ARTICLE | Clinical News

Cariprazine: Phase II data

September 6, 2010 7:00 AM UTC

Top-line data from an exploratory, double-blind, U.S. Phase II trial in 233 patients showed that low- and high-dose daily oral cariprazine each missed the primary endpoint of significantly improving MADRS scores from baseline to week 8 vs. placebo. However, Forest and Gedeon Richter said there was evidence of a "clinically relevant" treatment effect in the high-dose cariprazine arm vs. placebo. Patients received 0.25-0.75 mg/day cariprazine (low dose), 1.5-3 mg/day cariprazine (high dose) or placebo. The partners said they are considering conducting an additional Phase II trial to evaluate a wider range of cariprazine doses, but plan to complete a full analysis of the current Phase II trial before determining next steps. ...