Clinical Trial: Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Study of the Efficacy of Atomoxetine in Treating the Inattention, Impulsivity and Hyperactivity in Children With Fetal Alcohol Syndrome or Effects

Brief Summary: The purpose of this study is to determine if atomoxetine hydrochloride improves inattention, hyperactivity, and impulsivity problems in children exposed to alcohol during birth.

Detailed Summary: Abnormalities of attention, function, and activity level in children exposed to alcohol in utero share similarities and differences to children who do not have alcohol exposure. Previous psychological studies have examined either core attention deficit hyperactivity disorder (ADHD)symptoms of hyperactivity, inattention, and impulsivity or hypothesized neuropsychological differences in children with fetal alcohol syndrome (FAS) and ADHD. Atomoxetine Hydrochloride is a non-stimulant medication used to treat ADHD. This study will determine if atomoxetine HCL significantly reduces symptoms of ADD/ADHD in children with fetal alcohol exposure.
Sponsor: University of Oklahoma

Current Primary Outcome: ADHD Rating Scale - IV [ Time Frame: length of protocol ]

Original Primary Outcome: ADHDRS-IV Assessment outcomes performed at each visit.

Current Secondary Outcome:

  • Determine if atomoxetine is safe and well tolerated by children with FAS. [ Time Frame: length of protocol ]
  • Determine if atomoxetine is effective in both school and home, and significantly reduces symptoms of inattention, hyperactivity, and impulsivity in children with FAS compared to children with FAS receiving placebo. [ Time Frame: length of protocol ]
  • Determine if atomoxetine improves behaviors in the mornings and evenings. [ Time Frame: Length of protocol ]
  • Determine if parents of children with FAS are satisfied with the effectiveness of atomoxetine. [ Time Frame: Length of protocol ]
  • Determine if there are any differences in the adverse effects profile of children with FAS compared to the overall profile for atomoxetine. [ Time Frame: Length of protocol ]
  • Determine the degree of functional limitation experienced by this group of children with FAS and whether this impairment is decreased by treatment with atomoxetine as demonstrated by the Pediatric Evaluation of Disability Inventory (PEDI) [ Time Frame: Length of protocol ]


Original Secondary Outcome:

  • Determine if atomoxetine is safe and well tolerated by children with FAS.
  • Determine if atomoxetine is effective in both school and home, and significantly reduces symptoms of inattention, hyperactivity, and impulsivity in children with FAS compared to children with FAS receiving placebo.
  • Determine if atomoxetine improves behaviors in the mornings and evenings.
  • Determine if parents of children with FAS are satisfied with the effectiveness of atomoxetine.
  • Determine if there are any differences in the adverse effects profile of children with FAS compared to the overall profile for atomoxetine.
  • Determine the degree of functional limitation experienced by this group of children with FAS and whether this impairment is decreased by treatment with atomoxetine as demonstrated by the Pediatric Evaluation of Disability Inventory (PEDI)


Information By: University of Oklahoma

Dates:
Date Received: January 2, 2007
Date Started: August 2005
Date Completion:
Last Updated: April 6, 2017
Last Verified: April 2017