An open-label, dose-ranging study of atomoxetine in children with attention deficit hyperactivity disorder

Objective: The goal of this study was to evaluate the tolerability and effe ctiveness of the experimental, noradrenergic specific reuptake inhibitor at omoxetine in the treatment of children with attention deficit hyperactivity disorder (ADHD). Methods: This was an open, prospective, dose-ranging study of atomoxetine m onotherapy in the treatment of 30 children with ADHD between the ages of 7 and 14 years. Atomoxetine was started at 10-20 mg/day and titrated weekly u p to 90 mg over 11 weeks, depending on response and adverse effects. Twenty -two children completed the full 11 weeks. We assessed efficacy with weekly clinician and parent ratings of ADHD and oppositional symptoms and monitor ed adverse effects, laboratory findings, and cardiovascular parameters. Results: Treatment with atomoxetine (mean final, total daily dose of 1.9 mg /kg/day) was very well tolerated without meaningful adverse effects. Atomox etine significantly reduced core symptoms of ADHD (ADHD-Rating Scale-IV; 38 .6% decrease vs. baseline, p < 0.001) with significant improvement (p < 0.0 5) in all but 1 of the 18 individual items in the ADHD-Rating Scale-IV. Mor e than 75% of subjects who completed 10 weeks of treatment showed > 25% dec rease in ADHD symptoms. Conclusions: These findings extend to children the positive results previou sly reported in adults diagnosed with ADHD who were treated with atomoxetin e. These results support additional controlled trials of atomoxetine in cas es of pediatric ADHD.