At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 238 enrolled
Drug / intervention
Cariprazine (RGH-188) +1 moredrug
Likely dose
Cariprazine (RGH-188) 3 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 Evaluation of the Safety and Efficacy of RGH-188 in Patients With Acute Mania Associated With Bipolar I Disorder
In Brief
A Phase 2 clinical trial evaluating Cariprazine (RGH-188) and Placebo for Bipolar Disorder. Completed, enrolled 238 participants across 1 site.
Detailed Summary
This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188 monotherapy in the treatment of acute mania. This study will be 5 weeks in duration; 3 weeks double-blind treatment and 2-weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of two treatment groups: RGH-188 or placebo
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
CollaboratorsGedeon Richter Ltd.
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2007
First PostedJun 2007
Primary CompletionJul 2008
TodayJul 2026
First PostedJun 20, 2007
Enrollment StartJun 1, 2007
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 19.0 years ago
Interventions
Cariprazine (RGH-188)drug
Cariprazine 3 mg - 12 mg oral administration, once per day.
Placebodrug
Dose-matched placebo oral administration, once per day.