Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania

Summary

This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188 monotherapy in the treatment of acute mania. This study will be 5 weeks in duration; 3 weeks double-blind treatment and 2-weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of two treatment groups: RGH-188 or placebo

Timeline

Start

2007-06

Primary completion

2008-07

Completion

2008-07

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Cariprazine; p <0.0001; Least Squares Mean Difference -6.1 (95% CI -8.9 to -3.3); ANCOVA NCT00488618 ↗

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