Clinical Responses to Atomoxetine in Attention-Deficit/Hyperactivity Disorder: The Integrated Data Exploratory Analysis (IDEA) Study
Abstract
Objective Clinical experience suggests that some (but not all) patients with attention-deficit/hyperactivity disorder (ADHD) are highly responsive to the nonstimulant atomoxetine. We conducted a retrospective analysis of randomized controlled trials (RCTs) to identify potential baseline (moderator) and on-treatment (mediator) predictors of responses.Method Data from 6 U.S. RCTs among patients aged 6 to 18 years were pooled (N = 1,069; subjects treated with atomoxetine, n = 618). Subjects were categorized as much improved (> or = 40% decrease in ADHD Rating Scale-IV-Parent Version: Investigator Administered and Scored total score), minimally improved (25%-< 40% decline), or nonresponders (< 25% decrease). Logistic regression, analyses of variance, and repeated-measures analyses were used to explore associations between baseline and on-treatment variables, achieving a much improved response at trial endpoint (6-9 weeks).Results Forty-seven percent of patients showed a much improved clinical response, and 40% did not respond. Only 13% of the patients had a minimal response. No baseline characteristics predicted achieving a much improved clinical response; the only predictor of achieving this response was being at least minimally improved by treatment week 4 (sensitivity = 81%, specificity = 72%, positive predictive value = 75%, and negative predictive value = 79%).Conclusions Clinical response to atomoxetine was bimodal, with most subjects being either responders who were much improved or nonresponders. There were no demographic or clinical predictors of response. However, subjects who ultimately achieved a much improved response were likely to be at least minimal responders by week 4. The recommendation to consider either augmenting or switching treatment in patients who do not achieve at least this level of response to atomoxetine by 4 weeks offers a method for limiting the extended duration of titration to subjects who are most likely to benefit further, while minimizing the duration of exposure in those less likely to achieve an excellent response.
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A meta-analysis including six randomized controlled trials found that previous treatment with psychostimulants did not influence clinical response to ATX.
“In support of this conclusion, a meta-analysis including six randomized controlled trials found that previous treatment with psychostimulants did not influence clinical response to ATX [34].”
A bimodal pattern of clinical response to atomoxetine has been described, with no obvious demographic or clinical predictors of clinical response.
“A bimodal pattern of clinical response to atomoxetine has been described, with no obvious demographic or clinical predictors of clinical response [33].”
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- Authors
- Newcorn, J. H., Sutton, V. K., Weiss, M. D., & Sumner, C. R.
- Affiliations
- University of British Columbia (CA)
- Corresponding author
- Newcorn, Jeffrey H.
- Venue
- Journal of the American Academy of Child & Adolescent Psychiatry
- Publisher
- Elsevier BV
- Published
- 2009-05
- Volume
- 48
- Issue
- 5
- Pages
- 511-518
- ISSN
- 0890-8567 (ISSN-L)
- OpenAlex
- W2027451644
- Cited by
- 92
- References
- 33
- Citations by year
- 2026: 3 · 2025: 7 · 2024: 6 · 2023: 7 · 2022: 3 · 2021: 4 · 2020: 2 · 2019: 3 · 2017: 4 · 2016: 5 · 2015: 10 · 2014: 9 · 2013: 4 · 2012: 6
- FWCI
- 4.91
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of the American Academy of Child & Adolescent 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 › Developmental and Educational Psychology › Behavioral and Psychological Studies
- Keywords
- atomoxetine, attention deficit hyperactivity disorder, non-stimulant medication, treatment response prediction, predictors of treatment response, baseline predictors, ADHD Rating Scale-IV, children with ADHD, treatment titration, treatment switching
- MeSH terms
- Atomoxetine Hydrochloride, Adolescent, Analysis of Variance, Attention Deficit Disorder with Hyperactivity, Child, Dose-Response Relationship, Drug, Female, Humans, Male, Propylamines, Psychiatric Status Rating Scales, Retrospective Studies, Logistic Models, Randomized Controlled Trials as Topic, Treatment Outcome, Adrenergic Uptake Inhibitors
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