title: Atomoxetine Increased Effect over Time in Adults with Attention-Deficit/Hyperactivity Disorder Treated for up to 6 Months: Pooled Analysis of Two Double-Blind, Placebo-Controlled, Randomized Trials.
abstract: Changes in the magnitude of efficacy throughout 26 weeks of atomoxetine treatment, along with impact of dosing, were evaluated in adults with ADHD from two randomized, double-blind, placebo-controlled studies.
  
  
  
  Pooled placebo (n = 485) and atomoxetine (n = 518) patients, dosed 25, 40, 60, 80 (target dose), or 100 mg daily, were assessed. Change from baseline in Conners' Adult ADHD Rating Scale-Investigator Rated Scale: Screening Version (CAARS) total ADHD symptoms score and Adult ADHD Investigator Symptom Rating Scale (AISRS) total score were analyzed using mixed-model repeated measures, with least squares mean change, effect size, and response rate calculated at 1, 2, 4, 8, 12, 16, 22, and 26 weeks.
  
  
  
  Decreases on CAARS for atomoxetine- versus placebo-treated patients were consistently statistically significantly greater at every time point beginning at one week (P ≤ 0.006, 0.28 effect size). By 4 weeks, comparison was -13.19 compared with -8.84 (P < 0.0001, 0.45 effect size). By 26 weeks, mean change was -15.42 versus -9.71 (0.52 effect size); increase in effect size over time was most pronounced in the 80 mg group (0.82 effect size). AISRS demonstrated similar results. Atomoxetine response rate (CAARS 50% decrease) continued to increase throughout 26 weeks.
  
  
  
  Atomoxetine treatment in adults with ADHD was associated with small effect sizes after 4 weeks and moderate effect sizes by 6 months of treatment. The data support increased effect size and response rate over time during longer-term treatment at target dose.
authors.affiliation: Eli Lilly and Company and/or one of its Subsidiaries, Indianapolis, IN, USA.
authors.forename: Linda A
authors.initials: LA
authors.lastname: Wietecha
authors.affiliation: Eli Lilly and Company and/or one of its Subsidiaries, Indianapolis, IN, USA.
authors.forename: David B
authors.initials: DB
authors.lastname: Clemow
authors.affiliation: Eli Lilly and Company and/or one of its Subsidiaries, Indianapolis, IN, USA.
authors.forename: Andrew S
authors.initials: AS
authors.lastname: Buchanan
authors.affiliation: Rochester Center for Behavioral Medicine, Wayne State University School of Medicine, Detroit, MI, USA.
authors.forename: Joel L
authors.initials: JL
authors.lastname: Young
authors.affiliation: Sarkis Clinical Trials, Gainesville, FL, USA.
authors.forename: Elias H
authors.initials: EH
authors.lastname: Sarkis
authors.affiliation: Department of Psychiatry, Johns Hopkins University and the Kennedy Krieger Institute, Baltimore, MD, USA.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Findling
mesh_terms: D000293:Adolescent; D018759:Adrenergic Uptake Inhibitors / Q000627:therapeutic use*; D000328:Adult; D000069445:Atomoxetine Hydrochloride / Q000627:therapeutic use*; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011569:Psychiatric Status Rating Scales; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D018759:Adrenergic Uptake Inhibitors; D000069445:Atomoxetine Hydrochloride
keywords: Adult; Atomoxetine; Attention-deficit/hyperactivity disorder; Treatment efficacy