A Double-Blind, Placebo-Controlled Study of Atomoxetine in Young Children With ADHD
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Objective To evaluate the efficacy and tolerability of atomoxetine for the treatment of attention-deficit/hyperactivity disorder (ADHD) in 5- and 6-year-old children. Methods This was an 8-week, double-blind, placebo-controlled randomized clinical trial of atomoxetine in 101 children with ADHD. Atomoxetine or placebo was flexibly titrated to a maximum dose of 1.8 mg/kg per day. The pharmacotherapist reviewed psychoeducational material on ADHD and behavioral-management strategies with parents during each study visit. Results Significant mean decreases in parent (P = .009) and teacher (P = .02) ADHD-IV Rating Scale scores were demonstrated with atomoxetine compared with placebo. A total of 40% of children treated with atomoxetine met response criteria (Clinical Global Impression-Improvement Scale indicating much or very much improved) compared with 22% of children on placebo, which was not significant (P = .1). Decreased appetite, gastrointestinal upset, and sedation were significantly more common with atomoxetine than placebo. Although some children demonstrated a robust response to atomoxetine, for others the response was more attenuated. Sixty-two percent of subjects who received atomoxetine were moderately, markedly, or severely ill according to the Clinical Global Impression-Severity Scale at study completion. Conclusions To our knowledge, this is the first randomized controlled trial of atomoxetine in children as young as 5 years. Atomoxetine generally was well tolerated…
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Adolescents are at greater risk for substance use than are younger children.
“Clinicians should also be aware that adolescents are at greater risk for substance use than are younger children44,45,47”
From Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents (2019) · cites this paper as [47]
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- Authors
- Kratochvil, C. J., Vaughan, B. S., Stoner, J. A., Daughton, J. M., Lubberstedt, B. D., Murray, D. W., Chrisman, A. K., Faircloth, M. A., Itchon-Ramos, N. B., Kollins, S. H., Maayan, L. A., Greenhill, L. L., Kotler, L. A., Fried, J., & March, J. S.
- Affiliations
- University of Nebraska Medical Center (US)
- University of Oklahoma Health Sciences Center (US)
- Duke Medical Center (US)
- Nathan Kline Institute for Psychiatric Research (US)
- New York State Psychiatric Institute (US)
- New York University (US)
- ORCID
- Venue
- Pediatrics
- Publisher
- American Academy of Pediatrics (AAP)
- Published
- 2011-04-01
- Volume
- 127
- Issue
- 4
- Pages
- e862-e868
- ISSN
- 0031-4005 (ISSN-L)
- 1098-4275
- PMC
- PMC3387889
- OpenAlex
- W1977031327
- Cited by
- 70
- References
- 24
- Citations by year
- 2025: 2 · 2024: 2 · 2023: 5 · 2022: 3 · 2021: 4 · 2020: 2 · 2019: 6 · 2018: 4 · 2017: 7 · 2016: 6 · 2015: 4 · 2014: 5 · 2013: 6 · 2012: 9
- FWCI
- 5.28
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- PEDIATRICS (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- Brown University
- University of Nebraska Medical Center
- Janssen Scientific Affairs
- National Institutes of Health (5k23mh066127-05)
- National Institute of Mental Health (5K23MH06612701)
- National Institute on Drug Abuse (K24DA023464)
- 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, young children, ADHD medication, drug tolerability, adverse effects, appetite loss, sedation, gastrointestinal upset, parent and teacher ratings, Clinical Global Impression Scale, behavior management
- MeSH terms
- Atomoxetine Hydrochloride, Age Factors, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Child, Preschool, Combined Modality Therapy, Dose-Response Relationship, Drug, Double-Blind Method, Education, Female, Humans, Male, Personality Assessment, Propylamines, Psychometrics, Off-Label Use
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