title: Mixed amphetamine salts extended-release in the treatment of adult ADHD: a randomized, controlled trial.
abstract: BACKGROUND
  Attention-deficit/hyperactivity disorder (ADHD) is a serious neurobehavioral disorder of childhood onset that often persists into adolescence and adulthood. Functional impairments, underachievement, and difficult interpersonal relationships illustrate the need for effective treatment of ADHD through adulthood.
  
  
  METHODS
  This prospective, multisite, randomized, double-blind, placebo-controlled, parallel-group, dose-escalation study was conducted to assess the efficacy, safety, and duration of action of mixed amphetamine salts extended-release (MAS XR) in adults with ADHD, combined type. Adults > or =18 years of age were given placebo or MAS XR 20, 40, or 60 mg/day for 4 weeks. The main outcome measures were the ADHD Rating Scale and Conners' Adult ADHD Rating Scale Short Version Self-Report (CAARS-S-S).
  
  
  RESULTS
  Two hundred fifty-five subjects were randomly assigned to treatment with MAS XR or placebo. MAS XR treatment was associated with statistically and clinically significant ADHD symptom reduction at endpoint; mean ADHD Rating Scale scores were 18.5 for the 20-mg group (P=.001), 18.4 for the 40-mg group (P<.001), and 18.5 for the 60-mg group (P<.001). Adults with severe symptoms (ADHD Rating Scale score >32 at baseline) had significantly greater symptom reduction with the highest MAS XR dose (60 mg/day), however, this dose-response relationship was determined by post-hoc analysis. The mean MAS XR effect size was 0.8. Statistically significant (P<.05) improvements in CAARS-S-S ADHD index scores occurred at 4- and 12-hours postdose for all MAS XR groups, indicating a 12-hour duration of effect. Symptoms improved within the first treatment week. Most adverse events reported were mild or moderate in intensity, and the most commonly reported adverse events were consistent with the known profile of stimulant medications. Vital signs and electrocardiograms showed no clinically significant cardiovascular changes.
  
  
  CONCLUSIONS
  These results suggest that MAS XR is safe and effective in adults with ADHD and controlled ADHD symptoms for up to 12 hours.
authors.affiliation: University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. rweisler@aol.com
authors.forename: Richard H
authors.initials: RH
authors.lastname: Weisler
authors.forename: Joseph
authors.initials: J
authors.lastname: Biederman
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Spencer
authors.forename: Timothy E
authors.initials: TE
authors.lastname: Wilens
authors.forename: Stephen V
authors.initials: SV
authors.lastname: Faraone
authors.forename: Allan K
authors.initials: AK
authors.lastname: Chrisman
authors.forename: Stephanie C
authors.initials: SC
authors.lastname: Read
authors.forename: Simon J
authors.initials: SJ
authors.lastname: Tulloch
mesh_terms: D000293:Adolescent; D000328:Adult; D000662:Amphetamines / Q000009:adverse effects / Q000627:therapeutic use*; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D000662:Amphetamines; D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations