Atomoxetine benefits young children with ADHD, but symptoms remain

April 1, 2011

Atomoxetine is well tolerated and reduces core attention-deficit/hyperactivity disorder (ADHD) symptoms in preschool children, according to a study reported in Pediatrics.

Atomoxetine is well tolerated and reduces core attention-deficit/hyperactivity disorder (ADHD) symptoms in preschool children, according to a study reported in Pediatrics.

Despite improvements, however, the majority of children continue to have clinically significant symptoms, investigators found.

Atomoxetine has been shown to be safe and effective for treatment of ADHD in children 6 years of age and older. The current study is the first randomized, controlled trial of the nonstimulant drug in children younger than 6 years, for whom its use is off-label.

A total of 101 children 5 to 6 years of age with a primary diagnosis of ADHD were randomized to atomoxetine or placebo for 8 weeks. Atomoxetine was started at a dose of 0.5 mg/kg/day and could be titrated to a maximum of 1.8 mg/kg/day. Children receiving psychotropic or other medications with central nervous system effects were excluded from the trial.

Significant mean decreases in both parent and teacher ADHD-IV Rating Scale scores were seen in children who received atomoxetine compared with placebo. The effects were similar to those achieved in older children. Reductions in ADHD symptom frequency and intensity did not necessarily result in overall functional improvement. At week 8, 40% of children in the atomoxetine group and 22% of those in the placebo group met response criteria: Clinical Global Impression-Improvement Scale scores of 1 (very much improved) or 2 (much improved). However, the difference between the groups was not significant.

Some children had a robust response to atomoxetine, but others had a more attenuated response. At study completion, 62% of children who received atomoxetine and 77% of those who received placebo had Clinical Global Impression-Severity Scale scores indicating moderate, marked, or severe illness.

Decreased appetite, gastrointestinal upset, and sedation occurred significantly more often with atomoxetine than with placebo, but the effects were mild or moderate. No clinically significant changes in laboratory tests or electrocardiogram findings were observed.

Kratochvil CJ, Vaughan BS, Stoner JA, et al. A double-blind, placebo-controlled study of atomoxetine in young children with ADHD. Pediatrics. 2011;127(4):e862-e868.