A Randomized, Double-Blind, Placebo-Controlled Study of Atomoxetine in Japanese Children and Adolescents with Attention-Deficit/Hyperactivity Disorder
Abstract
OBJECTIVES: Until the recent approval of methylphenidate (MPH), Japan had no approved treatment for attention-deficit/hyperactivity disorder (ADHD). The need still exists for an effective, safe, nonstimulant treatment. This first placebo-controlled Japan study of an ADHD nonstimulant therapy assessed atomoxetine efficacy and safety to determine the optimal dose for controlling ADHD symptoms in children and adolescents. METHODS: A total of 245 Japanese children and adolescents, aged 6-17 years and diagnosed with ADHD, were randomly assigned to receive placebo or one of three atomoxetine doses (0.5, 1.2, and 1.8 mg/kg per day) over 8 weeks. Symptoms were assessed with the Japanese Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator scored and integrated with teacher reports (ADHD RS-IV-J:I/Sch). Adverse events, vital signs, laboratory tests, and electrocardiograms (ECGs) were obtained for safety analysis. RESULTS: In all, 234 patients completed the study. Atomoxetine at 1.8 mg/kg per day was significantly superior to placebo in reducing ADHD symptoms (p = 0.01; one-sided). Decreased appetite and vomiting were significantly greater in the atomoxetine treatment groups; however, no clinically significant differences were observed. Two patients discontinued due to affect lability and headache. A linear dose-response and vital signs similar to those from other atomoxetine studies were observed. CONCLUSION: Atomoxetine provides an effective and safe nonstimulant option for the treatment of Japanese pediatric patients with ADHD.
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Atomoxetine efficacy has been confirmed in populations around the world, including for children with oppositional defiant disorder or those who have received previous stimulant therapy.
“studies in populations around the world have continued to confirm its efficacy [78-81], including for children with oppositional defiant disorder [82] or those who have received previous stimulant therapy [83].”
From Advances in understanding and treating ADHD (2011) · cites this paper as [80]
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Self-citation
- Authors
- Takahashi, M., Takita, Y., Yamazaki, K., Hayashi, T., Ichikawa, H., Kambayashi, Y., Koeda, T., Oki, J., Saito, K., Takeshita, K., & Allen, A. J.
- Affiliations
- Eli Lilly (Japan) (JP)
- Mejiro University (JP)
- Yamaguchi Prefectural University (JP)
- Tokyo Metropolitan Umegaoka Hospital, Tokyo, Japan.
- Chuo University (JP)
- Tottori University (JP)
- Asahikawa Kosei Hospital (JP)
- Kohnodai Hospital, National Center for Global Health and Medicine (JP)
- Fukuoka Social Medical Welfare University (JP)
- Eli Lilly (United States) (US)
- Corresponding author
- Takahashi, Michihiro
- Venue
- Journal of Child and Adolescent Psychopharmacology
- Publisher
- SAGE Publications
- Published
- 2009-08
- Volume
- 19
- Issue
- 4
- Pages
- 341-350
- ISSN
- 1044-5463 (ISSN-L)
- 1557-8992
- OpenAlex
- W2021696244
- Cited by
- 36
- References
- 22
- Citations by year
- 2025: 3 · 2023: 1 · 2022: 1 · 2020: 2 · 2019: 1 · 2018: 1 · 2017: 3 · 2016: 4 · 2015: 2 · 2014: 4 · 2013: 3 · 2012: 4
- FWCI
- 2.27
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Child and Adolescent Psychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Eli Lilly Japan
- Janssen Pharmaceuticals
- 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, dose-response relationship, ADHD symptom reduction, drug safety, appetite loss, vomiting, vital signs, ADHD-RS-IV
- MeSH terms
- Atomoxetine Hydrochloride, Adolescent, Age Factors, Attention Deficit Disorder with Hyperactivity, Child, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Propylamines, Asian People
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