title: 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.
abstract: OBJECTIVE
  This study was designed to evaluate the short-term efficacy and safety of once-daily lurasidone (80 mg/day and 160 mg/day) in the treatment of an acute exacerbation of schizophrenia.
  
  
  METHODS
  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 was evaluated using a mixed-model repeated-measures analysis of the change from Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) total score (the primary efficacy measure) and Clinical Global Impressions severity (CGI-S) score (the key secondary efficacy measure).
  
  
  RESULTS
  Treatment with both doses of lurasidone or with QXR-600 mg was associated with significantly greater improvement at Week 6 on PANSS total score, PANSS positive and negative subscale scores, and CGI-S score compared with placebo. The endpoint responder rate (≥ 20% improvement in PANSS total score) was higher in subjects treated with lurasidone 80 mg (65%; p<0.001), lurasidone 160 mg (79%; p<0.001), and QXR-600 mg (79%; p<0.001) compared with placebo (41%). The proportion of patients experiencing ≥ 7% weight gain was 4% for each lurasidone group, 15% for the QXR-600 mg group, and 3% for the placebo group. Endpoint changes in levels of cholesterol, triglycerides, and low-density lipoprotein (LDL) cholesterol were comparable for both lurasidone groups and placebo, while the QXR-600 mg group showed a significant median increase compared with the placebo group in levels of cholesterol (p<0.001), LDL cholesterol (p<0.01), and triglycerides (p<0.05).
  
  
  CONCLUSIONS
  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. Dose-related adverse effects were limited, and both doses were generally well-tolerated.
authors: Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.
authors: Antony
authors: A
authors: Loebel
authors: Josephine
authors: J
authors: Cucchiaro
authors: Kaushik
authors: K
authors: Sarma
authors: Lei
authors: L
authors: Xu
authors: Chuanchieh
authors: C
authors: Hsu
authors: Amir H
authors: AH
authors: Kalali
authors: Andrei
authors: A
authors: Pikalov
authors: Steven G
authors: SG
authors: Potkin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D017109:Akathisia, Drug-Induced; D000704:Analysis of Variance; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001480:Basal Ganglia Diseases / Q000139:chemically induced; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects; D003987:Dibenzothiazepines / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D006801:Humans; D054833:Isoindoles / Q000627:therapeutic use*; D000069056:Lurasidone Hydrochloride; D008297:Male; D008875:Middle Aged; D015233:Models, Statistical; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D000069348:Quetiapine Fumarate; D012559:Schizophrenia / Q000188:drug therapy*; D012720:Severity of Illness Index; D013844:Thiazoles / Q000627:therapeutic use*; D013997:Time Factors; D055105:Waist Circumference / Q000187:drug effects; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D003987:Dibenzothiazepines; D054833:Isoindoles; D013844:Thiazoles; D000069348:Quetiapine Fumarate; D000069056:Lurasidone Hydrochloride