A randomized, placebo-controlled study of once-daily atomoxetine in the school setting in children with ADHD

Margaret Weiss, Rosemary Tannock, Christopher Kratochvil, David Dunn, Jesus Velez-Borras, Christine Thomason, Roy Tamura, Douglas Kelsey, Linda Stevens, Albert J. Allen

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Abstract

Objective: Five studies have demonstrated the effectiveness of atomoxetine compared with placebo in reducing symptoms of attention-deficit/hyperactivity disorder (ADHD) based on parent reports. The primary objective of this clinical trial was to assess the efficacy of once-daily atomoxetine compared with placebo using teacher reports. Method: One hundred fifty-three patients aged 8-12 years were randomly assigned to receive once-daily atomoxetine or placebo in a 2:1 ratio for 7 weeks. ADHD symptoms at school were primarily assessed by baseline-to-endpoint change on the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Teacher Version: Investigator administered and scored (ADHDRS-IV-Teacher:Inv) as rated by investigators using teacher reports. Results: ADHDRS-IV-Teacher:Inv total scores were significantly lower for children treated with atomoxetine compared with those treated with placebo (p = .001 ). Similar results were observed for the inattentive (p = .016) and hyperactive/impulsive (p < .001) ADHDRS-IV-Teacher:Inv subscales, the clinician-rated Clinical Global Impressions severity scale (p = .001), the Conners Global Index-Teacher scale (p = .008), and the Conners Parent Rating Scale-Revised: Short Form ADHD Index T-Score (p < .001). Discontinuations due to adverse events were low in both groups (atomoxetine 5.9%, placebo 0%, p = .096). Conclusions: This study extends previous results based on parent reports showing that once-daily administration of atomoxetine is safe and effective in improving ADHD symptoms in children and demonstrates that outcomes at school are similar when symptoms are reported by teachers.

Original languageEnglish (US)
Pages (from-to)647-655
Number of pages9
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume44
Issue number7
DOIs
StatePublished - Jul 2005

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Keywords

  • Atomoxetine
  • Attention-deficit/hyperactivity disorder
  • Nonstimulants
  • School

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Developmental and Educational Psychology

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