Establishment of a prospective cohort for long-term surveillance
Leader: dr. D. Coghill / University of Dundee (UNIVDUN), UK
The ADDUCE team acknowledges the limitations of the existing literature and that the analysis of the retrospective datasets will still leave many of the long-term drug safety issues raised by the EMA associated with methylphenidate unanswered. A large prospective cohort study will therefore be carried out to generate high quality data which will enable us to address several of these questions. The proposed cohort study will enrol a total of 1600 subjects of whom 800 are receiving methylphenidate treatment for ADHD and 800 controls. At the same time as collecting data for psychiatric, growth, neurological and cardiovascular outcome measures, the analysis and interpretation of the above outcomes will be conducted in conjunction with the relevant clinical WPs (WP 5-8) and WP4.
PRIMARY OBJECTIVE: To establish three prospective cohorts of children and adolescents:
1) Treatment cohort: Children and adolescents with ADHD who are “new starters” prescribed methylphenidate i.e. are stimulant naive at entry to the study and about to be started on methylphenidate for the first time
2) Control cohorts:
A) Unmedicated ADHD controls: Children and adolescents with ADHD but not treated with medication
B) Non-ADHD siblings controls: Non-ADHD siblings of the medicated ADHD children and adolescents
1) To conduct a 24-month prospective open-label naturalistic observational cohort pharmacovigilance study to provide data required to answer the specific questions raised by WPs 5-8 regarding long-term adverse effects of methylphenidate use including:
A) Growth and Development (WP5)
* Growth velocity
* Pubertal maturation
* Bone age (in a sub group only)
B) Neurological problems (WP6)
* Sleep problems
C) Psychiatric outcomes (WP7)
* Mood disorder
* Mood lability
* Suicidal behaviour
* Psychotic symptoms
* Substance misuse
* Tics and Tourettes
D) Cardiovascular status (WP8)
* Blood pressure
* Pulse rate
2) To maintain an ongoing cohort of children and adolescents on long-term treatment with methylphenidate that will be available for longer term (> 2 years) pharmacovigilance studies (subject to the availability of a successful further funding application)
The fifth ADDUCE Newsletter is now available!
Here, you can read about the finalisation of the project,
the European Medicines Agency and General Assembly meetings
and the dissemination of the results!
The fourth ADDUCE Newsletter is available!
In this newsletter, you can find some information on the final recruitment status of the 2 main studies:
- the prospective open-label methylphenidate pharmacovigilance study
- the long-term cardiascular effects of methylphenidate use
Also, you can read about the future plans of the project!
More than 1500 children, adolescents and adults across all Europe already took part in our study! Thanks to them, we have already gathered lots of information so we can know a lot more about methylphenidate than ever before!
Did you participate in the ADDUCE studies and are you curious about the latest news on the project?
Here you can find some information!
News for children, April 2015
News for adolescents, April 2015
News for parents, April 2015
The third ADDUCE Newsletter is available!
- the prospective open-label methylphenidate pharmacovigilance study: recruitment status and spin-
- the long-term cardiovascular effects of methylphenidate use: study design and participation
and much more in the ADDUCE Newsletter 3, March 2015
WP3: prospective open-label methylphenidate
- WP8: long-term cardiovascular effects of methylphenidate use
and much more in the ADDUCE Newsletter 2, February 2013
16 - 19 OCTOBER 2016:
4rd EUNETHYDIS International Conference on ADHD, Berlin - Germany
from basis neuroscience to optimised clinical care
17 & 18 APRIL 2016:
ADDUCE Consortium meeting, London - UK
28 - 31 MAY 2015:
5th World Congress on ADHD: from Child to Adult Disorder, Glasgow - Scotland
20 & 21 APRIL 2015:
ADDUCE Consortium meeting, Salina - Italy
21 - 24 MAY 2014:
3rd EUNETHYDIS International Conference on ADHD, Istanbul - Turkey
ADHD and related disorders
19 & 20 MAY 2014:
ADDUCE Consortium meeting, Istanbul - Turkey
3 - 6 OCTOBER 2013:
23rd EUNETHYDIS Network Meeting, Prague Czech Republic
A meeting of the European Network of Hyperkinetic Disorders
6 - 9 JUNE 2013:
4th World Congress on ADHD: from Childhood to Adult Disease, Milan - Italy
4 & 5 JUNE 2013:
ADDUCE Consortium meeting, Milan - Italy
6 & 7 JUNE 2012:
ADDUCE Consortium meeting, Cagliari - Italy
23 MAY 2012:
2nd EUNETHYDIS International Conference on ADHD, Barcelona - Spain