Aripiprazole in Children and Adolescents With Bipolar I Disorder

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.

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

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Aripiprazole

Criteria

Inclusion Criteria:

• Child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features

Exclusion Criteria:

• Patients with certain other psychological disorders

• Patients with a co-morbid serious, uncontrolled systemic illness

• Patients with significant risk of committing suicide