Varying the wear time of the methylphenidate transdermal system in children with attention-deficit/hyperactivity disorder.
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.


METHODS
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.
Wilens
Timothy E
TE
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.
Boellner
Samuel W
SW
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.
López
Frank A
FA
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.
Turnbow
John M
JM
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.
Wigal
Sharon B
SB
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.
Childress
Ann C
AC
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.
Abikoff
Howard B
HB
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.
Manos
Michael J
MJ
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.
D000279:Administration, Cutaneous; D000293:Adolescent; D001288:Attention / Q000187:drug effects; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage* / Q000009:adverse effects; D010552:Personality Assessment; D016896:Treatment Outcome
D000697:Central Nervous System Stimulants; D008774:Methylphenidate