Once-daily Atomoxetine Treatment for Children and Adolescents With Attention Deficit Hyperactivity Disorder: A Randomized, Placebo-Controlled Study

Am J Psychiatry. 2002 Nov;159(11):1896-901. doi: 10.1176/appi.ajp.159.11.1896.


Objective: The authors assessed the efficacy of once-daily atomoxetine administration in the treatment of children and adolescents with attention deficit hyperactivity disorder (ADHD).

Method: In a double-blind study, children and adolescents with ADHD (N=171, age range=6-16 years) were randomly assigned to receive 6 weeks of treatment with either atomoxetine (administered once daily) or placebo.

Results: Outcomes among atomoxetine-treated patients were superior to those of the placebo treatment group as assessed by investigator, parent, and teacher ratings. The treatment effect size (0.71) was similar to those observed in previous atomoxetine studies that used twice-daily dosing. Parent diary ratings suggested that drug-specific effects were sustained late in the day. Discontinuations due to adverse events were low (less than 3%) for both treatment groups, and no serious safety concerns were observed.

Conclusions: Once-daily administration of atomoxetine is an effective treatment for children and adolescents with ADHD.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Antidepressive Agents / administration & dosage*
  • Antidepressive Agents / adverse effects
  • Atomoxetine Hydrochloride
  • Attention Deficit Disorder with Hyperactivity / diagnosis
  • Attention Deficit Disorder with Hyperactivity / drug therapy*
  • Attention Deficit Disorder with Hyperactivity / psychology
  • Child
  • Drug Administration Schedule
  • Female
  • Humans
  • Male
  • Personality Assessment
  • Propylamines / administration & dosage*
  • Propylamines / adverse effects
  • Treatment Outcome


  • Antidepressive Agents
  • Propylamines
  • Atomoxetine Hydrochloride