At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 584 enrolled
Drug / intervention
Placebo +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 Bipolar Depression
In Brief
A Phase 2 clinical trial evaluating Placebo and Cariprazine for Depression, Bipolar. Completed, enrolled 584 participants across 88 sites in 6 countries.
Detailed Summary
The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Bipolar
CountriesBulgaria, Canada, Colombia, Russia, Ukraine, United States
CollaboratorsGedeon Richter Ltd.
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 2011
Enrollment StartJul 2011
Primary CompletionJan 2014
TodayJul 2026
First PostedJul 18, 2011
Enrollment StartJul 26, 2011
Primary CompletionJan 10, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 15.0 years ago
Interventions
Placebodrug
Placebo was supplied in capsules.
Cariprazinedrug
Cariprazine was supplied in capsules.