Comparative short term efficacy and tolerability of methylphenidate and atomoxetine in attention deficit hyperactivity disorder.

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). CONCLUSIONS 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.