Study of Aripiprazole (Abilify) in Children With ADHD (Attention Deficit Hyperactivity Disorder)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Cognitive Effects of Aripiprazole in Children|
- Effectiveness and cognitive effects [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]To examine effectiveness and cognitive effects during open-label pilot
|Study Start Date:||April 2005|
|Study Completion Date:||April 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Open label treatment with aripiprazole
After 1-3 week screening phase, entered six week open trial of aripiprazole initiated at 2.5mg/day. DOsing was increased weekly in 2.5mg increments in order to reach maximum dose of 10mg/d.
Other Name: As previously described.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221962
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Robert L Findling, MD||University Hospitals Cleveland Medical Center|