Functional outcomes from a head-to-head, randomized, double-blind trial of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder and an inadequate response to methylphenidate

Peter Nagy, Alexander Häge, David R. Coghill, Beatriz Caballero, Ben Adeyi, Colleen S. Anderson, Vanja Sikirica, Esther Cardo

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    Abstract

    Attention-deficit/hyperactivity disorder (ADHD) is associated with functional impairments in multiple domains of patients’ lives. A secondary objective of this randomized, active-controlled, head-to-head, double-blind, dose-optimized clinical trial was to compare the effects of lisdexamfetamine dimesylate (LDX) and atomoxetine (ATX) on functional impairment in children and adolescents with ADHD. Patients aged 6–17 years with an ADHD Rating Scale IV total score ≥28 and an inadequate response to methylphenidate treatment (judged by investigators) were randomized (1:1) to once-daily LDX or ATX for 9 weeks. Parents/guardians completed the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) at baseline and at week 9 or early termination. p values were nominal and not corrected for multiple comparisons. Of 267 randomized patients, 200 completed the study (LDX 99, ATX 101). At baseline, mean WFIRS-P total score in the LDX group was 0.95 [standard deviation (SD) 0.474; 95 % confidence interval (CI) 0.87, 1.03] and in the ATX group was 0.91 (0.513; 0.82, 1.00). Scores in all WFIRS-P domains improved from baseline to endpoint in both groups, with least-squares mean changes in total score of −0.35 (95 % CI −0.42, −0.29) for LDX and −0.27 (−0.33, −0.20) for ATX. The difference between LDX and ATX was statistically significant (p < 0.05) for the Learning and School (effect size of LDX vs ATX, 0.43) and Social Activities (0.34) domains and for total score (0.27). Both treatments reduced functional impairment in children and adolescents with ADHD; LDX was statistically significantly more effective than ATX in two of six domains and in total score.

    Original languageEnglish
    Pages (from-to)141-149
    Number of pages9
    JournalEuropean Child & Adolescent Psychiatry
    Volume25
    Issue number2
    Early online date22 May 2015
    DOIs
    Publication statusPublished - Feb 2016

    Keywords

    • Atomoxetine
    • Attention-deficit/hyperactivity disorder
    • Functional impairment
    • Lisdexamfetamine dimesylate
    • Weiss Functional Impairment Rating Scale-Parent Report

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