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, doubleblind, 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 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; lowdensity 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: ClinicalTrials.gov identifier: NCT00615433 Clin Psychiatry 2013;74(5):507-515 J

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