At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 488 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 Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating The Efficacy, Safety And Tolerability Of Cariprazine In Patients With Bipolar I Depression
In Brief
A Phase 3 clinical trial evaluating Cariprazine and Placebo for Bipolar Disorder and Depression. Completed, enrolled 488 participants across 74 sites in 6 countries.
Detailed Summary
This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Depression
CountriesBulgaria, Estonia, Lithuania, Poland, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartMar 2016
Primary CompletionJul 2017
TodayJul 2026
First PostedFeb 1, 2016
Enrollment StartMar 17, 2016
Primary CompletionJul 19, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.4 years ago
Interventions
Cariprazinedrug
Placebodrug