title: Effects of open-label lisdexamfetamine dimesylate on self-reported quality of life in adults with ADHD.
abstract: OBJECTIVE
  To assess improvements in quality of life measurements during the open-label portion of a trial examining duration of efficacy of lisdexamfetamine dimesylate in a simulated adult workplace environment.
  
  
  METHODS
  A 4-week, open-label, dose-optimization phase followed by a randomized, double-blind, multicenter, placebo-controlled, 2-way crossover phase to evaluate safety and efficacy of lisdexamfetamine dimesylate in the adult workplace environment was conducted. Clinical assessments included the ADHD Impact Module for Adults (AIM-A) to assess the effect of lisdexamfetamine dimesylate on perception of quality of life and the Clinical Global Impressions-Severity/Improvement to assess symptom severity at baseline and improvement over time. Safety assessments included physical examination, treatment-emergent adverse events, vital signs, and electrocardiogram measurements.
  
  
  RESULTS
  Questions 1 and 4 of the AIM-A suggest improvement from baseline in overall quality of life at week 4 with lisdexamfetamine dimesylate treatment. Post-hoc analysis revealed no significant differences attributable to either age or sex. Overall responses to questions 2 and 3, which related to overall life goals, did not change in a majority of participants during the 4-week open-label phase of this study. For all lisdexamfetamine dimesylate doses combined, treatment-emergent adverse events occurring in ≥ 5% of participants during the dose-optimization phase were decreased appetite (36.6%), dry mouth (30.3%), headache (19.7%), insomnia (18.3%), upper respiratory tract infection (9.9%), irritability (8.5%), nausea (7.7%), anxiety (5.6%), and feeling jittery (5.6%).
  
  
  CONCLUSIONS
  At the end of the dose-optimization phase, lisdexamfetamine dimesylate treatment suggested quality of life improvements in adults with ADHD, with a safety profile consistent with long-acting stimulant use.
authors.affiliation: Bayou City Research, Houston, TX 77007, USA. drmattbrams@aol.com
authors.forename: Matthew
authors.initials: M
authors.lastname: Brams
authors.forename: John
authors.initials: J
authors.lastname: Giblin
authors.forename: Maria
authors.initials: M
authors.lastname: Gasior
authors.forename: Joseph
authors.initials: J
authors.lastname: Gao
authors.forename: Timothy
authors.initials: T
authors.lastname: Wigal
mesh_terms: D000293:Adolescent; D000328:Adult; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000523:psychology; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018592:Cross-Over Studies; D003913:Dextroamphetamine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000069478:Lisdexamfetamine Dimesylate; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D057566:Self Report; D017132:Workplace; D055815:Young Adult
chemical_list: D000697:Central Nervous System Stimulants; D000069478:Lisdexamfetamine Dimesylate; D003913:Dextroamphetamine