A Controlled Trial of the Methylphenidate Transdermal System on Before-School Functioning in Children With Attention-Deficit/Hyperactivity Disorder
J Clin Psychiatry 2010;71(5):548-556
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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
J Clin Psychiatry 2010;71(5):548–556
Submitted: October 16, 2009; accepted February 1, 2010.
Corresponding author: Timothy E. Wilens, MD, Massachusetts General Hospital, 55 Fruit St, YAW 6900, Boston, MA 02114 (firstname.lastname@example.org).