Adverse Reactions to Methylphenidate Treatment for Attention-Deficit/Hyperactivity Disorder: Structure and Associations with Clinical Characteristics and Symptom Control
Publication: Journal of Child and Adolescent Psychopharmacology
Volume 19, Issue Number 6
Abstract
Background: Methylphenidate (MPH)-related adverse events are well characterized. Their predictors and their relationship with therapeutic effects are less well understood. Here we examine these issues in relation to two long-acting formulations.
Method: Comparison of Methylphenidates in the Analog Classroom Setting (COMACS) was made in a large (n = 184) placebo-controlled trial comparing Equasym XL®/Metadate CD®, Concerta®, and placebo (PLA) using a Laboratory School protocol. Therapeutic effects were measured using direct observation, scores on a simple math productivity task and parent ratings. Parents also completed the Barkley Stimulant Side Effect Rating Scale (BSSERS).
Results: The BSSERS had six factors: Emotionality, sleep/appetite, disengaged, dizzy, uninterested, and aches. Treatment effects were seen only for emotionality (which improved) and sleep and appetite (which worsened). Adverse events were not predictable from personal and clinical characteristics of patients. Sleep/appetite adverse events were not associated with therapeutic effects. Improvements in attention-deficit/hyperactivity disorder (ADHD) and emotionality were correlated.
Discussion: The results support a narrow conceptualization of MPH adverse events with problems restricted to appetite and sleep. These effects were not predictable on the basis of available information and may be due to an underlying mechanism rather distinct from those determining therapeutic effects.
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Published In
Journal of Child and Adolescent Psychopharmacology
Volume 19 • Issue Number 6 • December 2009
Pages: 683 - 690
PubMed: 20035586
Copyright
Copyright 2009, Mary Ann Liebert, Inc.
History
Published online: 26 December 2009
Published in print: December 2009
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Disclosures
Edmund Sonuga-Barke is currently a consultant for Shire pharmaceutical and UCB-Pharma; has in the last 3 years received grant funding from Janssen Cilag, UCB-Pharma, and QB-tech; has recently served on the advisory boards for Shire pharmaceuticals, UCB-Pharma, and Flynn Pharma; and has spoken at events spon689sored by UCB-Pharma, Shire Pharmaceuticals, and Janssen Cilag. David Coghill is currently a consultant for Shire Pharmaceutical; has in the last 3 years received grant funding from Shire Pharmaceutical and Eli Lilly; has recently served on the advisory boards for Shire Pharmaceuticals, UCB-Pharma, Eli Lilly, Pfizer, and Flynn Pharma; and has spoken at events sponsored by UCB-Pharma, Eli Lilly, Flynn Pharma, and Janssen Cilag. Jim Swanson is or has been a consultant for Elli Lilly & Co, McNeil, Shire, Cephalon, Celltech, UCB, and Novartis; he has received grant funding from McNeil, Shire, Cephalon, Celltech, UCB, and Novartis; he has received speakers fees from McNeil, Shire, Cephalon, Celltech, UCB, and Novartis. Tim Wigal has since January, 2008, received research support and consulting honoraria from Eli Lilly, McNeil, Otsuka, and Shire. In the past 10 years, he has received research support, consulting honoraria, and/or speaker's bureau from the following pharmaceutical companies: Celltech, Cephalon, Eli Lilly, Janssen, McNeil, Novartis, Otsuka, and Shire. He has no stock or equity interests. In addition Tim Wigal has or currently received funding from the National Institute of Mental Health (NIMH), National Institute of Child Health and Human Development (NICHD), and National Institute on Drug Abuse (NIDA). Marc DeBacker is a full-time employee of UCB-Pharma.
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