Phase III data for cariprazine positive for acute mania associated with Bipolar 1 Disorder.

A five-week study of cariprazine ,a dopamine D3-preferring D3/D2 receptor partial agonist, from Forest Laboratories and Gedeon Richter, enrolled 312 adult patients with acute mania associated with bipolar 1 disorder meeting the DSM-IV-TR criteria who were randomised to receive at least one dose of cariprazine (3-12mg/day) for three weeks followed by a two week period of safety assessments. Its primary endpoint was change from baseline to week three on the Young Mania Rating Scale using the mixed effects model of repeated measures analysis, and significant improvement was seen with cariprazine: �19.6 vs �15.3, p<0.001).the rate of premature discontinuation was 32 for cariprazine and 31 for placebo patients. the most common adverse events>10% and twice the rate of placebo) were akathisia, extrapyramidal disorder, tremor, dyspepsia and vomiting. The discontinuation rate due to adverse events was 10% compared with 7% for placebo.