NCT00254462

Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

Pharmacological Treatment of ADHD in Young Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 5 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of attention deficit hyperactivity disorder (ADHD) in young children.

Detailed description

Attention deficit hyperactivity disorder (ADHD) is one of the most common mental disorders in children. Children with ADHD often have impaired functioning in home and school and usually experience difficulty relating to peers. If left untreated, the disorder can have long-term adverse effects into adolescence and adulthood. Atomoxetine is a selective noradrenergic reuptake inhibitor that is FDA-approved for the treatment of ADHD in children, adolescents, and adults. Unlike most other medications for ADHD, atomoxetine is not a stimulant. Studies have shown that atomoxetine is effective in treating ADHD, but more information is needed on its effectiveness in young children. This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of ADHD in young children. Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. In addition, all children will receive parent training for the duration of the study. For the first 5 weeks, participants will report to the study site weekly for assessments of ADHD symptoms. Study visits will occur every other week for the remainder of the study.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DRUG	Atomoxetine	Participants will receive atomoxetine for 8 weeks up to a maximum of 1.8 mg/kg/day. Dosed once daily in capsule formulation.
DRUG	Placebo	Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation.
BEHAVIORAL	Parent Training	All children will receive parent training for the duration of the study.

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-08-01
• Completion: 2008-09-01
• First posted: 2005-11-16
• Last updated: 2023-10-02
• Results posted: 2013-07-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study