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Original Research

Effectiveness of Lurasidone for Patients With Schizophrenia Following 6 Weeks of Acute Treatment With Lurasidone, Olanzapine, or Placebo: A 6-Month, Open-Label, Extension Study

Stephen M. Stahl, MD, PhD; Josephine Cucchiaro, PhD; Doreen Simonelli, PhD; Jay Hsu, PhD; Andrei Pikalov, MD, PhD; and Antony Loebel, MD

Published: March 13, 2013

Article Abstract

Objective: The primary objective was to evaluate the safety and tolerability of lurasidone, a new atypical antipsychotic agent, in the longer-term treatment of schizophrenia (DSM-IV). Persistence of symptom improvement was assessed as a secondary outcome.

Method: Patients who completed a 6-week, double-blind, placebo-controlled study evaluating the efficacy of fixed doses of once-daily lurasidone (40 or 120 mg) or olanzapine 15 mg (to confirm assay sensitivity) were eligible to receive flexibly dosed lurasidone 40 to 120 mg/d in this 6-month, open-label extension study (conducted from March 2008 to December 2009). Assessments of safety and tolerability were conducted at open-label baseline, at day 10, and monthly thereafter.

Results: Of 254 enrolled patients, 113 (44.5%) completed 6 months of open-label treatment. During the open-label study (month 6 observed cases), small decreases were observed in mean weight (−0.1 kg) and median lipid levels (total cholesterol, −6.5 mg/dL; low-density lipoprotein, 0.0 mg/dL; high-density lipoprotein, 0.0 mg/dL; triglycerides, −8.5 mg/dL). Patients previously treated with olanzapine (n = 69) experienced decrease in weight and improvement in lipid levels, whereas patients previously treated with lurasidone (n = 115) or placebo (n = 62) experienced minimal changes. No clinically meaningful changes were observed in median prolactin levels. The 2 most commonly reported adverse events were akathisia (13.0%) and insomnia (11.0%). Persistent antipsychotic efficacy of lurasidone was shown for patients who had previously received lurasidone, olanzapine, or placebo; further reductions from open-label baseline to final visit were observed in mean PANSS total score (−8.7) for all patients.

Conclusions: Open-label treatment with flexibly dosed lurasidone (40-120 mg/d) was generally safe, well tolerated, and effective over a 6-month period in patients who had completed a preceding 6-week, double-blind study.

Trial Registration: identifier: NCT00615433

J Clin Psychiatry

Submitted: August 7, 2012; accepted February 15, 2013.

Online ahead of print: March 13, 2013 (doi:10.4088/JCP.12m08084).

Corresponding author: Stephen M. Stahl, MD, PhD, 1930 Palomar Point Way, Ste 103, Carlsbad, CA 92008 (

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