title: Atomoxetine effects on executive function as measured by the BRIEF--a in young adults with ADHD: a randomized, double-blind, placebo-controlled study.
abstract: OBJECTIVE
  To evaluate the effect of atomoxetine treatment on executive functions in young adults with attention-deficit/hyperactivity disorder (ADHD).
  
  
  METHODS
  In this Phase 4, multi-center, double-blind, placebo-controlled trial, young adults (18-30 years) with ADHD were randomized to receive atomoxetine (20-50 mg BID, N = 220) or placebo (N = 225) for 12 weeks. The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) consists of 75 self-report items within 9 nonoverlapping clinical scales measuring various aspects of executive functioning. Mean changes from baseline to 12-week endpoint on the BRIEF-A were analyzed using an ANCOVA model (terms: baseline score, treatment, and investigator).
  
  
  RESULTS
  At baseline, there were no significant treatment group differences in the percentage of patients with BRIEF-A composite or index T-scores ≥60 (p>.5), with over 92% of patients having composite scores ≥60 (≥60 deemed clinically meaningful for these analyses). At endpoint, statistically significantly greater mean reductions were seen in the atomoxetine versus placebo group for the BRIEF-A Global Executive Composite (GEC), Behavioral Regulation Index (BRI), and Metacognitive Index (MI) scores, as well as the Inhibit, Self-Monitor, Working Memory, Plan/Organize and Task Monitor subscale scores (p<.05), with decreases in scores signifying improvements in executive functioning. Changes in the BRIEF-A Initiate (p = .051), Organization of Materials (p = .051), Shift (p = .090), and Emotional Control (p = .219) subscale scores were not statistically significant. In addition, the validity scales: Inconsistency (p = .644), Infrequency (p = .097), and Negativity (p = .456) were not statistically significant, showing scale validity.
  
  
  CONCLUSIONS
  Statistically significantly greater improvement in executive function was observed in young adults with ADHD in the atomoxetine versus placebo group as measured by changes in the BRIEF-A scales.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00510276.
authors.affiliation: Departments of Psychiatry and Child and Adolescent Psychiatry, New York University, New York, New York, United States of America.
authors.forename: Lenard A
authors.initials: LA
authors.lastname: Adler
authors.affiliation: Lilly USA, LLC, Indianapolis, Indiana, United States of America.
authors.forename: David B
authors.initials: DB
authors.lastname: Clemow
authors.affiliation: inVentiv Health Clinical, Indianapolis, Indiana, United States of America.
authors.forename: David W
authors.initials: DW
authors.lastname: Williams
authors.affiliation: Lilly USA, LLC, Indianapolis, Indiana, United States of America.
authors.forename: Todd M
authors.initials: TM
authors.lastname: Durell
mesh_terms: D018759:Adrenergic Uptake Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D000328:Adult; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000523:psychology*; D056344:Executive Function / Q000187:drug effects*; D005260:Female; D006801:Humans; D008297:Male; D011437:Propylamines / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride