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 trans dermal 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-RSIV total score compared to PTS at endpoint (P<.0001). The majority of the adverse events (98.5%) were mild or moderate in intensity, the most common of which were decreased appetite, headache, irritability, and upper respiratory tract infection. Three subjects in the MTS group discontinued because of an application site reaction. Conclusions: MTS therapy was generally well tolerated and resulted in significantly greater improvements in ADHD symptoms in adolescents when compared to PTS.