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These authors enrolled 101 schoolchildren between the ages of 5 years and 6 years who had ADHD of at least moderate severity (clinical global impression severity score = 4) for at least 9 months. The children were randomly assigned to receive atomoxetine titrated to a dosage of 1.8 mg per kg per day or matching placebo (concealed allocation unknown) . Parents were given a handout on behavioral management, but no additional training or support. Analysis was not by intention to treat; only children who attended at least 1 follow-up visit (92%) were included in the final analysis. After 8 weeks, scores on the ADHD Rating Scale-IV were significantly lower in the atomoxetine group than in the placebo group, with decreases of 13.2 vs 5.8 on the parent scale (P = .009) and 12.5 vs 5.0 on the teacher scale (P = .02). Using the Clinical Global Impression -- Improvement Scale, there was no difference between treatment and placebo with regard to the percentage of children who were "much improved" or "very much improved" (40% vs 22%). More than 60% of children did not respond to treatment and were considered moderately to severely ill. Side effects rates, which may have increased a placebo response in the treated children, were significantly higher for decreased appetite, gastrointestinal upset, and sedation.