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00925njm 22002777a 4500 dc Nagy, Peter author Haege, Alexander author Coghill, David R author Caballero, Beatriz author Adeyi, Ben author Anderson, Colleen S author Sikirica, Vanja author Cardo-Jalon, Esther author 2016-02 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 a parts per thousand yen28 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. Nagy P, Haege A, Coghill DR, Caballero B, Adeyi B, Anderson Colleen S, et al. 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. Eur Child Adolesc Psych. 2016 Feb;25(2):141-9. Epub 2015 May 22. 10.1007/s00787-015-0718-0 1435-165X 1018-8827 European Child & Adolescent Psychiatry http://hdl.handle.net/20.500.13003/10485 25999292 L604499217 2-s2.0-84957843622 http://hdl.handle.net/20.500.12105/20247 369325900003 Atomoxetine Attention-deficit/hyperactivity disorder Functional impairment Lisdexamfetamine dimesylate Weiss Functional Impairment Rating Scale-Parent Report 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