A Randomized, Double-Blind, Placebo-Controlled, Laboratory Classroom Assessment of Methylphenidate Transdermal System in Children With ADHD
Abstract
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.
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The rate of discontinuations related to TEAEs was consistent with those seen for other stimulants in similar settings.
“The rate of discontinuations related to TEAEs was consistent with those seen for other stimulants in similar settings [10,30,31].”
From A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder (2009) · cites this paper as [30]
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- Authors
- McGough, J. J., Wigal, S. B., Abikoff, H., Turnbow, J. M., Posner, K., & Moon, E.
- Affiliations
- University of California, Los Angeles (US)
- University of California, Irvine (US)
- New York University (US)
- Texas Tech University (US)
- New York State Psychiatric Institute (US)
- Clinical Trials of Texas (US)
- Corresponding author
- McGough, James J.
- Venue
- Journal of Attention Disorders
- Publisher
- SAGE Publications
- Published
- 2006-02
- Volume
- 9
- Issue
- 3
- Pages
- 476-485
- ISSN
- 1087-0547 (ISSN-L)
- 1557-1246
- OpenAlex
- W2056663519
- Cited by
- 103
- References
- 31
- Citations by year
- 2025: 1 · 2024: 1 · 2023: 1 · 2022: 2 · 2021: 3 · 2020: 1 · 2019: 1 · 2018: 1 · 2017: 3 · 2016: 2 · 2015: 7 · 2014: 8 · 2013: 3 · 2012: 7
- FWCI
- 8.92
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Attention Disorders (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Social Sciences › Psychology › Developmental and Educational Psychology › Behavioral and Psychological Studies
- Keywords
- attention deficit hyperactivity disorder, children, transdermal drug delivery, attention, academic performance, treatment tolerability, duration of action, dose optimization, placebo comparison
- MeSH terms
- Administration, Cutaneous, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Double-Blind Method, Drug Administration Schedule, Drug Tolerance, Female, Humans, Male, Methylphenidate
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