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Objective: This open-label study assessed the long-term effectiveness and tolerability of reboxetine maintenance treatment in children with attention-deficit/hyperactivity disorder (ADHD).

Methods: Six children aged 9–13 (mean ± standard deviation, SD, 10.7 ± 1.6) years, diagnosed with ADHD and successfully treated with reboxetine for 6 weeks were enrolled in a long-term (18–36 months) follow-up study. Assessments included rater-administered scales (ADHD Rating Scale; Clinical Global Impressions Scale) and a parent-administered scale (the Abbreviated Conners' Rating Scale). The safety and tolerability were evaluated by documenting spontaneous self-reported adverse effects as well as by vital signs, electrocardiogram, body weight, and routine blood screen. Reboxetine was maintained at a dose of 4 mg/day.

Results: The children were followed up to 36 months (mean ± SD, 24 ± 6.6; range, 18–36). The significant decrease in ADHD symptoms achieved in the short-term phase (first 6 weeks) was maintained throughout the study. No new onset adverse effects was detected during this follow-up period. No suicidal attempt or ideation was noted.

Conclusions: The results suggest the long-term effectiveness and safety of reboxetine maintenance treatment in children with ADHD. Future large-scale, long-term, placebo/comparator-controlled studies should assess the benefit/risk ratio of reboxetine in ADHD children.