At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder
In Brief
A Phase 3 clinical trial evaluating Cariprazine and Placebo for Mania and Bipolar I Disorder. Completed, enrolled 497 participants across 66 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks.