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).

Full 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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Author information

Author/s: Prasad, Suyash (S); Harpin, Val (V); Poole, Lynne (L); Zeitlin, Harry (H); Jamdar, Saroj (S); Puvanendran, Kanagasabai (K); The SUNBEAM Study Group;

Affiliation: Dept Neurosciences, Eli Lilly and Co Ltd., Basingstoke, UK. suyash(-atsign-)suyashprasad.com

Journal and publication information

Publication Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: Current medical research and opinion (Curr Med Res Opin), published in England. (Language: eng)

Reference: 2007-Feb; vol 23 (issue 2) : pp 379-94

Dates: Created 2007/02/09; Completed 2007/03/15;

PMID: 17288692, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Adolescent
Adrenergic Uptake Inhibitors - administration & dosage; adverse effects; therapeutic use
Attention Deficit Disorder with Hyperactivity - drug therapy
Child
Clonidine - administration & dosage; therapeutic use
Drug Therapy, Combination
Female
Headache - chemically induced

Humans
Male
Methylphenidate - administration & dosage; therapeutic use
Nausea - chemically induced
Propylamines - administration & dosage; adverse effects; therapeutic use
Prospective Studies
Severity of Illness Index
Treatment Outcome

Associated Chemicals: Adrenergic Uptake Inhibitors (0) ; Propylamines (0) ; Methylphenidate (113-45-1) ; Clonidine (4205-90-7) ; atomoxetine (83015-26-3)

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