title: Executive function deficits in children with attention-deficit/hyperactivity disorder and improvement with lisdexamfetamine dimesylate in an open-label study.
abstract: OBJECTIVE
  To assess the effects of lisdexamfetamine dimesylate (LDX) on executive function (EF) behaviors in children with attention-deficit/hyperactivity disorder (ADHD).
  
  
  METHODS
  This observational, open-label, 7-week, dose-optimization study of LDX (20-70  mg/day) in children with ADHD evaluated efficacy with the ADHD Rating Scale IV; safety measures included adverse events (AEs). EF was assessed with the Behavior Rating Inventory of Executive Function (BRIEF). Post hoc analyses examined BRIEF scores by sex, ADHD subtype, comorbid psychiatric symptoms, and common treatment-emergent AEs (TEAEs). ADHD Rating Scale IV scores were assessed in subjects categorized by baseline BRIEF global executive composite T scores with clinically significant (≥65) or not clinically significant (<65) impairment in EF.
  
  
  RESULTS
  Mean (standard deviation) change from baseline to endpoint for BRIEF of -17.9 (12.5) for Global Executive Composite, -15.4 (12.6) for Behavioral Regulation Index, and -17.6 (12.3) for Metacognition Index demonstrated improvement with LDX (pooled doses; p < 0.0001 for all). Improvements in BRIEF scores were seen regardless of sex, ADHD subtype, comorbid psychiatric symptoms, common TEAEs, or baseline EF impairment category. TEAEs included decreased appetite, decreased weight, irritability, insomnia, headache, upper abdominal pain, and initial insomnia.
  
  
  CONCLUSIONS
  Improvements were demonstrated in EF behaviors and ADHD symptoms with LDX. LDX safety profile was consistent with long-acting stimulant use.
authors.affiliation: University of Toronto, Toronto, Canada.
authors.forename: Atilla
authors.initials: A
authors.lastname: Turgay
authors.forename: Lawrence
authors.initials: L
authors.lastname: Ginsberg
authors.forename: Elias
authors.initials: E
authors.lastname: Sarkis
authors.forename: Rakesh
authors.initials: R
authors.lastname: Jain
authors.forename: Ben
authors.initials: B
authors.lastname: Adeyi
authors.forename: Joseph
authors.initials: J
authors.lastname: Gao
authors.forename: Bryan
authors.initials: B
authors.lastname: Dirks
authors.forename: Thomas
authors.initials: T
authors.lastname: Babcock
authors.forename: Brian
authors.initials: B
authors.lastname: Scheckner
authors.forename: Cynthia
authors.initials: C
authors.lastname: Richards
authors.forename: Robert
authors.initials: R
authors.lastname: Lasser
authors.forename: Robert L
authors.initials: RL
authors.lastname: Findling
mesh_terms: D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000503:physiopathology; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D003913:Dextroamphetamine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D056344:Executive Function / Q000187:drug effects*; D005260:Female; D006801:Humans; D000069478:Lisdexamfetamine Dimesylate; D008297:Male; D009483:Neuropsychological Tests; D011446:Prospective Studies; D011594:Psychometrics
chemical_list: D000697:Central Nervous System Stimulants; D000069478:Lisdexamfetamine Dimesylate; D003913:Dextroamphetamine