Lurasidone in the Treatment of Schizophrenia: A Randomized, Double-Blind, Placebo- and Olanzapine-Controlled Study

作者：Herbert Y. Meltzer, Josephine Cucchiaro, Robert Silva, Masaaki Ogasa, Debra Phillips, Jane Xu, Amir H Kalali, Edward E. Schweizer, Andrei Pikalov, Antony Loebel · 发表于：American Journal of Psychiatry · 年份：2011 · DOI：10.1176/appi.ajp.2011.10060907 · 被引用次数：252 · 研究领域：Schizophrenia research and treatment、Healthcare Decision-Making and Restraints、Bipolar Disorder and Treatment

OBJECTIVE: The study was designed to evaluate the short-term efficacy and safety of lurasidone in the treatment of acute schizophrenia. METHOD: 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. 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 (as the primary efficacy measure) and Clinical Global Impressions severity (CGI-S) score (as the key secondary efficacy measure). RESULTS: Treatment with both doses of lurasidone or with olanzapine 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. There was no statistically significant difference in mean PANSS total or CGI-S change scores for the lurasidone groups compared with the olanzapine group. With responders defined as those with an improvement of at least 20% on the PANSS, endpoint responder rates were significant compared with placebo for olanzapine only. The incidence of akathisia was higher with 120 mg of lurasidone (22.9%) than with 40 mg of lurasidone (11.8%), olanzapine (7.4%), or placebo (0.9%). The proportion of patients ...