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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 [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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Metadata
- 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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