At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 234 enrolled
Drug / intervention
cariprazine +2 moredrug
Likely dose
cariprazine 0.75 mgfrom 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 Study of RGH-188 (Cariprazine) in Bipolar Depression
In Brief
A Phase 2 clinical trial evaluating cariprazine and placebo for Bipolar Depression. Completed, enrolled 234 participants across 26 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Depression
CountriesUnited States
CollaboratorsGedeon Richter Ltd.
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2009
Enrollment StartJun 2009
Primary CompletionJun 2010
TodayJul 2026
First PostedFeb 26, 2009
Enrollment StartJun 30, 2009
Primary CompletionJun 15, 2010
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 17.3 years ago
Interventions
cariprazinedrug
Drug: cariprazine (0.25 - 0.75 mg/day)
cariprazinedrug
Drug: cariprazine (1.5 - 3.0 mg/day)
placebodrug
placebo capsules, oral administration, once daily dosing