The ADDUCE Project

Aims of the ADDUCE Project

The KEY OBJECTIVES of the ADDUCE project are:
 
1.  To perform a series of pharmacovigilance studies that will lead to innovative knowledge with respect to the long-term adverse effects of methylphenidate that constitutes major public health concerns as specified by the EMA.
 
2.  To address scientific questions about prevalence, clinical significance, development and moderating and/or mediating factors of four specific classes of long-term adverse effects of methylphenidate: growth, neurological, psychiatric and cardiovascular.
 
3.  To develop new research tools and to identify new safety issues for future pharmacovigilance research for the treatment of ADHD.
 
4.  To promote public health by disseminating the innovative knowledge acquired by the proposed studies to regulatory authorities, scientific community, medical and mental health professionals, to patients and their families, policy makers and to society in general, in order to promote the safer use of methylphenidate.
 
 
 
KEY OBJECTIVE 1 includes the following specific aims:
 
Aim 1. To identify and acquire appropriate and high quality retrospective data to investigate the longterm safety of methylphenidate for the treatment of ADHD.
 
Aim 2. To conduct a 24-month prospective open-label observational cohort pharmacovigilance study with 2 control groups (untreated ADHD patients and healthy siblings), to investigate the long-term safety of methylphenidate for the treatment of ADHD.
 
Aim 3. To ensure that when performing these pharmacovigilance studies due consideration is paid to medical ethical issues.
 
 
 
KEY OBJECTIVE 2 includes the following specific aims:
 
Aim 4. To determine whether methylphenidate treatment for ADHD is associated with a statistically significant increase in long-term (> 1 year) risk of negative effects on: the rate of growth (i.e. height and weight) and of pubertal maturation.
 
Aim 5. To determine whether methylphenidate treatment for ADHD is associated with a statistically significant increase in long-term (> 1 year) risk for the following neurological outcomes: Seizures, Sleepproblems and Dyskinesia. 
 
Aim 6. To determine whether methylphenidate treatment for ADHD is associated with a statistically significant increase in long-term (> 1 year) risk for the following psychiatric outcomes: Mood disorder, Suicidal behaviour, Psychotic symptoms, Substance misuse, Tics/ Tourette’s disorder.
 
Aim 7. To determine whether the long-term use (>3 years) of methylphenidate increases the bloodpressure and causes left ventricular hypertrophy (LVH) identified by echocardiography in late adolescent (>15 years) and young adults with ADHD.
 
Aim 8. To determine whether the increases in blood pressure and pulse rate seen in children with ADHD identified with short term exposure to methylphenidate persist in the longterm (> 1 year).
 
Aim 9. To explore the moderating and/or mediating factors of the long-term safety of methylphenidate in children, adolescents and adults with ADHD. Moderators identify in whom and under which circumstances treatment has different effects. Mediators identify why and how adverse effects occur.
 
Aim 10. To determine whether methylphenidate treatment for ADHD is associated with a statistically significant increase in long-term (> 1 year) risk for other adverse effects as assessed by a semistructured interview addressing all major body systems.
 
 
 
KEY OBJECTIVE 3 includes the following specific aims:
 
Aim 11. To explore the application of intensive monitoring of bone age as a tool to study adverse developmental effects of Methylphenidate.
 
Aim 12. To develop validated reliable tools for the evaluation of negative cognitive effects including: reduced cognitive flexibility, reduced motivation and increased or decreased sensitivity to reward.
 
Aim 13. To identify and propose new research areas to enhance the safety of long-term use of methylphenidate in patients with ADHD.
 
 
 
KEY OBJECTIVES 4 includes the following specific aims.
 
Aim 14. To directly interact with the EMA to ensure the protocols and results are able to aid the EMA in making regulatory decisions regarding the marketing authorization of methylphenidate including the product information warnings for doctors and patients.
 
Aim 15. Publish the results of these studies as peer-reviewed papers in international journals and in leading national medical and mental health journals.
 
Aim 16. Present the data in national and international meetings in the form of symposia, workshops and clinical training sessions. We will pay particular attention to knowledge transfer to new EU states and associated and candidate states.
 
Aim 17. To translate the results of the proposed studies into evidence for developing new and updating existing clinical guidelines and practice parameters for the treatment of ADHD.

News

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!
 

Read more about the ADDUCE studies:

- the prospective open-label methylphenidate pharmacovigilance study: recruitment status and spin-
off studies
- the long-term cardiovascular effects of methylphenidate use: study design and participation
 

and much more in the ADDUCE Newsletter 3, March 2015

 

The second ADDUCE Newsletter is available!
Read more about the 2 main ADDUCE studies:

  • WP3: prospective open-label methylphenidate
    pharmacovigilance study
  • WP8: long-term cardiovascular effects of methylphenidate use

and much more in the ADDUCE Newsletter 2, February 2013

Events

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