An observational study to test whether ECT induces epigenetic alterations of certain genes in blood lymphocytes and whether these alterations are associated with the cognitive side-effects of ECT treatment and the response to the treatment.
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
cognitieve en aandachtsstoornissen en -afwijkingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. association between the epigenetic changes like DNA-methylation and histone
modifications of certain genes in blood lymphocytes and the cognitive side
effects of ECT treatment
2. association between the epigenetic changes like DNA-methylation and histone
modifications of certain genes in blood lymphocytes and the response to ECT.
The endpoint of the study will be 6 weeks after cessation of the ECT treatment.
Secondary outcome
not applicable
Background summary
Recent research has suggested that epigenetic factors play a major role in the
aetiology and course of many, if not all, psychiatric diseases. However,
research evidence on this topic has been sparse since the methodology to
investigate epigenetic alterations has only recently been developed. We
hypothesize that environmental changes induce epigenetic alterations,
measurable in blood lymphocytes, and that these alterations are associated with
the aetiopathology of psychiatric symptoms. In this proof-of-principle study,
we specifically hypothesize that electroconvulsive therapy (ECT) in patients
with a severe depression results in epigenetic alterations such as changes of
DNA methylation or histone modifications in certain genes (involved in the
aetiopathogenesis of depressive disorder) and that these changes are associated
with response to the treatment.
Study objective
An observational study to test whether ECT induces epigenetic alterations of
certain genes in blood lymphocytes and whether these alterations are associated
with the cognitive side-effects of ECT treatment and the response to the
treatment.
Study design
observational study
Study burden and risks
Nature of burden of participation for the participants is to allow for
additional (to standard medical care) venous blood sampling ans saliva sampling
for DNA collection, periodic interviews and questionnaires of psychiatric
symptoms and consent to subsequent genetic analyses. When possible the
additional blood sampling will be minimized, using the peripheral IV line
patients will receive for the administration of anaesthetics, to collect blood.
When blood sampling is not possible trough the peripheral IV line, the vena
puncture necessary for blood sampling is considered a burden for the
participant. The short interviews and questionnaires on psychiatric symptoms
and cognitive functioning are not expected to pose any burden or risk for the
participating subjects; as these are, with some additions, considered part of
the standard medical care
Vijverdalseweg 1
6226 NB Maastricht
Nederland
Vijverdalseweg 1
6226 NB Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
depressive disorder and eligible for ECT treatment
Exclusion criteria
• age < 18 years and age >65 jaar
• major medical conditions that may interfere with the study procedures: cancer, cerebrovascular disorders, organic psychiatric syndromes, active drug abuse, mental retardation, dementia and other neurodegenerative disorders. Psychopathology will be assesses by a psychiatric interview.
• Illiteracy
• any condition which in the opinion of the (co-) investigator might interfere with the evaluation of the study objectives
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL26735.068.09 |