Cited by 335Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesDevelopmental and Educational Neuropsychology

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Results From 2 Proof-of-Concept, Placebo-Controlled Studies of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder

Spencer, Thomas, Heiligenstein, John H., Biederman, Joseph, Faries, Douglas E., Kratochvil, Christopher J., Conners, C. Keith, Potter, William Z.·2002·The Journal of Clinical Psychiatry

DOI 10.4088/jcp.v63n1209

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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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“…event-related potentials, N200, P300 in treating ADHD symptoms by numerous studies (Adler, Spencer, Milton, Moore, & Michelson, 2005; Biederman et al., 2002; Buitelaar et al., 2004; Kaplan et al., 2004; Kelsey et al., 2004; Michelson et al., 2001; Spencer et al.,1998, Spencer et al., 2002).”
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Background
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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)
ORCID: Spencer, Thomas
Biederman, Joseph
Faries, Douglas E.
Kratochvil, Christopher J.
Potter, William Z.
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)
DOI: 10.4088/jcp.v63n1209
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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Results From 2 Proof-of-Concept, Placebo-Controlled Studies of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder

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