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EPA-0775 – Efficacy of Lisdexamfetamine Dimesylate and Atomoxetine in Child and Adolescent Subgroups from a Head-Tohead, Double-Blind, Randomized Trial in Patients with Attention-Deficit/Hyperactivity Disorder

Published online by Cambridge University Press:  15 April 2020

R.W. Dittmann ,
E. Cardo ,
D.R. Coghill ,
P. Nagy ,
C.S. Anderson ,
B. Adeyi ,
B. Caballero ,
P. Hodgkins  and
R. Civil
R.W. Dittmann
Affiliation:
Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Mannheim, Germany
E. Cardo
Affiliation:
Son Llàtzer Hospital and Research Institute on Health Sciences, University of the Balearic Islands, Palma de Mallorca, Spain
D.R. Coghill
Affiliation:
Division of Neuroscience, University of Dundee, Dundee, United Kingdom
P. Nagy
Affiliation:
Vadaskert Child and Adolescent Psychiatry Hospital and Outpatient Clinic, Vadaskert Child and Adolescent Psychiatry Hospital and Outpatient Clinic, Budapest, Hungary
C.S. Anderson
Affiliation:
Global Clinical Programs, Shire Development LLC, Wayne, United Kingdom
B. Adeyi
Affiliation:
Global Biostatistics, Shire Development LLC, Wayne, United Kingdom
B. Caballero
Affiliation:
Clinical Development and Medical Affairs, Shire AG, Eysins, Switzerland
P. Hodgkins
Affiliation:
Global Health Economics and Outcomes Research, Shire Development LLC, Wayne, United Kingdom
R. Civil
Affiliation:
Clinical Development and Medical Affairs, Shire Development LLC, Wayne, United Kingdom

Abstract

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Introduction:

Symptoms of attention-deficit/hyperactivity disorder (ADHD) appear in childhood and may persist into adolescence and beyond.

Objective:

Evaluate the efficacy of lisdexamfetamine dimesylate (LDX) and atomoxetine in subgroups of children and adolescents with ADHD.

Methods:

In this 9-week, double-blind study, patients aged 6–17 with ADHD and an inadequate response to previous methylphenidate therapy were randomized (1:1) to optimized doses of LDX or atomoxetine. Efficacy measures included ADHD Rating Scale IV (ADHD-RS-IV) total score and dichotomized Clinical Global Impressions-Improvement (CGI-I) score (improved, 1–2; not improved, 3–7).

Results:

The full analysis set (n=262) comprised 194 children aged 6–12 (LDX, n=93; atomoxetine, n=101) and 68 adolescents aged 13–17 (LDX, n=34; atomoxetine, n=34). Mean optimized doses were: LDX, 52.5 (SD, 16.10) mg/day; atomoxetine, 40.2 (20.05) mg/day. Baseline mean ADHD-RS-IV total score was similar across treatment and age groups. Table shows efficacy results; safety profiles were consistent with previous studies.

 LDXAtomoxetine
Mean change in ADHD-RS-IV total score by visit 9 (95% confidence interval)
Overall−26.3 (−28.4, −24.2)−19.4 (−21.6, −17.2)
Children−27.5 (−29.8, −25.1)−19.4 (−22.0, −16.7)
Adolescents−22.9 (−27.3, −18.5)−19.5 (−23.7, −15.3)
Patients (%) with improved CGI-I score by visit 9 (95% confidence interval)
Overall81.7 (75.0, 88.5)63.6 (55.4, 71.8)
Children83.9 (76.4, 91.3)61.2 (51.6, 70.9)
Adolescents75.8 (61.1, 90.4)70.6 (55.3, 85.9)

Conclusion:

Within each treatment group, improvements in symptomatological scales and global improvement ratings were observed in children and adolescents.

Study funded by Shire.

Type
E06 - e-Poster Oral Session 06: Child Psychiatry and Personality Disorders
Information
European Psychiatry , Volume 29 , Issue S1: Abstracts of the 22nd European Congress of Psychiatry , 2014 , pp. 1
Copyright
Copyright © European Psychiatric Association 2014
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