Forest Laboratories Inc and Gedeon Richter Plc announce results from a Phase II study of cariprazine for the treatment of bipolar depression.

Forest Laboratories Inc (Forest) and Gedeon Richter Plc (Gedeon) announced preliminary top-line results from an 8-week Phase II clinical trial of the novel, investigational antipsychotic agent cariprazine for the treatment of bipolar depression. Cariprazine is currently undergoing Phase III trials for separate indications of schizophrenia and bipolar mania. A total of 233 patients were randomised to enter one of two active (low dose or high dose) treatment arms or placebo. The primary endpoint was the Montgomery Asberg Depression Rating Scale (MADRS) score. The study was designed to be exploratory. Although the overall difference observed between the drug-treated and placebo-treated …