Study Demonstrating Lurasidone Is Effective in Patients With Schizophrenia Published in The Journal of Clinical ...(verity of Illness scale) (-0.6 vs. -0.2;...),Health

Lurasidone significantly improved depressive symptoms associated with schizophrenia, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at the study endpoint. The mean changes in MADRS score were -2.9 vs. -0.1 (p=0.019) for lurasidone and placebo, respectively.

Lurasidone's effect on weight (median change 0.9 kg for lurasidone vs. 0.5 kg for placebo), lipids, and glucose was similar to placebo. No clinically important differences were observed between lurasidone and placebo for EPS (assessed using the Simpson-Angus Scale) or symptoms of tardive dyskinesia (assessed using the Abnormal Involuntary Movements Scale). There was a modest but significant worsening at endpoint in akathisia symptoms (assessed using the Barnes Akathisia Scale) for lurasidone versus placebo.

Lurasidone was well-tolerated with generally mild adverse events reported during the trial. The most commonly reported adverse events (reported frequency greater than or equal to 10% among lurasidone subjects) for lurasidone versus placebo were nausea (16% vs. 3%), headache (11.1% vs. 10%), constipation (11.1% vs. 5.6%), vomiting (11.1% vs. 5.6%), dyspepsia (11.1% vs. 3.3%), somnolence (11.1% vs. 3.3%), insomnia (10.0% vs. 3.3%) and sedation (10.0% vs. 4.4%). Lurasidone had a lower overall discontinuation rate (42.2%) compared to placebo (48.8%) with few adverse-event related discontinuations (6.7% and 1.1% for lurasidone and placebo, respectively).

Study Design

This randomized, placebo-controlled, double-blind, multicenter clinical trial conducted in the U.S. evaluated the efficacy of lurasidone 80 mg once daily compared to placebo over six weeks in patients hospitalized for an acute exacerbation of schizophrenia (diagnosed using DSM-IV criteria). A total of 180 patients were randomized equally to the two treatment arms. Patients remained in
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