Secondary Logo

Journal Logo

Institutional members access full text with Ovid®

Long-term safety and tolerability of lurasidone in schizophrenia: a 12-month, double-blind, active-controlled study

Citrome, Lesliea; Cucchiaro, Josephineb; Sarma, Kaushikb; Phillips, Debrab; Silva, Robertb; Tsuchiya, Satorub; Loebel, Antonyb

International Clinical Psychopharmacology: May 2012 - Volume 27 - Issue 3 - p 165–176
doi: 10.1097/YIC.0b013e32835281ef

The aim of this study is to evaluate the long-term safety and tolerability of lurasidone in the treatment of schizophrenia. Clinically stable adult outpatients with schizophrenia were randomized in a 2 : 1 ratio to 12 months of double-blind treatment with once-daily, flexibly-dosed lurasidone (40–120 mg) or risperidone (2–6 mg). Outcome measures included adverse events (AEs), vital signs, ECG, and laboratory tests. Secondary assessments included measures of psychopathology. A total of 427 patients were randomized to treatment with lurasidone and 202 with risperidone. The three most frequent AEs in the lurasidone group (vs. risperidone) were nausea (16.7 vs. 10.9%), insomnia (15.8 vs. 13.4%), and sedation (14.6 vs. 13.9%); the three most frequent AEs in the risperidone group (vs. lurasidone) were increased weight (19.8 vs. 9.3%), somnolence (17.8 vs. 13.6%), and headache (14.9 vs. 10.0%). A higher proportion of patients receiving risperidone had at least a 7% endpoint increase in weight (14 vs. 7%). The median endpoint change in prolactin was significantly higher for risperidone (P<0.001). A comparable improvement in efficacy measures was observed with both agents and the rates of relapse were similar. All-cause discontinuation rates were higher for lurasidone versus risperidone. Long-term treatment with lurasidone was generally well tolerated in this study, with minimal effects on weight and metabolic outcomes.

aDepartment of Psychiatry & Behavioral Sciences, New York Medical College, Valhalla, New York, USA

bSunovion Pharmaceuticals Inc., Fort Lee, New Jersey, USA

Correspondence to Leslie Citrome, MD, MPH, 11 Medical Park Drive, Suite 106, Pomona, NY 10970, USA Tel: +1 845 362 2081; fax: +1 845 362 8745; e-mail:

Received August 30, 2011

Accepted February 13, 2012

© 2012 Lippincott Williams & Wilkins, Inc.