Is atomoxetine useful for ADHD in young children?

January 01, 0001

Is atomoxetine useful for ADHD in young children?

Atomoxetine has been used to treat attention- deficit/hyperactivity disorder (ADHD). These American researchers examined its usefulness for ADHD in 5- and 6-year-old children via an 8-week, double- blind, placebo-controlled randomized clinical trial (n=101). Enrollees were randomzed to atomoxetine or placebo and were titrated to a maximum dose of 1.8 mg/kg per day. Educational materials on ADHD and behavioral-management strategies were reviewed with the enrollee’s parents at each visit.

The researchers found: "Significant mean decreases in and teacher 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 placebo, which was not significant. 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."

The researchers concluded: "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."

This randomized controlled trial found some clinical but little functional improvement with atomoxetine use for ADHD in young children.

For the full abstract, click here.

Pediatrics 127(4):e862-e868, April 2011
© 2011 American Academy of Pediatrics
A Double-Blind, Placebo-Controlled Study of Atomoxetine in Young Children With ADHD. Christopher J. Kratochvil, Brigette S. Vaughan, Julie A. Stoner.

Category: P. Psychological. Keywords: ADHD, attention-deficit/hyperactivity disorder, children, functionl, atomoxetine, randomized controlled trial, journal watch.
Synopsis edited by Dr Paul Schaefer, Toledo, Ohio. Posted on Global Family Doctor 17 June 2011

Pearls are an independent product of the Cochrane primary care group and are meant for educational use and not to guide clinical care.