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Cited by 84Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesPharmacology and Obesity Treatment

Atomoxetine versus Methylphenidate in Paediatric Outpatients with Attention Deficit Hyperactivity Disorder: A Randomized, Double-Blind Comparison Trial

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Wang, Yufeng, Zheng, Yi, Du, Yasong, Song, Dong H., Shin, Yee-Jin, Cho, Soo C., Kim, Bung N., Ahn, Dong H. +4 more·2007·Australian & New Zealand Journal of Psychiatry
DOI 10.1080/00048670601057767
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Abstract

Objective: To (i) test whether atomoxetine is non-inferior to methylphenidate in treating symptoms of attention deficit hyperactivity disorder (ADHD) in paediatric patients; and (ii) determine the tolerability of the two drugs. Method: This double-blind study was conducted in 6- to 16-year-old outpatients with ADHD (DSM-IV) in China, Korea and Mexico (January–October 2004). Patients were randomly assigned to once-daily atomoxetine (0.8–1.8 mg kg −1 day −1 ; n = 164) or twice-daily methylphenidate (0.2–0.6 mg kg −1 day −1 ; n = 166) for ∼8 weeks. Primary efficacy assessment was the comparison of response rates (≥40% reduction from baseline to end point in total score) on the Attention Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and -Scored. Tolerability measures included, but were not limited to, the assessment of treatment-emergent adverse events (TEAEs) and weight. Results: Atomoxetine was non-inferior to methylphenidate in improving ADHD symptoms based on response rates (atomoxetine, 77.4%; methylphenidate, 81.5%; one-sided 95% lower confidence limit = −11.7%, p = 0.404). Treatment-emergent adverse effects experienced significantly more frequently in the atomoxetine group, compared with the methylphenidate group, included anorexia (37.2% vs. 25.3%; p = 0.024), nausea (20.1% vs. 10.2%; p = 0.014), somnolence (26.2% vs. 3.6%; p <0.001), dizziness (15.2% vs. 7.2%; p = 0.024) and vomiting (11.6% vs. 3.6%; p = 0.007), most of which were of mild or moderate severity. Atomoxetine-treated patients experienced a small but significantly greater mean weight loss from baseline to end point than methylphenidate-treated patients (−1.2 kg vs. −0.4 kg; p <0.001). Conclusions: This study suggests that atomoxetine is non-inferior to methylphenidate in the improvement of ADHD symptoms in paediatric outpatients. Although both of the drugs were well tolerated, atomoxetine was associated with a higher incidence of TEAEs than methylphenidate.

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Authors
Wang, Y., Zheng, Y., Du, Y., Song, D. H., Shin, Y.-J., Cho, S. C., Kim, B. N., Ahn, D. H., Marquez-Caraveo, M. E., Gao, H., Williams, D. W., & Levine, L. R.
Affiliations
  • Institute of Mental Health, Beijing Medical University, Beijing, China
  • Beijing An Ding Hospital, Beijing, China
  • Shanghai Mental Health Center (CN)
  • Yonsei University (KR)
  • Seoul National University Hospital (KR)
  • Hanyang University Seoul Hospital (KR)
  • Child Psychiatric Hospital ‘Dr Juan N. Navarro’, Mexico City, Mexico
  • Eli Lilly (United States) (US)
Corresponding author
Levine, Louise R.
ORCID
Venue
Australian & New Zealand Journal of Psychiatry
Publisher
SAGE Publications
Published
2007-03
Volume
41
Issue
3
Pages
222-230
ISSN
  • 0004-8674 (ISSN-L)
  • 1440-1614
DOI
10.1080/00048670601057767
OpenAlex
W2144962889
Cited by
84
References
40
Citations by year
2026: 1 · 2025: 1 · 2024: 3 · 2023: 1 · 2022: 3 · 2021: 1 · 2019: 1 · 2018: 3 · 2017: 5 · 2016: 6 · 2015: 9 · 2014: 8 · 2013: 8 · 2012: 6
FWCI
3.63
Type
journal article
Language
en
Open access
Licence
Locations
  • Australian & New Zealand Journal of Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
  • YUHSpace (Yonsei University Medical Library) (submittedVersion, cc-by-nc-nd)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
Keywords
atomoxetine, methylphenidate, attention deficit hyperactivity disorder, non-inferiority, treatment-emergent adverse events, weight loss, tolerability, ADHD Rating Scale-IV, anorexia, sleepiness, dizziness, nausea, vomiting, outpatients, Latin America, North America
MeSH terms
Atomoxetine Hydrochloride, Adolescent, Central Nervous System Stimulants, Child, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Methylphenidate, Personality Assessment, Propylamines, Adrenergic Uptake Inhibitors

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