A double-blind, placebo-controlled study of atomoxetine in young children with ADHD

Christopher J. Kratochvil, Brigette S. Vaughan, Julie A. Stoner, Joan M. Daughton, Brian D. Lubberstedt, Desiree W. Murray, Allan K. Chrisman, Melissa A. Faircloth, Nilda B. Itchon-Ramos, Scott H. Kollins, Lawrence A. Maayan, Laurence L. Greenhill, Lisa A. Kotler, Jane Fried, John S. March

Research output: Contribution to journalArticlepeer-review

52 Scopus citations


OBJECTIVE: To evaluate the efficacy and tolerability of atomoxetine for the treatment of attention-deficit/hyperactivity disorder (ADHD) in 5-and 6-year-old children. METHODS: This was an 8-week, double-blind, placebo-controlled randomized clinical trial of atomoxetine in 101 children with ADHD. Atomoxetine or placebo was flexibly titrated to a maximum dose of 1.8 mg/kg per day. The pharmacotherapist reviewed psychoeducational material on ADHD and behavioral-management strategies with parents during each study visit. RESULTS: Significant mean decreases in parent (P = .009) and teacher (P = .02) ADHD-IV Rating Scale scores were demonstrated with atomoxetine compared with placebo. A total of 40% of children treated with atomoxetine met response criteria (Clinical Global Impression-Improvement Scale indicating much or very much improved) compared with 22% of children on placebo, which was not significant (P=.1). Decreased appetite, gastrointestinal upset, and sedation were significantly more common with atomoxetine than placebo. Although some children demonstrated a robust response to atomoxetine, for others the response was more attenuated. Sixty-two percent of subjects who received atomoxetine were moderately, markedly, or severely ill according to the Clinical Global Impression-Severity Scale at study completion. CONCLUSIONS: To our knowledge, this is the first randomized controlled trial of atomoxetine in children as young as 5 years. Atomoxetine generally was well tolerated and reduced core ADHD symptoms in the children on the basis of parent and teacher reports. Reductions in the ADHD-IV Rating Scale scores, however, did not necessarily translate to overall clinical and functional improvement, as demonstrated on the Clinical Global Impression-Severity Scale and the Clinical Global Impression-Improvement Scale. Despite benefits, the children in the atomoxetine group remained, on average, significantly impaired at the end of the study.

Original languageEnglish (US)
Pages (from-to)e862-e868
Issue number4
StatePublished - Apr 2011


  • ADHD
  • Atomoxetine
  • Child
  • Pharmacotherapy

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health


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