
baselineweek 6
Lurasidone 40 mg44.211.3
Lurasidone 80 mg44.611.9
Placebo43.97.5

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Change From Baseline in PANSS Excitability Subscale Scores

"Excitability subscale scores (range 4-28): consists of the following four items from the PANSS: excitement, hostility, uncooperativeness, and poor impulse control~Higher values of PANSS Excitability Subscale Score represent greater severity of illness~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction." (NCT01911429)
Timeframe: baseline, week 6

,,
Interventionunits on a scale (Mean)
baselineweek 6
Lurasidone 40 mg10.8-0.6
Lurasidone 80 mg11.1-1.7
Placebo10.7-2.4

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Change From Baseline in PANSS General Psychopathology Subscale Scores

"PANSS general psychopathology subscale score: changes from baseline over time - mixed model for repeated measures -- General psychopathology (range 16-112): sum of Items G1 to G16 in the general psychopathology subscale -Higher values of PANSS General Psychopathology Subscale Score represent greater severity of illness~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction." (NCT01911429)
Timeframe: baseline, week 6

,,
Interventionunits on a scale (Mean)
baselineweek 6
Lurasidone 40 mg46.2-8.1
Lurasidone 80 mg45.5-8.1
Placebo45.0-5.3

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Change From Baseline in PANSS Positive Subscale Scores

"PANSS positive subscale score: changes from baseline over time - mixed model for repeated measures -Positive subscale (range 7-49): sum of Items P1 to P7 in the positive subscale - Higher values of PANSS Positive Subscale Score represent greater severity of illness~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction." (NCT01911429)
Timeframe: baseline, week 6

,,
Interventionunits on a scale (Mean)
baselineweek 6
Lurasidone 40 mg24.1-6.3
Lurasidone 80 mg24.0-6.3
Placebo23.4-3.1

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Change From Baseline in PANSS Positive, Negative Subscale Scores

"PANSS Negative subscale score: changes form baseline over time - Mixed model for repeated measures - - Negative subscale (range 7-49): sum of Items N1 to N7 in the negative subscale - Higher values of PANSS Negative Subscale Score represent greater severity of illness~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction." (NCT01911429)
Timeframe: baseline, week 6

,,
Interventionunits on a scale (Mean)
baselineweek 6
Lurasidone 40 mg24.2-4.0
Lurasidone 80 mg24.5-3.8
Placebo24.4-2.3

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Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q)

"PQ-LES-Q percentage maximum possible score: summary statistics over time - PQ-LES-Q % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life.~LS Mean and SE for change from baseline are from an ANCOVA model including factors of treatment, pooled country and age group (stratification factor), and corresponding Baseline score as covariate and LOCF approach." (NCT01911429)
Timeframe: baseline, week 6

,,
Interventionunits on a scale (Mean)
baselineweek 6
Lurasidone 40 mg51.35.6
Lurasidone 80 mg53.66.1
Placebo52.50.3

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

"PANNS total score: Changes from baseline over time - mixed model for repeated measures at week 6 -PANSS total score may range from 30 to 210- Higher values of PANSS total score represent greater severity of illness~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, PANSS total score at baseline, and treatment-by-visit interaction." (NCT01911429)
Timeframe: Baseline to 6 weeks

,,
Interventionunits on a scale (Mean)
baselineWeek 6
Lurasidone 40 mg94.5-18.6
Lurasidone 80 mg94.0-18.3
Placebo92.8-10.5

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Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score at Week 6

The ABC hyperactivity and noncompliance subscale score is the sum of 16 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC hyperactivity and noncompliance subscale score may range from 0 to 48. In general, higher values of ABC subscale scores represent greater severity of illness. (NCT01911442)
Timeframe: Baseline to 6 Weeks

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20 mg Once Daily-9.7
Lurasidone 60 mg Once Daily-6.6
Placebo-7.1

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Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) Modified for Pervasive Developmental Disorders (PDDs)

CY-BOCS total score ranges from 0 to 20. The higher value of CY-BOCS scores the greater severity of illness. This table is a summary of Y-BOCS compulsion total score. (NCT01911442)
Timeframe: 6 Weeks

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20 mg Once Daily-1.0
Lurasidone 60 mg Once Daily-1.0
Placebo-1.2

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

The Clinical Global Impression - Severity of Illness (CGI-S) Scale is rated on a 7-point scale of severity with 1 = Normal, not at all ill to 7 = Among the most extremely ill patients. Higher values of CGI-S scores represent greater severity of illness. (NCT01911442)
Timeframe: Baseline to 6 Weeks

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20 mg Once Daily-1.1
Lurasidone 60 mg Once Daily-1.0
Placebo-0.7

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Change From Baseline in the Caregiver Strain Questionnaire (CGSQ)

CGSQ is a caregiver reported assessment to assesses extent to which caregivers are affected by special demands associated with caring for a child with emotional/behavioral problems. CGSQ is comprised of three subscales which range in severity from 1 to 5 (Objective Strain, Subjective Externalized Strain, Subjective Internalized Strain), The 3 subscales are calculated as the averages of the corresponding individual items. Higher scores on each indicates greater strain. A Global Strain score is calculated by summing the three subscales (Objective Strain, Subjective Externalized Strain, Subjective Internalized Strain) to provide an indication of the total impact of the special demands on the family. Global Strain scores range from 3 to 15. As with the individual subscales, higher scores indicate greater strain. (NCT01911442)
Timeframe: 6 Weeks

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20 mg Once Daily-1.49
Lurasidone 60 mg Once Daily-1.66
Placebo-1.35

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Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6

The ABC irritability subscale score is the sum of 15 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC irritability subscale score ranges from 0 to 45. Higher values of ABC subscale scores represent greater severity of illness. (NCT01911442)
Timeframe: Baseline to 6 Weeks

Interventionunits on a scale (Least Squares Mean)
Lurasidone 20 mg Once Daily8.8
Lurasidone 60 mg Once Daily9.4
Placebo7.5

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Proportion of Subjects Who Have at Least 25% Reduction From Baseline to Week 6 in the ABC Irritability Subscale Score.

(NCT01911442)
Timeframe: 6 Weeks

Interventionpercentage of subjects (Number)
Lurasidone 20 mg25
Lurasidone 60 mg26
Placebo23

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Proportion of Subjects Who Have CGI-I Score of 1 (Very Much Improved) or 2 (Much Improved) at Week 6

(NCT01911442)
Timeframe: 6 Weeks

Interventionpercentage of subjects (Number)
Lurasidone 20 mg17
Lurasidone 60 mg17
Placebo14

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Change From Baseline in PANSS Negative Subscale Score

Change from Baseline in PANSS Negative Subscale Score for subjects continued from study D1050301 The Negative scale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; Negative subscale (range 7-49) is calculated as sum of Items N1 to N7 in the negative subscale Higher values of PANSS sub-scale scores represent greater severity of illness. (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionunits on a scale (Mean)
Open Label baselineWeek 28Week 52Week 104
Rollover From D105030120.5-2.6-3.4-4.3

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Change From Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score

Change from Baseline in PAR Total Score for subjects continued from study D1050326 The PARS is a clinician-rated instrument for assessing over time the severity of anxiety symptoms associated with common DSM-IV anxiety disorders in children ages 6 17 years. The PARS is administered separately to the subject and to the caregiver. The instrument has 2 sections. The first section includes a 50-item symptom checklist, which the clinician rates as present or absent during the past week. The second section is comprised of 7 severity impairment items reflecting the severity/impairment of all symptoms endorsed in Section 1 of the PARS (during the past week). Each question is answered on a 0-5 Likert scale (0 for none, and 1-5 for minimal to extreme) with alternative responses of 8=Not Applicable and 9=Does Not Know. Scores of 8 or 9 are not counted in the summation as per the PARS instructions. The PARS total score over all 7 questions ranges in value from 0 to 35.A higher PARS total score (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionunits on a scale (Mean)
Open label baselineWeek 28Week 52Week 104
Rollover From D10503268.0-2.7-3.2-4.9

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Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score

"Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score for subjects continued from study D1050301~The Pediatric Q-LES-Q is a 15-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living, based on the content of the Short From of the Q-LES-Q. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The first 14 items are the same as the General Activities section of the regular Q-LES-Q form and are used to compute the raw score. The PQ-LES-Q-SF percentage maximum possible score is calculated as follows:~% Max = 100 × (Raw Score - Minimum Score) / (Maximum Score - Minimum Score), where the Minimum Score equals 14 and the Maximum Score equals 70, and the % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life." (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionpercent of score (Mean)
Open label baselineWeek 28Week 52Week 104
Rollover From D105030157.147.489.9811.74

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Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score

"Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score for subjects continued from study D1050326~The Pediatric Q-LES-Q is a 15-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living, based on the content of the Short From of the Q-LES-Q. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The first 14 items are the same as the General Activities section of the regular Q-LES-Q form and are used to compute the raw score. The PQ-LES-Q-SF percentage maximum possible score is calculated as follows:~% Max = 100 × (Raw Score - Minimum Score) / (Maximum Score - Minimum Score), where the Minimum Score equals 14 and the Maximum Score equals 70, and the % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life." (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionscore (Mean)
Open label baselineWeek 28Week 52Week 104
Rollover From D105032659.528.1611.3714.75

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Change From Baseline in the Clinical Global Impression -Severity Score

Change from Baseline in the Clinical Global Impression -Severity Score for subjects continued from study D1050301 The CGI-S is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1='Normal, not at all ill' to 7='Among the most extremely ill patients'. A higher score is associated with greater illness severity (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionunits on a scale (Mean)
Open label baselineWeek 28Week 52Week 104
Rollover From D10503014.0-0.87-1.10-1.31

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

"Change from Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score for subjects continued from study D1050301.~PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210 Higher values of PANSS total score represents greater severity of illness." (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionunits on a scale (Mean)
Open Label BaselineWeek 28Week 52Week 104
Rollover From D105030176.0-11.9-15.6-18.4

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Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs)

The Safety population consists of all subjects who received at least one dose of study drug in this study. (NCT01914393)
Timeframe: During 104 Weeks (2-years) treatment period

,,,
InterventionParticipants (Number)
Subjects with at least one treatment emergent AESubjects with at least one treatment emergent SAESubjects with AE Leading to Discontinuation
Lurasidone (All Indications)5727877
Rollover From D10503012142828
Rollover From D10503251061318
Rollover From D10503262523731

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Change From Baseline in PANSS Positive Subscale Score

Change from Baseline in PANSS Positive Subscale Score for subjects continued from study D1050301 The Positive scale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness /persecution, and hostility; Positive subscale (range 7-49) is calculated as sum of Items P1 to P7 in the positive subscale Higher values of PANSS sub-scale scores represent greater severity (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionunits on a scale (Mean)
Open Label baselineWeek 28Week 52Week 104
Rollover From D105030117.9-3.9-5.1-5.4

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Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score

"Change from Baseline in ABC Hyperactivity and Noncompliance Subscale Score for subjects continued from study D1050325 The ABC contains 58 items resolve into five subscales: (1) irritability and agitation (15 items), (2) lethargy and social withdrawal (16 items), (3) stereotypic behavior (7 items), (4) hyperactivity and noncompliance (16 items), and (5) inappropriate speech (4 items). Each item is rated for severity on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree).~Hyperactivity and noncompliance Subscale Score is calculated as summing of 1, 7, 13, 15, 18, 21, 24, 28, 31, 38, 39, 44, 48, 51, 54, and 56 items. ABC hyperactivity and noncompliance Subscale Score ranges from 0 to 48.~In general, higher values of ABC subscale scores represent greater severity of illness. If one or more items are missing, no imputation was performed and the scores of the subscales that include these items was left missing" (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionscore (Mean)
Open label baselineWeek 28Week 52Week 104
Rollover From D105032524.1-3.8-4.3-5.6

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Change From Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score

"Change from Baseline in ABC Inappropriate Speech Subscale Score for subjects continued from study D1050325 The ABC contains 58 items resolve into five subscales: (1) irritability and agitation (15 items), (2) lethargy and social withdrawal (16 items), (3) stereotypic behavior (7 items), (4) hyperactivity and noncompliance (16 items), and (5) inappropriate speech (4 items). Each item is rated for severity on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree).~Inappropriate speech Subscale Score is calculated as summing of 9, 22, 33, and 46 items. ABC inappropriate speech Subscale Score ranges from 0 to 12.~In general, higher values of ABC subscale scores represent greater severity of illness. If one or more items are missing, no imputation was performed and the scores of the subscales that include these items was left missing" (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionscore (Mean)
Open label baselineWeek 28Week 52Week 104
Rollover From D10503255.2-0.7-0.7-0.5

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Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score

"Change from Baseline in ABC Irritability Subscale Score for subjects continued from study D1050325 The Aberrant Behavior Checklist (ABC) contains 58 items resolve into five subscales: (1) irritability and agitation (15 items), (2) lethargy and social withdrawal (16 items), (3) stereotypic behavior (7 items), (4) hyperactivity and noncompliance (16 items), and (5) inappropriate speech (4 items). Each item is rated for severity on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree).~Irritability Subscale Score is calculated as summing of items 2, 4, 8, 10, 14, 19, 25, 29, 34, 36, 41, 47, 50, 52, and 57; as a result, ABC irritability subscale score ranges from 0 to 45.~In general, higher values of ABC subscale scores represent greater severity of illness. If one or more items are missing, no imputation was performed and the scores of the subscales that include these items was left missing" (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionunits on a scale (Mean)
Open label baselineWeek 28Week 52Week 104
Rollover From D105032519.0-2.1-2.9-4.2

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Change From Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score

