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.
BACKGROUND
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
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.


BACKGROUND
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.


BACKGROUND
NCT01470261.
Division of Neuroscience, School of Medicine, University of Dundee & Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.
S K
SK
Inglis
Child and Adolescent Neuropsychiatry Unit, Department of Biomedical Science, University of Cagliari, Cagliari, Italy.
S
S
Carucci
Vadaskert Child and Adolescent Psychiatric Hospital, Budapest, Hungary.
P
P
Garas
Department of Child & Adolescent Psychiatry and Psychotherapy, Medical Faculty Mannheim, Central Institute of Mental Health, University of Heidelberg, Mannheim, Germany.
A
A
Häge
Department of Child & Adolescent Psychiatry and Psychotherapy, Medical Faculty Mannheim, Central Institute of Mental Health, University of Heidelberg, Mannheim, Germany.
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T
Banaschewski
Cognition and Behavior, Department of Cognitive Neuroscience, Radboud University Medical Centre, Donders Institute for Brain, Karakter Child and Adolescent Psychiatry University Centre, Nijmegen, The Netherlands.
J K
JK
Buitelaar
Department of Child & Adolescent Psychiatry and Psychotherapy, Medical Faculty Mannheim, Central Institute of Mental Health, University of Heidelberg, Mannheim, Germany.
R W
RW
Dittmann
Univercity Paris-Sud, Univ. Paris-Descartes, AP-HP, INSERM U1178, Paris, France.
B
B
Falissard
Faculty of Medicine & Health Sciences, Institute of Mental Health, University of Nottingham, Nottingham, UK.
C
C
Hollis
Academic Unit of Psychology, University of Southampton, Southampton, UK.
H
H
Kovshoff
Faculty of Medicine & Health Sciences, Institute of Mental Health, University of Nottingham, Nottingham, UK.
E
E
Liddle
School of Pharmacy, University College Cork, Cork, Ireland.
S
S
McCarthy
Vadaskert Child and Adolescent Psychiatric Hospital, Budapest, Hungary.
P
P
Nagy
Department of Paediatrics and Adolescents Medicine, University Hospital Erlangen, Erlangen, Germany.
A
A
Neubert
Evelina Children's Hospital, St Thomas' Hospital, London, UK.
E
E
Rosenthal
UK and Department of Experimental Clinical & Health Psychology, University of Southampton, Ghent University, Belgium.
E
E
Sonuga-Barke
UCL School of Pharmacy, 29-39 Brunswick Square, London, UK.
I
I
Wong
Child and Adolescent Neuropsychiatry Unit, Department of Biomedical Science, University of Cagliari, Cagliari, Italy.
A
A
Zuddas
Division of Neuroscience, School of Medicine, University of Dundee, Dundee, UK.
D C
DC
Coghill
D000293:Adolescent; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000009:adverse effects*; D002648:Child; D005260:Female; D005858:Germany; D006801:Humans; D006814:Hungary; D007558:Italy; D016015:Logistic Models; D008137:Longitudinal Studies; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage* / Q000009:adverse effects*; D060735:Pharmacovigilance; D011446:Prospective Studies; D016896:Treatment Outcome; D006113:United Kingdom
D000697:Central Nervous System Stimulants; D008774:Methylphenidate
Attention Deficit Hyperactivity Disorder; Methylphenidate