Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221962
Status:
COMPLETED
Last Update Posted:
2014-12-15
First Post:
2005-09-16
Brief Title:
Study of Aripiprazole Abilify in Children With ADHD Attention Deficit Hyperactivity Disorder
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
University Hospitals Cleveland Medical Center
Study Overview
Official Title:
The Cognitive Effects of Aripiprazole in Children
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 1234 and 6
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 1234 and 6
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None