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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Methylphenidate Transdermal System in Pediatric Patients With Attention-Deficit/Hyperactivity Disorder
Robert L. Findling, M.D.; Oscar G. Bukstein, M.D., M.P.H.; Raun D. Melmed, M.D.; Frank A. López, M.D.; Floyd R. Sallee, M.D., Ph.D.; L. Eugene Arnold, M.D.; and Raymond D. Pratt, M.D.
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
(J Clin Psychiatry 2008;69:149–159; online ahead of print January 3, 2008)
Received June 22, 2007; accepted Dec. 2, 2007. From the University Hospitals Case Medical Center, Cleveland, Ohio (Dr. Findling); the University of Pittsburgh School of Medicine, Pittsburgh, Pa. (Dr. Bukstein); the Melmed Center, Scottsdale, Ariz. (Dr. Melmed); the Children's Developmental Center, Winter Park, Fla. (Dr. López); University of Cincinnati School of Medicine, Cincinnati, Ohio (Dr. Sallee); Ohio State University College of Medicine, Columbus (Dr. Arnold); and Shire Development Inc., Wayne, Pa. (Dr. Pratt).
This study was supported by funding from Shire Development Inc., Wayne, Pa.
The authors acknowledge participating children and their families. Writing and editorial support was provided by Michelle Roberts, M.S., and Michelle Snowden, Pharm.D., The JB Ashtin Group, Inc., with financial support provided by Shire Development Inc. Ms. Roberts and Dr. Snowden report no additional financial affiliation relevant to the subject of this article.
Financial disclosure is listed at the end of the article.
Corresponding author and reprints: Robert L. Findling, M.D., University Hospitals Case Medical Center, 11100 Euclid Ave., Cleveland, OH 44106 (e-mail: robert.findling@UHhospitals.org).