A proof-of-principle study to test whether an environmental factor, i.e. here IFNα treatment, induces epigenetic alterations of certain genes in blood lymphocytes and whether these alterations correlate with the severity of psychiatric symptoms, i.e…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter: association between the changes in DNA methylation of
certain genes in blood lymphocytes and the severity of depressive symptoms
during IFNα treatment. Endpoint 8 weeks after cessation of IFNα treatment
Secondary outcome
no
Background summary
Recent research has suggested that epigenetic factors play major roles 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 is only recently developed. We hypothesize
that certain environmental factors result in epigenetic alterations, measurable
in blood lymphocytes, and that these alterations are associated with the onset
and severity of psychiatric symptoms. In this proof-of-principle study we
specifically hypothesize that IFNα treatment (a routine medical treatment for
hepatitis patients) results in epigenetic alterations (such as changes of DNA
methylation of certain genes) and that these changes correlate with the
severity of depressive symptoms.
Study objective
A proof-of-principle study to test whether an environmental factor, i.e. here
IFNα treatment, induces epigenetic alterations of certain genes in blood
lymphocytes and whether these alterations correlate with the severity of
psychiatric symptoms, i.e. here depressive symptoms
Study design
Observational study
Study burden and risks
Burden:
periodical self rating scales on depressive symptoms
periodic bloodsampling of additional 20ml of blood, which occurs when routine
clinical care implies blood sampling (i.e. every 4 weeks), and saliva samples
Risks:
Screening/interviewing for depressive symptoms may worsen depressive symptoms.
Subjects which develop a depressive disorder are offered psychiatric treatment.
DOT 10
6200 MD Maastricht
NL
DOT 10
6200 MD Maastricht
NL
Listed location countries
Age
Inclusion criteria
chronis hepatitis infection
eligible for IFNα treatment
Exclusion criteria
- age < 18 years
- major medical or psychiatric conditions that may interfere with the study procedures: cancer, cerebrovascular disorders, organic psychiatric syndromes, active drug abuse, major mental disorders as schizophrenia, bipolar disorder, mental retardation, dementia and other neurodegenerative disorders
- illiteracy
- any condition which in the opinion of the 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 | NL21334.068.08 |