title: Comparison of the clinical efficacy of twice-daily Ritalin and once-daily Equasym XL with placebo in children with Attention Deficit/Hyperactivity Disorder.
abstract: OBJECTIVE
  To compare the efficacy and safety of two methylphenidate (MPH) formulations--once-daily modified-release MPH (EqXL, Equasym XL) and twice-daily immediate-release methylphenidate (MPH-IR, Ritalin)--and placebo in children with Attention Deficit/Hyperactivity Disorder (ADHD).
  
  
  METHODS
  Children aged 6-12 years on a stable dose of MPH were randomized into a double-blind, three-arm, parallel-group, multi-center study and received 3 weeks of EqXL (20, 40, or 60 mg qd), MPH-IR (10, 20, or 30 mg bid) or placebo. Non-inferiority of EqXL to MPH-IR was assessed by the difference in the inattention/overactivity component of the overall teacher's IOWA Conners' Rating Scale on the last week of treatment (per protocol population). Safety was monitored by adverse events, laboratory parameters, vital signs, physical exam, and a Side Effect Rating Scale.
  
  
  RESULTS
  The lower 97.5% confidence interval bound of the difference between MPH groups fell above the non-inferiority margin (-1.5 points) not only during the last week of treatment but during all three treatment weeks. Both MPH-treatment groups experienced superior benefit when compared to placebo during all treatment weeks (P < 0.001). All treatments were well tolerated.
  
  
  CONCLUSIONS
  EqXL given once-daily was non-inferior to MPH-IR given twice-daily. Both treatments were superior to placebo in reducing ADHD symptoms.
authors.affiliation: Discovery and Wellness Center for Children, Dept. of Psychiatry, University Hospitals of Cleveland Case Western Reserve University, 11100 Euclid Avenue, Cleveland, OH 44106-5080, USA.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Findling
authors.forename: Declan
authors.initials: D
authors.lastname: Quinn
authors.forename: Simon J
authors.initials: SJ
authors.lastname: Hatch
authors.forename: Sara J
authors.initials: SJ
authors.lastname: Cameron
authors.forename: Heleen H
authors.initials: HH
authors.lastname: DeCory
authors.forename: Michael
authors.initials: M
authors.lastname: McDowell
mesh_terms: D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000523:psychology; D002648:Child; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D008774:Methylphenidate