"Change from Baseline in ABC Lethargy and Social Withdrawal Subscale Score for subjects continued from study D1050325 The ABC contains 58 items resolve into five subscales: (1) irritability and agitation (15 items), (2) lethargy and social withdrawal (16 items), (3) stereotypic behavior (7 items), (4) hyperactivity and noncompliance (16 items), and (5) inappropriate speech (4 items). Each item is rated for severity on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree).~Lethargy and Social Withdrawal Subscale Score is calculated as summing of items 3, 5, 12, 16, 20, 23, 26, 30, 32, 37, 40, 42, 43, 53, 55, and 58. ABC Lethargy and Social Withdrawal Subscale Score ranges from 0 to 48.~In general, higher values of ABC subscale scores represent greater severity of illness. If one or more items are missing, no imputation was performed and the scores of the subscales that include these items was left missing" (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionscore (Median)
Open label baselineWeek 28Week 52Week 104
Rollover From D105032510.3-0.7-1.1-1.1

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Change From Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score

"Change from Baseline in ABC Stereotypic Behavior Subscale Score for subjects continued from study D1050325. The ABC contains 58 items resolve into five subscales: (1) irritability and agitation (15 items), (2) lethargy and social withdrawal (16 items), (3) stereotypic behavior (7 items), (4) hyperactivity and noncompliance (16 items), and (5) inappropriate speech (4 items). Stereotypic behavior Subscale Score is calculated as summing of 6, 11, 17, 27, 35, 45, and 49 items . ABC Stereotypic behavior Subscale Score ranges from 0 to 21. Each item is rated for severity on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree). To score the ABC, the individual items for each subscale are simply summed to their respective totals. It is inappropriate to compute a total aberrant score, based on a summation of all 58 items, as the subscales are largely independent. In general, higher values of ABC subscale scores represent greater severity" (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionscore (Mean)
Open label baselineWeek 28Week 52Week 104
Rollover From D10503256.1-0.9-0.9-1.1

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Change From Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score

Change from Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score for subjects continued from study D1050326 The ADHD-RS IV is a validated scale that measures the behaviors of children with ADHD. The ADHD-RS IV consists of 18 items reflecting current symptomatology of ADHD based on DSM-IV-TR criteria. Each item is scored from a range of 0 (no symptoms) to 3 (severe symptoms) with total scores ranging from 0 to 54. The 18 items may be grouped into two sub-scales: hyperactivity/impulsivity (even number items 2 through 18) and inattentiveness (odd number items 1 through 17), ranging from 0 to 27. A higher ADHD-RS total score and sub-scales scores are associated with greater illness severity (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionunits on a scale (Mean)
Open label baselineWeek 28Week 52Week 104
Rollover From D10503269.4-2.2-2.4-3.3

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Change From Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score

"Change from Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score for subjects continued from study D1050325 The CGSQ is comprised of total 21 items. Each item is rated on a 5-point Likert-type scale (1 (not at all a problem) to 5 (very much a problem)) and is grouped into three subscales: objective strain, subjective externalized strain, and subjective internalized strain. The 3 subscale scores are calculated as the averages of the corresponding individual items, which range in severity from 1 to 5.~Higher scores on each of these subscale scales indicate greater strain. A global strain score is calculated by summing the three subscales (i.e., objective strain, subjective externalized strain, and subjective internalized strain) to provide an indication of the total impact of the special demands on the family. Global strain scores range from 3 to 15. As with the individual subscales, higher scores indicate greater strain" (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionscore (Mean)
Open label baselineWeek 28Week 52Week 104
Rollover From D10503257.95-0.48-0.60-0.63

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Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score

Change from Baseline in CDRS-R Total Score for subjects continued from study D1050326 CDRS-R is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 17 years. It contains 17 ordinally-scaled items that evaluate the presence and severity of symptoms commonly associated with depression in childhood. The CDRS-R is administered separately to the patient and to the caregiver; among 17 items, 14 items are based on separate interviews with child and parent, 3 items are based solely on the rater's observation of child (ie, no questions).The 14 items are rated on a 1 (no psychopathology) to 7 (most psychopathology) scale, where a rating of 3 represents mild psychopathology. The 3 items (sleep disturbance, appetite disturbance, listless speech) are rated on a 1 (no pathology) to 5 (most pathology) scale. The CDRS-R total score ranges from 17-113. In general, higher values of CDRS-R total score represent greater severity of illness (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionunits on a scale (Mean)
Open label baselineWeek 28Week 52Week 104
Rollover From D105032639.2-9.9-13.4-16.4

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Change From Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS)

"Change from Baseline in CY-BOCS for subjects continued from study D1050325 CY-BOCS used in the study is a modification of the Yale-Brown Obsessive Compulsive Scale and contains total 7 items for compulsion. Obsessions section was removed as it is difficult to obtain valid information given typical language/cognitive delays in the population. Each item of the compulsive scale ranges from 0 to 4. At this time, item 1b (compulsion-free interval) and item 6 (peculiarity of the behavior) are not being used in the scoring. Item 7 is a rating for reliability, ranging from 0 (excellent) to 3 (poor). It reflects the interview's judgment regarding the confidence in the data collected hence it is not counted in the CY-BOCS total score. The CY-BOCS compulsion total score is the sums of item 1-5. As a result, the CY-BOCS compulsion total score may range from 0 to 20. In general, higher values of CY-BOCS scores represent greater severity of illness" (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionunits on a scale (Mean)
Open label baselineWeek 28Week 52Week 104
Rollover From D105032510.2-2.2-2.3-3.2

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

Change from Baseline in Clinical Global Impression (CGI) - Severity Score for subjects continued from study D1050325 The CGI-S is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1='Normal, not at all ill' to 7='Among the most extremely ill patients'. A higher score is associated with greater illness severity (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionunits on a scale (Mean)
Open label baselineWeek 28Week 52Week 104
Rollover From D10503253.9-0.43-0.71-0.78

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Change From Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score

Change from Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score for subjects continued from study D1050326 The CGI-BP-S is a three-question clinician-rated assessment of the subject's current illness state (depression, mania, and overall) using a 7-point scale (1(normal, not ill) to 7 (very severely ill)) for each question, where a higher score is associated with greater illness severity. (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionunits on a scale (Mean)
Open label baselineWeek 28Week 52Week 104
Rollover From D10503263.2-1.10-1.36-1.61

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Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score

"Change from Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score for subjects continued from study D1050326 The Children's Global Assessment Scale (CGAS) is a numeric scale (1 through 100) used by mental health clinicians to rate the general functioning of children under the age of 18, where 1 represents the most impaired functioning and 100, superior functioning. Each decile (e.g., 1-10, 11-20) has a descriptive header (e.g., Moderate impairment in functioning in most domains) and examples of behaviors and types of environmental accommodations that might be seen at that level of functioning. Scores above 70 on the CGAS indicate functioning within the range of typically developing children of the same age as the child being rated while scores below 60 indicate a definite clinical case" (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionunits on a scale (Mean)
Open label baselineWeek 28Week 52Week 104
Rollover From D105032661.111.1714.6718.96

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Change From Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score

"Change from Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score for subjects continued from study D1050301 The Children's Global Assessment Scale (CGAS) is a numeric scale (1 through 100) used by mental health clinicians to rate the general functioning of children under the age of 18, where 1 represents the most impaired functioning and 100, superior functioning. Each decile (e.g., 1-10, 11-20) has a descriptive header (e.g., Moderate impairment in functioning in most domains) and examples of behaviors and types of environmental accommodations that might be seen at that level of functioning. Scores above 70 on the CGAS indicate functioning within the range of typically developing children of the same age as the child being rated while scores below 60 indicate a definite clinical case" (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionunits on a scale (Mean)
Open label baselineWeek 28Week 52Week 104
Rollover From D105030155.010.9414.2817.85

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Change From Baseline in PANSS Excitability Subscale Score

Change from Baseline in PANSS Excitability Subscale Score for subjects continued from study D1050301 Subscale of Excitability consists of the following four items from the PANSS: excitement, hostility, uncooperativeness, and poor impulse control. The sum of the four items ranges from 4 to 28 Higher values of PANSS sub-scale scores represent greater severity of illness. (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionunits on a scale (Mean)
Open label baselineWeek 28Week 52week 104
Rollover From D10503019.0-1.3-1.7-2.1

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Change From Baseline in PANSS General Psychopathology Subscale Score

Change from Baseline in PANSS General Psychopathology Subscale Score for subjects continued from study D1050301 The General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation; General psychopathology subscale (range 16-112) is calculated as sum of Items G1 to G16 in the general psychopathology subscale Higher values of PANSS sub-scale scores represent greater severity of illness. (NCT01914393)
Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Interventionunits on a scale (Mean)
Open label baselineWeek 28Week 52Week 104
Rollover From D105030137.5-5.4-7.2-8.7

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Change From Baseline in the YMRS Total Score at Week 6

"YMRS (Young Mania Rating Scale) is a clinician-rated assessment of the severity of mania in subjects with a diagnosis of bipolar disorder.~The YMRS total score ranges from a minimum of 0 to a maximum of 60. For the YMRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The YMRS contains eleven (11) items. The total score is computed as the sum of the scores for the 11 items." (NCT01986101)
Timeframe: Baseline to 6 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-0.51
SM-13496 20 - 60 mg/Day-0.98
SM-13496 80 - 120 mg/Day-0.99

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Change From Baseline in the SDS Total Score at Week 6 (LOCF)

"Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of functional impairment in work/school, social life and family life/home responsibilities.~The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items." (NCT01986101)
Timeframe: Baseline to 6 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-5.7
SM-13496 20 - 60 mg/Day-7.6
SM-13496 80 - 120 mg/Day-6.8

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Change From Baseline in the HAM-A Total Score at Week 6 (LOCF)

"The Hamilton Rating Scale for Anxiety (HAM-A) scale is a rating scale developed to quantify the severity of anxiety symptomatology.~The HAM-A total score ranges from a minimum of 0 to a maximum of 56. For the HAM-A total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The HAM-A contains fourteen (14) items. The total score is computed as the sum of the scores for the 14 items." (NCT01986101)
Timeframe: Baseline to 6 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-5.7
SM-13496 20 - 60 mg/Day-7.4
SM-13496 80 - 120 mg/Day-6.4

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Change From Baseline in the CGI-BP-S (Depression) Score at Week 6

"Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression.~The CGI depression score ranges from a minimum of 1 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome." (NCT01986101)
Timeframe: Baseline to 6 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-1.11
SM-13496 20 - 60 mg/Day-1.51
SM-13496 80 - 120 mg/Day-1.41

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

"Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression.~The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items." (NCT01986101)
Timeframe: Baseline to 6 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-10.6
SM-13496 20 - 60 mg/Day-13.6
SM-13496 80 - 120 mg/Day-12.6

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Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR)

The number and percentage of subjects with at least one adverse event and adverse drug reaction (NCT01986114)
Timeframe: 28, 52 weeks

InterventionParticipants (Count of Participants)
SM-13496 20-120mg (Overall, 28 Weeks)352
SM-13496 20-120mg (Japan, 52 Weeks)169

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Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score

"Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression.~The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items." (NCT01986114)
Timeframe: Baseline, 52 weeks and each month

Interventionunits on a scale (Mean)
SM-13496 20-120mg (Overall, 28 Weeks)-4.4
SM-13496 20-120mg (Japan, 52 Weeks)1.1

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Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score.

"YMRS (Young Mania Rating Scale) is a clinician-rated assessment of the severity of mania in subjects with a diagnosis of bipolar disorder.~The YMRS total score ranges from a minimum of 0 to a maximum of 60. For the YMRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The YMRS contains eleven (11) items. The total score is computed as the sum of the scores for the 11 items." (NCT01986114)
Timeframe: Baseline, 52 weeks and each month

Interventionunits on a scale (Mean)
SM-13496 20-120mg (Overall, 28 Weeks)-1.0
SM-13496 20-120mg (Japan, 52 Weeks)-2.0

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Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder.

The number and percentage of subjects who experienced recurrence/relapse of any mood event from clinical stability of bipolar disorder. (NCT01986114)
Timeframe: Baseline to 52 weeks

InterventionParticipants (Count of Participants)
SM-13496 20-120mg (Overall, 28 Weeks)14
SM-13496 20-120mg (Japan, 52 Weeks)18

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Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores.

Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 6 at the end of treatment. PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. It have 30 evaluation items, which include 7 positive sub-scale, 7 negative sub-scale and 16 general psychopathology sub-scale on a score of 1 to 7. The total score is the sum of the 30 scale items. The minimum score is 30 and the maximum score is 210. Patient with PANSS total scores<70 is the normal,but the scores>120 is more serious. (NCT02002832)
Timeframe: From baseline to Week 6(day 42).

Interventionunits on a scale (Least Squares Mean)
Lurasidone Group-31.2
Risperidone Group-34.9

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Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6.

"The Clinical Global Impression Scale-Improvement (CGI-I) Score is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to baseline state at the beginning of the intervention. Response is rated as one of the following, in which higher scores indicate less improvement or worsening:~1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse." (NCT02002832)
Timeframe: From baseline to Week 6(day 42).

Interventionunits on a scale (Least Squares Mean)
Lurasidone Group2.0
Risperidone Group1.9

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Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) Score as Compared to Placebo.

ADHD-RS total score: changes from baseline over time -ANCOVA-LS Mean and SE for change from baseline are based on ANCOVA. The Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q is a 15-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living, based on the content of the Short From of the Q-LES-Q. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The first 14 items are the same as the General Activities section of the regular Q-LES-Q form and are used to compute the raw score. The PQ-LES-Q-SF percentage maximum possible score is calculated as follows:% Max = 100 × (Raw Score - Minimum Score) / (Maximum Score - Minimum Score),where the Minimum Score equals 14 and the Maximum Score equals 70, and the % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life. (NCT02046369)
Timeframe: baseline and week 6

,
Interventionunits on a scale (Least Squares Mean)
baselineweek 6
Luradisone11.8-2.6
Placebo12.3-2.0

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Change in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score as Compared to Placebo From Double-Blind Baseline to Week 6 (Day 43) Baseline

"CDRS-R total score: changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures.~The CDRS-R total score ranges from 17-113. In general, higher values of CDRS-R total score represent greater severity of illness.~The primary efficacy endpoint will be assessed between the placebo and treatment group." (NCT02046369)
Timeframe: baseline, Week 6

,
Interventionunits on a scale (Least Squares Mean)
baselineweek 6
Luradisone59.2-21.0
Placebo58.6-15.3

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Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Score as Compared to Placebo.

