title: An open-label trial of OROS methylphenidate in adults with late-onset ADHD.
abstract: BACKGROUND
  Many adults with current impairing symptoms of attention-deficit/hyperactivity disorder (ADHD) do not report an age at onset before 7 years of age and cannot, therefore, be assigned the full Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), diagnosis of ADHD. We hypothesized that treatment with oral release osmotic system (OROS) methylphenidate (MPH) will be safe and efficacious for the treatment of adults with late-onset ADHD.
  
  
  METHODS
  This was a 6-week, open-label, prospective treatment study of OROS MPH monotherapy in 36 adult patients with late-onset ADHD (onset later than the required 7 years of age) using standardized instruments for diagnosis and a robust oral daily dose of up to 1.3 mg/kg/day. Symptom severity was assessed with the Adult ADHD Investigator Symptom Report Scale (AISRS) and the Clinical Global Impression (CGI) scale.
  
  
  RESULTS
  Subjects reported robust current symptoms of ADHD at pre-treatment baseline (11.1+/-2.8 DSM-IV symptoms), but had an atypical mean age at onset of 14.2+/-8.6 years. Treatment with OROS MPH at an average daily dose of 78.2+/-29.4 mg was associated with a statistically and clinically significant reduction in ADHD symptoms relative to baseline as assessed through the AISRS (-16.4+/-10.5; P<.001). Using a categorical definition of response (CGI-I much or very much improved), a majority (n = 26; 72%) of subjects were rated as improved at endpoint.
  
  
  CONCLUSIONS
  These results extend previous findings in adults with full ADHD to adults meeting criteria for late-onset ADHD and support the need for further controlled clinical trials in this population.
authors.affiliation: Joint Program, Pediatric Psychopharmacology Research Office, Massachusetts General Hospital, Boston, MA 02114, USA. jbiederman@partners.org
authors.forename: Joseph
authors.initials: J
authors.lastname: Biederman
authors.forename: Eric
authors.initials: E
authors.lastname: Mick
authors.forename: Thomas
authors.initials: T
authors.lastname: Spencer
authors.forename: Craig
authors.initials: C
authors.lastname: Surman
authors.forename: Paul
authors.initials: P
authors.lastname: Hammerness
authors.forename: Robert
authors.initials: R
authors.lastname: Doyle
authors.forename: Megan
authors.initials: M
authors.lastname: Dougherty
authors.forename: Megan
authors.initials: M
authors.lastname: Aleardi
authors.forename: Karl
authors.initials: K
authors.lastname: Schweitzer
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D017668:Age of Onset; D000368:Aged; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000627:therapeutic use*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D012720:Severity of Illness Index
chemical_list: D000697:Central Nervous System Stimulants; D008774:Methylphenidate