Study of Aripiprazole (Abilify) in Children With ADHD (Attention Deficit Hyperactivity Disorder)
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|ClinicalTrials.gov Identifier: NCT00221962|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: Aripiprazole||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Cognitive Effects of Aripiprazole in Children|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
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.
- Effectiveness and cognitive effects [ Time Frame: 6 weeks ]To examine effectiveness and cognitive effects during open-label pilot
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|