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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.”
In the citing paper
“The outcome in three of these trials favoured atomoxetine suggesting that higher doses of atomoxetine administered twice daily may be more effective.”
In the citing paper
“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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Items 101–200 of 335
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Effect of Atomoxetine on Executive Function Impairments in Adults With ADHD
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“In the pediatric population, registration trials demonstrated the efficacy and safety of atomoxetine for treating ADHD (Spencer et al., 2002).”
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“Consistent with this is the evidence for Atomoxetine as a therapeutic agent for ADHD, given its role in blocking the norepinephrine transporter (Spencer et al., 2002).”
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“0.4 kg to 0.9 kg (Michelson et al. 2001; Michelson et al. 2002; Spencer et al. 2002).”
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“The efficacy of atomoxetine for treating ADHD has been demonstrated in children and adolescents when administered once daily(2,3) and twice daily.(4,5) Given that the half-life of this drug is about 5 hours in most patients, the efficacy of once-daily dosing suggests that after several days the therapeutic effects per…”
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“Clinical relevance was defined based on AEs associated with ATX treatment in previous studies (Spencer et al. 1998, 2001, 2002; Michelson et al. 2001, 2002; Kelsey et al. 2004).”
The epidemiology of psychotropic drug use in children and adolescents
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“At the beginning of the observation period, CGI-S ratings were very similar to those seen in controlled clinical trials (Michelson et al. 2001; Spencer et al. 2001; Michelson et al. 2002; Spencer et al. 2002; Kelsey et al. 2004), whilst mean ADHD-RS baseline scores appeared to be lower (by approximately five points).”
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Self-citationAtomoxetine: a novel treatment for child and adult ADHD
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“Atomoxetine was associated with an improvement in oppositional behavior in children with ADHD (Spencer et al. 2002), and another study reboxetine, as aggressiveness is one of the most predominant symptoms of HCD Decreasing aggressive behavior can improve quality of life for the child and the family…”
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InfluentialIsolated atomoxetine (Strattera™) ingestions commonly result in toxicity
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Self-citationHemodynamic Effects of Acute Administration of Atomoxetine and Methylphenidate
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“The effectiveness of atomoxetine in the treatment of ADHD has been demonstrated in children, adolescents, and adults.(1,2) It is metabolized through the cytochrome P450 2D6 (CYP2D6) pathway.”
BackgroundTravers, C., & King, R. (2005) · Journal of Personality Disorders · doi:10.1521/pedi.19.1.1.62181 · Cited by 23
Cervelló, X. C., Sáez, M., Barcheni, M., Cunill, R., Serrano, D., López, B., & Lissa, C. J. V. (2021) · The International Journal of Neuropsychopharmacology · doi:10.1093/ijnp/pyab054 · Cited by 22
Ota, T., Iida, J., Nakanishi, Y., Sawada, S., Matsuura, H., Yamamuro, K., Ueda, S., Uratani, M., Kishimoto, N., Negoro, H., et al. (2014) · Psychiatry and Clinical Neurosciences · doi:10.1111/pcn.12251 · Cited by 20
“Neurobiological studies have reported that prefrontal dysfunction is a component of the pathophysiology of ADHD.”
BackgroundInfluentialDittmann, R., Wehmeier, P. M., Schacht, A., Minarzyk, A., Lehmann, M., Sevecke, K., & Lehmkuhl, G. (2009) · Child and Adolescent Psychiatry and Mental Health · doi:10.1186/1753-2000-3-21 · Cited by 23
Impact of atomoxetine on health-related quality of life and functional status in patients with ADHD
Matza, L. S., Stoeckl, M. N., Shorr, J. M., & Johnston, J. A. (2006) · Expert Review of Pharmacoeconomics & Outcomes Research · doi:10.1586/14737167.6.4.379 · Cited by 22
Buchanan, T., Charles, M. S., Rigler, M., & Hart, C. (2010) · International Journal of Disability Development and Education · doi:10.1080/1034912x.2010.524407 · Cited by 22
Review of long-acting stimulants in the treatment of attention deficit hyperactivity disorder
Weisler, R. H. (2007) · Expert Opinion on Pharmacotherapy · doi:10.1517/14656566.8.6.745 · Cited by 22
“Efficacy of once- or twice-daily dosing of ATM for ADHD has been shown in placebo-controlled trials with children, adolescents, and adults [59-64].”
Harpin, V. (2008) · Archives of Disease in Childhood Education & Practice · doi:10.1136/adc.2006.106864 · Cited by 21
The evidence-based pharmacological treatment of paediatric ADHD
Vaughan, B. S., March, J. S., & Kratochvil, C. J. (2011) · The International Journal of Neuropsychopharmacology · doi:10.1017/s1461145711000095 · Cited by 25
“Two large, DBPC efficacy studies demonstrated significant improvement in ADHD symptoms with atomoxetine compared to placebo, with 64.1% and 58.7% of atomoxetine subjects responding (Spencer et al .”
InfluentialSelf-citationAtomoxetine Treatment in Adolescents with Attention-Deficit/Hyperactivity Disorder
Wietecha, L. A., Williams, D. W., Herbert, M., Melmed, R. D., Greenbaum, M., & Schuh, K. (2009) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2008.074 · Cited by 21
“Numerous clinical trials have demonstrated the efficacy and safety of atomoxetine for treating ADHD (Michelson et al. 2001; Michelson et al. 2003; Michelson et al. 2002; Spencer et al. 2002; Kelsey et al. 2004; Allen et al. 2005).”
Quality of Life and Attention-Deficit/Hyperactivity Disorder Core Symptoms
Escobar, R., Schacht, A., Wehmeier, P. M., & Wagner, T. (2010) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0b013e3181d21763 · Cited by 21
Wehmeier, P. M., Schacht, A., Escobar, R., Savill, N., & Harpin, V. (2010) · Child and Adolescent Psychiatry and Mental Health · doi:10.1186/1753-2000-4-30 · Cited by 21
Schlander, M. (2007) · Child and Adolescent Psychiatry and Mental Health · doi:10.1186/1753-2000-1-13 · Cited by 21
Drug Class Review on Pharmacologic Treatments for ADHD
McDonagh, M. S., Peterson, K., & Thakurta, S. (2005) · Cited by 21
van Wyk, G. W., Hazell, P., Kohn, M. R., Granger, R. E., & Walton, R. (2011) · Journal of Attention Disorders · doi:10.1177/1087054710389989 · Cited by 20
“The percentage of patients with comorbid ODD in each trial was 61.7% (111/180; Prasad et al., 2007), 53.6% (45/84; Spencer et al., 2002), 51.6% (112/217; Kratochvil et al., 2002), 47.6% (39/82; Sangal et al., 2006), 44.2% Table 1.”
BackgroundMethodInfluentialSpirometry is Affected by Intelligence and Behavior in Duchenne Muscular Dystrophy
GAULD, L. M., Boynton, A., Betts, G. A., et al. (2005) · Pediatric Pulmonology · doi:10.1002/ppul.20278 · Cited by 20
“It is often used to assess treatment outcome and effectiveness.(23) Confirmatory factor analysis established a 7-factor psychometric structure, with oppositionality being one of these factors and constituting a separate ‘‘scale.”
MethodOpen-Label Amantadine in Children with Attention-Deficit/Hyperactivity Disorder
Donfrancesco, R., Calderoni, D., & Vitiello, B. (2007) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2006.0128 · Cited by 20
“(Greenhill et al. 2001), although not too distant from the 59% and 64% reported for atomoxetine in some controlled studies (Spencer et al. 2002).”
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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