Preliminary top-line results from cariprazine 8-week Phase II trial against major depressive disorder

Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc. today 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 randomized 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 placebo-treated groups was not statistically significant, over the course of the trial, there was evidence of a treatment effect in the high-dose arm of the study compared to placebo.

In addition, tolerability results for cariprazine support further investigation in this patient population. Approximately 3% of patients discontinued the study early due to adverse events in the high-dose and 1% in the low-dose study arm compared to 3% in the placebo arm.

The companies are considering conducting an additional Phase II dose-response trial examining a wider range of doses.