Карипразин

Forest Laboratories Inc. and Gedeon Richter announced in September the preliminary results from an eight-week phase 2 clinical trial of the antipsychotic agent cariprazine for the treatment of bipolar depression.

A total of 233 patients were randomized to enter one of two active (low dose or high dose) treatment arms or receive a placebo. The primary endpoint was the Montgomery-Asberg Depression Rating Scale (MADRS) score. Although the overall difference observed between the drugtreated and placebo-treated groups was not statistically significant, over the course of the trial there was evidence of a clinically relevant treatment effect in the high-dose arm of the study compared with placebo. Approximately 9 percent of patients discontinued the study early due to adverse events in the high-dose study arm compared with 3 percent in the placebo arm. The companies are considering conducting an additional phase 2 dose-response trial examining a wider range of doses.

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