Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder

• Status: Completed
• Trial end date: 2012-02-29
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patients who have provided informed consent prior to any study specific procedures.

• Patients 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 for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID).

• Patients who experienced a manic or mixed episode that required treatment within the past 12 months.

• Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).

Exclusion Criteria:

• Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder.