A randomized, double-blind, multicenter, parallel-group, placebo-controlled, dose-optimization study of the methylphenidate transdermal system for the treatment of ADHD in adolescents

CNS Spectrums
Robert L FindlingYunfeng Li

Abstract

The current report evaluates the efficacy and safety of methylphenidate transdermal system (MTS) compared with placebo transdermal system (PTS) in adolescents with attention-deficit/hyperactivity disorder (ADHD). A total of 217 subjects participated in a 7-week, randomized, double-blind, multicenter, parallel-group, placebo-controlled, dose-optimization study of MTS (10-, 15-, 20- or 30-mg/9 hours). Subjects were randomized into a 2:1 MTS to PTS ratio and titrated to an optimal dose during an initial 5-week period. Subjects maintained their optimal dose through a subsequent 2-week period. The primary outcome measure was the ADHD-Rating Scale-IV (ADHD-RS-IV). Safety of MTS was assessed throughout the study by analyzing adverse events, results of physical examinations, laboratory evaluations, vital sign data, electrocardiograms, and dermal evaluations. Treatment with MTS demonstrated greater reductions from baseline in ADHD-RS-IV total score compared to PTS at endpoint (P%lt;.0001). The majority of the adverse events (98.5%) were mild or moderate in intensity, the most common of which were decreased appetite, headache, irritability, and upper respiratory tract infection. Three subjects in the MTS group discontinued because of an ...Continue Reading

References

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Citations

Jul 10, 2014·PloS One·Florence T BourgeoisKenneth D Mandl
Nov 26, 2015·The Cochrane Database of Systematic Reviews·Ole Jakob StorebøChristian Gluud
Nov 26, 2011·Expert Review of Clinical Pharmacology·Josephine EliaKarin Borgmann-Winter
Nov 22, 2013·The Annals of Pharmacotherapy·Alok Sharma, Justin Couture
Feb 10, 2012·Drugs·Ann C Childress, Sally A Berry
Jun 22, 2012·Neurotherapeutics : the Journal of the American Society for Experimental NeuroTherapeutics·Mark A SteinLaura Hlavaty

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