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Cited by 148Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesBehavioral and Psychological Studies

ADHD Treatment With Once-Daily OROS Methylphenidate: Interim 12-Month Results From a Long-Term Open-Label Study

WILENS, TIMOTHY, PELHAM, WILLIAM, STEIN, MARK, CONNERS, C. KEITH, ABIKOFF, HOWARD, ATKINS, MARC, AUGUST, GERALD, GREENHILL, LAURENCE +4 more·2003·Journal of the American Academy of Child & Adolescent Psychiatry
DOI 10.1097/01.chi.0000046814.95464.7d
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Abstract

Objective Few treatment studies of attention-deficit/hyperactivity disorder (ADHD) extend beyond a few months. This article reports an interim analysis of a 24-month study evaluating the 12-month tolerability and effectiveness of a once-daily OROS formulation of methylphenidate (OROS MPH) in children with ADHD.Method Children, aged 6-13 years, with ADHD who participated in previous controlled studies and were MPH responders, received once-daily OROS MPH in this multicenter, open-label, nonrandomized study. Effectiveness was evaluated monthly by parents/caregivers and schoolteachers using validated rating scales (e.g., IOWA Conners). Safety and adverse events assessments involved objective (e.g., vital signs, growth) and subjective (sleep quality, tics) reporting.Results Seventy-one percent of subjects (289/407) completed 12 months' treatment. Effectiveness was maintained throughout 12 months as demonstrated by stable IOWA Conners ratings and sustained improvements in peer interaction and Global Assessment Scale scores. OROS MPH was well tolerated, with adverse events similar to those expected with short-acting stimulant medication. OROS MPH had minimal impact on sleep quality and tics. There were no clinically meaningful changes in blood pressure, pulse, or height. The apparent absence of meaningful changes is tempered by the fact that children were MPH responders and were medicated at baseline, most for extended periods prior to enrollment.Conclusion In this open-label study, once-daily OROS MPH treatment appears to be well tolerated and effectiveness was maintained for up to 12 months in these children with ADHD.

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Crossref · 10.1097/01.chi.0000046814.95464.7d

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  • In children with ADHD, sleep quality was rated as good or excellent by parents after 1 and 12 months of open-label OROS-MPH treatment.

    “Sleep quality was also rated as good or excellent by parents after 1 and 12 months of open-label OROS-MPH treatment in children with ADHD (Wilens et al. 2003).”

    From Associations of sleep disturbance with ADHD: implications for treatment (2015) · cites this paper as Wilens et al. 2003

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Authors
WILENS, T., PELHAM, W., STEIN, M., CONNERS, C. K., ABIKOFF, H., ATKINS, M., AUGUST, G., GREENHILL, L., MCBURNETT, K., PALUMBO, D., SWANSON, J., & WOLRAICH, M.
Affiliations
  • Harvard University (US)
  • University at Buffalo, State University of New York (US)
  • Children's National (US)
  • Duke Medical Center (US)
  • NYU Langone Health (US)
  • University of Illinois Chicago (US)
  • University of Minnesota (US)
  • New York State Psychiatric Institute (US)
  • University of California, San Francisco (US)
  • University of Rochester Medicine (US)
  • University of California, Irvine (US)
  • University of Oklahoma (US)
Corresponding author
WILENS, TIMOTHY
ORCID
Venue
Journal of the American Academy of Child & Adolescent Psychiatry
Publisher
Elsevier BV
Published
2003-04
Volume
42
Issue
4
Pages
424-433
ISSN
0890-8567 (ISSN-L)
DOI
10.1097/01.chi.0000046814.95464.7d
OpenAlex
W2051188089
Cited by
148
References
55
Citations by year
2025: 3 · 2024: 1 · 2023: 1 · 2021: 2 · 2020: 4 · 2019: 2 · 2018: 2 · 2017: 2 · 2016: 2 · 2015: 4 · 2014: 6 · 2013: 2 · 2012: 10
FWCI
11.83
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Journal of the American Academy of Child & Adolescent 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, methylphenidate, children, long-term treatment effectiveness, tolerability, adverse events, sleep quality, tics, blood pressure, growth, peer interaction
MeSH terms
Adolescent, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Male, Methylphenidate

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