Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression
Safety and Efficacy 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.
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)