Cariprazine in the treatment of Bipolar Disorder: A systematic review and meta-analysis.

ABSTRACT

OBJECTIVES: Cariprazine is a partial agonist at D2/D3 receptors that has been approved for the treatment of mania associated with bipolar disorder (BD). This meta-analysis aimed to assess the efficacy and tolerability of cariprazine in the treatment of BD. METHODS: Randomized controlled trials investigating the efficacy of cariprazine in BD were included. Of the 391 studies yielded by search, 7 were included. The PRISMA protocol was followed and a set of analyses involving random-effects model with restricted maximum-likelihood estimator were used to synthesize effect sizes. RESULTS: Cariprazine was associated with a moderate and significant reduction of manic symptoms based on YMRS change scores (SMD -0.52; 95%CI -0.82 to -0.21; P = .018). Cariprazine resulted in significantly higher remission (OR 2.05; 95%CI 1.61-2.61; P = .006) and response rates (OR 2.31; 95%CI 1.35-3.95; P = .021) for manic and mixed episodes compared with placebo. Both cariprazine 1.5 mg and 3 mg doses were associated with small but significant reduction in depressive symptoms assessed with MADRS scores (SMD -0.26, 95%CI -0.49 to -0.02; P = .040) (SMD -0.21, 95%CI -0.41 to -0.01; P = .045), respectively. Cariprazine was significantly associated with the development of adverse effects but not with dropouts due to these adverse effects, when compared to placebo. CONCLUSION: Cariprazine appears to be safe and efficacious in the treatment of acute mania and mixed episodes associated with BD. Cariprazine at doses of 1.5-3 mg/day is efficacious in acute bipolar depression but the effect sizes were smaller. Controlled studies evaluating its efficacy for prophylaxis are needed.