Outcomes of OROS® methylphenidate compared with atomoxetine in children with ADHD:: A multicenter, randomized prospective study

This community-based study was designed to evaluate treatment outcomes with OROS (R) methylphenidate (MPH) and atomoxetine in children with attention-deficit/hyperactivity disorder (ADHD), as assessed by physicians and parents in a setting that resembles clinical practice. In a multicenter, prospective, open-label study, children 6 to 12 years of age with ADHD were randomized (2:1, respectively) to 3 weeks of treatment with once-daily OROS MPH or atomoxetine. Investigator-rated measures of symptoms included the ADHD Rating Scale (ADHD-RS) and the Clinical Global Impression-Improvement of Illness scale (CGI-I). Assessments were made at baseline and during a telephone interview in week 1, a clinic visit in week 2, and a final clinic visit in week 3. In total, 1323 patients received OROS MPH (n=850) or atomoxetine (n=473). Significant reductions from baseline in investigator-evaluated ADHD-RS scores were observed among patients receiving OROS MPH and those receiving atomoxetine. At the end of the study, mean decreases from baseline ADHD-RS scores were 20.24 for OROS MPH and 16 for atomoxetine (P <.001). Between-treatment differences appeared to increase over time (2.77, 3.44, and 4.24 at weeks 1, 2, and 3, respectively; P <.001). Treatment response (ie, 25% reduction from baseline ADHD-RS scores) was significantly greater at each evaluation for patients taking OROS MPH than for those taking atomoxetine (P <.001). Similar percentages of patients taking OROS MPH (4.8%) and atomoxetine (5.5%) withdrew because of adverse events. Although community-based studies often lack the control of randomized, placebo-controlled trials, these results nevertheless suggest greater ADHD symptom improvement with OROS MPH compared with atomoxetine.