A randomized, double-blind, placebo-controlled, parallel-group study of methylphenidate transdermal system in pediatric patients with attention-deficit/hyperactivity disorder.
OBJECTIVE
To evaluate the efficacy and safety of methylphenidate transdermal system compared with placebo, using osmotic-release oral system (OROS) methylphenidate as a reference therapy.


METHODS
We conducted a 7-week, randomized, double-blind, double-dummy, placebo-controlled trial in children diagnosed with attention-deficit/hyperactivity disorder by DSM-IV-TR criteria, within a community setting. The study was conducted from August 2004 to February 2005. Participants were randomly assigned to 1 of 3 treatments: methylphenidate transdermal system patch plus placebo capsule (N = 100), OROS methylphenidate capsule plus placebo patch (N = 94), or placebo capsule plus placebo patch (N = 88). Over 5 weeks, once-daily doses were optimized using 10-, 15-, 20-, and 30-mg methylphenidate transdermal system patches (9-hour wear time) or 18-, 27-, 36-, and 54-mg OROS methylphenidate capsules. Thereafter, optimal treatment doses were maintained for 2 weeks with blinded ratings of attention, behavior, and academic performance occurring at the end of each week. The primary efficacy measure was the clinician-rated ADHD Rating Scale-Version IV (ADHD-RS-IV). Additional measures included teacher, parent, and other clinician rating scales. Safety and tolerability were assessed throughout the study.


RESULTS
The mean change from baseline in ADHD-RS-IV scores was greater for participants receiving methylphenidate transdermal system and OROS methylphenidate treatments compared with placebo (p < .0001). Similar results were observed for parent and teacher rating scales. More participants receiving active treatments compared with placebo were rated as improved by clinicians and parents (p < .0001). Adverse events were generally mild or moderate in intensity, and the most common included decreased appetite, nausea, vomiting, and insomnia.


CONCLUSIONS
The results of this study suggest that the methylphenidate transdermal system is an efficacious treatment option for children with attention-deficit/hyperactivity disorder.


BACKGROUND
clinicaltrials.gov Identifier: NCT00444574.
Findling
Robert L
RL
University Hospitals Case Medical Center, Cleveland, Ohio 44106, USA. robert.findling@UHhospitals.org
Bukstein
Oscar G
OG
Melmed
Raun D
RD
López
Frank A
FA
Sallee
Floyd R
FR
Arnold
L Eugene
LE
Pratt
Raymond D
RD
D000279:Administration, Cutaneous; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000627:therapeutic use; D002648:Child; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage* / Q000627:therapeutic use; D012720:Severity of Illness Index
D000697:Central Nervous System Stimulants; D008774:Methylphenidate