A randomized controlled trial investigation of a non-stimulant in attention deficit hyperactivity disorder (ACTION): Rationale and design

T W Tsang; M R Kohn; Daniel F Hermens; S D Clarke; C R Clark; D Efron; N Cranswick; C Lamb; L M Williams

doi:10.1186/1745-6215-12-77

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A randomized controlled trial investigation of a non-stimulant in attention deficit hyperactivity disorder (ACTION): Rationale and design

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A randomized controlled trial investigation of a non-stimulant in attention deficit hyperactivity disorder (ACTION): Rationale and design

T W Tsang, M R Kohn, Daniel F Hermens, S D Clarke, C R Clark, D Efron, N Cranswick, C Lamb and L M Williams

Trials, Vol.12, 77

2011

DOI: https://doi.org/10.1186/1745-6215-12-77

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Abstract

Background: The ACTION study (Attention deficit hyperactivity disorder Controlled Trial Investigation Of a Non-stimulant) is a multi-center, double-blind, randomized cross-over trial of the non-stimulant medication, Atomoxetine, in children and adolescents with attention deficit hyperactivity disorder (ADHD). The primary aims are to examine the efficacy of atomoxetine for improving cognition and emotional function in ADHD and whether any improvements in these outcomes are more pronounced in participants with comorbid anxiety; and to determine if changes in these outcomes after atomoxetine are more reliable than changes in diagnostic symptoms of ADHD. This manuscript will describe the methodology and rationale for the ACTION study.Methods: Children and adolescents aged 6 - 17 y with ADHD will be enrolled. Clinical interview and validated scales will be used to confirm diagnosis and screen for exclusion criteria, which include concurrent stimulant use, and comorbid psychiatric or neurological conditions other than anxiety. Three assessment sessions will be conducted over the 13-week study period: Session 1 (Baseline, pre-treatment), Session 2 (six weeks, atomoxetine or placebo), and Session 3 (13 weeks, cross-over after one-week washout period). The standardized touch-screen battery, "IntegNeuroâ„¢", will be used to assess cognitive and emotional function. The primary measure of response will be symptom ratings, while quality of life will be a secondary outcome. Logistic regression will be used to determine predictors of treatment response, while repeated measures of analysis will determine any differences in effect of atomoxetine and placebo.Results: The methodology for the ACTION study has been detailed.Conclusions: The ACTION study is the first controlled trial to investigate the efficacy of atomoxetine using objective cognitive and emotional function markers, and whether these objective measures predict outcomes with atomoxetine in ADHD with and without comorbid anxiety. First enrollment was in March 2008. The outcomes of this study will be a significant step towards a 'personalized medicine' (and therefore a more efficient) approach to ADHD treatment.Trial registration: Australian and New Zealand Clinical Trials Registry ANZCTRN12607000535471. © 2011 Tsang et al; licensee BioMed Central Ltd.

Details

Title: A randomized controlled trial investigation of a non-stimulant in attention deficit hyperactivity disorder (ACTION): Rationale and design
Authors: T W Tsang (Author) - University of Sydney
M R Kohn (Author) - Sydney Medical School and Westmead Millennium Institute
Daniel F Hermens (Author) - University of Sydney
S D Clarke (Author) - Sydney Medical School and Westmead Millennium Institute
C R Clark (Author) - Flinders University
D Efron (Author) - Royal Children's Hospital
N Cranswick (Author) - Murdoch Children's Research Institute
C Lamb (Author) - Women's and Children's Hospital
L M Williams (Author) - University of Sydney
Publication details: Trials, Vol.12, 77; 11
Publisher: BioMed Central Ltd.
Date published: 2011
DOI: 10.1186/1745-6215-12-77
ISSN: 1745-6215
Copyright note: Copyright © 2011 Tsang et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Organisation Unit: University of the Sunshine Coast, Queensland; Thompson Institute
Language: English
Record Identifier: 99450458502621
Output Type: Journal article

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