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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.

AbstractOBJECTIVE:
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.
AuthorsAntony Loebel, Josephine Cucchiaro, Kaushik Sarma, Lei Xu, Chuanchieh Hsu, Amir H Kalali, Andrei Pikalov, Steven G Potkin
JournalSchizophrenia research (Schizophr Res) Vol. 145 Issue 1-3 Pg. 101-9 (Apr 2013) ISSN: 1573-2509 [Electronic] Netherlands
PMID23415311 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2013 Elsevier B.V. All rights reserved.
Chemical References
  • Antipsychotic Agents
  • Dibenzothiazepines
  • Isoindoles
  • Thiazoles
  • Quetiapine Fumarate
  • Lurasidone Hydrochloride
Topics
  • Adolescent
  • Adult
  • Aged
  • Akathisia, Drug-Induced
  • Analysis of Variance
  • Antipsychotic Agents (therapeutic use)
  • Basal Ganglia Diseases (chemically induced)
  • Body Mass Index
  • Body Weight (drug effects)
  • Dibenzothiazepines (therapeutic use)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Electrocardiography
  • Female
  • Humans
  • Isoindoles (therapeutic use)
  • Lurasidone Hydrochloride
  • Male
  • Middle Aged
  • Models, Statistical
  • Prospective Studies
  • Psychiatric Status Rating Scales
  • Quetiapine Fumarate
  • Schizophrenia (drug therapy)
  • Severity of Illness Index
  • Thiazoles (therapeutic use)
  • Time Factors
  • Waist Circumference (drug effects)
  • Young Adult

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