A randomized, double-blind, placebo-controlled clinical trial on once-daily atomoxetine in Taiwanese children and adolescents with attention-deficit/hyperactivity disorder.

OBJECTIVE

The aim of this study was to assess the efficacy and safety of the once-daily atomoxetine compared with placebo in pediatric patients with attention-deficit/hyperactivity disorder (ADHD) in Taiwan.

METHODS

The study sample included 106 patients aged 6-16 years who met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria of ADHD randomly assigned to atomoxetine once daily (n = 72) and placebo once daily (n = 34) in a double-blind, 6-week treatment study. The primary efficacy measure was the total score of the ADHD Rating Scale-IV Parents Version: Investigator Administered and Scored. The secondary efficacy measures included the Clinical Global Impressions--ADHD--Severity and Chinese Conner's Parent and Teacher Rating Scale--Revised: Short Form. Data were analyzed on an intent-to-treat basis and a last-observation-carried-forward approach.

RESULTS

The two treatment groups did not differ in demographics and baseline measures. Compared to the placebo group, the atomoxetine group showed significantly greater reductions in ADHD-related symptoms according to the ratings of investigators, parents, and teachers. The treatment effect size of the primary efficacy measure was 0.70 at the end of study. Adverse events reported significantly more frequently with atomoxetine were decreased appetite (36.1%) and nausea (16.6%). No drug-related serious adverse event was observed.

CONCLUSIONS

Once-daily atomoxetine is an effective, well-tolerable, and safe treatment for children and adolescents with ADHD in Taiwan.