Study identification

PURI

https://redirect.ema.europa.eu/resource/3986

EU PAS number

EUPAS3985

Study ID

3986

Official title and acronym

Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects observational, open label pharmacovigilance study (ADDUCE)

DARWIN EU® study

No

Study countries

Germany
Hungary
Italy
United Kingdom

Study description

This is a 2 year naturalistic pharmacovigilance European multicentre study investigating the long-term safety of methylphenidate in children and young people aged between 6 and 17 years. Clinicians of participating centres in Hungary, Italy, Germany and the United Kingdom will compare 800 patients with attention deficit hyperactivity disorder (ADHD) who are newly prescribed methylphenidate in a 2 year longitudinal naturalistic prospective design with two control groups, 400 children without ADHD matched for age, gender and socio-economic status and 400 patients with ADHD not prescribed ADHD medications. The primary focus will be on adverse effects affecting growth and development, the neurological and cardiovascular systems, and psychiatric symptoms. Participants of all three groups (i.e., medicated ADHD, unmedicated ADHD, non-ADHD ) will all have identical assessments throughout the study. Full assessments will take place at baseline and thereafter at 6, 12 and 24-months to assess effectiveness of treatment and potential adverse events. Comparisons will be made with ADHD subjects not being treated with medication and children without ADHD matched for age, gender and socio-economic status.

Study status

Ongoing
Research institution and networks

Institutions

University of Dundee
United Kingdom
First published:
01/02/2024
Institution
Educational Institution
Division of Neuroscience,Medical Research Institute
University of Dundee Dundee, UK, NHS Fife UK, NHS Lothian UK, Northumberland, Tyne and Wear NHS Trust UK, Tees, Esk and Wear Valley NHS Trust UK, Zentralinstitut fuer Seelische Gesundheit Mannheim, Germany, Klinik und Poliklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie Würzburg, Germany, Klinik für Psychiatrie, Neurologie, Psychosomatik und Psychotherapie im Kindes- und Jungendalter Rostock, Germany, Università degli Studi di Cagliari Cagliari, Italy, 16 more study centres in UK, Germany, Italy, Hungary

Networks

Contact details

David Coghill

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
EU institutional research programme
Other

More details on funding

FP7-HEALTH Grant 260576, Participating Centres
Regulatory

Was the study required by a regulatory body?

Yes