title: Relapse prevention in pediatric patients with ADHD treated with atomoxetine: a randomized, double-blind, placebo-controlled study.
abstract: OBJECTIVE
  Attention-deficit/hyperactivity disorder (ADHD) is typically treated over extended periods; however, few placebo-controlled, long-term studies of efficacy have been reported.
  
  
  METHODS
  In a global multicenter study, children and adolescents who responded to an initial 12-week, open-label period of treatment with atomoxetine, a nonstimulant treatment for ADHD, were randomized to continued atomoxetine treatment or placebo for 9 months under double-blind conditions.
  
  
  RESULTS
  A total of 416 patients completed acute atomoxetine treatment and were randomized. At end point, atomoxetine was superior to placebo in preventing relapse defined as a return to 90% of baseline symptom severity (proportion relapsing: atomoxetine 65 of 292 [22.3%], placebo 47 of 124 [37.9%], p =.002). The proportion of patients with a 50% worsening in symptoms post-randomization was also lower on atomoxetine (atomoxetine 83 of 292 [28.4%], placebo 59 of 124 [47.6%], p <.001). Compared with patients in the placebo group, atomoxetine-treated patients had superior psychosocial functioning at end point. Discontinuations for adverse events were low in both groups, and tolerability was similar to that observed in acute treatment trials.
  
  
  CONCLUSIONS
  In patients who responded favorably to 12 weeks of initial treatment, atomoxetine was superior to placebo in maintaining response for the ensuing 9 months. This result supports the value of maintenance treatment with atomoxetine in patients with ADHD who respond to initial treatment.
authors.affiliation: Lilly Research Laboratories, Indianapolis, IN 46285, USA. michelson@lilly.com
authors.forename: David
authors.initials: D
authors.lastname: Michelson
authors.forename: Jan K
authors.initials: JK
authors.lastname: Buitelaar
authors.forename: Marina
authors.initials: M
authors.lastname: Danckaerts
authors.forename: Christopher
authors.initials: C
authors.lastname: Gillberg
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Spencer
authors.forename: Alessandro
authors.initials: A
authors.lastname: Zuddas
authors.forename: Douglas E
authors.initials: DE
authors.lastname: Faries
authors.forename: Shuyu
authors.initials: S
authors.lastname: Zhang
authors.forename: Joseph
authors.initials: J
authors.lastname: Biederman
mesh_terms: D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D011437:Propylamines / Q000627:therapeutic use*; D055502:Secondary Prevention
chemical_list: D011437:Propylamines; D000069445:Atomoxetine Hydrochloride