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
Results First Posted : August 23, 2018
Last Update Posted : August 23, 2018
|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|
|Actual Study Start Date :||June 30, 2009|
|Actual Primary Completion Date :||June 15, 2010|
|Actual Study Completion Date :||June 15, 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
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline to Week 8 ]The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity.
- Change in Baseline in Clinical Global Impressions-Improvement ( CGI-I ) [ Time Frame: Baseline to Week 8 ]The patient was rated on a scale from 1 to 7, with 1 indicating the patient was very much improved and 7 indicating that the patient was very much worse.
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.|