Safety and Efficacy of Cariprazine for Mania

Summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.

Timeline

Start

2010-02

Primary completion

2011-07

Completion

2011-07

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Cariprazine; p = 0.0004; Least Squares Mean Difference -4.3 (95% CI -6.7 to -1.9); Mixed Models Analysis NCT01058096 ↗

Publications

• McIntyre RS, Masand PS, Earley W, Patel M. Cariprazine for the treatment of bipolar mania with mixed features: A post hoc pooled analysis of 3 trials. J Affect Disord. 2019 Oct 1;257:600-606. doi: 10.1016/j.jad.2019.07.020. Epub 2019 Jul 5.
• Earley W, Durgam S, Lu K, Ruth A, Nemeth G, Laszlovszky I, Yatham LN. Clinically relevant response and remission outcomes in cariprazine-treated patients with bipolar I disorder. J Affect Disord. 2018 Jan 15;226:239-244. doi: 10.1016/j.jad.2017.09.040. Epub 2017 Sep 25.

Drugs

Indications