Objective: To assess the effect of Osmotic-Release Oral System (OROS) methylphenidate (MPH) on a variety of measures evaluating academic performance, cognition, and social behavior in children with attention-deficit/hyperactivity disorder (ADHD).
Methods: This double-blind, randomized, placebo-controlled, crossover laboratory school study enrolled 78 children aged 9-12 years with ADHD who responded to OROS MPH. After determining individualized OROS MPH dosing (18-54 mg/day), 71 subjects received blinded treatment (OROS MPH or placebo then vice versa) on each of 2 laboratory school days, separated by 1 week. Primary efficacy was measured by Permanent Product Measure of Performance at 4 hours after study drug administration.
Results: Treatment with OROS MPH resulted in statistically significant improvement in Permanent Product Measure of Performance and Swanson, Kotkin, Agler, M-Flynn, and Pelham scores, measures of response time, and of working memory compared to placebo. Other measures did not meet all pre-established criteria for significance (maintenance of the overall type I error rate at 5%). Adverse events were consistent with previous reports of stimulant medications used in the management of ADHD. There were no discontinuations due to adverse events, and no serious adverse events or deaths.
Conclusions: OROS MPH dosed to reduce core symptoms of ADHD to within the normal range also improved performance on a variety of academic tasks in school-aged children compared to placebo. Adverse effects reported were consistent with prior studies. CLINICAL TRIAL REGISTRY INFORMATION: Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral and Cognitive Effects of Concerta on Older Children with ADHD, URL: http://clinicaltrials.gov/ct2/show/NCT00799409, unique identifier: NCT00799409.