A Randomized, Double-Blind, Multicenter, Parallel-Group, Placebo-Controlled, Dose-Optimization Study of the Methylphenidate Transdermal System for the Treatment of ADHD in Adolescents

Introduction : The current report evaluates the efficacy and safety of methylphenidate transdermal system (MTS) compared with placebo transdermal system (PTS) in adolescents with attention-deficit/hyperactivity disorder (ADHD). Methods : A total of 217 subjects participated in a 7-week, randomized, double-blind, multicenter, parallel-group, placebo-controlled, dose-optimization study of MTS (10-, 15-, 20- or 30-mg/9 hours). Subjects were randomized into a 2:1 MTS to PTS ratio and titrated to an optimal dose during an initial 5-week period. Subjects maintained their optimal dose through a subsequent 2-week period. The primary outcome measure was the ADHD Rating Scale-IV (ADHD-RS-IV). Safety of MTS was assessed throughout the study by analyzing adverse events, results of physical examinations, laboratory evaluations, vital sign data, electrocardiograms, and dermal evaluations. Results : Treatment with MTS demonstrated greater reductions from baseline in ADHD-RS-IV total score compared to PTS at endpoint (P Conclusions : MTS therapy was generally well-tolerated and resulted in significantly greater improvements in ADHD symptoms in adolescents when compared to PTS.