• Am J Psychiatry · Sep 2011

    Randomized Controlled Trial Multicenter Study Comparative Study

    Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo- and olanzapine-controlled study.

    • Herbert Y Meltzer, Josephine Cucchiaro, Robert Silva, Masaaki Ogasa, Debra Phillips, Jane Xu, Amir H Kalali, Edward Schweizer, Andrei Pikalov, and Antony Loebel.
    • Department of Psychiatry, Vanderbilt University School of Medicine, Nashville, Tenn., USA. herbert.meltzer@vanderbilt.edu
    • Am J Psychiatry. 2011 Sep 1; 168 (9): 957-67.

    ObjectiveThe study was designed to evaluate the short-term efficacy and safety of lurasidone in the treatment of acute schizophrenia.MethodParticipants, 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).ResultsTreatment 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 experiencing ≥ 7% weight gain was 5.9% for the lurasidone groups combined, 34.4% for the olanzapine group, and 7.0% for the placebo group.ConclusionsLurasidone was an effective treatment for patients with acute schizophrenia. Safety assessments indicated a higher frequency of adverse events associated with 120 mg/day of lurasidone compared with 40 mg/day.

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