"PQ-LES-Q percentage maximum possible score: changes from baseline over time - mixed model for repeated measures~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures" (NCT02046369)
Timeframe: baseline

,
Interventionunits on a scale (Least Squares Mean)
baselineweek 6
Luradisone49.611.8
Placebo49.77.9

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Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Score as Compared to Placebo.

PARS score: changes from baseline over time - mixed model for repeated measures-LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures.The PARS is a clinician-rated instrument for assessing over time the severity of anxiety symptoms associated with common DSM-IV anxiety disorders in children ages 6-17 years. The PARS is administered separately to the subject and to the caregiver. The instrument has 2 sections. The first section includes a 50-item symptom checklist, which the clinician rates as present or absent during the past week. The second section is comprised of 7 severity impairment items reflecting the severity/impairment of all symptoms endorsed in Section 1 of the PARS (during the past week). Each question is answered on a 0-5 Likert scale (0 for none, and 1-5 for minimal to extreme) with alternative responses of 8=Not Applicable and 9=Does Not Know. The PAR total score over all 7 questions ranges in value from 0 to 35. (NCT02046369)
Timeframe: baseline and week 6

,
Interventionunits on a scale (Least Squares Mean)
baselineweek 6
Luradisone10.9-3.4
Placebo11.5-2.3

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Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score as Compared to Placebo.

CGAS Score: changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures (NCT02046369)
Timeframe: baseline and week 6

,
Interventionunits on a scale (Least Squares Mean)
baselineweek 6
Luradisone48.814.0
Placebo49.59.3

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Change From Baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) Depression Score

Change from baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) depression score changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures.The CGI-BP-S is a three-question clinician-rated assessment of the subject's current illness state (depression, mania, and overall) using a 7-point scale (1(normal, not ill) to 7 (very severely ill)) for each question, where a higher score is associated with greater illness severity. (NCT02046369)
Timeframe: baseline and week 6

,
Interventionunits on a scale (Least Squares Mean)
baselineweek 6
Luradisone4.6-1.49
Placebo4.5-1.05

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Lurasidone Tmax

Tmax：Time to maximum (peak) drug serum concentration (NCT02174510)
Timeframe: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

Interventionh (Median)
20mg Lurasidone2.00
40mg Lurasidone2.00
80mg Lurasidone1.50

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Lurasidone CL/F

CL/F：Apparent total clearance. (NCT02174510)
Timeframe: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

InterventionL/h (Geometric Mean)
20mg Lurasidone187
40mg Lurasidone231
80mg Lurasidone212

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Lurasidone Cmax

Cmax：Maximum (peak) observed drug serum concentration. (NCT02174510)
Timeframe: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

Interventionng/ml (Geometric Mean)
20mg Lurasidone32.9
40mg Lurasidone50.9
80mg Lurasidone113

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Lurasidone MRT

MRT：Mean residence time. (NCT02174510)
Timeframe: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

Interventionh (Geometric Mean)
20mg Lurasidone13.2
40mg Lurasidone11.1
80mg Lurasidone11.7

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Lurasidone t1/2

t1/2 :Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve (NCT02174510)
Timeframe: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

Interventionh (Geometric Mean)
20mg Lurasidone25.5
40mg Lurasidone18.1
80mg Lurasidone18.1

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Lurasidone VZ/F

VZ/F: Apparent volume of distribution at terminal phase (correlated with λz) (NCT02174510)
Timeframe: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

InterventionL (Geometric Mean)
20mg Lurasidone6887
40mg Lurasidone6022
80mg Lurasidone5523

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Lurasidone λZ

λZ：Elimination rate constant (NCT02174510)
Timeframe: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

Intervention1/h (Geometric Mean)
20mg Lurasidone0.0271
40mg Lurasidone0.0383
80mg Lurasidone0.0383

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Lurasidone AUC

AUC：Area under the serum concentration-time curve (NCT02174510)
Timeframe: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

,,
Interventionng･h/mL (Geometric Mean)
AUC0-24AUC0-tAUC0-∞
20mg Lurasidone90.397.9107
40mg Lurasidone151163174
80mg Lurasidone322353378

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Lurasidone Vzss/F

(NCT02174523)
Timeframe: Day 8

InterventionL (Geometric Mean)
40mg Lurasidone10618

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Lurasidone λz

(NCT02174523)
Timeframe: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8

Intervention1/h (Geometric Mean)
40mg Lurasidone0.0199

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Lurasidone λz

(NCT02174523)
Timeframe: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

Intervention1/h (Geometric Mean)
40mg Lurasidone0.0360

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Accumulation Ratios Lurasidone,Ratio of Cmax,Ratio of AUC0-∞,Ratio of AUC0-τ,

(NCT02174523)
Timeframe: Day 8/Day 1

InterventionRatios (Mean)
Ratio of CmaxRatio of AUC0-∞Ratio of AUC0-τRatio of Cτ
40mg Lurasidone0.941.741.252.52

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Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 4 and Day 5

(NCT02174523)
Timeframe: Pre-dose (-0.5h) of Day4 and Day5

Interventionng/ml (Geometric Mean)
Day4 Pre-dose (-0.5h)Day5Pre-dose (-0.5h)
40mg Lurasidone0.2771.15

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Lurasidone AUC0-∞

(NCT02174523)
Timeframe: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

Interventionng･h/mL (Geometric Mean)
40mg Lurasidone179

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Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 6 and Day 7

(NCT02174523)
Timeframe: Pre-dose (-0.5h) of Day6 and Day7

Interventionng/ml (Geometric Mean)
Day6 Pre-dose (-0.5h)Day7 Pre-dose (-0.5h)
40mg Lurasidone1.562.00

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Lurasidone Vz/F

(NCT02174523)
Timeframe: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

InterventionL (Geometric Mean)
40mg Lurasidone6198

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CLss/F

(NCT02174523)
Timeframe: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8

InterventionL/h (Geometric Mean)
40mg Lurasidone211

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Lurasidone AUC 0-24

(NCT02174523)
Timeframe: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8

Interventionng･h/mL (Geometric Mean)
40mg Lurasidone190

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Lurasidone AUC 0-24

(NCT02174523)
Timeframe: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

Interventionng･h/mL (Geometric Mean)
40mg Lurasidone152

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Lurasidone AUC 0-τ

(NCT02174523)
Timeframe: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8

Interventionng･h/mL (Geometric Mean)
40mg Lurasidone234

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Lurasidone AUC 0-τ

(NCT02174523)
Timeframe: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

Interventionng･h/mL (Geometric Mean)
40mg Lurasidone166

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Lurasidone AUC0-∞

(NCT02174523)
Timeframe: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8

Interventionng･h/mL (Geometric Mean)
40mg Lurasidone314

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Lurasidone CL/F

(NCT02174523)
Timeframe: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

InterventionL/h (Geometric Mean)
40mg Lurasidone223

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Lurasidone Cmax

Maximum (peak) observed drug serum concentration. (NCT02174523)
Timeframe: Day8

Interventionng/mL (Geometric Mean)
40mg Lurasidone48.5

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Lurasidone Cmax

Maximum (peak) observed drug serum concentration. (NCT02174523)
Timeframe: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

Interventionng/mL (Geometric Mean)
40mg Lurasidone50.2

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Lurasidone MRT

(NCT02174523)
Timeframe: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8

Interventionh (Geometric Mean)
40mg Lurasidone22.0

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Lurasidone MRT

(NCT02174523)
Timeframe: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

Interventionh (Geometric Mean)
40mg Lurasidone12.2

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Lurasidone t1/2

(NCT02174523)
Timeframe: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8

Interventionh (Geometric Mean)
40mg Lurasidone34.9

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Lurasidone t1/2

(NCT02174523)
Timeframe: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

Interventionh (Geometric Mean)
40mg Lurasidone19.3

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Lurasidone Tmax

(NCT02174523)
Timeframe: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8

Interventionh (Median)
40mg Lurasidone1.75

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Lurasidone Tmax

(NCT02174523)
Timeframe: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

Interventionh (Median)
40mg Lurasidone1.50

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Brief Assessments of Cognition in Schizophrenia Scores (BACS)

"Mean of cognition was assessed by BACS, which measures neurocognitive function in schizophrenia. BACs is a validated, composite measure of cognition which is used in schizophrenia. It is composed of Verbal memory (range: 0-75), Working memory (range: 0-28), Motor speed (range: 0-100), Verbal Fluency (number of words generated), Information processing (range: 0-110) and Executive functions (range: 0-22).~Higher z-scores indicate a better performance and outcome. BACS composite score are represented as z-scores which can be positive or negative. There is no minimum or maximum as this is a continuous measure." (NCT02199743)
Timeframe: Baseline and 4 weeks

,
InterventionBACS composite score (z score) (Mean)
Baseline (week 0)week 4
Lurasidone-1.596573107-2.002433521
Non-Lurasidone-1.933853656-1.500292967

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Cerebral Glutamate Levels

"Mean values of cerebral glutamate levels was measured by high resolution 3T magnetic resonance spectroscopy (MRS) in the anterior cingulate cortex (ACC). Data were acquired from the dorsal anterior cingulate cortex (ACC) using single voxel localized PRESS (TE1, TE2) = (32, 65) ms with an 8-channel head coil in a 3T whole-body scanner (Philips Medical Systems). Voxel size was 30x20x15 mm3 (9 mL) and were placed over the bilateral anterior cingulate cortex (ACC). All values are normalized to water.~More negative values represent less cerebral glutamate levels." (NCT02199743)
Timeframe: Baseline and 4 weeks

,
Interventionrelative unit (RU as compared to water) (Mean)
Baseline (week 0)week 4
Lurasidone-1.434662171-1.412294235
Non-Lurasidone-1.933853656-1.838991525

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Montgomery-Asberg Rating Scale for Depression (MADRS)

"The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression.~Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe)." (NCT02239094)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Lurasidone (Latuda)24.3

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Montgomery-Asberg Rating Scale for Depression (MADRS) at Week8

"The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression.~Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe)." (NCT02239094)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Lurasidone (Latuda)8

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BDM Score (BISS-derived MADRS) Change From Baseline at Day 42

"The study will measure the difference on BISS-derived MADRS score between NRX-101 and lurasidone (comparator) groups. The Bipolar Inventory of Symptom Scale (BISS) is a validated 42-item clinician-rated scale (21 items each for the depression and mania subscales) in which each item is rated on a 0-4 severity scale where higher values indicate worse severity.~BISS-derived MADRS (BDM): MADRS is a 10-item clinician-rated scale, with each item rated on a 0-6 severity scale, where a higher number indicates worse severity. Responses to each question are equally weighted and summed. The BDM has a minimum score of 0 and a maximum of 40, where higher scores indicate a worse severity, therefore decreases in average BDM are considered a better outcome. Data are presented as mean change from baseline (end of stage 1, Day 1) using LOCF" (NCT02974010)
Timeframe: Day 42

,,,
Interventionscore on a scale (Least Squares Mean)
Day 2Day 7Day 14Day 21Day 28Day 35Day 42
Ketamine Followed by Lurasidone2.44.811.410.011.210.811.0
Ketamine Followed by NRX-1013.32.02.24.53.52.83.7
Saline Followed by Lurasidone0000000
Saline Followed by NRX-101-1.06-0.50.311.01.691.750.38

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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 Simpson Angus Scale (SAS) Values

SAS scale consists of 10 items including 7 items that address bradykinesia-rigidity and additional single items for tremor, glabellar tap, and salivation. Each item represents a specific physical condition and is rated on a 5-point category rating scale ranging from 0 (complete absence of the condition) to 4 (the condition is present to an extreme degree).The total score is obtained by adding the scores for the 10 individual items making the maximum possible score is 40. Higher scores are indicative of more severe Parkinsonian-type symptoms. (NCT03557931)
Timeframe: Baseline, week 6 and week 12

,,
Interventionparticipants (Number)
BaselineWeek 6Week 12
ASP4345 150 mg000
ASP4345 50 mg000
Placebo000

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Number of Participants With Clinically Significant Differences in Barnes Akathisia Rating Scale (BARS) Values

BARS is used to rate observable, restless movements of drug induced akathisia and subjective awareness of restlessness and any distress associated with the akathisia. BARS consists of the following 4 items: objective assessment of akathisia symptoms, subjective assessment of the participants's awareness of inner restlessness, distress restlessness, and global clinical assessment of akathisia. First three items are rated on a 4-point scale ranging from 0 (no abnormal movements or absence of inner restlessness or no distress) to 3 (severe akathisia or awareness of intense compulsion to move most of the time or severe distress). The last item, the global clinical assessment of akathisia, is rated on a 6-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Total BARS score ranges from 0 to 14 with a higher score representing worse results. (NCT03557931)
Timeframe: Baseline, week 6 and week 12

,,
Interventionparticipants (Number)
BaselineWeek 6Week 12
ASP4345 150 mg000
ASP4345 50 mg000
Placebo000

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Number of Participants With Clinically Significant Differences in Abnormal Involuntary Movement Scale (AIMS) Values

AIMS is a 14-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant's incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 to 14 are yes/no questions regarding the global judgement and dental status of the participant. The total score is the sum of the scores for the 14 items and the possible total score ranges from 0 to 44. A higher total score is indicative of more severe dyskinetic movements. (NCT03557931)
Timeframe: Baseline, week 6 and week 12

,,
Interventionparticipants (Number)
BaselineWeek 6Week 12
ASP4345 150 mg000
ASP4345 50 mg000
Placebo000

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Number of Participants With Clinically Significant Differences in Columbia-Suicide Severity Rating Scale (C-SSRS) Values

