Safety and Efficacy of RGH-188 (Cariprazine) in 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)