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Journal of Attention Disorders, Vol. 9, No. 3, 476-485 (2006)
DOI: 10.1177/1087054705284089

A Randomized, Double-Blind, Placebo-Controlled, Laboratory Classroom Assessment of Methylphenidate Transdermal System in Children With ADHD

James J. McGough

University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior, jmcgough{at}mednet.ucla.edu

Sharon B. Wigal

University of California, Irvine, Child Development Center

Howard Abikoff

New York University Child Study Center

John M. Turnbow

Texas Tech University Medical School

Kelly Posner

New York State Psychiatric Institute

Eliot Moon

Elite Clinical Trials, Temecula, California

Objective: This study evaluates the efficacy, duration of action, and tolerability of methylphenidate transdermal system (MTS) in children with ADHD. Method: Participants were dose optimized over 5 weeks utilizing patch doses of 10, 16, 20, and 27 mg applied in the morning and worn for 9 hours. Following optimization, 80 participants were randomized to 1 week of MTS or placebo followed by 1 week of the opposite treatment. Laboratory classroom sessions conducted after each randomized week included blinded ratings of attention, behavior, and academic performance. Results: MTS was well tolerated and displayed significant improvement compared with placebo. Improvements were seen at the first postdose time point measured and continued through 12 hours. Conclusions: Treatment with MTS resulted in statistically significant improvements on all efficacy measures. Time course and therapeutic effects of MTS suggest that this novel methylphenidate delivery system is an efficacious once-daily treatment for ADHD.

Key Words: methylphenidate transdermal system • ADHD • laboratory classroom study • stimulant • patch


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