The C-SSRS is a questionnaire used for suicide risk assessment. Affirmative or negative responses are provided to items 1 to 5 for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods [not plan] without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and items 6 to 10 for suicide behavior (6. Preparatory acts or behavior, 7. Aborted attempt, 8. Interrupted attempt, 9. Actual attempt, 10. Completed suicide). (NCT03557931)
Timeframe: Baseline up to EoS (week 14)

Interventionparticipants (Number)
Placebo0
ASP4345 50 mg0
ASP4345 150 mg0

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Change From Baseline to Week 12/EoT in University of California San Diego Performance-based Skills Assessment-2 Extended Range (UPSA-2-ER) Total Score

The UPSA-2-ER assesses the functional abilities of the participant with schizophrenia in 6 domains: household management, communication, financial skills, transportation, comprehension/planning and medication management. The UPSA-2-ER total score has a range from 0 to 105. A higher score indicates less impairment. (NCT03557931)
Timeframe: Baseline and week 12/EoT

Interventionunits on a scale (Least Squares Mean)
Placebo3.11
ASP4345 50 mg3.86
ASP4345 150 mg2.56

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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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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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Area Under the Curve From Time 0 to Time of Last Quantifiable Concentration [AUC0-last] for Lurasidone After Lurasidone Injectable Suspension Administration

The area Under the Curve from time 0 to time of last quantifiable concentration [AUC0-last] for lurasidone after lurasidone injectable suspension administration (NCT03627195)
Timeframe: Day 61

Interventionng*h/mL (Geometric Mean)
Lurasidone 30 mg628
Lurasidone 75 mg2000
Lurasidone 150 mg3540
Lurasidone 300 mg4910
Lurasidone 450 mg7490
Placebo0

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Maximum Serum Concentration [Cmax] for Lurasidone After Lurasidone Injectable Suspension Administration

The maximum Serum Concentration [Cmax] for lurasidone after lurasidone injectable suspension administration (NCT03627195)
Timeframe: Day 61

Interventionng/mL (Geometric Mean)
Lurasidone 30 mg1.08
Lurasidone 75 mg3.90
Lurasidone 150 mg5.08
Lurasidone 300 mg8.85
Lurasidone 450 mg9.50
Placebo0

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Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs ) Leading to Study Discontinuation

Number of subjects with any Adverse Events (AEs), serious adverse events (SAEs), and Adverse Events (AEs ) leading to study discontinuation (NCT03627195)
Timeframe: Day 61

,,,,,
Interventioncount of participants (Number)
Incidence of AEsIncidence of SAEsIncidence of AEs leading to study discontinuation
Lurasidone 150 mg200
Lurasidone 30 mg400
Lurasidone 300 mg400
Lurasidone 450 mg500
Lurasidone 75 mg400
Placebo500

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Montgomery Asberg Depression Rating Scale

Measures severity of depression symptoms; Scale from 0 to 54; higher numbers mean greater depression severity, so a decrease in score is a better outcome. (NCT03902613)
Timeframe: 15 minutes

