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A 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

A 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
A 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
Introduction: 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.
1-26
Inglis, S.K.
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Carucci, S.
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Garas, P.
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Hage, A.
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Banachewski, T.
467e3ebc-b911-4eec-97cf-0522ee345d50
Buitelaar, J.
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Dittmann, R.W.
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Falissard, B.
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Hollis, C.
dc8c2836-32b3-4f5a-a53a-aeeef1ae0334
Kovshoff, H.
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Liddle, E.
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McCArthy, S.
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Nagy, P.
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Neubert, A.
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Rosenthal, E.
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Sonuga-Barke, E.
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Wong, I.
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Zuddas, A.
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Coghill, D.C.
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and the, ADDUCE Consortium
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Inglis, S.K.
4acc15cd-6a96-4ac4-85f9-2ad5cd441652
Carucci, S.
2742f5af-0769-49bb-a830-8c49a05c4f5d
Garas, P.
c451112e-bea7-44d2-ab63-6c260733fe1f
Hage, A.
92726028-1db7-4e4c-8449-563c047be88c
Banachewski, T.
467e3ebc-b911-4eec-97cf-0522ee345d50
Buitelaar, J.
fa22aba5-1307-4627-9ae8-e564013a5af8
Dittmann, R.W.
32055009-a293-468b-94d2-66ad6d0e914b
Falissard, B.
28ecff35-44af-4e32-846e-544c478b565f
Hollis, C.
dc8c2836-32b3-4f5a-a53a-aeeef1ae0334
Kovshoff, H.
82c321ee-d151-40c5-8dde-281af59f2142
Liddle, E.
ba481ec0-8809-4d7b-aec3-4849da5088b0
McCArthy, S.
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Nagy, P.
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Neubert, A.
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Rosenthal, E.
e24b88c9-f64d-492e-bcc7-40c0354e0ada
Sonuga-Barke, E.
bc80bf95-6cf9-4c76-a09d-eaaf0b717635
Wong, I.
655a30a1-ca15-43ed-bd74-90f086c42679
Zuddas, A.
487c598f-2f61-4f20-bef7-dcdbbdfb4633
Coghill, D.C.
cab2628d-082d-425c-81b5-11c37d07db52
and the, ADDUCE Consortium
d95c8369-6a4c-4590-b445-ab27005a227e

Inglis, S.K., Carucci, S., Garas, P., Hage, A., Banachewski, T., Buitelaar, J., 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., Coghill, D.C. and and the, ADDUCE Consortium (2016) A 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 (e010433), 1-26. (doi:10.1136/bmjopen-2015-010433). (PMID:27118284)

Record type: Article

Abstract

Introduction: 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.

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More information

Accepted/In Press date: 18 March 2016
e-pub ahead of print date: 26 April 2016
Published date: April 2016
Organisations: Clinical Neuroscience

Identifiers

Local EPrints ID: 391295
URI: http://eprints.soton.ac.uk/id/eprint/391295
PURE UUID: 36894b6a-c4bf-4ecb-bc24-68e826cd7282
ORCID for H. Kovshoff: ORCID iD orcid.org/0000-0001-6041-0376

Catalogue record

Date deposited: 04 May 2016 08:09
Last modified: 15 Mar 2024 03:14

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Contributors

Author: S.K. Inglis
Author: S. Carucci
Author: P. Garas
Author: A. Hage
Author: T. Banachewski
Author: J. Buitelaar
Author: R.W. Dittmann
Author: B. Falissard
Author: C. Hollis
Author: H. Kovshoff ORCID iD
Author: E. Liddle
Author: S. McCArthy
Author: P. Nagy
Author: A. Neubert
Author: E. Rosenthal
Author: E. Sonuga-Barke
Author: I. Wong
Author: A. Zuddas
Author: D.C. Coghill
Author: ADDUCE Consortium and the

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