ORIGINAL ARTICLESLong-term safety and tolerability of lurasidone in schizophrenia: a 12-month, double-blind, active-controlled studyCitrome, Lesliea; Cucchiaro, Josephineb; Sarma, Kaushikb; Phillips, Debrab; Silva, Robertb; Tsuchiya, Satorub; Loebel, AntonybAuthor Information 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: firstname.lastname@example.org Received August 30, 2011 Accepted February 13, 2012 International Clinical Psychopharmacology: May 2012 - Volume 27 - Issue 3 - p 165-176 doi: 10.1097/YIC.0b013e32835281ef Buy Metrics Abstract 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. © 2012 Lippincott Williams & Wilkins, Inc.