Interventionunits on a scale (Mean)
Lurasidone34

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SubstanceRelationship StrengthStudiesTrialsClassesRoles
gamma-aminobutyric acid
gamma-Aminobutyric Acid: The most common inhibitory neurotransmitter in the central nervous system.. gamma-aminobutyric acid : A gamma-amino acid that is butanoic acid with the amino substituent located at C-4.		2.1710amino acid zwitterion;
gamma-amino acid;
monocarboxylic acid		human metabolite;
neurotransmitter;
Saccharomyces cerevisiae metabolite;
signalling molecule
glycerol
Moon: The natural satellite of the planet Earth. It includes the lunar cycles or phases, the lunar month, lunar landscapes, geography, and soil.		2.1310alditol;
triol		algal metabolite;
detergent;
Escherichia coli metabolite;
geroprotector;
human metabolite;
mouse metabolite;
osmolyte;
Saccharomyces cerevisiae metabolite;
solvent
histamine
[no description available]		2.1710aralkylamino compound;
imidazoles		human metabolite;
mouse metabolite;
neurotransmitter
urea
pseudourea: clinical use; structure. isourea : A carboximidic acid that is the imidic acid tautomer of urea, H2NC(=NH)OH, and its hydrocarbyl derivatives.		2.0710isourea;
monocarboxylic acid amide;
one-carbon compound		Daphnia magna metabolite;
Escherichia coli metabolite;
fertilizer;
flour treatment agent;
human metabolite;
mouse metabolite;
Saccharomyces cerevisiae metabolite
dan 2163
[no description available]		2.610aromatic amide;
aromatic amine;
benzamides;
pyrrolidines;
sulfone		environmental contaminant;
second generation antipsychotic;
xenobiotic
caffeine
[no description available]		2.1110purine alkaloid;
trimethylxanthine		adenosine A2A receptor antagonist;
adenosine receptor antagonist;
adjuvant;
central nervous system stimulant;
diuretic;
EC 2.7.11.1 (non-specific serine/threonine protein kinase) inhibitor;
EC 3.1.4.* (phosphoric diester hydrolase) inhibitor;
environmental contaminant;
food additive;
fungal metabolite;
geroprotector;
human blood serum metabolite;
mouse metabolite;
mutagen;
plant metabolite;
psychotropic drug;
ryanodine receptor agonist;
xenobiotic
chlorpromazine
Chlorpromazine: The prototypical phenothiazine antipsychotic drug. Like the other drugs in this class chlorpromazine's antipsychotic actions are thought to be due to long-term adaptation by the brain to blocking DOPAMINE RECEPTORS. Chlorpromazine has several other actions and therapeutic uses, including as an antiemetic and in the treatment of intractable hiccup.. chlorpromazine : A substituted phenothiazine in which the ring nitrogen at position 10 is attached to C-3 of an N,N-dimethylpropanamine moiety.		2.0810organochlorine compound;
phenothiazines;
tertiary amine		anticoronaviral agent;
antiemetic;
dopaminergic antagonist;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor;
phenothiazine antipsychotic drug
citalopram
Citalopram: A furancarbonitrile that is one of the serotonin uptake inhibitors used as an antidepressant. The drug is also effective in reducing ethanol uptake in alcoholics and is used in depressed patients who also suffer from TARDIVE DYSKINESIA in preference to tricyclic antidepressants, which aggravate dyskinesia.. citalopram : A racemate comprising equimolar amounts of (R)-citalopram and its enantiomer, escitalopram. It is used as an antidepressant, although only escitalopram is active.. 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile : A nitrile that is 1,3-dihydro-2-benzofuran-5-carbonitrile in which one of the hydrogens at position 1 is replaced by a p-fluorophenyl group, while the other is replaced by a 3-(dimethylamino)propyl group.		2.31102-benzofurans;
cyclic ether;
nitrile;
organofluorine compound;
tertiary amino compound
valproic acid
Valproic Acid: A fatty acid with anticonvulsant and anti-manic properties that is used in the treatment of EPILEPSY and BIPOLAR DISORDER. The mechanisms of its therapeutic actions are not well understood. It may act by increasing GAMMA-AMINOBUTYRIC ACID levels in the brain or by altering the properties of VOLTAGE-GATED SODIUM CHANNELS.. valproic acid : A branched-chain saturated fatty acid that comprises of a propyl substituent on a pentanoic acid stem.		13.332410branched-chain fatty acid;
branched-chain saturated fatty acid		anticonvulsant;
antimanic drug;
EC 3.5.1.98 (histone deacetylase) inhibitor;
GABA agent;
neuroprotective agent;
psychotropic drug;
teratogenic agent
fluoxetine
Fluoxetine: The first highly specific serotonin uptake inhibitor. It is used as an antidepressant and often has a more acceptable side-effects profile than traditional antidepressants.. fluoxetine : A racemate comprising equimolar amounts of (R)- and (S)-fluoxetine. A selective serotonin reuptake inhibitor (SSRI), it is used (generally as the hydrochloride salt) for the treatment of depression (and the depressive phase of bipolar disorder), bullimia nervosa, and obsessive-compulsive disorder.. N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine : An aromatic ether consisting of 4-trifluoromethylphenol in which the hydrogen of the phenolic hydroxy group is replaced by a 3-(methylamino)-1-phenylpropyl group.		6.95120(trifluoromethyl)benzenes;
aromatic ether;
secondary amino compound
haloperidol
Haloperidol: A phenyl-piperidinyl-butyrophenone that is used primarily to treat SCHIZOPHRENIA and other PSYCHOSES. It is also used in schizoaffective disorder, DELUSIONAL DISORDERS, ballism, and TOURETTE SYNDROME (a drug of choice) and occasionally as adjunctive therapy in INTELLECTUAL DISABILITY and the chorea of HUNTINGTON DISEASE. It is a potent antiemetic and is used in the treatment of intractable HICCUPS. (From AMA Drug Evaluations Annual, 1994, p279). haloperidol : A compound composed of a central piperidine structure with hydroxy and p-chlorophenyl substituents at position 4 and an N-linked p-fluorobutyrophenone moiety.		6.0541aromatic ketone;
hydroxypiperidine;
monochlorobenzenes;
organofluorine compound;
tertiary alcohol		antidyskinesia agent;
antiemetic;
dopaminergic antagonist;
first generation antipsychotic;
serotonergic antagonist
imipramine
Imipramine: The prototypical tricyclic antidepressant. It has been used in major depression, dysthymia, bipolar depression, attention-deficit disorders, agoraphobia, and panic disorders. It has less sedative effect than some other members of this therapeutic group.. imipramine : A dibenzoazepine that is 5H-dibenzo[b,f]azepine substituted by a 3-(dimethylamino)propyl group at the nitrogen atom.		2.1310dibenzoazepineadrenergic uptake inhibitor;
antidepressant;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor
ketamine
Ketamine: A cyclohexanone derivative used for induction of anesthesia. Its mechanism of action is not well understood, but ketamine can block NMDA receptors (RECEPTORS, N-METHYL-D-ASPARTATE) and may interact with sigma receptors.. ketamine : A member of the class of cyclohexanones in which one of the hydrogens at position 2 is substituted by a 2-chlorophenyl group, while the other is substituted by a methylamino group.		3.5920cyclohexanones;
monochlorobenzenes;
secondary amino compound		analgesic;
environmental contaminant;
intravenous anaesthetic;
neurotoxin;
NMDA receptor antagonist;
xenobiotic
ketanserin
Ketanserin: A selective serotonin receptor antagonist with weak adrenergic receptor blocking properties. The drug is effective in lowering blood pressure in essential hypertension. It also inhibits platelet aggregation. It is well tolerated and is particularly effective in older patients.. ketanserin : A member of the class of quinazolines that is quinazoline-2,4(1H,3H)-dione which is substituted at position 3 by a 2-[4-(p-fluorobenzoyl)piperidin-1-yl]ethyl group.		2.0810aromatic ketone;
organofluorine compound;
piperidines;
quinazolines		alpha-adrenergic antagonist;
antihypertensive agent;
cardiovascular drug;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor;
serotonergic antagonist
ketoconazole
1-acetyl-4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine : A dioxolane that is 1,3-dioxolane which is substituted at positions 2, 2, and 4 by imidazol-1-ylmethyl, 2,4-dichlorophenyl, and [para-(4-acetylpiperazin-1-yl)phenoxy]methyl groups, respectively.		3.1910dichlorobenzene;
dioxolane;
ether;
imidazoles;
N-acylpiperazine;
N-arylpiperazine
lamotrigine
[no description available]		6.11701,2,4-triazines;
dichlorobenzene;
primary arylamine		anticonvulsant;
antidepressant;
antimanic drug;
calcium channel blocker;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor;
environmental contaminant;
excitatory amino acid antagonist;
geroprotector;
non-narcotic analgesic;
xenobiotic
loxapine
Loxapine: An antipsychotic agent used in SCHIZOPHRENIA.		2.3110dibenzooxazepineantipsychotic agent;
dopaminergic antagonist
mecamylamine
Mecamylamine: A nicotinic antagonist that is well absorbed from the gastrointestinal tract and crosses the blood-brain barrier. Mecamylamine has been used as a ganglionic blocker in treating hypertension, but, like most ganglionic blockers, is more often used now as a research tool.		2.1310primary aliphatic amine
methylphenidate
Methylphenidate: A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.. methylphenidate : A racemate comprising equimolar amounts of the two threo isomers of methyl phenyl(piperidin-2-yl)acetate. A central stimulant and indirect-acting sympathomimetic, is used (generally as the hydrochloride salt) in the treatment of hyperactivity disorders in children and for the treatment of narcolepsy.. methyl phenyl(piperidin-2-yl)acetate : A amino acid ester that is methyl phenylacetate in which one of the hydrogens alpha to the carbonyl group is replaced by a piperidin-2-yl group.		3.1810beta-amino acid ester;
methyl ester;
piperidines
modafinil
Modafinil: A benzhydryl acetamide compound, central nervous system stimulant, and CYP3A4 inducing agent that is used in the treatment of NARCOLEPSY and SLEEP WAKE DISORDERS.. modafinil : A racemate comprising equimolar amounts of armodafinil and (S)-modafinil. A central nervous system stimulant, it is used for the treatment of sleeping disorders such as narcolepsy, obstructive sleep apnoea, and shift-work sleep disorder. The optical enantiomers of modafinil have similar pharmacological actions in animals.. 2-[(diphenylmethyl)sulfinyl]acetamide : A sulfoxide that is dimethylsulfoxide in which two hydrogens attached to one of the methyl groups are replaced by phenyl groups, while one hydrogen attached to the other methyl group is replaced by a carbamoyl (aminocarbonyl) group.		4.1120monocarboxylic acid amide;
sulfoxide
risperidone
Risperidone: A selective blocker of DOPAMINE D2 RECEPTORS and SEROTONIN 5-HT2 RECEPTORS that acts as an atypical antipsychotic agent. It has been shown to improve both positive and negative symptoms in the treatment of SCHIZOPHRENIA.. risperidone : A member of the class of pyridopyrimidines that is 2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one carrying an additional 2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl group at position 2.		12.251971,2-benzoxazoles;
heteroarylpiperidine;
organofluorine compound;
pyridopyrimidine		alpha-adrenergic antagonist;
dopaminergic antagonist;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor;
H1-receptor antagonist;
psychotropic drug;
second generation antipsychotic;
serotonergic antagonist
rofecoxib
[no description available]		2.0610butenolide;
sulfone		analgesic;
cyclooxygenase 2 inhibitor;
non-steroidal anti-inflammatory drug
sucrose
Saccharum: A plant genus of the family POACEAE widely cultivated in the tropics for the sweet cane that is processed into sugar.		2.4110glycosyl glycosidealgal metabolite;
Escherichia coli metabolite;
human metabolite;
mouse metabolite;
osmolyte;
Saccharomyces cerevisiae metabolite;
sweetening agent
carbostyril
Quinolones: A group of derivatives of naphthyridine carboxylic acid, quinoline carboxylic acid, or NALIDIXIC ACID.. quinolin-2(1H)-one : A quinolone that is 1,2-dihydroquinoline substituted by an oxo group at position 2.		8.53121monohydroxyquinoline;
quinolone		bacterial xenobiotic metabolite
acetonitrile
acetonitrile: RN given refers to unlabeled cpd. acetonitrile : A nitrile that is hydrogen cyanide in which the hydrogen has been replaced by a methyl group.		2.0610aliphatic nitrile;
volatile organic compound		EC 3.5.1.4 (amidase) inhibitor;
NMR chemical shift reference compound;
polar aprotic solvent
phencyclidine
Phencyclidine: A hallucinogen formerly used as a veterinary anesthetic, and briefly as a general anesthetic for humans. Phencyclidine is similar to KETAMINE in structure and in many of its effects. Like ketamine, it can produce a dissociative state. It exerts its pharmacological action through inhibition of NMDA receptors (RECEPTORS, N-METHYL-D-ASPARTATE). As a drug of abuse, it is known as PCP and Angel Dust.. phencyclidine : A member of the class of piperidines that is piperidine in which the nitrogen is substituted with a 1-phenylcyclohexyl group. Formerly used as an anaesthetic agent, it exhibits both hallucinogenic and neurotoxic effects.		3.7290benzenes;
piperidines		anaesthetic;
neurotoxin;
NMDA receptor antagonist;
psychotropic drug
pyrroles
1H-pyrrole : A tautomer of pyrrole that has the double bonds at positions 2 and 4.. pyrrole : A five-membered monocyclic heteroarene comprising one NH and four CH units which forms the parent compound of the pyrrole group of compounds. Its five-membered ring structure has three tautomers. A 'closed class'.. azole : Any monocyclic heteroarene consisting of a five-membered ring containing nitrogen. Azoles can also contain one or more other non-carbon atoms, such as nitrogen, sulfur or oxygen.		2.5220pyrrole;
secondary amine
thiophenes
Thiophenes: A monocyclic heteroarene furan in which the oxygen atom is replaced by a sulfur.. thiophenes : Compounds containing at least one thiophene ring.		5.3580mancude organic heteromonocyclic parent;
monocyclic heteroarene;
thiophenes;
volatile organic compound		non-polar solvent
pregnenolone
[no description available]		2.171020-oxo steroid;
3beta-hydroxy-Delta(5)-steroid;
C21-steroid		human metabolite;
mouse metabolite
quinazolines
Quinazolines: A group of aromatic heterocyclic compounds that contain a bicyclic structure with two fused six-membered aromatic rings, a benzene ring and a pyrimidine ring.. quinazoline : A mancude organic heterobicyclic parent that is naphthalene in which the carbon atoms at positions 1 and 3 have been replaced by nitrogen atoms.. quinazolines : Any organic heterobicyclic compound based on a quinazoline skeleton and its substituted derivatives.		2.0710azaarene;
mancude organic heterobicyclic parent;
ortho-fused heteroarene;
quinazolines
isoxazoles
Isoxazoles: Azoles with an OXYGEN and a NITROGEN next to each other at the 1,2 positions, in contrast to OXAZOLES that have nitrogens at the 1,3 positions.. isoxazole : A monocyclic heteroarene with a structure consisting of a 5-membered ring containing three carbon atoms and an oxygen and nitrogen atom adjacent to each other. It is the parent of the class of isoxazoles.. isoxazoles : Oxazoles in which the N and O atoms are adjacent.		7.06140isoxazoles;
mancude organic heteromonocyclic parent;
monocyclic heteroarene
thiazoles
[no description available]		18.38109281,3-thiazoles;
mancude organic heteromonocyclic parent;
monocyclic heteroarene
hydrazine
diamine : Any polyamine that contains two amino groups.		2.4110azane;
hydrazines		EC 4.3.1.10 (serine-sulfate ammonia-lyase) inhibitor
alpha-aminopyridine
alpha-aminopyridine: RN given refers to parent cpd; structure in Merck Index, 9th ed, #485. aminopyridine : Compounds containing a pyridine skeleton substituted by one or more amine groups.		2.0710
lithium carbonate
Lithium Carbonate: A lithium salt, classified as a mood-stabilizing agent. Lithium ion alters the metabolism of BIOGENIC MONOAMINES in the CENTRAL NERVOUS SYSTEM, and affects multiple neurotransmission systems.		5.8722carbonate salt;
lithium salt		antimanic drug
s,n,n'-tripropylthiocarbamate
Reward: An object or a situation that can serve to reinforce a response, to satisfy a motive, or to afford pleasure.. vernolate : A monounsaturated fatty acid anion that is the conjugate base of vernolic acid, obtained by deprotonation of the carboxy group; major species at pH 7.3.		3.5911tertiary amine
pimozide
