title: Efficacy and safety of dexmethylphenidate extended-release capsules in adults with attention-deficit/hyperactivity disorder.
abstract: BACKGROUND
  This multicenter, randomized, fixed-dose, double-blind, placebo-controlled study evaluated efficacy of extended-release dexmethylphenidate (d-MPH-ER) in adults with attention-deficit/hyperactivity disorder (ADHD).
  
  
  METHODS
  Randomized adults with ADHD (n=221) received once-daily d-MPH-ER 20 mg, 30 mg, or 40 mg or placebo for 5 weeks. The primary efficacy variable was change from baseline to final visit in DSM-IV ADHD Rating Scale (ADHD-RS) total score. Secondary efficacy parameters included the proportion of patients with improvement>or=30% in ADHD-RS total score and final scores on Clinical Global Impressions-Improvement (CGI-I) scale.
  
  
  RESULTS
  Of 218 evaluable patients, 184 completed the study. All d-MPH-ER doses were significantly superior to placebo in improving ADHD-RS total scores. Placebo scores improved by 7.9; d-MPH-ER, 20 mg, improved by 13.7 (p=.006); d-MPH-ER, 30 mg, improved by 13.4 (p=.012); and d-MPH-ER, 40 mg, improved by 16.9 (p<.001). Overall distribution of CGI-I ratings at final visit was significantly better with each d-MPH-ER dosage than with placebo. There were no unexpected safety or tolerability concerns, based on experience with racemic methylphenidate (MPH) in adults and dexmethylphenidate (d-MPH) in children.
  
  
  CONCLUSIONS
  Once-daily d-MPH-ER at 20 mg, 30 mg, or 40 mg is a safe and effective treatment for adults with ADHD.
authors.affiliation: Pediatric Psychopharmacology Research Clinic, Massachusetts General Hospital, Boston, Massachusetts 02114, and New York University School of Medicine, New York, NY, USA. spencer@helix.mgh.harvard.edu
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Spencer
authors.forename: Lenard A
authors.initials: LA
authors.lastname: Adler
authors.forename: James J
authors.initials: JJ
authors.lastname: McGough
authors.forename: Rafael
authors.initials: R
authors.lastname: Muniz
authors.forename: Hai
authors.initials: H
authors.lastname: Jiang
authors.forename: Linda
authors.initials: L
authors.lastname: Pestreich
mesh_terms: D000328:Adult; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D064699:Dexmethylphenidate Hydrochloride; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
chemical_list: D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D064699:Dexmethylphenidate Hydrochloride; D008774:Methylphenidate