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

• Status: Completed
• Trial end date: 2014-01-10
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Collaborator: Gedeon Richter Ltd.
• Treatments: Cariprazine

Criteria

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.