A Double-blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed/flexible-dose study in adult patients with a primary diagnosis of schizophrenia. The total study duration is 9 weeks: a no-drug screening period of up to 7 days, followed by 6 weeks of double-blind treatment and a 2-week safety follow-up period. At the end of the screening period, patients meeting eligibility criteria will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio: placebo, cariprazine 3 to 6 mg/day, or cariprazine 6 to 9 mg/day. This study will be performed at approximately 40 study centers in the US, India, and other countries. A total of 450 patients (approximately 170 patients in India) are planned to be randomized in this study. The primary outcome measure is the PANSS and the secondary outcome measure is the CGI-S. The tentative date for patient enrollment at an Indian site is in last week of October, 2010.