Status:
COMPLETED
Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression
Lead Sponsor:
Forest Laboratories
Collaborating Sponsors:
Gedeon Richter Ltd.
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.
Eligibility Criteria
Inclusion
- Men and women, 18-65 years old
- Currently meet the DSM-IV-TR criteria for Bipolar I or II Disorder without psychotic features, with a current depressive episode
- A verified previous manic, hypomanic, or mixed episode
- Score of 20 or higher on the HAMD-17
- Score of 2 or higher on Item 1 of the HAMD
Exclusion
- Score greater than 12 on the Young Mania Rating Scale
- Eight or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months prior to Visit 1
- Principal DSM-IV-TR-based diagnosis of an axis I disorder other than bipolar disorder (a secondary diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety Disorder, or specific phobias is acceptable)
Key Trial Info
Start Date :
June 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2010
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT00852202
Start Date
June 30 2009
End Date
June 15 2010
Last Update
August 23 2018
Active Locations (26)
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1
Forest Investigative Site 005
Encino, California, United States, 91316
2
Forest Investigative Site 017
Garden Grove, California, United States, 92845
3
Forest Investigative Site 027
National City, California, United States, 91950
4
Forest Investigative Site 013
Newport Beach, California, United States, 92660