Forest Laboratories Inc and Gedeon Richter Plc announce results from a Phase II study of cariprazine as adjunctive therapy in major depressive disorder.

Forest Laboratories Inc and Gedeon Richter Plc announced preliminary top-line results from an 8-week Phase II clinical trial of the novel, investigational antipsychotic agent cariprazine as adjunctive therapy in major depressive disorder. Cariprazine is currently undergoing Phase III trials for the separate and additional indications of schizophrenia and bipolar mania. In this exploratory Phase II trial, a total of 231 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. Although the overall difference observed between the drug-treated and …