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Lurasidone for the treatment of acutely psychotic patients with schizophrenia: a 6-week, randomized, placebo-controlled study.

Abstract
Despite the availability of established antipsychotic agents for the treatment of schizophrenia, continued unmet needs exist for effective medications with lower adverse-effect burden. The present study evaluated the efficacy, safety, and tolerability of treatment with the atypical antipsychotic lurasidone for patients with an acute exacerbation of schizophrenia. Patients were randomized to 6 weeks of double-blind treatment with lurasidone 40 mg/day, 80 mg/day, or 120 mg/day, or placebo. Changes in Positive and Negative Syndrome Scale (PANSS) scores were evaluated using mixed-model repeated-measures (MMRM) analysis. Vital signs, laboratory parameters, extrapyramidal symptoms, and electrocardiogram were assessed. Treatment with lurasidone 80 mg/day resulted in significantly greater improvement in PANSS total score compared with placebo (-23.4 versus -17.0; p < 0.05) at study endpoint (MMRM); lurasidone 40 mg/day and 120 mg/day achieved clinically meaningful overall PANSS score reductions from baseline (-19.2 and -20.5), but not significant separation from placebo. Differences between all lurasidone groups and placebo for changes in laboratory parameters and electrocardiographic measures were minimal. Weight gain ≥ 7% occurred in 8.2% of patients receiving lurasidone and 3.2% receiving placebo. Modest increases in prolactin (median increase, 0.7 ng/mL) and extrapyramidal symptoms were observed following treatment with lurasidone compared with placebo. Akathisia was the most commonly reported adverse event with lurasidone (17.6%, versus 3.1% with placebo). In this study, in which a large placebo response was observed, lurasidone 80 mg/day, but not 40 mg/day or 120 mg/day, was statistically superior to placebo in treating acute exacerbation of chronic schizophrenia. All lurasidone doses were generally well tolerated.
AuthorsHenry A Nasrallah, Robert Silva, Debra Phillips, Josephine Cucchiaro, Jay Hsu, Jane Xu, Antony Loebel
JournalJournal of psychiatric research (J Psychiatr Res) Vol. 47 Issue 5 Pg. 670-7 (May 2013) ISSN: 1879-1379 [Electronic] England
PMID23421963 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2013 Elsevier Ltd. All rights reserved.
Chemical References
  • Antipsychotic Agents
  • Isoindoles
  • Thiazoles
  • Lurasidone Hydrochloride
Topics
  • Adolescent
  • Adult
  • Aged
  • Analysis of Variance
  • Antipsychotic Agents (therapeutic use)
  • Basal Ganglia Diseases (drug therapy)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • International Cooperation
  • Isoindoles (therapeutic use)
  • Lurasidone Hydrochloride
  • Male
  • Middle Aged
  • Psychiatric Status Rating Scales
  • Psychotic Disorders (drug therapy, etiology)
  • Schizophrenia (complications, drug therapy)
  • Thiazoles (therapeutic use)
  • Treatment Outcome
  • Young Adult

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