A dose-ranging study of a methylphenidate transdermal system in children with ADHD.
OBJECTIVE
This was a multicenter, double-blind, randomized, dose-ranging study of a methylphenidate (MPH) transdermal system (MTS). Medication (placebo, 0.45, 0.9, and 1.8 mg/h) was crossed with application time (6 a.m., 7 a.m.) to evaluate MTS efficacy and influence of exposure time on morning effects.


METHODS
The study took place in a summer treatment program (STP) at three sites, with 36 children aged 7-12 years with attention-deficit/hyperactivity disorder. Each treatment was administered for 1 day in random order, for a total of 8 days. Behavioral and academic measures were taken as well as patch wear characteristics and side effects.


RESULTS
Evaluable participant data were analyzed in a series of dose x application time multivariate analyses of variance. All MTS conditions were significantly different from placebo across measures. Time of application had no significant effect on daily behavior, and effects of application time on morning behavior were inconclusive. Consistent with previous results in this setting, the highest dose produced limited incremental benefit compared with the mid-range dose. The wear characteristics of the MTS were acceptable, and the formulation was well tolerated.


CONCLUSIONS
The MTS produced significant effects that were similar to those previously reported with comparable MPH doses. There does not appear to be a substantial effect of application time on total daily functioning in this setting; further controlled time-course studies will be necessary to evaluate the question of morning onset fully.
Pelham
William E
WE
State University of New York at Buffalo, NY, USA. pelham@acsu.buffalo.edu
Manos
Michael J
MJ
Ezzell
Cora E
CE
Tresco
Katy E
KE
Gnagy
Elizabeth M
EM
Hoffman
Martin T
MT
Onyango
Adia N
AN
Fabiano
Gregory A
GA
Lopez-Williams
Andy
A
Wymbs
Brian T
BT
Caserta
Donald
D
Chronis
Andrea M
AM
Burrows-Maclean
Lisa
L
Morse
Gene
G
D000279:Administration, Cutaneous; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000697:Central Nervous System Stimulants; D008774:Methylphenidate