A randomized, double-blind, placebo-controlled, parallel-group study of methylphenidate transdermal system in pediatric patients with attention-deficit/hyperactivity disorder.

ABSTRACT

OBJECTIVE: To evaluate the efficacy and safety of methylphenidate transdermal system compared with placebo, using osmotic-release oral system (OROS) methylphenidate as a reference therapy. METHOD: We conducted a 7-week, randomized, double-blind, double-dummy, placebo-controlled trial in children diagnosed with attention-deficit/hyperactivity disorder by DSM-IV-TR criteria, within a community setting. The study was conducted from August 2004 to February 2005. Participants were randomly assigned to 1 of 3 treatments methylphenidate transdermal system patch plus placebo capsule (N = 100), OROS methylphenidate capsule plus placebo patch (N = 94), or placebo capsule plus placebo patch (N = 88). Over 5 weeks, once-daily doses were optimized using 10-, 15-, 20-, and 30-mg methylphenidate transdermal system patches (9-hour wear time) or 18-, 27-, 36-, and 54-mg OROS methylphenidate capsules. Thereafter, optimal treatment doses were maintained for 2 weeks with blinded ratings of attention, behavior, and academic performance occurring at the end of each week. The primary efficacy measure was the clinician-rated ADHD Rating Scale-Version IV (ADHD-RS-IV). Additional measures included teacher, parent, and other clinician rating scales. Safety and tolerability were assessed throughout the study. RESULTS: The mean change from baseline in ADHD-RS-IV scores was greater for participants receiving methylphenidate transdermal system and OROS methylphenidate treatments compared with placebo (p < .0001). Similar results were observed for parent and teacher rating scales. More participants receiving active treatments compared with placebo were rated as improved by clinicians and parents (p < .0001). Adverse events were generally mild or moderate in intensity, and the most common included decreased appetite, nausea, vomiting, and insomnia. CONCLUSIONS: The results of this study suggest that the methylphenidate transdermal system is an efficacious treatment option for children with attention-deficit/hyperactivity disorder. TRIAL REGISTRATION clinicaltrials.gov Identifier NCT00444574.