Type

Journal Article

Authors

D C Coghill
A Zuddas
I Wong
E Sonuga-Barke
E Rosenthal
A Neubert
P Nagy
S McCarthy
E Liddle
H Kovshoff
and 9 others

Subjects

Psychiatry

Topics
longitudinal study child development cardiovascular system methylphenidate ethical approval drug efficacy follow up adverse effects european commission children and adolescents controlled clinical trial child growth drug safety attention deficit disorder growth and development drug tolerability drug surveillance program attention deficit hyperactivity disorder adhd psychopharmacotherapy

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. (2016)

Abstract 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. 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. 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. NCT01470261.
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Full list of authors on original publication

D C Coghill, A Zuddas, I Wong, E Sonuga-Barke, E Rosenthal, A Neubert, P Nagy, S McCarthy, E Liddle, H Kovshoff and 9 others

Experts in our system

1
David Coghill
University College Cork
Total Publications: 5
 
2
Alessandro Zuddas
University College Cork
Total Publications: 4
 
3
Ian C K Wong
University College Cork
Total Publications: 10
 
4
Edmund Sonuga-Barke
University College Cork
Total Publications: 7
 
5
Peter Nagy
University College Cork
Total Publications: 4
 
6
Suzanne McCarthy
University College Cork
Total Publications: 34
 
7
E Liddle
University College Cork
Total Publications: 4
 
8
Hanna Kovshoff
University College Cork
Total Publications: 4