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How effective and safe is transdermal methylphenidate for Attention Deficit Hyperactivity Disorder (ADHD) compared with oral methyphenidate or placebo?
282 children (6–12 years old) with ADHD who were either stimulant naive or responsive; who had IQ ⩾80, and ADHD Rating Scale-IV total score ⩾26. Main exclusions: comorbid psychiatric diagnosis (except oppositional defiant disorder); tic disorder; seizures in past 2 years; concurrent illness potentially compromising study safety; use of certain medications including antidepressants, antipsychotics, and anxiolytics in the 30 days prior to study entry. Children who did not respond (ie, <25% reduction in symptoms) to the 5-week dose optimisation phase, or who had an unacceptable safety profile, were withdrawn from the study.
Community-based study in the USA; performed August 2004 to February 2005.
Daily receipt of a patch and a capsule in one of the following three combinations: methylphenidate transdermal system (MTS) plus placebo capsule, osmotic-release oral system methylphenidate (OROSM) plus placebo patch, or placebo capsule plus placebo patch. …
Source of funding: Shire Development Inc.
Additional notes and a reference list are published online only at http://ebmh.bmj.com/content/vol11/issue4
Competing interests: JS has been reimbursed by McNeil, the manufacturer of Concerta, for attending several conferences and received an investigator initiated grant from McNeil to investigate stimulant-related growth suppression. JS has served on advisory boards and speaker bureaus and received honoraria and travel expenses from several companies (UCB, McNeil, Janssen, Shire, Lilly, Cephalon and Novartis) that manufacture and market medications for the treatment of ADHD.
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