NCT00221962

Study of Aripiprazole (Abilify) in Children With ADHD (Attention Deficit Hyperactivity Disorder)

The Cognitive Effects of Aripiprazole in Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Accepted

Summary

To look at the cognitive effects of abilify in children with a primary diagnosis of Attention Deficit Hyperactivity Disorder. To examine the safety, effectiveness and tolerability of abilify in children with a primary diagnosis of Attention Deficit Hyperactivity Disorder.

Detailed description

This will be a prospective, open-label, 6-week trial of APZ in outpatient children 8-12 years of age with a primary diagnosis of ADHD free of other major psychopathology. The six-week treatment phase will be proceeded by a 1-3 week screening phase. The study cohort will consist of 10 children with ADHD combined type and 10 children with ADHD predominantly inattentive type who complete the study. Cognitive measures will be assessed prior to APZ therapy and after 6 weeks of APZ treatment. Safety assessments and measures of ADHD symptomatology will be collected prior to and during APZ therapy. While receiving APZ treatment, patients will be seen at baseline, Week 1,2,3,4, and 6.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Aripiprazole	Open label

Timeline

• Start date: 2005-04-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2005-09-22
• Last updated: 2014-12-15

Locations

1 site across 1 country: United States