The objective of the study is to answer the following research questions:1) What differences do exist in functional connectivity between patients with unipolar depression and healthy controls? 2) Can changes in functional connectivity be used as…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in structural T1, DTI, functional resting-state and functional
task-related connectivity and effective connectivity between:
1)depressed patients and healthy controls
2)depressed patients and healthy participants with a genetic vulnerability to
depression
3)healthy controls and healthy participants with a genetic vulnerability to
depression
4)depressed patients before and after 9 months of treatment
Correlations between:
1)severity of depression and functional/anatomical connectivity
2)cognitive performance and functional/anatomical connectivity
3)treatment success and changes in functional/anatomical connectivity
Secondary outcome
Not applicable
Background summary
Major depression is characterized by persistent, pervasive feelings of sadness,
guilt, and worthlessness. This baseline state has triggered a wealth of
positron emission tomography (PET) or single photon computed tomography (SPECT)
resting state studies. It was shown that patients suffering from major
depression show decreased brain activation in prefrontal cortex regions,
implicated in cognition, and increased activation in the regions involved in
emotion processing. These neuroimaging methods have significant limitations
which might be overcome by using non-invasive functional Magnetic Resonance
Imaging (fMRI). Furthermore, newly developed fMRI methods that assess slow
fluctuations in the blood oxygen level dependent (BOLD) response allow the
investigation of the functional connectivity between brain regions. Insight
into changes in functional connectivity will increase our knowledge about what
goes wrong in *a depressed brain*.
Study objective
The objective of the study is to answer the following research questions:
1) What differences do exist in functional connectivity between patients with
unipolar depression and healthy controls?
2) Can changes in functional connectivity be used as neurobiological marker for
depression?
3) Do changes in anatomical connectivity underlie these changes in functional
connectivity?
4) Is the severity of the depression related to the changes in
functional/anatomical connectivity?
5) How does connectivity change after treatment?
6) Do healthy controls with an increased risk to develop depression, also show
the changes in functional/anatomical connectivity that are found in depressed
patients?
7) What is the effect of sad mood induction on effective connectivity, and is
there a difference between the effect on healthy volunteers with and without a
family history of depression and depressed participants?
8) Do depressed people have difficulty disengaging their attention from
emotional stimuli compared to healthy participants, and
9) Does treatment modify the abnormal attentional patterns of depression?
Study design
Research questions 1 till 4 and questions 6-8 will be answered with a
between-subject design: functional and anatomical connectivity, mood and
cognition will be measured in all three groups of participants. Research
questions 5 and 9 will be answered with a within-subject design: the group of
depressed patients will be tested before and 9 months after treatment. Research
question 7 will be answered with a within-subject design: effective
connectivity will be measured before and after a mood induction.
Study burden and risks
BURDEN
Depressed patients recruited from the participating centres will be tested on
two occasions: once before treatment and once 9 months later. People with
depression recruited from the general population who do not receive treatment
will be tested once. For those participants a screening session of about 2
hours will take place before testing. Healthy volunteers will be tested once. A
test session includes MRI scanning (63 min in total, including performing two
cognitive tasks (25 min) and mood induction (10 min) and two resting state
scans (8 min each)) and performing two cognitive tasks outside the scanner (50
min) and lasts in total about two hours. Additionally, all participants will be
asked to complete a series of questionnaires at home (30 min) before each
session.
RISKS
Although the risks involved in this study are minor, there is in MRI research
the possibility of an incidental finding. Further, while the effects of musical
sad mood induction procedure are considered transient, there is the possibility
of a longer lasting effect on participants* mood.
Universiteitssinel 40
6229 ER Maastricht
NL
Universiteitssinel 40
6229 ER Maastricht
NL
Listed location countries
Age
Inclusion criteria
PATIENTS
Between 18 - 70 years old and able to give voluntary informed consent
Diagnosis of unipolar depression. The diagnosis of depression will be made by the participants* treating psychiatrist/ psychologist and confirmed with the Structured Clinical Interview for DSM-IV (SCID-I).
Severity of the depression: moderate to severe (BDI-II score >=20)
Duration of the depression: longer than 2 months
Are already receiving or will receive in the coming weeks treatment for depression;HEALTHY PARTICIPANTS WITH FAMILY HISTORY OF DEPRESSION
Between 18 - 70 years old
No current or history of major psychiatric illness
A first-degree relative (i.e. father, mother, brother or sister) that has been diagnosed with unipolar depression. This diagnosis needs to be confirmed by the GP, psychologist or psychiatrist of the family member;HEALTHY CONTROLS
Between 18 - 70 years old
No current or history of major psychiatric illness
No family history of major depression
Exclusion criteria
PATIENTS
Meeting DSM-IV criteria for schizophrenia, schizo-affective disorder, bipolar disorder or an anxiety disorder as a primary diagnosis
Meeting DSM-IV criteria for drug dependence as a primary diagnosis
High suicidal risk (evaluated by the treating clinicians as part of standard therapy procedures)
MRI contra-indications, such as claustrophobia, metal parts in the body and, for women, current pregnancy or breastfeeding
Serious medical or neurological illness
Currently taking centrally acting medication which is known to have a large effect on brain functioning, such as benzodiazepam
HEALTHY PARTICIPANTS WITH FAMILY HISTORY OF DEPRESSION
Meeting DSM-IV criteria for drug dependence, except caffeine or nicotine
MRI contra-indications, such as claustrophobia, metal parts in the body and, for women, current pregnancy or breastfeeding
Serious medical or neurological illness
Currently taking centrally acting medication which is known to have a large effect on brain functioning, such as benzodiazepam
HEALTHY CONTROLS
Meeting DSM-IV criteria for drug dependence, except caffeine or nicotine
MRI contra-indications, such as claustrophobia, metal parts in the body and, for women, current pregnancy or breastfeeding.
Serious medical or neurological illness
Currently taking centrally acting medication which is known to have a large effect on brain functioning, such as benzodiazepam
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 | NL34583.068.10 |