Overview

Aripiprazole for the Treatment of Mania in Children and Adolescents With Bipolar Disorder

Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
This is an open-labeled study of Aripiprazole, testing its efficacy in the treatment of mania in children and adolescents with Bipolar I, Bipolar II and Bipolar Spectrum Disorder over 8 weeks. This is an exploratory, pilot study, seeking to determine whether Aripiprazole is efficacious and well tolerated in the treatment of youth with pediatric bipolar and bipolar spectrum disorder. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
Phase:
Phase 4
Details
Lead Sponsor:
Massachusetts General Hospital
Collaborator:
Bristol-Myers Squibb
Treatments:
Aripiprazole