A Controlled Trial of the Methylphenidate Transdermal System on Before-School Functioning in Children With Attention-Deficit/Hyperactivity Disorder
Abstract
OBJECTIVE: Children with attention-deficit/hyperactivity disorder (ADHD) frequently manifest behavioral difficulties in the morning prior to school. Our aim was to examine the effects of the methylphenidate transdermal system (MTS) on before-school ADHD symptoms and functioning in children with ADHD. METHOD: In this randomized crossover study, conducted from May 2007 until December 2008, 6- to 12-year-old subjects with DSM-IV-defined ADHD received either MTS or a placebo transdermal system (PTS) at 10 mg for 1 week and then 20 mg for 1 week. Subjects were then crossed over directly to the other treatment for the remaining 2 weeks. The primary efficacy measure was the ADHD Rating Scale. All analyses were intent to treat, with the last observation carried forward. RESULTS: Thirty subjects completed at least 1 week of treatment, and 26 subjects completed the entire protocol. The sample was primarily male, with a mean +/- SD age of 9.17 +/- 1.84 years. Compared to PTS, there were significant reductions with MTS in the ADHD Rating Scale score (P < .001). Adverse effects of MTS during the active (versus PTS) phase were similar to those seen in other controlled trials of MTS. CONCLUSIONS: These results show that MTS is effective not only for morning ADHD symptoms, but also in improving associated activities and functioning that occur before school in children with ADHD. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00586157.
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Transdermal methylphenidate in short-term studies is associated with efficacy throughout the day, improved family quality of life, and little effect on sleep when carefully titrated.
“Transdermal methylphenidate bypasses the oral route entirely, and in short-term studies is associated with efficacy throughout the day, with improved family quality of life, and when carefully titrated, little effect on sleep [44-46].”
From Advances in understanding and treating ADHD (2011) · cites this paper as [45]
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Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD)
Storebø, O. J., Ramstad, E., Krogh, H. B., Nilausen, T. D., Skoog, M., Holmskov, M., Rosendal, S., Groth, C., Magnusson, F. L., Moreira-Maia, C. R., et al. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd009885.pub2 · Cited by 347 · see citing works
Advances in understanding and treating ADHD
Antshel, K. M., Hargrave, T. M., Simonescu, M., Kaul, P., Hendricks, K., & Faraone, S. V. (2011) · BMC Medicine · doi:10.1186/1741-7015-9-72 · Cited by 140 · see citing works
“Transdermal methylphenidate bypasses the oral route entirely, and in short-term studies is associated with efficacy throughout the day, with improved family quality of life, and when carefully titrated, little effect on sleep [ 44-46 ].”
BackgroundCoghill, D., Banaschewski, T., Soutullo, C. A., Cottingham, M. G., & Zuddas, A. (2017) · European Child & Adolescent Psychiatry · doi:10.1007/s00787-017-0986-y · Cited by 130 · see citing works
“87 for CHQ-PF50 Psychosocial summary score [low, medium and high dose, respectively]) [66, 99].”
BackgroundMethodInfluentialMethylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD)
Storebø, O. J., Storm, M. R. O., Ribeiro, J. P., Skoog, M., Groth, C., Edemann-Callesen, H., Schaug, J. P., Rasmussen, P. D., Huus, C.-M. L., Zwi, M., et al. (2023) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd009885.pub3 · Cited by 99 · see citing works
Pliszka, S. R., Wilens, T. E., Bostrom, S., Arnold, V. K., Marraffino, A., Cutler, A. J., López, F. A., DeSousa, N. J., Sallee, F. R., Incledon, B., et al. (2017) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2017.0084 · Cited by 44 · see citing works
“In addition, early morning administration may potentially compromise ADHD coverage in the late afternoon/early evening (Wilens et al. 2010).”
BackgroundMethodInfluentialSelf-citationFaraone, S. V., Po, M. D., Komolova, M., & Cortese, S. (2019) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.18r12210 · Cited by 41 · see citing works
Sallee, F. R. (2015) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2014.0160 · Cited by 39 · see citing works
“…placebo-controlled study has focused exclusively on inadequately controlled ADHD symptoms and associated EMF impairments in children ages 6–12 years with ADHD by examining the efficacy of a transdermal MPH formulation (MTS) administered once-daily between 6:00 and 7:00 a.m. (Wilens et al. 2010).”
