title: Executive function in adults with attention-deficit/hyperactivity disorder during treatment with atomoxetine in a randomized, placebo-controlled, withdrawal study.
abstract: We assessed the executive function in adults with attention-deficit/hyperactivity disorder (ADHD) during atomoxetine treatment in a randomized withdrawal trial. Responders (Conners' ADHD Rating Scale-Investigator Rated: Screening Version [adult prompts] ≥30% reduction from baseline and Clinical Global Impression Scale-ADHD Severity score ≤3) to open-label atomoxetine (40-100 mg/d, 12 weeks) entered a 37-week double-blind maintenance period. Patients who maintained response (double-blind atomoxetine for 12 weeks) were randomized 1:1 to atomoxetine (80-100 mg/d, n = 266) or placebo (n = 258) for 25 weeks (total duration, 1 year). Patients and investigators were blinded to response criteria and randomization timing. Change in executive function was assessed with the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Self-Report and Informant T scores from the randomization to the last-observation-carried-forward postrandomization week 25 (after week 17). Of the enrolled patients (n = 2017; mean age, 33.2 years; male, 58.7%), 524 responders were randomized. During open-label atomoxetine, subscales and individual items on both BRIEF-A questionnaires showed significant improvement (P < 0.001). After randomization, the following T scores improved significantly (P ≤ 0.05) with patients in the atomoxetine group versus those in the placebo group: global executive composite, behavioral regulation, and metacognition indices; plan/organize, working memory, inhibit, task monitor and shift (both BRIEF-A questionnaires), emotional control and organization of materials (BRIEF-A Informant), and initiate (BRIEF-A Self-Report). Atomoxetine significantly improved the executive function compared with placebo, which was maintained for 25 weeks or more; the executive function of patients in the placebo group worsened but did not return to baseline levels after randomization.
authors: From the *New York University School of Medicine; and †New York VA Harbor Healthcare System, New York, NY; ‡Eli Lilly and Company, Neuroscience, Indianapolis, IN; §inVentiv Health Clinical, LLC, Ann Arbor, MI; ∥University of Mississippi Medical School, Jackson, MS; ¶Tufts University School of Medicine, Boston, MA; #Indiana University School of Medicine, Indianapolis, IN; and **Lilly Research Laboratories, Kobe, Japan.
authors: Lenard
authors: L
authors: Adler
authors: Yoko
authors: Y
authors: Tanaka
authors: David
authors: D
authors: Williams
authors: Paula T
authors: PT
authors: Trzepacz
authors: Taro
authors: T
authors: Goto
authors: Albert J
authors: AJ
authors: Allen
authors: Rodrigo
authors: R
authors: Escobar
authors: Himanshu P
authors: HP
authors: Upadhyaya
mesh_terms: D018759:Adrenergic Uptake Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D000328:Adult; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology*; D004311:Double-Blind Method; D056344:Executive Function / Q000187:drug effects*; D005260:Female; D006801:Humans; D008297:Male; D011437:Propylamines / Q000494:pharmacology / Q000627:therapeutic use*; D013375:Substance Withdrawal Syndrome / Q000175:diagnosis / Q000523:psychology*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride