title: Once-daily multilayer-release methylphenidate in a double-blind, crossover comparison to immediate-release methylphenidate in children with attention-deficit/hyperactivity disorder.
abstract: OBJECTIVE
  The purpose of this study was to evaluate the comparative efficacy and safety of a novel long-duration multilayer-release (MLR) methylphenidate (MPH) formulation and immediate-release (IR) MPH in attention-deficit/hyperactivity disorder (ADHD) children.
  
  
  METHODS
  This study was a randomized, double-blind, crossover comparison of once-daily MLR and twice-daily IR-MPH in home and school settings in children with a Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of ADHD. Patients completed a 1-week baseline followed by two active medication titration phases. Each phase of treatment was 1-4 weeks of titration with an additional stable dose week. The final dose was based on efficacy and adverse events for each patient. Efficacy measures included Clinical Global Impressions (CGI) and Conners' Parent and Teacher Rating Scales (CPRS and CTRS). The Clinical Assessment of Side Effects (CASE) scale assessed frequency of adverse events.
  
  
  RESULTS
  Of the 90 enrolled patients, aged 6.4-17.5 years, 79 (88%) completed the study. Stable daily doses were 32.0 and 32.5 mg for MLR and IR-MPH, respectively. All efficacy parameters were significantly improved from baseline. A total of 73.2% and 81.0% of patients on MLR and IR-MPH were rated as "much" or "very much improved" on the CGI. A total of 77.4% and 81.1% of patients were normalized on the CPRS-R and 78.9 and 90.4% of patients were normalized on the CTRS-R for MLR and IR-MPH, respectively. The mean CASE score was not different from baseline for either treatment.
authors.affiliation: Children's & Women's Health Centre of BC, Vancouver, British Columbia, Canada.
authors.forename: Margaret
authors.initials: M
authors.lastname: Weiss
authors.forename: Lily
authors.initials: L
authors.lastname: Hechtman
authors.forename: Atilla
authors.initials: A
authors.lastname: Turgay
authors.forename: Umesh
authors.initials: U
authors.lastname: Jain
authors.forename: Declan
authors.initials: D
authors.lastname: Quinn
authors.forename: Tahira S
authors.initials: TS
authors.lastname: Ahmed
authors.forename: Timothy
authors.initials: T
authors.lastname: Yates
authors.forename: Joseph L
authors.initials: JL
authors.lastname: Reiz
authors.forename: Graeme A E
authors.initials: GA
authors.lastname: Donnelly
authors.forename: Zoltan
authors.initials: Z
authors.lastname: Harsanyi
authors.forename: Andrew C
authors.initials: AC
authors.lastname: Darke
mesh_terms: D000293:Adolescent; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000523:psychology; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D018592:Cross-Over Studies; D003627:Data Interpretation, Statistical; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
chemical_list: D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D008774:Methylphenidate