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

Robert L Findling, John Turnbow, John Burnside, Raun Melmed, Rich Civil, Yunfeng Li

Research output: Contribution to journalArticle

Abstract

Introduction: 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). Methods: 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-, 20or 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. Results: Treatment with MTS demonstrated greater reductions from baseline in ADHD-RSIV total score compared to PTS at endpoint (P

Original languageEnglish (US)
Pages (from-to)419-430
Number of pages12
JournalCNS Spectrums
Volume15
Issue number7
StatePublished - Jul 2010
Externally publishedYes

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Methylphenidate
Attention Deficit Disorder with Hyperactivity
Placebos
Therapeutics
Safety
Vital Signs
Physical Examination
Electrocardiography
Outcome Assessment (Health Care)
Skin

ASJC Scopus subject areas

  • Clinical Neurology
  • Psychiatry and Mental health

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A randomized, double-blind, multicenter, parallel-group, placebo-controlled, dose-optimization study of the methylphenidate transdermal system for the treatment of ADHD in adolescents. / Findling, Robert L; Turnbow, John; Burnside, John; Melmed, Raun; Civil, Rich; Li, Yunfeng.

In: CNS Spectrums, Vol. 15, No. 7, 07.2010, p. 419-430.

Research output: Contribution to journalArticle

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