title: A dose-ranging study of a methylphenidate transdermal system in children with ADHD.
abstract: 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.
authors.affiliation: State University of New York at Buffalo, NY, USA. pelham@acsu.buffalo.edu
authors.forename: William E
authors.initials: WE
authors.lastname: Pelham
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Manos
authors.forename: Cora E
authors.initials: CE
authors.lastname: Ezzell
authors.forename: Katy E
authors.initials: KE
authors.lastname: Tresco
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: Gnagy
authors.forename: Martin T
authors.initials: MT
authors.lastname: Hoffman
authors.forename: Adia N
authors.initials: AN
authors.lastname: Onyango
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Fabiano
authors.forename: Andy
authors.initials: A
authors.lastname: Lopez-Williams
authors.forename: Brian T
authors.initials: BT
authors.lastname: Wymbs
authors.forename: Donald
authors.initials: D
authors.lastname: Caserta
authors.forename: Andrea M
authors.initials: AM
authors.lastname: Chronis
authors.forename: Lisa
authors.initials: L
authors.lastname: Burrows-Maclean
authors.forename: Gene
authors.initials: G
authors.lastname: Morse
mesh_terms: 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
chemical_list: D000697:Central Nervous System Stimulants; D008774:Methylphenidate