Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/25/2018 |
| Start Date: | June 30, 2009 |
| End Date: | June 15, 2010 |
A Double-blind, Placebo-controlled Study of RGH-188 (Cariprazine) in Bipolar Depression
The purpose of this study is to evaluate the efficacy, safety, and tolerability of
cariprazine in the treatment of outpatients with bipolar depression.
cariprazine in the treatment of outpatients with bipolar depression.
Inclusion Criteria:
- 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 Criteria:
- 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)
We found this trial at
26
sites
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