Objective: To compare the short term efficacy and tolerability of methylphenidate and atomoxetine in children with Attention deficit hyperactivity disorder (ADHD). Design: Open label randomized parallel group clinical trial. Setting: Child Guidance Clinic of a tertiary care hospital of Northern India from October 2010 to June 2012. Participants: 69 patients (age 6-14 y) with a diagnosis of ADHD receiving methylphenidate or atomoxetine. Intervention: Methylphenidate (0.2-1 mg/kg/d) or atomoxetine (0.5-1.2 mg/kg/d) for eight weeks. Main outcome measures: Treatment response (>25% change in baseline Vanderbilt ADHD Diagnostic Parent Rating Scale (VADPRS); Vanderbilt ADHD Diagnostic Teacher Rating Scale (VADTRS); Clinical Global Impression Severity Scale (CGI-S) at eight weeks and adverse effects. Results: Treatment response was observed in 90.7% patients from methylphenidate group and 86.2% patients of atomoxetine group at an average dose of 0.45 mg/kg/d and 0.61 mg/kg/d, respectively. The patients showed comparable improvement on VADPRS (P=0.500), VADTRS (P=0.264) and CGI-S (P=0.997). Weight loss was significantly higher in methylphenidate group (-0.57+/-0.78 kg; P=0.001), and heart rate increase was observed at higher rate in atomoxetine group (7+/- 9 bpm; P=0.021). Conclusion: Methylphenidate and atomoxetine are efficacious in Indian children with ADHD at lesser doses than previously used. Their efficacy and tolerability are comparable. Trial Registration No.: CTRI/2011/08/001981. © 2014 Indian Academy of Pediatrics.
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