At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 323 enrolled
Drug / intervention
Cariprazine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized 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 Bipolar Disorder and Mania. Completed, enrolled 323 participants across 28 sites in 2 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
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Mania
CountriesIndia, United States
CollaboratorsGedeon Richter Ltd.
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2010
Enrollment StartFeb 2010
Primary CompletionJul 2011
TodayJul 2026
First PostedJan 28, 2010
Enrollment StartFeb 1, 2010
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.4 years ago
Interventions
Cariprazinedrug
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine.
Placebodrug
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo.