Atomoxetine effects on executive function as measured by the BRIEF--a in young adults with ADHD: a randomized, double-blind, placebo-controlled study

• Published in: PloS one 2014-08, Vol.9 (8), p.e104175
• Main Authors: Adler, Lenard A, Clemow, David B, Williams, David W, Durell, Todd M
• Format: Article
• Language: English
• Subjects: Adrenergic Uptake Inhibitors - pharmacology; Adrenergic Uptake Inhibitors - therapeutic use; Adult; Adults; Atomoxetine Hydrochloride; Attention Deficit Disorder with Hyperactivity - drug therapy; Attention Deficit Disorder with Hyperactivity - psychology; Attention deficit hyperactivity disorder; Balances (scales); Biology and Life Sciences; Clinical trials; Double-blind studies; Executive function; Executive Function - drug effects; Female; Humans; Hyperactivity; Male; Medical diagnosis; Medicine and health sciences; Patients; Propylamines - pharmacology; Propylamines - therapeutic use; Randomization; Short term memory; Significance; Statistical analysis; Statistical significance; Studies; Treatment Outcome; Young Adult; Young adults
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0104175

To evaluate the effect of atomoxetine treatment on executive functions in young adults with attention-deficit/hyperactivity disorder (ADHD). 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). 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