Allergan announced positive results from their Phase 3 study of cariprazine for the treatment of adults with major depressive episodes associated with bipolar I disorder.
Cariprazine, a once-daily atypical antipsychotic, is already approved for the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder, and also for the treatment of schizophrenia in adults.
A total of 488 individuals with bipolar I disorder were enrolled in the ‘RGH-MD-54′ trial and administered either cariprazine 1.5mg, 3mg or placebo. Results showed that both groups had significantly greater improvements than placebo for the change from baseline to week 6 (P<0.05) on the Montgomery-Asberg Depression Rating Scale (MADRS) total score.
“Having another product proven to treat the full range of bipolar disorder would be a welcome addition to the treatment options currently available to the psychiatry community and patients,” said Gary Sachs, MD, Professor at Harvard Medical School.
Cariprazine was generally well-tolerated in the study. Sedation, somnolence, dizziness, akathisia and nausea were the most commonly reported adverse events.
For more information visit ClinicalTrials.gov.