Clinical Trial: A Study of Atomoxetine for Attention Deficit and Hyperactive/Impulsive Behaviour Problems in Children With ASD
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open Label Pilot Study of Atomoxetine for Attention Deficit and Hyperactive/Impulsive Behavior Problems in Children and Adolescents With Autistic Spectrum Disorders
Brief Summary: The primary purpose of this study is to evaluate the tolerability and effectiveness of atomoxetine in the treatment of attention problems, hyperactivity, and impulsivity in children with ASD, and secondarily, to evaluate the possible response to atomoxetine on the core symptoms of ASD
Detailed Summary:
Sponsor: Eli Lilly and Company
Current Primary Outcome: Test whether atomoxetine is effective in reducing symptoms of inattention and overactivity/impulsivity as measured by the AHDHRS-IV-Parent:Inv scale in pediatric outpatients with ASD accompanied by ADHD behavior problems
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To assess whether atomoxetine will be effective in reducing symptoms of inattention and overactivity/impulsivity
- To assess whether atomoxetine will be effective for improving social functioning and personal sufficiency in children and adolescents with ASD+ADHD
- To assess whether atomoxetine has a positive or negative effect on frequently associated symptoms as impulsive aggression, agitation, self-injurious behavior, troublesome repetitive behavior and poor motor coordination
- To assess whether atomoxetine has a positive or negative effect on neuropsychological functioning
- To assess the overall influence on functioning and burden on the family
- To monitor clinical safety and side effects as assessed by adverse events elicited during open-ended questioning
Original Secondary Outcome: Same as current
Information By: Eli Lilly and Company
Dates:
Date Received: June 11, 2007
Date Started: February 2004
Date Completion:
Last Updated: June 11, 2007
Last Verified: June 2007
