A Randomized, Double-Blind, Multicenter, Parallel-Group, Placebo-Controlled, Dose-Optimization Study of the Methylphenidate Transdermal System for the Treatment of ADHD in Adolescents
Abstract
Introduction: The current report evaluates the efficacy and safety of methylphenidate transdermal system (MTS) compared with placebo transdermal system (PTS) in adolescents with attention-deficit/hyperactivity disorder (ADHD). Methods: A total of 217 subjects participated in a 7-week, randomized, double-blind, multicenter, parallel-group, placebo-controlled, dose-optimization study of MTS (10-, 15-, 20- or 30-mg/9 hours). Subjects were randomized into a 2:1 MTS to PTS ratio and titrated to an optimal dose during an initial 5-week period. Subjects maintained their optimal dose through a subsequent 2-week period. The primary outcome measure was the ADHD Rating Scale-IV (ADHD-RS-IV). Safety of MTS was assessed throughout the study by analyzing adverse events, results of physical examinations, laboratory evaluations, vital sign data, electrocardiograms, and dermal evaluations. Results: Treatment with MTS demonstrated greater reductions from baseline in ADHD-RS-IV total score compared to PTS at endpoint (P <.0001). The majority of the adverse events (98.5%) were mild or moderate in intensity, the most common of which were decreased appetite, headache, irritability, and upper respiratory tract infection. Three subjects in the MTS group discontinued because of an application site reaction. Conclusions: MTS therapy was generally well-tolerated and resulted in significantly greater improvements in ADHD symptoms in adolescents when compared to PTS.
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The co-occurrence of ADHD and SUD complicates diagnosis and treatment of both disorders.
“which complicates diagnosis and treatment”
From Treatment of Adolescents with Concurrent Substance Use Disorder and Attention-Deficit/Hyperactivity Disorder: A Systematic Review (2021) · cites this paper as [27]
The co-occurrence of ADHD and SUD is associated with poor treatment outcomes.
“and is associated with poor treatment outcomes”
From Treatment of Adolescents with Concurrent Substance Use Disorder and Attention-Deficit/Hyperactivity Disorder: A Systematic Review (2021) · cites this paper as [27]
Open-label extension studies of MPH, LDX, MAS-XR, and atomoxetine in adolescents showed maintained efficacy and side-effects and tolerability consistent with the antecedent controlled studies.
“In these follow-up studies, efficacy was maintained, and side-effects and tolerability were consistent with those found in the antecedent, controlled studies.”
From Treatment of Adolescents with Concurrent Substance Use Disorder and Attention-Deficit/Hyperactivity Disorder: A Systematic Review (2021) · cites this paper as [27]
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Methylphenidate Transdermal System
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- Authors
- Findling, R. L., Turnbow, J., Burnside, J., Melmed, R., Civil, R., & Li, Y.
- Affiliations
- Case Western Reserve University (US)
- The University of Texas at San Antonio Health Science Center (US)
- Venue
- CNS Spectrums
- Publisher
- Cambridge University Press (CUP)
- Published
- 2010-07
- Volume
- 15
- Issue
- 7
- Pages
- 419-430
- ISSN
- 1092-8529 (ISSN-L)
- 2165-6509
- OpenAlex
- W2467079106
- Cited by
- 31
- References
- 0
- Citations by year
- 2025: 2 · 2024: 1 · 2023: 2 · 2022: 1 · 2021: 4 · 2020: 1 · 2019: 1 · 2018: 2 · 2016: 2 · 2015: 2 · 2014: 5 · 2013: 1 · 2012: 4
- FWCI
- 1.75
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- CNS Spectrums (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
- Life Sciences › Neuroscience › Cognitive Neuroscience › Neuroethics, Human Enhancement, Biomedical Innovations
- Keywords
- attention deficit hyperactivity disorder, adolescents, ADHD Rating Scale-IV, dose titration, drug safety, adverse events, transdermal drug delivery
- MeSH terms
- Adolescent, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Dose-Response Relationship, Drug, Double-Blind Method, Humans, Methylphenidate
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