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Epstein, J. N., & Weiss, M. D. (2012) · The Primary Care Companion For CNS Disorders · doi:10.4088/pcc.11r01336 · Cited by 37 · see citing works
Findling, R. L., & Dinh, S. M. (2014) · CNS Drugs · doi:10.1007/s40263-014-0141-y · Cited by 35 · see citing works
“Before-school symptom control and functioning were assessed as secondary outcomes in a randomized, placebocontrolled, crossover designed study of 30 children with ADHD to determine the time of onset of ADHD symptom improvement following MTS application [30].”
MethodResultChildress, A. C., Cutler, A. J., Marraffino, A., McDonnell, M. A., Turnbow, J. M., Brams, M. N., DeSousa, N. J., Incledon, B., Sallee, F. R., & Wigal, S. B. (2019) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2019.0070 · Cited by 29 · see citing works
“During the open-label, DR/ER-MPH treatment-optimization phase, 6 weeks of DR/ER-MPH treatment decreased mean (SD) ADHD-RS-IV from 42.5 (6.60) to 11.0 (7.14), BSFQ from 40.7 (10.28) to 7.3 (6.45), and CGI-P from 22.0 (5.11) to 5.5 (4.08).”
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“A crossover study of ADHD youth compared the methylphenidate transdermal system (MTS) with a placebo transdermal system (PTS) (Wilens et al. 2010).”
BackgroundWilens, T. E., McBurnett, K., Turnbow, J. M., Rugino, T. A., White, C., & Youcha, S. H. (2013) · Journal of Attention Disorders · doi:10.1177/1087054713500144 · Cited by 20 · see citing works
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“An adapted version of the Before School Functioning Questionnaire (BSFQ; Wilens et al., 2010) was used to evaluate the effects of interventions on the children’s routines.”
MethodThe Use of Transdermal Therapeutic Systems in Psychiatric Care: A Primer on Patches
Stevens, J. R., Coffey, M. J., Fojtik, M., Kurtz, K., & Stern, T. A. (2015) · Psychosomatics · doi:10.1016/j.psym.2015.03.007 · Cited by 16 · see citing works
Reliability and Validity of the Before-School Functioning Scale in Children With ADHD
Faraone, S. V., Hammerness, P. G., & Wilens, T. E. (2015) · Journal of Attention Disorders · doi:10.1177/1087054714564623 · Cited by 15 · see citing works
“Details of the study were previously reported by Wilens et al. (2010).”
BackgroundMethodResultInfluentialSelf-citationOptimizing outcomes in ADHD treatment: from clinical targets to novel delivery systems
Mattingly, G., & Anderson, R. H. (2016) · CNS Spectrums · doi:10.1017/s1092852916000808 · Cited by 17 · see citing works
Reliability and Validity of the Daily Parent Rating of Evening and Morning Behavior Scale, Revised
Faraone, S. V., Childress, A. C., Wigal, S. B., Kollins, S. H., McDonnell, M. A., DeSousa, N. J., & Sallee, F. R. (2015) · Journal of Attention Disorders · doi:10.1177/1087054715619009 · Cited by 13 · see citing works
“In a crossover study of 30 ADHD youth 6 to 12 years of age, Wilens et al. (2010) compared the methylphenidate transdermal system (MTS) with a placebo transdermal system (PTS).”
