Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression

Phase 2 Completed 234 enrolled Forest Laboratories Gedeon Richter Ltd. · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.

Timeline

Start: 2009-06-30
Primary completion: 2010-06-15
Completion: 2010-06-15

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs 0.25 to 0.75 mg Cariprazine; p = 0.7408; ANCOVA NCT00852202 ↗

registry analysis (superiority test); Placebo vs 1.5 to 3.0 mg Cariprazine; p = 0.9961; ANCOVA NCT00852202 ↗

Publications

Earley WR, Burgess M, Rekeda L, Hankinson A, McIntyre RS, Suppes T, Calabrese JR, Yatham LN. A pooled post hoc analysis evaluating the safety and tolerability of cariprazine in bipolar depression. J Affect Disord. 2020 Feb 15;263:386-395. doi: 10.1016/j.jad.2019.11.098. Epub 2019 Nov 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cariprazine	Small molecule	0.25 mg	Oral
Subject	Cariprazine	Small molecule	0.75 mg	Oral
Subject	Cariprazine	Small molecule	1.5 mg	Oral
Subject	Cariprazine	Small molecule	3 mg	Oral