Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression
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|ClinicalTrials.gov Identifier: NCT00852202|
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : July 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Depression||Drug: cariprazine Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||234 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Double-blind, Placebo-controlled Study of RGH-188 (Cariprazine) in Bipolar Depression|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||June 2010|
0.25 - 0.75 mg/day cariprazine capsules, oral administration, once daily dosing.
Drug: cariprazine (0.25 - 0.75 mg/day)
1.5 - 3.0 mg/day cariprazine capsules, oral administration, once daily dosing.
Drug: cariprazine (1.5 - 3.0 mg/day)
Placebo Comparator: 3
Matching placebo capsules, oral administration, once daily dosing.
placebo capsules, oral administration, once daily dosing
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ]
- Clinical Global Impression - Improvement (CGI-I) [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852202
Show 26 Study Locations
|Study Director:||William Greenberg, MD||Forest Research Institute, a subsidiary of Forest Laboratories, Inc.|