NCT00417794

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 4 Years – 11 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Fetal Alcohol Syndrome
• Attention Deficit Disorder With Hyperactivity (ADHD)
• Attention Deficit Disorder (ADD)

Interventions

Type	Name	Description
DRUG	Strattera	escalating dosage: 0.5 mg/kg, 1.0 mg/kg, and 1.4 mg/kg titrated up or down according to adverse effects to therapy
DRUG	Placebo	0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with breakfast.

Timeline

• Start date: 2005-08-01
• Primary completion: 2015-04-22
• Completion: 2015-04-22
• First posted: 2007-01-04
• Last updated: 2017-04-10

Locations

1 site across 1 country: United States