title: Dose effects and comparative effectiveness of extended release dexmethylphenidate and mixed amphetamine salts.
abstract: OBJECTIVE
  To compare the dose effects of long-acting extended-release dexmethylphenidate (ER d-MPH) and ER mixed amphetamine salts (ER MAS) on attention-deficit/hyperactivity disorder (ADHD) symptom dimensions, global and specific impairments, and common adverse events associated with stimulants.
  
  
  METHODS
  Fifty-six children and adolescents with ADHD participated in an 8-week, double-blind, crossover study comparing ER d-MPH (10, 20, 25-30 mg) and ER MAS (10, 20, 25-30) with a week of randomized placebo within each drug period. Efficacy was assessed with the ADHD Rating Scale-IV (ADHD-RS-IV), whereas global and specific domains of impairment were assessed with the Clinical Global Impressions Severity and Improvement Scales and the parent-completed Weiss Functional Impairment Scale, respectively. Insomnia and decreased appetite, common stimulant-related adverse events, were measured with the parent-completed Stimulant Side Effects Rating Scale.
  
  
  RESULTS
  Both ER d-MPH and ER MAS were associated with significant reductions in ADHD symptoms. Improvement in Total ADHD and Hyperactivity/Impulsivity symptoms were strongly associated with increasing dose, whereas improvements in Inattentive symptoms were only moderately associated with dose. About 80% demonstrated reliable change on ADHD-RS-IV at the highest dose level of ER MAS compared with 79% when receiving ER d-MPH. Decreased appetite and insomnia were more common at higher dose levels for both stimulants. Approximately 43% of the responders were preferential responders to only one of the stimulant formulations.
  
  
  CONCLUSIONS
  Dose level, rather than stimulant class, was strongly related to medication response.
authors.affiliation: Institute for Juvenile Research, University of Illinois, Chicago, Illinois 60608, USA. mstein@uic.edu
authors.forename: Mark A
authors.initials: MA
authors.lastname: Stein
authors.forename: Irwin D
authors.initials: ID
authors.lastname: Waldman
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Charney
authors.forename: Subhash
authors.initials: S
authors.lastname: Aryal
authors.forename: Craig
authors.initials: C
authors.lastname: Sable
authors.forename: Reut
authors.initials: R
authors.lastname: Gruber
authors.forename: Jeffrey H
authors.initials: JH
authors.lastname: Newcorn
mesh_terms: D000293:Adolescent; D000662:Amphetamines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001066:Appetite / Q000187:drug effects; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations / Q000009:adverse effects / Q000627:therapeutic use*; D064699:Dexmethylphenidate Hydrochloride; D004305:Dose-Response Relationship, Drug; 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 / Q000706:statistics & numerical data; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced
chemical_list: D000662:Amphetamines; D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D064699:Dexmethylphenidate Hydrochloride; D008774:Methylphenidate