Prospective observational study protocol to investigate long-term adverse effects of methylphenidate in children and adolescents with ADHD: the Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects (ADDUCE) study

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dc.contributor.authorInglis, S. K.
dc.contributor.authorCarucci, Sara
dc.contributor.authorHäge, A.
dc.contributor.authorBanaschewski, Tobias
dc.contributor.authorBuitelaar, Jan K.
dc.contributor.authorDittmann, Ralf W.
dc.contributor.authorFalissard, B.
dc.contributor.authorHollis, C.
dc.contributor.authorKovshoff, Hanna
dc.contributor.authorLiddle, E.
dc.contributor.authorMcCarthy, Suzanne
dc.contributor.authorNagy, Peter
dc.contributor.authorNeubert, A.
dc.contributor.authorRosenthal, E.
dc.contributor.authorSonuga-Barke, E.
dc.contributor.authorWong, I.
dc.contributor.authorZuddas, A.
dc.contributor.authorCoghill, D.
dc.contributor.authorGaras, P.
dc.contributor.funderEuropean Commissionen
dc.contributor.funderSeventh Framework Programmeen
dc.date.accessioned2017-02-27T15:55:52Z
dc.date.available2017-02-27T15:55:52Z
dc.date.issued2016-03
dc.date.updated2017-02-27T15:41:20Z
dc.description.abstractIntroduction: Methylphenidate is the most frequently used medication for the treatment of attention-deficit/hyperactivity disorder (ADHD) in Europe. Following concerns about its safety, the European Commission called for research into the long-term effects of methylphenidate on children and adolescents with ADHD. The Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects (ADDUCE) research programme was designed to address this call. At the heart of this programme is a 2-year longitudinal naturalistic pharmacovigilance study being conducted in 27 European sites. Methods and analysis: 3 cohorts of children and adolescents (aged 6–17) living in the UK, Germany, Italy and Hungary are being recruited: Group 1 (Medicated ADHD): 800 ADHD medication-naive children and adolescents with a clinical diagnosis of ADHD about to start methylphenidate treatment for the first time. Group 2 (Unmedicated ADHD): 400 children and adolescents with a clinical diagnosis of ADHD who have never been treated with ADHD medication and have no intention of beginning medication. Group 3 (Non-ADHD): 400 children and adolescents without ADHD who are siblings of individuals in either group 1 or 2. All participants will be assessed 5 times during their 2-year follow-up period for growth and development, psychiatric, neurological and cardiovascular health. The primary outcome measure will be the height velocity SD score. Ethics and dissemination Ethical approval for the study has been granted by the East of Scotland Research Ethics Service. Following this approval, patient information leaflets and consent forms were translated as necessary and submissions made by lead sites in each of the other 3 countries to their own ethics committees. Following ethical approval in each country, local ethical permissions at each site were sought and obtained as needed. The study's website (http://www.adhd-adduce.org/page/view/2/Home) provides information for researchers, participants and the general public. Trial registration number NCT01470261.en
dc.description.sponsorshipEuropean Commission (European Union's Seventh Framework Programme for research, technological development and demonstration under grant agreement no 324487)en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationInglis, S. K., Carucci, S., Garas, P., Häge, A., Banaschewski, T., Buitelaar, J. K., Dittmann, R. W., Falissard, B., Hollis, C., Kovshoff, H., Liddle, E., McCarthy, S., Nagy, P., Neubert, A., Rosenthal, E., Sonuga-Barke, E., Wong, I., Zuddas, A. and Coghill, D. C. (2016) 'Prospective observational study protocol to investigate long-term adverse effects of methylphenidate in children and adolescents with ADHD: the Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects (ADDUCE) study', BMJ Open, 6(4). doi:10.1136/bmjopen-2015-010433en
dc.identifier.doi10.1136/bmjopen-2015-010433
dc.identifier.endpagee010433-12en
dc.identifier.issn2044-6055
dc.identifier.journaltitleBMJ Openen
dc.identifier.startpagee010433-1en
dc.identifier.urihttps://hdl.handle.net/10468/3700
dc.identifier.volume6en
dc.language.isoenen
dc.publisherBMJ Publishing Groupen
dc.rights© 2016, The Authors. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/en
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/en
dc.subjectMethylphenidateen
dc.subjectAttention deficit disorderen
dc.subjectCardiovascular systemen
dc.subjectChild developmenten
dc.subjectChild growthen
dc.subjectControlled clinical trialen
dc.subjectDrug efficacyen
dc.subjectDrug safetyen
dc.subjectDrug surveillance programen
dc.subjectDrug tolerabilityen
dc.subjectPsychopharmacotherapyen
dc.titleProspective observational study protocol to investigate long-term adverse effects of methylphenidate in children and adolescents with ADHD: the Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects (ADDUCE) studyen
dc.typeArticle (peer-reviewed)en
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