Pimozide: A diphenylbutylpiperidine that is effective as an antipsychotic agent and as an alternative to HALOPERIDOL for the suppression of vocal and motor tics in patients with Tourette syndrome. Although the precise mechanism of action is unknown, blockade of postsynaptic dopamine receptors has been postulated. (From AMA Drug Evaluations Annual, 1994, p403). pimozide : A member of the class of benzimidazoles that is 1,3-dihydro-2H-benzimidazol-2-one in which one of the nitrogens is substituted by a piperidin-4-yl group, which in turn is substituted on the nitrogen by a 4,4-bis(p-fluorophenyl)butyl group.		3.1810benzimidazoles;
heteroarylpiperidine;
organofluorine compound		antidyskinesia agent;
dopaminergic antagonist;
first generation antipsychotic;
H1-receptor antagonist;
serotonergic antagonist
molindone
Molindone: An indole derivative effective in schizophrenia and other psychoses and possibly useful in the treatment of the aggressive type of undersocialized conduct disorder. Molindone has much lower affinity for D2 receptors than most antipsychotic agents and has a relatively low affinity for D1 receptors. It has only low to moderate affinity for cholinergic and alpha-adrenergic receptors. Some electrophysiologic data from animals indicate that molindone has certain characteristics that resemble those of CLOZAPINE. (From AMA Drug Evaluations Annual, 1994, p283)		3.5110indoles
glutamic acid
Glutamic Acid: A non-essential amino acid naturally occurring in the L-form. Glutamic acid is the most common excitatory neurotransmitter in the CENTRAL NERVOUS SYSTEM.. glutamic acid : An alpha-amino acid that is glutaric acid bearing a single amino substituent at position 2.		3.350glutamic acid;
glutamine family amino acid;
L-alpha-amino acid;
proteinogenic amino acid		Escherichia coli metabolite;
ferroptosis inducer;
micronutrient;
mouse metabolite;
neurotransmitter;
nutraceutical
diltiazem
Diltiazem: A benzothiazepine derivative with vasodilating action due to its antagonism of the actions of CALCIUM ion on membrane functions.. diltiazem : A 5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl acetate in which both stereocentres have S configuration. A calcium-channel blocker and vasodilator, it is used as the hydrochloride in the management of angina pectoris and hypertension.		3.19105-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl acetateantihypertensive agent;
calcium channel blocker;
vasodilator agent
sertindole
sertindole : A phenylindole that is 1H-indole which is substituted on the nitrogen by a p-chlorophenyl group, at position 5 by chlorine, and at position 3 by a piperidin-4-yl group, which is itself substituted on the nitrogen by a 2-(2-oxoimidazolidin-1-yl)ethyl group.		3.3510heteroarylpiperidine;
imidazolidinone;
organochlorine compound;
organofluorine compound;
phenylindole		alpha-adrenergic antagonist;
H1-receptor antagonist;
second generation antipsychotic;
serotonergic antagonist
aripiprazole
Aripiprazole: A piperazine and quinolone derivative that is used primarily as an antipsychotic agent. It is a partial agonist of SEROTONIN RECEPTOR, 5-HT1A and DOPAMINE D2 RECEPTORS, where it also functions as a post-synaptic antagonist, and an antagonist of SEROTONIN RECEPTOR, 5-HT2A. It is used for the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER, and as an adjunct therapy for the treatment of depression.. aripiprazole : An N-arylpiperazine that is piperazine substituted by a 4-[(2-oxo-1,2,3,4-tetrahydroquinolin-7-yl)oxy]butyl group at position 1 and by a 2,3-dichlorophenyl group at position 4. It is an antipsychotic drug used for the treatment of Schizophrenia, and other mood disorders.		9.92211aromatic ether;
delta-lactam;
dichlorobenzene;
N-alkylpiperazine;
N-arylpiperazine;
quinolone		drug metabolite;
H1-receptor antagonist;
second generation antipsychotic;
serotonergic agonist
ziprasidone
ziprasidone: a benzisothiazoylpiperazine derivative; has combined dopamine and serotonin receptor antagonist activity; structurally related to tiospirone. 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.		9.681331,2-benzisothiazole;
indolones;
organochlorine compound;
piperazines		antipsychotic agent;
dopaminergic antagonist;
histamine antagonist;
muscarinic antagonist;
psychotropic drug;
serotonergic antagonist
3-aminoisobutyric acid
3-aminoisobutyric acid: RN given refers to cpd without isomeric designation. 3-aminoisobutyric acid : A beta-amino-acid that is isobutyric acid in which one of the methyl hydrogens is substituted by an amino group.		2.610amino acid zwitterion;
beta-amino acid		metabolite
cephalosporin c
cephalosporin C: RN given refers to parent cpd; structure in Merck, 9th ed, #1937. cephalosporin C : A cephalosporin antibiotic carrying a 3-acetoxymethyl substituent and a 6-oxo-N(6)-L-lysino group at position 7.		2.0710cephalosporinfungal metabolite
triazoles
Triazoles: Heterocyclic compounds containing a five-membered ring with two carbon atoms and three nitrogen atoms with the molecular formula C2H3N3.. triazoles : An azole in which the five-membered heterocyclic aromatic skeleton contains three N atoms and two C atoms.		3.98211,2,3-triazole
hp 873
iloperidone: an atypical, negative symptom antipsychotic agent. iloperidone : A member of the class of piperidines that is the 4-acetyl-2-methoxyphenyl ether of 3-(piperidin-1-yl)propan-1-ol which is substituted at position 4 of the piperidine ring by a 6-fluoro-1,2-benzoxazol-3-yl group. A member of the group of second generation antipsychotics (also known as an atypical antipsychotics), it is used for the treatment of schizophrenia.		6.881301,2-benzoxazoles;
aromatic ether;
aromatic ketone;
methyl ketone;
monoamine;
organofluorine compound;
piperidines;
tertiary amino compound		dopaminergic antagonist;
second generation antipsychotic;
serotonergic antagonist
s20098
[no description available]		2.1310acetamides
tandospirone
tandospirone: structure given in first source. tandospirone : A dicarboximide that is (3aR,4S,7R,7aS)-hexahydro-1H-4,7-methanoisoindole-1,3(2H)-dione which is substituted by a 4-[4-(pyrimidin-2-yl)piperazin-1-yl]butyl group at position 2. It is a potent and selective 5-HT1A receptor partial agonist (Ki = 27 nM).		3.1950bridged compound;
dicarboximide;
N-alkylpiperazine;
N-arylpiperazine;
pyrimidines		antidepressant;
anxiolytic drug
coumarin 6
coumarin 6: structure in first source		2.21107-aminocoumarinsfluorochrome
pregnenolone sulfate
pregnenolone sulfate: RN given refers to (3 beta)-isomer		2.1710steroid sulfateEC 2.7.1.33 (pantothenate kinase) inhibitor;
human metabolite
perospirone
perospirone: structure given in first source		3.1610N-arylpiperazine
blonanserin
[no description available]		4.4130organic molecular entity
proline
Proline: A non-essential amino acid that is synthesized from GLUTAMIC ACID. It is an essential component of COLLAGEN and is important for proper functioning of joints and tendons.. proline : An alpha-amino acid that is pyrrolidine bearing a carboxy substituent at position 2.		2.0710amino acid zwitterion;
glutamine family amino acid;
L-alpha-amino acid;
proline;
proteinogenic amino acid		algal metabolite;
compatible osmolytes;
Escherichia coli metabolite;
micronutrient;
mouse metabolite;
nutraceutical;
Saccharomyces cerevisiae metabolite
atazanavir sulfate
Atazanavir Sulfate: An azapeptide and HIV-PROTEASE INHIBITOR that is used in the treatment of HIV INFECTIONS and AIDS in combination with other ANTI-HIV AGENTS.		2.1310organic sulfate salt
asenapine
asenapine : A racemate consisting of equal amounts of (R,R)- and (S,S)-asenapine. Used as its maleate salt for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features.. (S,S)-asenapine : A 5-chloro-2-methyl-2,3,3a,12b-tetrahydrodibenzo[2,3:6,7]oxepino[4,5-c]pyrrole in which both of the stereocentres have S configuration.		6.881305-chloro-2-methyl-2,3,3a,12b-tetrahydrodibenzo[2,3:6,7]oxepino[4,5-c]pyrrole
benzofurans
Benzofurans: Compounds that contain a BENZENE ring fused to a furan ring.		2.5420
cerivastatin
cerivastatin: cerivastatin is the ((E)-(+))-isomer; structure given in first source. cerivastatin : (3R,5S)-3,5-dihydroxyhept-6-enoic acid in which the (7E)-hydrogen is substituted by a 4-(4-fluorophenyl)-2,6-diisopropyl-5-(methoxymethyl)pyridin-3-yl group. Formerly used (as its sodium salt) to lower cholesterol and prevent cardiovascular disease, it was withdrawn from the market worldwide in 2001 following reports of a severe form of muscle toxicity.		2.0610dihydroxy monocarboxylic acid;
pyridines;
statin (synthetic)
roflumilast
[no description available]		2.0710aromatic ether;
benzamides;
chloropyridine;
cyclopropanes;
organofluorine compound		anti-asthmatic drug;
phosphodiesterase IV inhibitor
posaconazole
[no description available]		3.5611aromatic ether;
conazole antifungal drug;
N-arylpiperazine;
organofluorine compound;
oxolanes;
triazole antifungal drug;
triazoles		trypanocidal drug
lithium
Lithium: An element in the alkali metals family. It has the atomic symbol Li, atomic number 3, and atomic weight [6.938; 6.997]. Salts of lithium are used in treating BIPOLAR DISORDER.		6.7761alkali metal atom
raclopride
Raclopride: A substituted benzamide that has antipsychotic properties. It is a dopamine D2 receptor (see RECEPTORS, DOPAMINE D2) antagonist.		2.0810salicylamides
sodium dodecyl sulfate
Sodium Dodecyl Sulfate: An anionic surfactant, usually a mixture of sodium alkyl sulfates, mainly the lauryl; lowers surface tension of aqueous solutions; used as fat emulsifier, wetting agent, detergent in cosmetics, pharmaceuticals and toothpastes; also as research tool in protein biochemistry.. sodium dodecyl sulfate : An organic sodium salt that is the sodium salt of dodecyl hydrogen sulfate.		2.4110organic sodium saltdetergent;
protein denaturant
pd 168,077
N-((4-(2-cyanophenyl)-1-piperazinyl)methyl)-3-methylbenzamide: a D4 dopamine receptor agonist		2.1510piperazines
a 85380
A 85380: structure given in first source; A-85380 is the S-enantiomer; A-159470 is the R-enantiomer		2.1310
l 745870
3-((4-(4-chlorophenyl)piperazin-1-yl)methyl)-1H-pyrrolo(2,3-b)pyridine: selective for D(4) receptors; structure in first source		2.5220piperazines
mdl 100907
Serotonin 5-HT2 Receptor Antagonists: Drugs that bind to but do not activate SEROTONIN 5-HT2 RECEPTORS, thereby blocking the actions of SEROTONIN or SEROTONIN 5-HT2 RECEPTOR AGONISTS. Included under this heading are antagonists for one or more specific 5-HT2 receptor subtypes.		8.0882
puerarin
[no description available]		7.2510C-glycosyl compound;
isoflavonoid
cysteine
Cysteine: A thiol-containing non-essential amino acid that is oxidized to form CYSTINE.. L-cysteinium : The L-enantiomer of cysteinium.. cysteine : A sulfur-containing amino acid that is propanoic acid with an amino group at position 2 and a sulfanyl group at position 3.		2.2510cysteiniumfundamental metabolite
dizocilpine maleate
Dizocilpine Maleate: A potent noncompetitive antagonist of the NMDA receptor (RECEPTORS, N-METHYL-D-ASPARTATE) used mainly as a research tool. The drug has been considered for the wide variety of neurodegenerative conditions or disorders in which NMDA receptors may play an important role. Its use has been primarily limited to animal and tissue experiments because of its psychotropic effects.. dizocilpine maleate : A maleate salt obtained by reaction of dizocilpine with one equivalent of maleic acid.		5.6361maleate salt;
tetracyclic antidepressant		anaesthetic;
anticonvulsant;
neuroprotective agent;
nicotinic antagonist;
NMDA receptor antagonist
sb 269970
SB 269970: a 5-HT(7) antagonist; structure in first source		2.0710sulfonamide
vilazodone hydrochloride
[no description available]		2.0710hydrochlorideantidepressant;
serotonergic agonist;
serotonin uptake inhibitor
paliperidone palmitate
Paliperidone Palmitate: A benzisoxazole derivative and active metabolite of RISPERIDONE that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST and SEROTONIN 5-HT2 RECEPTOR ANTAGONIST. It is an ANTIPSYCHOTIC AGENT used in the treatment of SCHIZOPHRENIA.. 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-4-oxo-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-9-yl hexadecanoate : A fatty acid ester obtained by the formal condensation of the carboxy group of hexadecanoic acid with the hydroxy group of 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one.. paliperidone palmitate : A racemate comprising equimolar amounts of (R)- and (S)-paliperidone palmitate. A long-acting injectable formulation of paliperidone (the major active metabolite of risperidone) that is used for treatment of schizophrenia.		6.441001,2-benzoxazoles;
fatty acid ester;
heteroarylpiperidine;
organofluorine compound;
pyridopyrimidine
ppi-0903
ceftaroline : A cephalosporin that is the active metabolite of the prodrug ceftaroline fosamil. Used for the treatment of adults with acute bacterial skin and skin structure infections.		2.07101,3-thiazoles;
cephalosporin;
iminium betaine;
organic phosphoramidate;
oxime O-ether;
thiadiazoles		antibacterial drug;
antimicrobial agent;
prodrug
ac 260584
4-(3-(4-butylpiperidin-1-yl)propyl)-7-fluoro-4H-benzo(1,4)oxazin-3-one: structure in first source		2.1510
vortioxetine
Vortioxetine: A piperazine derivative that acts as a serotonin reuptake inhibitor, as a 5-HT3 receptor antagonist, and 5-HT1A receptor agonist. It is used for the treatment of anxiety and depression.. vortioxetine : An N-arylpiperazine in which the aryl group is specified as 2-[(2,4-dimethylphenyl)sulfanyl]phenyl. Used (as its hydrobromide salt) for treatment of major depressive disorder.		4.5140aryl sulfide;
N-arylpiperazine		antidepressant;
anxiolytic drug;
serotonergic agonist;
serotonergic antagonist
n-((1-allyl-2-pyrrolidinyl)methyl)-5-(3-fluoropropyl)-2,3-dimethoxybenzamide
N-((1-allyl-2-pyrrolidinyl)methyl)-5-(3-fluoropropyl)-2,3-dimethoxybenzamide: structure in first source		4.411
sb-656104-a
SB-656104-A: structure in first source		2.0810
pimavanserin
pimavanserin: A 5-HT(2A) inverse agonist; ACP-103 is the dihydroxybutanedioate (2:1) salt. It is used to treat hallucinations and delusions associated with PARKINSON DISEASE; structure in first source.. pimavanserin : A member of the class of ureas in which three of the four hydrogens are replaced by 4-fluorobenzyl, 1-methylpiperidin-4-yl, and 4-(isopropyloxy)benzyl groups. An atypical antipsychotic that is used (in the form of its tartrate salt) for treatment of hallucinations and delusions associated with Parkinson's disease.		2.0710aromatic ether;
monofluorobenzenes;
piperidines;
tertiary amino compound;
ureas		5-hydroxytryptamine 2A receptor inverse agonist;
antipsychotic agent;
serotonergic antagonist
linagliptin
Linagliptin: A purine and quinazoline derivative that functions as an INCRETIN and DIPEPTIDYL-PEPTIDASE IV INHIBTOR. It is used as a HYPOGLYCEMIC AGENT in the treatment of TYPE II DIABETES MELLITUS.. linagliptin : A xanthine that is 7H-xanthine bearing (4-methylquinazolin-2-yl)methyl, methyl, but-2-yn-1-yl and 3-aminopiperidin-1-yl substituents at positions 1, 3, 7 and 8 respectively (the R-enantiomer). Used for treatment of type II diabetes.		2.0710aminopiperidine;
quinazolines		EC 3.4.14.5 (dipeptidyl-peptidase IV) inhibitor;
hypoglycemic agent
ly 379268
LY 379268: group II metabotropic glutamate receptor agonist; structure in first source. LY 379268 : An organic heterobicyclic compound that is (1R,5S)-2-oxabicyclo[3.1.0]hexane carrying amino, carboxy, and carboxy groups at positions 4R, 4R and 6R, respectively. It is a potent agonist of group II metabotropic glutamate receptors mGluR2 and mGluR3 (EC50 = 2.69 nM and 4.48 nM, respectively) that exhibits antipsychotic-like action in animal models of schizophrenia.		2.0610amino dicarboxylic acid;
bridged compound;
organic heterobicyclic compound		antipsychotic agent;
anxiolytic drug;
metabotropic glutamate receptor agonist;
neuroprotective agent
kaspar
kaspar: structure given in first source		2.2110
oxadiazoles
Oxadiazoles: Compounds containing five-membered heteroaromatic rings containing two carbons, two nitrogens, and one oxygen atom which exist in various regioisomeric forms.		2.0710
cariprazine
cariprazine: Structure in first source. cariprazine : An N-alkylpiperazine that is N,N-dimethyl-N'-{trans-4-[2-(piperazin-1-yl)ethyl]cyclohexyl}urea substituted at position 4 on the piperazine ring by a 2,3-dichlorophenyl group. Used (as the hydrochloride salt) for treatment of schizophrenia and bipolar disorder.		6.3890
pnu-282987
[no description available]		2.1310
scopolamine hydrobromide
[no description available]		4.8621
brexpiprazole
brexpiprazole: a serotonin agent; structure in first source		5.92100N-arylpiperazine
ro 10-5824
RO 10-5824: structure in first source		2.110
