The atypical antipsychotic cariprazine outperformed placebo in easing bipolar depression in a phase 3 study published online in The American Journal of Psychiatry.
“Cariprazine, a dopamine D3/D2 and 5-HT1A receptor partial agonist, was found to be effective in treating bipolar I depression in a previous phase 2 study,” researchers wrote. “This phase 3 study further assessed the efficacy, safety, and tolerability of cariprazine in bipolar I depression.”
The latest double-blind trial included 480 adults with bipolar I disorder who were experiencing a depressive episode. Researchers randomly assigned 157 participants to 1.5 mg of cariprazine daily, 165 participants to 3 mg of cariprazine daily, and 158 to placebo.
Practice Tool: Bipolar Spectrum Diagnostic Scale (BSDS)
Six weeks after the start of treatment, both dosages of cariprazine were significantly more effective than placebo in reducing total scores on the Montgomery-Åsberg Depression Rating Scale, the study found. Both cariprazine dosages also were associated with lower Clinical Global Impressions severity scores, although not significantly so.
Common adverse events, which affected at least 5% of participants in either cariprazine group and at twice the rate of the placebo group, included nausea, akathisia, dizziness, and sedation, researchers reported. Weight and metabolic changes tended to be small and comparable across groups.
“Cariprazine, at both 1.5 mg/day and 3.0 mg/day, was effective, generally well tolerated, and relatively safe in reducing depressive symptoms in adults with bipolar I depression,” researchers concluded.
Earley W, Victoria Burgess M, Rekeda L, et al. Cariprazine treatment of bipolar depression: a randomized double-blind placebo-controlled phase 3 study. The American Journal of Psychiatry. 2019 March 8;[Epub ahead of print].