BackgroundWilens, T. E., Faraone, S. V., Hammerness, P. G., Pliszka, S. R., Uchida, C. L., DeSousa, N. J., Sallee, F. R., Incledon, B., & Newcorn, J. H. (2021) · Journal of Attention Disorders · doi:10.1177/10870547211020073 · Cited by 12 · see citing works
Self-citationDrug Class Review: Pharmacologic Treatments for Attention Deficit Hyperactivity Disorder
McDonagh, M. S., & Peterson, K. (2011) · Cited by 7 · see citing works
Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD)
Storebø, O. J., Storm, M. R. O., Ribeiro, J. P., Skoog, M., Groth, C., Edemann-Callesen, H., Schaug, J. P., Darling, P. J., Huus, C.-M. L., Zwi, M., et al. (2025) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd009885.pub4 · Cited by 7 · see citing works
Childress, A. C., Yu, K. R., & Cuthbertson, L. (2022) · CNS Drugs · doi:10.1007/s40263-022-00978-2 · Cited by 6 · see citing works
A clinician’s guide for navigating the world of attention deficit hyperactivity disorder medications
Mattingly, G., & Young, J. (2021) · CNS Spectrums · doi:10.1017/s1092852921000146 · Cited by 5 · see citing works
“The Before School Functioning Questionnaire (BSFQ) has been developed to help clinicians better evaluate ADHD symptoms and functional impairments which cause significant disruption during the morning hours.(24) The Parent Rating of Evening and Morning Behavior (PREMB) evaluates behavioral problems both in the morning…”
MethodCorrell, C. U., Starling, B. R., & Huß, M. (2021) · CNS Spectrums · doi:10.1017/s1092852921000341 · Cited by 3 · see citing works
Pépin-Beauchesne, L., Lussier‐Desrochers, D., Villeneuve, A.-C., et al. (2020) · Lecture notes in computer science · doi:10.1007/978-3-030-49108-6_5 · Cited by 2 · see citing works
Développement et validation du Questionnaire sur l’exécution des habitudes quotidiennes
Simonato, I., Massé, L., Lussier‐Desrochers, D., Lemieux, A., & Ruel, R. (2024) · Revue québécoise de psychologie · doi:10.7202/1114899ar · Cited by 1 · see citing works
ADHS im Kindesalter: ätiologische und therapeutische Ansätze mit dem Schwerpunkt der Bildgebung
Steinmann, E., Siniatchkin, M., Petermann, F., & Gerber, W. (2012) · Zeitschrift für Neuropsychologie · doi:10.1024/1016-264x/a000077 · Cited by 1 · see citing works
Cassidy, P. B. (2012) · Digital Commons - PCOM (Philadelphia College of Osteopathic Medicine)
Stimulant medication in children and adolescents
Stevens, J. R., & Wilens, T. E. (2014) · Cambridge University Press eBooks · doi:10.1017/cbo9781139035491.021
Self-citationNie, T. (2023) · Drugs & Therapy Perspectives · doi:10.1007/s40267-023-01013-0
“By contrast, stimulants that are bioavailable from awakening, including methylphenidate transdermal system delivered via a patch that can be applied to the skin by a caregiver before awakening [12] and evening-dosed methylphenidate delayed release (DR)/ ER [8, 13], have demonstrated significant improvements in early m…”
BackgroundUpdate on The Evidence-Based Assessment of Attention-Deficit/Hyperactivity Disorder in Youth
Bunford, N., Koppány, D., Ágrez, K., Hámori, G., & Evans, S. W. (2026) · Journal of Clinical Child & Adolescent Psychology · doi:10.1080/15374416.2026.2660295
“There were only one or two studies on the BSFQ, CPS, DPREMB-R, HPC, SFS, and SSIS and three studies on the WFIRS.”
Influential
- Authors
- Wilens, T. E., Hammerness, P., Martelon, M., Brodziak, K., Utzinger, L., & Wong, P.
- Affiliations
- Massachusetts General Hospital (US)
- Corresponding author
- Wilens, Timothy E.
- Venue
- The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2010-05-15
- Volume
- 71
- Issue
- 05
- Pages
- 548-556
- ISSN
- 0160-6689 (ISSN-L)
- OpenAlex
- W2083107510
- Cited by
- 30
- References
- 0
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 1 · 2023: 3 · 2022: 1 · 2021: 3 · 2020: 1 · 2019: 2 · 2017: 3 · 2016: 1 · 2015: 5 · 2014: 2 · 2013: 1 · 2012: 3
- FWCI
- 1.31
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Psychiatry (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, ADHD Rating Scale, placebo-controlled crossover trial, adverse effects
- MeSH terms
- Administration, Cutaneous, Attention Deficit Disorder with Hyperactivity, Child, Child Behavior, Female, Humans, Male, Methylphenidate, Parents, Psychiatric Status Rating Scales, Surveys and Questionnaires, Schools, Cross-Over Studies, Executive Function
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