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

• Status: Completed
• Trial end date: 2010-06-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.

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

Details

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

Criteria

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)