title: A double-blind, placebo-controlled study of atomoxetine in young children with ADHD.
abstract: OBJECTIVE
  To evaluate the efficacy and tolerability of atomoxetine for the treatment of attention-deficit/hyperactivity disorder (ADHD) in 5- and 6-year-old children.
  
  
  METHODS
  This was an 8-week, double-blind, placebo-controlled randomized clinical trial of atomoxetine in 101 children with ADHD. Atomoxetine or placebo was flexibly titrated to a maximum dose of 1.8 mg/kg per day. The pharmacotherapist reviewed psychoeducational material on ADHD and behavioral-management strategies with parents during each study visit.
  
  
  RESULTS
  Significant mean decreases in parent (P = .009) and teacher (P = .02) ADHD-IV Rating Scale scores were demonstrated with atomoxetine compared with placebo. A total of 40% of children treated with atomoxetine met response criteria (Clinical Global Impression-Improvement Scale indicating much or very much improved) compared with 22% of children on placebo, which was not significant (P = .1). Decreased appetite, gastrointestinal upset, and sedation were significantly more common with atomoxetine than placebo. Although some children demonstrated a robust response to atomoxetine, for others the response was more attenuated. Sixty-two percent of subjects who received atomoxetine were moderately, markedly, or severely ill according to the Clinical Global Impression-Severity Scale at study completion.
  
  
  CONCLUSIONS
  To our knowledge, this is the first randomized controlled trial of atomoxetine in children as young as 5 years. Atomoxetine generally was well tolerated and reduced core ADHD symptoms in the children on the basis of parent and teacher reports. Reductions in the ADHD-IV Rating Scale scores, however, did not necessarily translate to overall clinical and functional improvement, as demonstrated on the Clinical Global Impression-Severity Scale and the Clinical Global Impression-Improvement Scale. Despite benefits, the children in the atomoxetine group remained, on average, significantly impaired at the end of the study.
authors.affiliation: Department of Psychiatry, University of Nebraska Medical Center, 985581 Nebraska Medical Center, Omaha, NE 68198-5581, USA. ckratoch@unmc.edu
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Kratochvil
authors.forename: Brigette S
authors.initials: BS
authors.lastname: Vaughan
authors.forename: Julie A
authors.initials: JA
authors.lastname: Stoner
authors.forename: Joan M
authors.initials: JM
authors.lastname: Daughton
authors.forename: Brian D
authors.initials: BD
authors.lastname: Lubberstedt
authors.forename: Desiree W
authors.initials: DW
authors.lastname: Murray
authors.forename: Allan K
authors.initials: AK
authors.lastname: Chrisman
authors.forename: Melissa A
authors.initials: MA
authors.lastname: Faircloth
authors.forename: Nilda B
authors.initials: NB
authors.lastname: Itchon-Ramos
authors.forename: Scott H
authors.initials: SH
authors.lastname: Kollins
authors.forename: Lawrence A
authors.initials: LA
authors.lastname: Maayan
authors.forename: Laurence L
authors.initials: LL
authors.lastname: Greenhill
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Kotler
authors.forename: Jane
authors.initials: J
authors.lastname: Fried
authors.forename: John S
authors.initials: JS
authors.lastname: March
mesh_terms: D000367:Age Factors; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004493:Education; D005260:Female; D006801:Humans; D008297:Male; D056687:Off-Label Use; D010552:Personality Assessment / Q000706:statistics & numerical data; D011437:Propylamines / Q000009:adverse effects / Q000627:therapeutic use*; D011594:Psychometrics
chemical_list: D000697:Central Nervous System Stimulants; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride