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Post MI Depression in the Picture; a fMRI study comparing depression following myocardial infarction and depression in a regular outpatient populatio

Completed
Conditions
depression
depression after heart attack
10028593
10027946
Registration Number
NL-OMON35007
Lead Sponsor
niversitair Medisch Centrum Groningen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
100
Inclusion Criteria

Inclusion criteria for all groups are:
- Age > 18 yr
- signing informed consent form
Incident post-MI depression:
-Meeting established criteria for recent (within 3 months before screening) MI: always documentation of increase of cardiac enzymes and either electro-cardial changes and/or chest pain.
Non-depressed MI patients:
-Meeting criteria for recent (3 months before screening) MI, as described above.
-No history of a previous or current depression
Regular depression:
- Meeting established criteria for an episode of major depressive disorder according to the DSM IV and severity as described above.
Healthy controls:
- Not fulfilling any of the above criteria.

Exclusion Criteria

General exclusion criteria:
- I) Neurological problems (including epilepsy, and serious visual problems)
- II) Use of drugs that may influence the task performance:
We aim at including patients without any psychotrophic medication. If we find out during the study that there are not enough medication free patients to include in the study, we will only include patients using SSRI*s and match on SSRI use with participants in the post MI depression group.
- III) Not being able to communicate in Dutch
- IV) In case participants report suïcidal ideation in the MINI-SCAN interview the participants psychiatrist or general practitioner (controls) will be informed and participant will be excluded from participating in the study.
- V) Due to the use of MRI scanning, the following additional criteria will apply:
The participants will have to fill out a detailed questionnaire covering safety aspects of the research in relation to the 3 Tesla magnetic field and the MRI environment.
These criteria are:
- MR incompatible implants in the body (such as ear prothesis or other metal implants)
- Any risk of having metal particles in the eyes due to manual work without proper eye protections
- Tattoos containing red pigments
- (Suspected) Pregnancy
- Claustrophobia
- The refusal to be informed of structural brain abnormalities that could be detected during the experiment ;Specific exclusion criteria per experimental group:;Incident post-MI depression
- Presence of any Life-time and current psychiatric disorder, excluding nicotine dependence, Generalized Anxiety Disorder (GAD) and MDD with post MI onset as established by:
I)Screening questions and eligible sections from MINI-scan interview
II)Questions on the use of psychotropic medication (antidepressive / anti-psychotic or sedative medication)
III)And, if possible, confirmation of this with information from the UMCG medical record;Non-depressed MI patients:
-Presence of any Life-time and current psychiatric disorder, excluding nicotine dependence, as established by the screening questions and eligible sections from the MINI-SCAN interview and a BDI score < 9.;Regular depression:
-Presence of any life time and current psychiatric disorder as diagnosed with the MINI scan, except MDD, nicotine dependence, Generalized Anxiety Disorder (GAD) as established by:
I)Screening questions and eligible sections from the MINI-SCAN interview
II)Questions on the use of psychotropic medication (antidepressive / anti-psychotic or sedative medication)
III)And, if possible, confirmation of this with information from the UMCG medical record
-Any cardiovascular disease, (MI, heart failure, CVA, serious stenosis of a major vessel) as indicated in a self report inventory.;Healthy controls:
-Presence of any Life-time and current psychiatric disorder excluding nicotine dependence, as established by the screening questions and eligible sections from the MINI-SCAN interview and a BDI score < 9.
-Any cardiovascular disease, (MI, heart failure, CVA, serious stenosis of a major vessel).

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Main study parameters are signal change in fMRI BOLD response to reward,<br /><br>self-evaluation and emotion regulation processes as well as behavioural<br /><br>differences between groups in terms of percentages correct and reaction times<br /><br>regarding the experimental tasks.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>n.a.</p><br>
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