ADHD treatment with once-daily OROS methylphenidate: Interim 12-month results from a long-term open-label study

Timothy Wilens, William Pelham, Mark Stein, C. Keith Conners, Howard Abikoff, Marc Atkins, Gerald August, Laurence Greenhill, Keith McBurnett, Donna Palumbo, James Swanson, Mark Wolraich

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128 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)424-433
Number of pages10
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume42
Issue number4
DOIs
StatePublished - Apr 2003

Bibliographical note

Funding Information:
This study was funded by McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, PA. The authors acknowledge the contributions of Joseph Biederman, M.D., Oscar Bukstein, M.D., Lisa Burrows-Maclean, Ph.D., Erika Coles, Karl Fiebelkorn, M.B.A., R.Ph., Martin Hoffman, M.D., Marc Lerner, M.D., Thomas Lock, M.D., Gene Morse, Pharm.D., Sharon Wigal, Ph.D., Elizabeth Winans, Pharm.D., and the Concerta ® Study Group.

Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.

Keywords

  • Attention-deficit/hyperactivity disorder
  • Long-term study
  • Methylphenidate
  • Safety

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