Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

Inclusion Criteria:

- Participants who have provided informed consent prior to any study specific
procedures.

- Participants currently meeting the Diagnostic and Statistical Manual of Mental
Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder
as confirmed by the Structured Clinical Interview (SCID) with a current with a current
major depressive episode of at least 4 weeks and not exceeding 12 months in duration.

- Participants with normal physical examination, laboratory, vital signs, and/or
echocardiogram (ECG).

- Verified previous manic or mixed episode.

- Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.

- Participants with a HAMD-17 item 1 score ≥ 2.

- Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.

Exclusion Criteria:

- Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I
disorder that was the primary focus of treatment within the previous 6 months.

- Women who are pregnant or breast feeding

- Participants with Young Mania Rating Scale (YMRS) total score > 10

- Participants who have dementia, mental retardation, schizophrenia/schizoaffective
disorder.