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dc.contributor.author | Nagy, Peter | |
dc.contributor.author | Haege, Alexander | |
dc.contributor.author | Coghill, David R | |
dc.contributor.author | Caballero, Beatriz | |
dc.contributor.author | Adeyi, Ben | |
dc.contributor.author | Anderson, Colleen S | |
dc.contributor.author | Sikirica, Vanja | |
dc.contributor.author | Cardo-Jalon, Esther | |
dc.date.accessioned | 2024-07-09T09:13:07Z | |
dc.date.available | 2024-07-09T09:13:07Z | |
dc.date.issued | 2016-02 | |
dc.identifier.citation | 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. | en |
dc.identifier.issn | 1018-8827 | |
dc.identifier.other | http://hdl.handle.net/20.500.13003/10485 | |
dc.identifier.uri | http://hdl.handle.net/20.500.12105/20247 | |
dc.description.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 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. | en |
dc.description.sponsorship | Study SPD489-317 was funded by Shire Development LLC. Shire develops and markets drugs to treat psychiatric disorders, including ADHD. The authors thank the patients and their parents/guardians and the investigators who took part in the study, including the coordinating principal investigator, Professor Ralf W Dittmann (Paediatric Psychopharmacology, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany). E Cardo, DR Coghill, A Hage, and P Nagy were investigators or principal investigators in this clinical study. CS Anderson, B Caballero, and V Sikirica contributed to the study design. B Adeyi was responsible for the statistical analysis. All authors were involved in discussion and interpretation of the data, critically revised the article, and approved the manuscript for submission. Shire International GmbH provided funding to Oxford PharmaGenesis (TM) Ltd for writing and editorial support for this publication. Dr T Gristwood and Dr E Southam of Oxford PharmaGenesis (TM) Ltd provided writing assistance under the direction of the authors. Editorial assistance in editing, fact checking, formatting, proofreading, and submission was also provided by Oxford PharmaGenesis (TM) Ltd. | es_ES |
dc.language.iso | eng | en |
dc.publisher | Springer | en |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | * |
dc.subject | Atomoxetine | |
dc.subject | Attention-deficit/hyperactivity disorder | |
dc.subject | Functional impairment | |
dc.subject | Lisdexamfetamine dimesylate | |
dc.subject | Weiss Functional Impairment Rating Scale-Parent Report | |
dc.subject.mesh | Child | * |
dc.subject.mesh | Central Nervous System Stimulants | * |
dc.subject.mesh | Dose-Response Relationship, Drug | * |
dc.subject.mesh | Humans | * |
dc.subject.mesh | Adolescent | * |
dc.subject.mesh | Attention Deficit Disorder with Hyperactivity | * |
dc.subject.mesh | Attention | * |
dc.subject.mesh | Double-Blind Method | * |
dc.subject.mesh | Methylphenidate | * |
dc.subject.mesh | Male | * |
dc.subject.mesh | Female | * |
dc.subject.mesh | Atomoxetine Hydrochloride | * |
dc.subject.mesh | Lisdexamfetamine Dimesylate | * |
dc.subject.mesh | Treatment Outcome | * |
dc.title | 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 | en |
dc.type | research article | en |
dc.rights.license | Attribution 4.0 International | * |
dc.identifier.pubmedID | 25999292 | es_ES |
dc.format.volume | 25 | es_ES |
dc.format.number | 2 | es_ES |
dc.format.page | 141-149 | es_ES |
dc.identifier.doi | 10.1007/s00787-015-0718-0 | |
dc.identifier.e-issn | 1435-165X | es_ES |
dc.relation.publisherversion | https://dx.doi.org/10.1007/s00787-015-0718-0 | en |
dc.identifier.journal | European Child & Adolescent Psychiatry | es_ES |
dc.rights.accessRights | open access | en |
dc.subject.decs | Resultado del Tratamiento | * |
dc.subject.decs | Femenino | * |
dc.subject.decs | Clorhidrato de Atomoxetina | * |
dc.subject.decs | Dimesilato de Lisdexanfetamina | * |
dc.subject.decs | Metilfenidato | * |
dc.subject.decs | Adolescente | * |
dc.subject.decs | Masculino | * |
dc.subject.decs | Método Doble Ciego | * |
dc.subject.decs | Trastorno por Déficit de Atención con Hiperactividad | * |
dc.subject.decs | Atención | * |
dc.subject.decs | Relación Dosis-Respuesta a Droga | * |
dc.subject.decs | Humanos | * |
dc.subject.decs | Estimulantes del Sistema Nervioso Central | * |
dc.subject.decs | Niño | * |
dc.identifier.scopus | 2-s2.0-84957843622 | |
dc.identifier.wos | 369325900003 | |
dc.identifier.pui | L604499217 |
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