alcaftadine
alcaftadine : An imidazobenzazepine that is 6,11-dihydro-5H-imidazo[2,1-b][3]benzazepine substituted at position 3 by a formyl group and at position 11 by a 1-methylpiperidin-4-ylidene group. An antihistamine used for treatment of allergic conjunctivitis.		2.0710aldehyde;
imidazobenzazepine;
piperidines;
tertiary amino compound		anti-allergic agent;
H1-receptor antagonist
suvorexant
suvorexant: an orexin receptor antagonist; structure in first source. suvorexant : An aromatic amide obtained by formal condensation of the carboxy group of 5-methyl-2-(2H-1,2,3-triazol-2-yl)benzoic acid with the secondary amino group of 5-chloro-2-[(5R)-5-methyl-1,4-diazepan-1-yl]-1,3-benzoxazole. An orexin receptor antagonist used for the management of insomnia.		2.21101,3-benzoxazoles;
aromatic amide;
diazepine;
organochlorine compound;
triazoles		central nervous system depressant;
orexin receptor antagonist
quetiapine fumarate
Quetiapine Fumarate: A dibenzothiazepine and ANTIPSYCHOTIC AGENT that targets the SEROTONIN 5-HT2 RECEPTOR; HISTAMINE H1 RECEPTOR, adrenergic alpha1 and alpha2 receptors, as well as the DOPAMINE D1 RECEPTOR and DOPAMINE D2 RECEPTOR. It is used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER and DEPRESSIVE DISORDER.		15.174611fumarate salt
piperidines
Piperidines: A family of hexahydropyridines.		7.19160
aripiprazole lauroxil
[no description available]		3.3510aromatic ether;
delta-lactam;
dichlorobenzene;
dodecanoate ester;
N-alkylpiperazine;
N-arylpiperazine;
quinolone		H1-receptor antagonist;
prodrug;
second generation antipsychotic;
serotonergic agonist
warfarin
Warfarin: An anticoagulant that acts by inhibiting the synthesis of vitamin K-dependent coagulation factors. Warfarin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, and atrial fibrillation with embolization. It is also used as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. Warfarin is also used as a rodenticide.. warfarin : A racemate comprising equal amounts of (R)- and (S)-warfarin. Extensively used as both an anticoagulant drug and as a pesticide against rats and mice.. 4-hydroxy-3-(3-oxo-1-phenylbutyl)-1-benzopyran-2-one : A member of the class of coumarins that is 4-hydroxycoumarin which is substituted at position 3 by a 1-phenyl-3-oxo-1-butyl group.		2.2110benzenes;
hydroxycoumarin;
methyl ketone
transforming growth factor beta
Transforming Growth Factor beta: A factor synthesized in a wide variety of tissues. It acts synergistically with TGF-alpha in inducing phenotypic transformation and can also act as a negative autocrine growth factor. TGF-beta has a potential role in embryonal development, cellular differentiation, hormone secretion, and immune function. TGF-beta is found mostly as homodimer forms of separate gene products TGF-beta1, TGF-beta2 or TGF-beta3. Heterodimers composed of TGF-beta1 and 2 (TGF-beta1.2) or of TGF-beta2 and 3 (TGF-beta2.3) have been isolated. The TGF-beta proteins are synthesized as precursor proteins.		2.1310
osimertinib
osimertinib: an EGFR tyrosine kinase inhibitor. osimertinib : A member of the class of aminopyrimidines that is 4-(1-methylindol-3-yl)pyrimidin-2-amine in which one of the amino hydrogens is replaced by a 2-methoxy-4-[2-(dimethylamino)ethyl](methyl)amino-5-acrylamidophenyl group. Used (as the mesylate salt) for treatment of EGFR T790M mutation positive non-small cell lung cancer.		2.3110acrylamides;
aminopyrimidine;
biaryl;
indoles;
monomethoxybenzene;
secondary amino compound;
secondary carboxamide;
substituted aniline;
tertiary amino compound		antineoplastic agent;
epidermal growth factor receptor antagonist
mk-8742
elbasvir: inhibits NS5A protein of hepatitis C virus. elbasvir : A complex organic heterotetracyclic compound that is a hepatitis C virus nonstructural protein 5A inhibitor used in combination with grazoprevir (under the brand name Zepatier) for treatment of chronic HCV genotypes 1 or 4 infection in adults.		2.3110carbamate ester;
imidazoles;
L-valine derivative;
N-acylpyrrolidine;
organic heterotetracyclic compound;
ring assembly		antiviral drug;
hepatitis C virus nonstructural protein 5A inhibitor;
hepatoprotective agent
exudates
Malaysia: A parliamentary democracy with a constitutional monarch in southeast Asia, consisting of 11 states (West Malaysia) on the Malay Peninsula and two states (East Malaysia) on the island of BORNEO. It is also called the Federation of Malaysia. Its capital is Kuala Lumpur. Before 1963 it was the Union of Malaya. It reorganized in 1948 as the Federation of Malaya, becoming independent from British Malaya in 1957 and becoming Malaysia in 1963 as a federation of Malaya, Sabah, Sarawak, and Singapore (which seceded in 1965). The form Malay- probably derives from the Tamil malay, mountain, with reference to its geography. (From Webster's New Geographical Dictionary, 1988, p715 & Room, Brewer's Dictionary of Names, 1992, p329)		6.1533
guanosine 5'-o-(3-thiotriphosphate)
Guanosine 5'-O-(3-Thiotriphosphate): Guanosine 5'-(trihydrogen diphosphate), monoanhydride with phosphorothioic acid. A stable GTP analog which enjoys a variety of physiological actions such as stimulation of guanine nucleotide-binding proteins, phosphoinositide hydrolysis, cyclic AMP accumulation, and activation of specific proto-oncogenes.		2.610nucleoside triphosphate analogue
rifampin
Rifampin: A semisynthetic antibiotic produced from Streptomyces mediterranei. It has a broad antibacterial spectrum, including activity against several forms of Mycobacterium. In susceptible organisms it inhibits DNA-dependent RNA polymerase activity by forming a stable complex with the enzyme. It thus suppresses the initiation of RNA synthesis. Rifampin is bactericidal, and acts on both intracellular and extracellular organisms. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p1160)		3.1910cyclic ketal;
hydrazone;
N-iminopiperazine;
N-methylpiperazine;
rifamycins;
semisynthetic derivative;
zwitterion		angiogenesis inhibitor;
antiamoebic agent;
antineoplastic agent;
antitubercular agent;
DNA synthesis inhibitor;
EC 2.7.7.6 (RNA polymerase) inhibitor;
Escherichia coli metabolite;
geroprotector;
leprostatic drug;
neuroprotective agent;
pregnane X receptor agonist;
protein synthesis inhibitor
clozapine
Clozapine: A tricylic dibenzodiazepine, classified as an atypical antipsychotic agent. It binds several types of central nervous system receptors, and displays a unique pharmacological profile. Clozapine is a serotonin antagonist, with strong binding to 5-HT 2A/2C receptor subtype. It also displays strong affinity to several dopaminergic receptors, but shows only weak antagonism at the dopamine D2 receptor, a receptor commonly thought to modulate neuroleptic activity. Agranulocytosis is a major adverse effect associated with administration of this agent.. clozapine : A benzodiazepine that is 5H-dibenzo[b,e][1,4]diazepine substituted by a chloro group at position 8 and a 4-methylpiperazin-1-yl group at position 11. It is a second generation antipsychotic used in the treatment of psychiatric disorders like schizophrenia.		5.9590benzodiazepine;
N-arylpiperazine;
N-methylpiperazine;
organochlorine compound		adrenergic antagonist;
dopaminergic antagonist;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor;
environmental contaminant;
GABA antagonist;
histamine antagonist;
muscarinic antagonist;
second generation antipsychotic;
serotonergic antagonist;
xenobiotic
olanzapine
Olanzapine: A benzodiazepine derivative that binds SEROTONIN RECEPTORS; MUSCARINIC RECEPTORS; HISTAMINE H1 RECEPTORS; ADRENERGIC ALPHA-1 RECEPTORS; and DOPAMINE RECEPTORS. It is an antipsychotic agent used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER; and MAJOR DEPRESSIVE DISORDER; it may also reduce nausea and vomiting in patients undergoing chemotherapy.. olanzapine : A benzodiazepine that is 10H-thieno[2,3-b][1,5]benzodiazepine substituted by a methyl group at position 2 and a 4-methylpiperazin-1-yl group at position 4.		13.7297benzodiazepine;
N-arylpiperazine;
N-methylpiperazine		antiemetic;
dopaminergic antagonist;
histamine antagonist;
muscarinic antagonist;
second generation antipsychotic;
serotonergic antagonist;
serotonin uptake inhibitor
tegaserod
tegaserod: a nonbenzamide 5-hydroxytryptamine(4) agonist; used in treatment of irritable bowel syndrome; marketing suspended 2007 in US due to higher incidence of MI, stroke, and unstable angina; structure given in first source		2.0610carboxamidine;
guanidines;
hydrazines;
indoles		gastrointestinal drug;
serotonergic agonist
norclozapine
norclozapine: structure given in first source. N-desmethylclozapine : A dibenzodoazepine substituted with chloro and piperazino groups which is a major metabolite of clozapine; a potent and selective 5-HT2C serotonin receptor antagonist.		2.1510dibenzodiazepine;
organochlorine compound;
piperazines		delta-opioid receptor agonist;
metabolite;
serotonergic antagonist
tak 491
azilsartan medoxomil: an azilsartan prodrug and angiotensin II type 1 receptor blocker. azilsartan medoxomil : A carboxylic ester obtained by formal condensation of the carboxy group of azilsartan with the hydroxy group of 4-(hydroxymethyl)-5-methyl-1,3-dioxol-2-one. A prodrug for azilsartan, it is used for treatment of hypertension.		2.07101,2,4-oxadiazole;
aromatic ether;
benzimidazoles;
carboxylic ester;
cyclic carbonate ester;
dioxolane		angiotensin receptor antagonist;
antihypertensive agent;
prodrug
amg531
[no description available]		2.4110
olanzapine-fluoxetine combination
olanzapine-fluoxetine combination: used to treat bipolar depression		5.8970
ConditionIndicatedRelationship StrengthStudiesTrials
Carcinoma, Non-Small Cell Lung
[description not available]		02.3110
Cancer of Lung
[description not available]		02.3110
Carcinoma, Non-Small-Cell Lung
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.		02.3110
Lung Neoplasms
Tumors or cancer of the LUNG.		02.3110
Depression, Involutional
Form of depression in those MIDDLE AGE with feelings of ANXIETY.		0132810
Dementia Praecox
[description not available]		020.6316665
Depressive Disorder, Major
Disorder in which five (or more) of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at least one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure. Symptoms include: depressed mood most of the day, nearly every daily; markedly diminished interest or pleasure in activities most of the day, nearly every day; significant weight loss when not dieting or weight gain; Insomnia or hypersomnia nearly every day; psychomotor agitation or retardation nearly every day; fatigue or loss of energy nearly every day; feelings of worthlessness or excessive or inappropriate guilt; diminished ability to think or concentrate, or indecisiveness, nearly every day; or recurrent thoughts of death, recurrent suicidal ideation without a specific plan, or a suicide attempt. (DSM-5)		0132810
Schizophrenia
A severe emotional disorder of psychotic depth characteristically marked by a retreat from reality with delusion formation, HALLUCINATIONS, emotional disharmony, and regressive behavior.		127.6316665
Hypomania
[description not available]		04.6641
Affective Psychosis, Bipolar
[description not available]		018.5511431
Bipolar Disorder
A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.		123.322862
Affective Disorders
[description not available]		04.540
Cognitive Decline
[description not available]		07.8372
Mood Disorders
Those disorders that have a disturbance in mood as their predominant feature.		04.540
Cognitive Dysfunction
Diminished or impaired mental and/or intellectual function.		07.8372
Weight Gain
Increase in BODY WEIGHT over existing weight.		09.01122
Coma, Hyperglycemic Hyperosmolar Nonketotic
[description not available]		02.4110
Acidosis, Diabetic
[description not available]		02.4110
Diabetic Ketoacidosis
A life-threatening complication of diabetes mellitus, primarily of TYPE 1 DIABETES MELLITUS with severe INSULIN deficiency and extreme HYPERGLYCEMIA. It is characterized by KETOSIS; DEHYDRATION; and depressed consciousness leading to COMA.		02.4110
Hyperphagia
Ingestion of a greater than optimal quantity of food.		02.4110
Disruptive, Impulse Control, and Conduct Disorders
Disorders whose essential features are the failure to resist an impulse, drive, or temptation to perform an act that is harmful to the individual or to others. Individuals experience an increased sense of tension prior to the act and pleasure, gratification or release of tension at the time of committing the act.		02.4110
Adverse Drug Event
[description not available]		03.8120
Electrocardiogram QT Prolonged
[description not available]		04.4760
Psychoses
[description not available]		011.81196
Long QT Syndrome
A condition that is characterized by episodes of fainting (SYNCOPE) and varying degree of ventricular arrhythmia as indicated by the prolonged QT interval. The inherited forms are caused by mutation of genes encoding cardiac ion channel proteins. The two major forms are ROMANO-WARD SYNDROME and JERVELL-LANGE NIELSEN SYNDROME.		04.4760
Psychotic Disorders
Disorders in which there is a loss of ego boundaries or a gross impairment in reality testing with delusions or prominent hallucinations. (From DSM-IV, 1994)		011.81196
Drug-Related Side Effects and Adverse Reactions
Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.		03.8120
Disease Models, Animal
Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases.		05.63160
Grippe
[description not available]		02.4110
Influenza, Human
An acute viral infection in humans involving the respiratory tract. It is marked by inflammation of the NASAL MUCOSA; the PHARYNX; and conjunctiva, and by headache and severe, often generalized, myalgia.		02.4110
Chronic Illness
[description not available]		03.3250
Recrudescence
[description not available]		09.28182
Chronic Disease
Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care (Dictionary of Health Services Management, 2d ed). For epidemiological studies chronic disease often includes HEART DISEASES; STROKE; CANCER; and diabetes (DIABETES MELLITUS, TYPE 2).		03.3250
Depression
Depressive states usually of moderate intensity in contrast with MAJOR DEPRESSIVE DISORDER present in neurotic and psychotic disorders.		010.28213
Symptom Cluster
[description not available]		04.2431
Syndrome
A characteristic symptom complex.		04.2431
Delusional Parasitosis
A delusional disorder of belief in infestation by insects or other parasites. This FORMICATION is typically accompanied by dermatological manifestation such as PRURITUS that may lead to self-mutilation in order to remove the perceived parasites. It can be either primary or secondary to a somatic or psychiatric condition.		02.4110
Urinary Retention
Inability to empty the URINARY BLADDER with voiding (URINATION).		02.920
Pregnancy
The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.		04.4870
Anhedonia
Inability to experience pleasure due to impairment or dysfunction of normal psychological and neurobiological mechanisms. It is a symptom of many PSYCHOTIC DISORDERS (e.g., DEPRESSIVE DISORDER, MAJOR; and SCHIZOPHRENIA).		02.6320
Agitation, Psychomotor
[description not available]		04.9621
Psychomotor Agitation
A feeling of restlessness associated with increased motor activity. This may occur as a manifestation of nervous system drug toxicity or other conditions.		04.9621
Body Weight
The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms.		06.9952
Acute Disease
Disease having a short and relatively severe course.		08.7772
Drug Overdose
Accidental or deliberate use of a medication or street drug in excess of normal dosage.		02.5520
Cardiometabolic Syndrome
A cluster of symptoms that are risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components not only include metabolic dysfunctions of METABOLIC SYNDROME but also HYPERTENSION, and ABDOMINAL OBESITY.		04.5511
Metabolic Syndrome
A cluster of symptoms that are risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components of metabolic syndrome include ABDOMINAL OBESITY; atherogenic DYSLIPIDEMIA; HYPERTENSION; HYPERGLYCEMIA; INSULIN RESISTANCE; a proinflammatory state; and a prothrombotic (THROMBOSIS) state.		04.5511
Anxiety
Feelings or emotions of dread, apprehension, and impending disaster but not disabling as with ANXIETY DISORDERS.		03.9440
Basal Ganglia Diseases
Diseases of the BASAL GANGLIA including the PUTAMEN; GLOBUS PALLIDUS; claustrum; AMYGDALA; and CAUDATE NUCLEUS. DYSKINESIAS (most notably involuntary movements and alterations of the rate of movement) represent the primary clinical manifestations of these disorders. Common etiologies include CEREBROVASCULAR DISORDERS; NEURODEGENERATIVE DISEASES; and CRANIOCEREBRAL TRAUMA.		06.6942
