Longterm adverse development effects of methylphenidate treatment for ADHD
Leader: prof. P. Panei / University of Cagliari (UNICA), Italy
EMA’S PROPOSED OBJECTIVES:
1) Study of long-term developmental effects including growth
2) Study of long-term effects on sexual development and fertility
3) Design of appropriate tools to study developmental effects
PRIMARY OBJECTIVES OF ADDUCE WP 5:
1) To determine whether methylphenidate treatment for ADHD is associated with a statistically significant increase in long-term (> 1 year) risk of negative effects on:
A) The rate of growth (i.e. height and weight)
B) The rate of pubertal maturation
2) To explore the application of intensive monitoring of bone age as a tool to study adverse developmental effects of methylphenidate
SECONDARY OBJECTIVES OF ADDUCE WP 5:
1) To explore the role of potential mediators, moderators and confounders (age, sex, socioeconomic status, chronic diseases, family functioning, perinatal conditions and parental height) in the relationship between methylphenidate treatment and adverse outcomes on growth and pubertal maturation
2) To describe the dose-response relationship (dosage, duration of treatment, discontinuation vs. continued use) between methylphenidate exposure and risk of adverse effects on growth and pubertal maturation
3) To estimate through consensus conference the clinical significance of adverse effects on growth and pubertal maturation in terms of their impact on prescribing practice and adherence/concordance
4) To develop a consensus evidence-based clinical guideline to aid the prevention, early identification and management of any adverse effects on growth and pubertal maturation associated with methylphenidate treatment for ADHD
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