Journal article

Efficacy and safety of lisdexamfetamine dimesylate and atomoxetine in the treatment of attention-deficit/hyperactivity disorder: A head-to-head, randomized, double-blind, phase IIIb study

RW Dittmann, E Cardo, P Nagy, CS Anderson, R Bloomfield, B Caballero, N Higgins, P Hodgkins, A Lyne, R Civil, D Coghill

CNS Drugs | ADIS INT LTD | Published : 2013

Abstract

Objectives: The aim of this study was to compare the efficacy and safety of the prodrug psychostimulant lisdexamfetamine dimesylate (LDX) and the non-stimulant noradrenergic compound atomoxetine (ATX) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who had previously responded inadequately to methylphenidate (MPH). Methods: This 9-week, head-to-head, randomized, double-blind, active-controlled study (SPD489-317; ClinicalTrials.gov NCT01106430) enrolled patients (aged 6-17 years) with at least moderately symptomatic ADHD and an inadequate response to previous MPH therapy. Patients were randomized (1:1) to an optimized daily dose of LDX (30, 50 or 70 mg) or ATX..

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University of Melbourne Researchers

Grants

Funding Acknowledgements

[ "This study was supported by funding from Shire. The authors thank the patients and their parents, and the investigators who took part in the study.", "C. S. Anderson, R. Bloomfield, B. Caballero, R. Civil, N. Higgins, P. Hodgkins and A. Lyne are employees of Shire and own stock/stock options. The following authors have received compensation for serving as consultants or speakers, or they or the institutions they work for have received research support or royalties from the companies or organizations indicated: E. Cardo (Eli Lilly, Health Spanish Ministry Research Fund, Ministry of Education Grant Research, Shire, UCB); D. Coghill (Flynn Pharma, Janssen-Cilag, Lilly, Medice, Novartis, Otsuka, Oxford University Press, Pfizer, Schering-Plough, Shire, UCB, Vifor Pharma); R. W. Dittmann (Ferring, Janssen-Cilag, Lilly, Otsuka, Shire, the German Research Foundation [DFG], the German Ministry of Education and Research [BMBF], the Ministry of Health/the German Regulatory Body [BfArM], the European Union [EU FP7 program], the US National Institute of Mental Health NIMH, and he is a former employee and stockholder of E. Lilly and Co.); P. Nagy (Tourette Syndrome Association of USA, Hungarian Ministry of Education, National Development Agency of Hungary, Otsuka, Shire)." ]