A Pilot Study of Atomoxetine in Young Children with Attention-Deficit/Hyperactivity Disorder
Journal of child and adolescent psychopharmacology
Objective: The purpose of this study was to assess the effectiveness and tolerability of atomoxetine during acute treatment of attention-deficit/hyperactivity disorder (ADHD) in 5 and 6 year olds. Method: Twenty two children (male n ؍ 19, 86%) with ADHD were treated with atomoxetine for 8 weeks in a three-site, open-label pilot study. Dosing was flexible, with titration to a maximum of 1.8 mg/kg per day. Parent education on behavior management was provided as part of each pharmacotherapy
... harmacotherapy visit. Results: Subjects demonstrated a mean decrease of 20.68 points (SD ؍ 12.80, p Ͻ 0.001)) on the ADHD Rating Scale-IV (ADHD-IV-RS) total score, 10.18 (SD ؍ 7.48, p Ͻ 0.001) on the inattentive subscale and 10.50 (SD ؍ 7.04, p Ͻ 0.001) on the hyperactive/impulsive subscale. Clinical Global Impression-Severity (CGI-S) was improved in 82% of the children (95% CI, 66-98%) and Children's Global Assessment (CGAS) scores improved 18.91 points on average (SD ؍ 12.20, p Ͻ 0.001). The mean final dose of atomoxetine was 1.25 mg/kg per day (SD ؍ 0.35 mg/kg per day). Mood lability was the most commonly reported adverse event (n ؍ 12, 54.5%). Eleven subjects (50%) reported decreased appetite and a mean weight loss of 1.04 kg (SD ؍ 0.80 kg) (p Ͻ 0.001) was observed for the group. Vital sign changes were mild and not clinically significant. There were no discontinuations due to adverse events or lack of efficacy. Conclusion: Atomoxetine was generally effective for reducing core ADHD symptoms in the 5 and 6 year olds in this open-label study.