Timothy E Wilens1, Samuel W Boellner2, Frank A López2, John M Turnbow2, Sharon B Wigal2, Ann C Childress2, Howard B Abikoff2, Michael J Manos2. 1. Dr. Wilens is with the Pediatric Psychopharmacology Unit, Massachusetts General Hospital, Harvard Medical School; Dr. Boellner is with the Neurology and Clinical Study Centers; Dr. López is with the Children's Developmental Center; Dr. Turnbow is with Westex Clinical Investigations; Dr. Wigal is with the University of California, Irvine; Dr. Childress is with the Center For Psychiatry and Behavioral Medicine Inc.; Dr. Abikoff is with New York University; and Dr. Manos is with The Cleveland Clinic.. Electronic address: twilens@partners.org. 2. Dr. Wilens is with the Pediatric Psychopharmacology Unit, Massachusetts General Hospital, Harvard Medical School; Dr. Boellner is with the Neurology and Clinical Study Centers; Dr. López is with the Children's Developmental Center; Dr. Turnbow is with Westex Clinical Investigations; Dr. Wigal is with the University of California, Irvine; Dr. Childress is with the Center For Psychiatry and Behavioral Medicine Inc.; Dr. Abikoff is with New York University; and Dr. Manos is with The Cleveland Clinic.
Abstract
OBJECTIVE:Children with attention-deficit/hyperactivity disorder often have varying needs for coverage of their symptoms throughout the day. The objectives of this study were to determine the efficacy, duration of action, and safety of methylphenidate transdermal system worn for variable times by children (ages 6-12) diagnosed with ADHD. METHOD:Methylphenidate dose was optimized over 5 weeks using 10-, 15-, 20-, or 30-mg patches worn for 9 hours. The efficacy of 4- and 6-hour wear times was then assessed in an Analog Classroom setting during a randomized, placebo-controlled, double-blind, three-way crossover phase. The main efficacy measures were the Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale deportment scale and the Permanent Product Measure of Performance math test. RESULTS: All of the efficacy measures indicated that 4- and 6-hour wear times improved ADHD symptoms and that medication effects on the Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale deportment scale and Permanent Product Measure of Performance math test decreased between 2 and 4 hours after patch removal. The majority of adverse events were transient and mild to moderate in severity. CONCLUSIONS: These findings suggest that the duration of medication effect is related to the wear time of the patch and may be tailored to accommodate the schedules of patients.
RCT Entities:
OBJECTIVE:Children with attention-deficit/hyperactivity disorder often have varying needs for coverage of their symptoms throughout the day. The objectives of this study were to determine the efficacy, duration of action, and safety of methylphenidate transdermal system worn for variable times by children (ages 6-12) diagnosed with ADHD. METHOD:Methylphenidate dose was optimized over 5 weeks using 10-, 15-, 20-, or 30-mg patches worn for 9 hours. The efficacy of 4- and 6-hour wear times was then assessed in an Analog Classroom setting during a randomized, placebo-controlled, double-blind, three-way crossover phase. The main efficacy measures were the Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale deportment scale and the Permanent Product Measure of Performance math test. RESULTS: All of the efficacy measures indicated that 4- and 6-hour wear times improved ADHD symptoms and that medication effects on the Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale deportment scale and Permanent Product Measure of Performance math test decreased between 2 and 4 hours after patch removal. The majority of adverse events were transient and mild to moderate in severity. CONCLUSIONS: These findings suggest that the duration of medication effect is related to the wear time of the patch and may be tailored to accommodate the schedules of patients.
Authors: L E Arnold; D R Bozzolo; P Hodgkins; M McKay; L Beckett-Thurman; M Greenbaum; O Bukstein; A Patel Journal: Curr Med Res Opin Date: 2010-01 Impact factor: 2.580
Authors: Oscar G Bukstein; L Eugene Arnold; Jeanne M Landgraf; Paul Hodgkins Journal: Child Adolesc Psychiatry Ment Health Date: 2009-12-10 Impact factor: 3.033