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Results From 2 Proof-of-Concept, Placebo-Controlled Studies of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder
Abstract
BACKGROUND: Atomoxetine is a nonstimulant drug being studied for the treatment of attention-deficit/hyperactivity disorder (ADHD). Atomoxetine is a highly specific inhibitor of the presynaptic norepinephrine transporter with minimal affinity for other noradrenergic receptors or other neurotransmitter transporters or receptors. Results of 2 proof-of-concept studies are reported that tested the hypothesis that a selective inhibitor of presynaptic norepinephrine uptake would be effective for the treatment of ADHD in school-aged children. METHOD: Two identical 12-week, stratified, randomized, double-blind, placebo-controlled trials were conducted in children who met DSM-IV criteria for ADHD. The primary efficacy outcome measure was the mean change from baseline to endpoint in the Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD RS) total score. Secondary efficacy measures included the Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) and the Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S). RESULTS: A total of 291 patients were randomized in the 2 trials combined (Study 1, N = 147; Study 2, N = 144). Stimulant-naive patients were randomized to atomoxetine, placebo, or methylphenidate. Patients with prior stimulant exposure were randomized to atomoxetine or placebo. Atomoxetine significantly reduced ADHD RS total scores compared with placebo in each study (p <.001). Changes in the CGI-ADHD-S (Study 1: p =.003; Study 2: p =.001) and CPRS-ADHD Index (Study 1: p =.023; Study 2: p <.001) also showed atomoxetine to be statistically significantly superior to placebo in reducing ADHD symptoms. Atomoxetine was found to be well tolerated in this population of pediatric patients. CONCLUSION: Two studies of atomoxetine early in its development confirmed that atomoxetine, a specific and selective inhibitor of noradrenergic uptake, was effective for the treatment of children with ADHD. In addition, atomoxetine was found to be well tolerated.
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“Nine randomized trials comparing methylphenidate and atomoxetine, with a total of 2762 participants were included.”
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“The outcome in three of these trials favoured atomoxetine suggesting that higher doses of atomoxetine administered twice daily may be more effective.”
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“When data on standard deviations were missing, study authors were contacted to provide missing data [18] or it was calculated using the standard error of subgroups or confidence intervals [19-21].”
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Sallee, F. R., Mcgough, J., Wigal, T., Donahue, J., Lyne, A., & Biederman, J. (2009) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1097/chi.0b013e318191769e · Cited by 391
Self-citation
Metadata
- Authors
- Spencer, T., Heiligenstein, J. H., Biederman, J., Faries, D. E., Kratochvil, C. J., Conners, C. K., & Potter, W. Z.
- Affiliations
- Massachusetts General Hospital (US)
- Venue
- The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2002-12-15
- Volume
- 63
- Issue
- 12
- Pages
- 1140-1147
- ISSN
- 0160-6689 (ISSN-L)
- OpenAlex
- W2016483680
- Cited by
- 333
- References
- 0
- Citations by year
- 2025: 1 · 2024: 2 · 2023: 2 · 2022: 4 · 2021: 4 · 2020: 1 · 2019: 2 · 2018: 2 · 2017: 6 · 2016: 8 · 2015: 10 · 2014: 17 · 2013: 12 · 2012: 13
- FWCI
- 16.42
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Social Sciences › Psychology › Neuropsychology and Physiological Psychology › Developmental and Educational Neuropsychology
- Keywords
- atomoxetine, attention deficit hyperactivity disorder, children, non-stimulant medication, norepinephrine transporter inhibitor, ADHD symptom reduction, methylphenidate, tolerability, ADHD Rating Scale
- MeSH terms
- Atomoxetine Hydrochloride, Antidepressive Agents, Attention Deficit Disorder with Hyperactivity, Child, Double-Blind Method, Female, Humans, Male, Propylamines, Treatment Outcome
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