A multi-centre, randomised, open-label study of atomoxetine compared with standard current therapy in UK children and adolescents with attention-deficit/hyperactivity disorder (ADHD)

Prasad, Suyash; Harpin, Val; Poole, Lynne; Zeitlin, Harry; Jamdar, Saroj; Puvanendran, Kanagasabai; on behalf of the SUNBEAM Study Group

doi:10.1185/030079906x167309

Cited by 97Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesChild and Adolescent Psychosocial and Emotional Development

A multi-centre, randomised, open-label study of atomoxetine compared with standard current therapy in UK children and adolescents with attention-deficit/hyperactivity disorder (ADHD)

Prasad, Suyash, Harpin, Val, Poole, Lynne, Zeitlin, Harry, Jamdar, Saroj, Puvanendran, Kanagasabai, on behalf of the SUNBEAM Study Group·2007·Current Medical Research and Opinion

DOI 10.1185/030079906x167309

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Abstract

OBJECTIVE: To assess the broader efficacy (i.e., improvements in quality of life/functional outcomes) of atomoxetine compared with standard current therapy (SCT) in UK paediatric patients with ADHD and to explore clinician/parent/child perceptions of ADHD. RESEARCH DESIGN AND METHODS: A total of 201 patients with ADHD were randomised into this multi-centre, open-label study to receive atomoxetine (n = 104) or SCT (n = 97) for 10 weeks. Broader efficacy was assessed using the parent-rated Child Health and Illness Profile-Child Edition (CHIP-CE) total (global) t-score. Secondary outcome measures included the five CHIP-CE domains; parent-rated Family Burden of Illness Module (FBIM); investigator-rated ADHD-Rating Scale; investigator-rated Clinical Global Impression (CGI)-Severity/Improvement scales; and child-rated Harter Self-Perception Profile (HSPP). RESULTS: Quality of life of children/adolescents with ADHD was extremely compromised at baseline (CHIP-CE total t-scores: atomoxetine, 23.2 +/- 12.2; SCT, 23.9 +/- 11.0), and improved during the 10-week study for both groups; the CHIP-CE score was statistically significantly higher for patients treated with atomoxetine (38.4 +/- 1.3) compared with SCT (30.8 +/- 1.3) at week 10 (p < 0.001). ADHD-RS, CGI-Severity, and CGI-Improvement scores were significantly different between the groups in favour of atomoxetine (p < 0.001). There was a statistically significant difference between the groups in the HSPP Social Acceptance domain in favour of atomoxetine, but not in the five other HSPP domains or FBIM total score. Atomoxetine was well-tolerated. CONCLUSIONS: Results from this open-label trial show that atomoxetine is superior to SCT in addressing broader efficacy and functional outcomes in UK children/adolescents with ADHD. This study contributes to the understanding of broader efficacy in children with ADHD, and is timely in light of recent NICE guidance.

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Nine randomized trials comparing methylphenidate and atomoxetine in ADHD children and adolescents were included, with a total of 2762 participants.
“Nine randomized trials comparing methylphenidate and atomoxetine, with a total of 2762 participants were included.”
From Comparative efficacy and acceptability of methylphenidate and atomoxetine in treatment of attention deficit hyperactivity disorder in children and adolescents: a meta-analysis (2011) · cites this paper as [20]
When data on standard deviations were missing, study authors were contacted or data were calculated using standard error of subgroups or confidence intervals.
“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].”
From Comparative efficacy and acceptability of methylphenidate and atomoxetine in treatment of attention deficit hyperactivity disorder in children and adolescents: a meta-analysis (2011) · cites this paper as [20]

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Authors: Prasad, S., Harpin, V., Poole, L., Zeitlin, H., Jamdar, S., Puvanendran, K., & on behalf of the SUNBEAM Study Group
Affiliations: Eli Lilly (United Kingdom) (GB)
Sheffield Children's Hospital NHS Trust, UK
University College London (GB)
Wigan Child and Family Mental Health Services, Wigan, UK
Basildon Hospital (GB)
Corresponding author: Prasad, Suyash
ORCID: Prasad, Suyash
Venue: Current Medical Research and Opinion
Publisher: Informa UK Limited
Published: 2007-01-17
Volume: 23
Issue: 2
Pages: 379-394
ISSN: 0300-7995 (ISSN-L)
1473-4877
DOI: 10.1185/030079906x167309
OpenAlex: W2077805314
Cited by: 97
References: 41
Citations by year: 2025: 2 · 2023: 1 · 2022: 1 · 2021: 3 · 2020: 2 · 2019: 2 · 2017: 6 · 2016: 5 · 2015: 3 · 2014: 6 · 2013: 8 · 2012: 1
FWCI: 9.45
Type: journal article
Language: en
Open access: closed
Locations: Current Medical Research and Opinion (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 › Clinical Psychology › Child and Adolescent Psychosocial and Emotional Development
Keywords: atomoxetine, attention deficit hyperactivity disorder, children and adolescents, quality of life, functional outcome, social acceptance, ADHD Rating Scale, drug tolerability
MeSH terms: Atomoxetine Hydrochloride, Adolescent, Attention Deficit Disorder with Hyperactivity, Child, Clonidine, Drug Therapy, Combination, Female, Headache, Humans, Male, Methylphenidate, Nausea, Propylamines, Prospective Studies, Severity of Illness Index, Treatment Outcome, Adrenergic Uptake Inhibitors

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A multi-centre, randomised, open-label study of atomoxetine compared with standard current therapy in UK children and adolescents with attention-deficit/hyperactivity disorder (ADHD)

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