NCT00194012

Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder

Aripiprazole in At-Risk Children With Symptoms of Bipolar Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test the effectiveness and tolerability/safety of aripiprazole (Abilify) in children with subsyndromal symptoms of bipolar disorder who also have a parent with bipolar disorder and other family member with a mood disorder.

Detailed description

This will be a double-blind, placebo-controlled, parallel-arm, randomized clinical trial that will last up to 12 weeks. This placebo-controlled portion will be followed by a 6-week open label extension/stabilization phase. In order to be eligible for participation in the extension/stabilization phase, subjects must: 1) in the investigator's opinion have had no dose-limiting side effects likely to be attributable to aripiprazole (APZ); 2) participated in the blinded portion of the clinical trial for a minimum of 4 weeks.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Aripiprazole	Addressed in arm description.
DRUG	Placebo	Addressed in arm description.

Timeline

• Start date: 2004-08-01
• Primary completion: 2012-05-01
• Completion: 2012-06-01
• First posted: 2005-09-19
• Last updated: 2017-06-26
• Results posted: 2014-05-05

Locations

1 site across 1 country: United States