title: Time course of treatment effect of OROS® methylphenidate in children with ADHD.
abstract: OBJECTIVE
  The authors evaluated the time course of the treatment effect of Osmotic-Release Oral System methylphenidate (OROS(®) MPH) HCl (Concerta(®), Raritan, NJ) CII in children with ADHD.
  
  
  METHODS
  Data were combined from two double-blind, randomized, placebo-controlled, cross-over, analog classroom studies in children (9-12 years) with ADHD. Participants received an individualized dose of placebo or OROS(®) MPH on two laboratory school days. Permanent Product Math Test and Swanson, Kotkin, Agler, M-Flynn, and Pelham scores were evaluated 0.5 hr before dosing and 1, 2, 4, 10, 11, and 12.5 hr post dose. Analysis used a repeated-measures mixed model.
  
  
  RESULTS
  Treatment effects were present at all postdose assessment points (p < .0001 for all comparisons, n = 139). Adverse events were similar to previous reports for OROS(®) MPH.
  
  
  CONCLUSIONS
  A robust treatment effect occurred with OROS(®) MPH; onset was at 1 hr and persisted for at least 12.5 hr after dosing.
authors.affiliation: Janssen Scientific Affairs, LLC, Raritan, NJ 08560, USA.
authors.forename: Robert B
authors.initials: RB
authors.lastname: Armstrong
authors.forename: C V
authors.initials: CV
authors.lastname: Damaraju
authors.forename: Steve
authors.initials: S
authors.lastname: Ascher
authors.forename: Lesley
authors.initials: L
authors.lastname: Schwarzman
authors.forename: James
authors.initials: J
authors.lastname: O'Neill
authors.forename: H Lynn
authors.initials: HL
authors.lastname: Starr
mesh_terms: D000284:Administration, Oral; D001288:Attention; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000627:therapeutic use; D002648:Child; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage* / Q000627:therapeutic use; D012574:Schools; D016896:Treatment Outcome
chemical_list: D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D008774:Methylphenidate