Safety and Efficacy of Cariprazine for Bipolar I Disorder

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

2011-12

Completion

2011-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Cariprazine (3-6 mg/Day); p <0.001; Least Squares Mean Difference -6.1 (95% CI -8.4 to -3.8); Mixed Models Analysis NCT01058668 ↗

registry analysis (superiority or other test); Placebo vs Cariprazine (6-12 mg/Day); p <0.001; Least Squares Mean Difference -5.9 (95% CI -8.2 to -3.6); Mixed Models Analysis NCT01058668 ↗

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.
• Calabrese JR, Keck PE Jr, Starace A, Lu K, Ruth A, Laszlovszky I, Nemeth G, Durgam S. Efficacy and safety of low- and high-dose cariprazine in acute and mixed mania associated with bipolar I disorder: a double-blind, placebo-controlled study. J Clin Psychiatry. 2015 Mar;76(3):284-92. doi: 10.4088/JCP.14m09081.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cariprazine	Small molecule	3 mg	Oral
Subject	Cariprazine	Small molecule	6 mg	Oral
Subject	Cariprazine	Small molecule	12 mg	Oral

Indications