Laryngeal Spasm
[description not available]		02.3110
Laryngismus
A disorder in which the adductor muscles of the VOCAL CORDS exhibit increased activity leading to laryngeal spasm. Laryngismus causes closure of the VOCAL FOLDS and airflow obstruction during inspiration.		02.3110
Diseases, Metabolic
[description not available]		05.7821
Cardiovascular Diseases
Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.		04.8521
Metabolic Diseases
Generic term for diseases caused by an abnormal metabolic process. It can be congenital due to inherited enzyme abnormality (METABOLISM, INBORN ERRORS) or acquired due to disease of an endocrine organ or failure of a metabolically important organ such as the liver. (Stedman, 26th ed)		05.7821
Anasarca
[description not available]		02.3110
Edema
Abnormal fluid accumulation in TISSUES or body cavities. Most cases of edema are present under the SKIN in SUBCUTANEOUS TISSUE.		02.3110
Behavior Disorders
[description not available]		03.8330
Mental Disorders
Psychiatric illness or diseases manifested by breakdowns in the adaptational process expressed primarily as abnormalities of thought, feeling, and behavior producing either distress or impairment of function.		03.8330
Anxiety Neuroses
[description not available]		03.9521
Aggression
Behavior which may be manifested by destructive and attacking action which is verbal or physical, by covert attitudes of hostility or by obstructionism.		04.2131
Anxiety Disorders
Persistent and disabling ANXIETY.		03.9521
Genetic Predisposition
[description not available]		03.5611
Neutropenia
A decrease in the number of NEUTROPHILS found in the blood.		02.1510
Cognition Disorders
Disorders characterized by disturbances in mental processes related to learning, thinking, reasoning, and judgment.		011.721610
Dyskinesia, Medication-Induced
[description not available]		02.1510
Dyskinesia, Drug-Induced
Abnormal movements, including HYPERKINESIS; HYPOKINESIA; TREMOR; and DYSTONIA, associated with the use of certain medications or drugs. Muscles of the face, trunk, neck, and extremities are most commonly affected. Tardive dyskinesia refers to abnormal hyperkinetic movements of the muscles of the face, tongue, and neck associated with the use of neuroleptic agents (see ANTIPSYCHOTIC AGENTS). (Adams et al., Principles of Neurology, 6th ed, p1199)		02.1510
Dystonia
An attitude or posture due to the co-contraction of agonists and antagonist muscles in one region of the body. It most often affects the large axial muscles of the trunk and limb girdles. Conditions which feature persistent or recurrent episodes of dystonia as a primary manifestation of disease are referred to as DYSTONIC DISORDERS. (Adams et al., Principles of Neurology, 6th ed, p77)		02.1510
Autism Spectrum Disorder
Wide continuum of associated cognitive and neurobehavioral disorders, including, but not limited to, three core-defining features: impairments in socialization, impairments in verbal and nonverbal communication, and restricted and repetitive patterns of behaviors. (from DSM-V)		03.0610
Stammering
[description not available]		02.1510
Stuttering
A disturbance in the normal fluency and time patterning of speech that is inappropriate for the individual's age. This disturbance is characterized by frequent repetitions or prolongations of sounds or syllables. Various other types of speech dysfluencies may also be involved including interjections, broken words, audible or silent blocking, circumlocutions, words produced with an excess of physical tension, and monosyllabic whole word repetitions. Stuttering may occur as a developmental condition in childhood or as an acquired disorder which may be associated with BRAIN INFARCTIONS and other BRAIN DISEASES. (From DSM-IV, 1994)		02.1510
Refractory Depression
[description not available]		02.8330
Depressive Disorder, Treatment-Resistant
Failure to respond to two or more trials of antidepressant monotherapy or failure to respond to four or more trials of different antidepressant therapies. (Campbell's Psychiatric Dictionary, 9th ed.)		02.8330
Neuroleptic Malignant Syndrome
A potentially fatal syndrome associated primarily with the use of neuroleptic agents (see ANTIPSYCHOTIC AGENTS) which are in turn associated with dopaminergic receptor blockade (see RECEPTORS, DOPAMINE) in the BASAL GANGLIA and HYPOTHALAMUS, and sympathetic dysregulation. Clinical features include diffuse MUSCLE RIGIDITY; TREMOR; high FEVER; diaphoresis; labile blood pressure; cognitive dysfunction; and autonomic disturbances. Serum CPK level elevation and a leukocytosis may also be present. (From Adams et al., Principles of Neurology, 6th ed, p1199; Psychiatr Serv 1998 Sep;49(9):1163-72)		02.1510
Aging
The gradual irreversible changes in structure and function of an organism that occur as a result of the passage of time.		02.1710
Delirium of Mixed Origin
[description not available]		02.6320
Critical Illness
A disease or state in which death is possible or imminent.		02.9130
Delirium
A disorder characterized by CONFUSION; inattentiveness; disorientation; ILLUSIONS; HALLUCINATIONS; agitation; and in some instances autonomic nervous system overactivity. It may result from toxic/metabolic conditions or structural brain lesions. (From Adams et al., Principles of Neurology, 6th ed, pp411-2)		02.6320
Obesity
A status with BODY WEIGHT that is grossly above the recommended standards, usually due to accumulation of excess FATS in the body. The standards may vary with age, sex, genetic or cultural background. In the BODY MASS INDEX, a BMI greater than 30.0 kg/m2 is considered obese, and a BMI greater than 40.0 kg/m2 is considered morbidly obese (MORBID OBESITY).		03.9821
Serotonin Syndrome
An adverse drug interaction characterized by altered mental status, autonomic dysfunction, and neuromuscular abnormalities. It is most frequently caused by use of both serotonin reuptake inhibitors and monoamine oxidase inhibitors, leading to excess serotonin availability in the CNS at the serotonin 1A receptor.		03.1210
Agitated Emergence
[description not available]		03.1210
Hypermelanosis
[description not available]		02.1710
Hand Dermatosis
[description not available]		02.1710
Hand Dermatoses
Skin diseases involving the HANDS.		02.1710
Hyperpigmentation
Excessive pigmentation of the skin, usually as a result of increased epidermal or dermal melanin pigmentation, hypermelanosis. Hyperpigmentation can be localized or generalized. The condition may arise from exposure to light, chemicals or other substances, or from a primary metabolic imbalance.		02.1710
Frigidity
[description not available]		04.8821
Sexual Dysfunctions, Psychological
Disturbances in sexual desire and the psychophysiologic changes that characterize the sexual response cycle and cause marked distress and interpersonal difficulty. (APA, DSM-IV, 1994)		04.8821
Nausea
An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.		05.1131
Exanthem
[description not available]		02.2110
Exanthema
Diseases in which skin eruptions or rashes are a prominent manifestation. Classically, six such diseases were described with similar rashes; they were numbered in the order in which they were reported. Only the fourth (Duke's disease), fifth (ERYTHEMA INFECTIOSUM), and sixth (EXANTHEMA SUBITUM) numeric designations survive as occasional synonyms in current terminology.		02.2110
Chronic Insomnia
[description not available]		05.1331
Sleep Initiation and Maintenance Disorders
Disorders characterized by impairment of the ability to initiate or maintain sleep. This may occur as a primary disorder or in association with another medical or psychiatric condition.		05.1331
Acathisia, Drug-Induced
[description not available]		09.993
Diabetes Mellitus
A heterogeneous group of disorders characterized by HYPERGLYCEMIA and GLUCOSE INTOLERANCE.		02.0810
Depression, Endogenous
[description not available]		013.012220
Depressive Disorder
An affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual activities. The mood disturbance is prominent and relatively persistent.		013.012220
Ataxia of Gait
[description not available]		02.0810
Pervasive Child Development Disorders
[description not available]		02.7830
MS (Multiple Sclerosis)
[description not available]		02.0810
Child Development Disorders, Pervasive
Severe distortions in the development of many basic psychological functions that are not normal for any stage in development. These distortions are manifested in sustained social impairment, speech abnormalities, and peculiar motor movements.		02.7830
Multiple Sclerosis
An autoimmune disorder mainly affecting young adults and characterized by destruction of myelin in the central nervous system. Pathologic findings include multiple sharply demarcated areas of demyelination throughout the white matter of the central nervous system. Clinical manifestations include visual loss, extra-ocular movement disorders, paresthesias, loss of sensation, weakness, dysarthria, spasticity, ataxia, and bladder dysfunction. The usual pattern is one of recurrent attacks followed by partial recovery (see MULTIPLE SCLEROSIS, RELAPSING-REMITTING), but acute fulminating and chronic progressive forms (see MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE) also occur. (Adams et al., Principles of Neurology, 6th ed, p903)		02.0810
Daytime Sleepiness
[description not available]		07.2542
Disorders of Excessive Somnolence
Disorders characterized by hypersomnolence during normal waking hours that may impair cognitive functioning. Subtypes include primary hypersomnia disorders (e.g., IDIOPATHIC HYPERSOMNOLENCE; NARCOLEPSY; and KLEINE-LEVIN SYNDROME) and secondary hypersomnia disorders where excessive somnolence can be attributed to a known cause (e.g., drug affect, MENTAL DISORDERS, and SLEEP APNEA SYNDROME). (From J Neurol Sci 1998 Jan 8;153(2):192-202; Thorpy, Principles and Practice of Sleep Medicine, 2nd ed, p320)		07.2542
Delayed Effects, Prenatal Exposure
[description not available]		02.5220
ADDH
[description not available]		03.4220
Attention Deficit Disorder with Hyperactivity
A behavior disorder originating in childhood in which the essential features are signs of developmentally inappropriate inattention, impulsivity, and hyperactivity. Although most individuals have symptoms of both inattention and hyperactivity-impulsivity, one or the other pattern may be predominant. The disorder is more frequent in males than females. Onset is in childhood. Symptoms often attenuate during late adolescence although a minority experience the full complement of symptoms into mid-adulthood. (From DSM-V)		03.4220
Long Sleeper Syndrome
[description not available]		02.110
Sleep Wake Disorders
Abnormal sleep-wake schedule or pattern associated with the CIRCADIAN RHYTHM which affect the length, timing, and/or rigidity of the sleep-wake cycle relative to the day-night cycle.		02.110
Insulin Sensitivity
[description not available]		02.110
Insulin Resistance
Diminished effectiveness of INSULIN in lowering blood sugar levels: requiring the use of 200 units or more of insulin per day to prevent HYPERGLYCEMIA or KETOSIS.		02.110
Chemical Dependence
[description not available]		02.1110
Drug Withdrawal Symptoms
[description not available]		02.1110
Substance Withdrawal Syndrome
Physiological and psychological symptoms associated with withdrawal from the use of a drug after prolonged administration or habituation. The concept includes withdrawal from smoking or drinking, as well as withdrawal from an administered drug.		02.1110
Substance-Related Disorders
Disorders related to substance use or abuse.		02.1110
Autism
[description not available]		03.5111
Autistic Disorder
A disorder beginning in childhood. It is marked by the presence of markedly abnormal or impaired development in social interaction and communication and a markedly restricted repertoire of activity and interest. Manifestations of the disorder vary greatly depending on the developmental level and chronological age of the individual. (DSM-V)		03.5111
Acoustic Perceptual Disorder
[description not available]		04.4311
Restless Leg Syndrome
[description not available]		02.1310
Restless Legs Syndrome
A disorder characterized by aching or burning sensations in the lower and rarely the upper extremities that occur prior to sleep or may awaken the patient from sleep.		02.1310
Autosomal Dominant Juvenile Parkinson Disease
[description not available]		03.0410
Dyslipidemia
[description not available]		03.0410
Hyperglycemia, Postprandial
Abnormally high BLOOD GLUCOSE level after a meal.		03.0410
Hyperprolactinaemia
[description not available]		04.3720
Hyperglycemia
Abnormally high BLOOD GLUCOSE level.		03.0410
Hyperprolactinemia
Increased levels of PROLACTIN in the BLOOD, which may be associated with AMENORRHEA and GALACTORRHEA. Relatively common etiologies include PROLACTINOMA, medication effect, KIDNEY FAILURE, granulomatous diseases of the PITUITARY GLAND, and disorders which interfere with the hypothalamic inhibition of prolactin release. Ectopic (non-pituitary) production of prolactin may also occur. (From Joynt, Clinical Neurology, 1992, Ch36, pp77-8)		04.3720
Parkinsonian Disorders
A group of disorders which feature impaired motor control characterized by bradykinesia, MUSCLE RIGIDITY; TREMOR; and postural instability. Parkinsonian diseases are generally divided into primary parkinsonism (see PARKINSON DISEASE), secondary parkinsonism (see PARKINSON DISEASE, SECONDARY) and inherited forms. These conditions are associated with dysfunction of dopaminergic or closely related motor integration neuronal pathways in the BASAL GANGLIA.		03.0410
Dyslipidemias
Abnormalities in the serum levels of LIPIDS, including overproduction or deficiency. Abnormal serum lipid profiles may include high total CHOLESTEROL, high TRIGLYCERIDES, low HIGH DENSITY LIPOPROTEIN CHOLESTEROL, and elevated LOW DENSITY LIPOPROTEIN CHOLESTEROL.		03.0410
HIV Coinfection
[description not available]		02.1310
HIV Infections
Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS).		02.1310
Premenstrual Tension
A term used to describe the psychological aspects of PREMENSTRUAL SYNDROME, such as the indescribable tension, depression, hostility, and increased seizure activity in women with seizure disorder.		02.1510
Premenstrual Syndrome
A combination of distressing physical, psychologic, or behavioral changes that occur during the luteal phase of the menstrual cycle. Symptoms of PMS are diverse (such as pain, water-retention, anxiety, cravings, and depression) and they diminish markedly 2 or 3 days after the initiation of menses.		02.1510
Hyperactivity, Motor
[description not available]		02.0510
Action Tremor
[description not available]		02.0510
Tremor
Cyclical movement of a body part that can represent either a physiologic process or a manifestation of disease. Intention or action tremor, a common manifestation of CEREBELLAR DISEASES, is aggravated by movement. In contrast, resting tremor is maximal when there is no attempt at voluntary movement, and occurs as a relatively frequent manifestation of PARKINSON DISEASE.		02.0510
Academic Disorder, Developmental
[description not available]		02.4620
Age-Related Memory Disorders
[description not available]		02.4620
Learning Disabilities
Conditions characterized by a significant discrepancy between an individual's perceived level of intellect and their ability to acquire new language and other cognitive skills. These may result from organic or psychological conditions. Relatively common subtypes include DYSLEXIA, DYSCALCULIA, and DYSGRAPHIA.		02.4620
Memory Disorders
Disturbances in registering an impression, in the retention of an acquired impression, or in the recall of an impression. Memory impairments are associated with DEMENTIA; CRANIOCEREBRAL TRAUMA; ENCEPHALITIS; ALCOHOLISM (see also ALCOHOL AMNESTIC DISORDER); SCHIZOPHRENIA; and other conditions.		02.4620
Sensitivity and Specificity
Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)		02.0610
Hypotension, Postural
[description not available]		02.9810
Hypotension, Orthostatic
A significant drop in BLOOD PRESSURE after assuming a standing position. Orthostatic hypotension is a finding, and defined as a 20-mm Hg decrease in systolic pressure or a 10-mm Hg decrease in diastolic pressure 3 minutes after the person has risen from supine to standing. Symptoms generally include DIZZINESS, blurred vision, and SYNCOPE.		02.9810