With this research-protocol we aim to investigate six important issues regarding recurrences of MDD-episodes:1. The differences between healthy controls and patients with recurrent MDD-episodes with respect to structural (sMRI) and functional (fMRI…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measurements:
Two phases (study entry and after recurrence of depressive symptoms) are
studied. In Phase I, two blocks of psychological tests will be obtained,
followed by structural and functional magnetic resonance imaging (MRI). During
the scanning, a mood induction will be performed. In Phase II, when patients
experience a recurrence during follow-up, we will invite them for a new
psychological test and an MRI-scan. At approximately the same moment during
follow-up we will invite a matched patient (matched by age ±10 years and sex)
who has not experienced a recurrence by then, for repeated testing as well.
Neuropsychological tests obtained are the Exogenous cueing task, Face
recognition task, Emotional categorization task, Emotional Memory (both Phases)
and the Dutch Adult Reading Test and the Negative affective priming (Phase I
only).
MRI scanning will consist of a structural scan, resting state scan,
Reinforcement learning task, Magnetic resonance spectroscopy, Diffusion Tensor
Imaging, Emotional faces and Internal Shift Task (both Phases); in Phase I an
Emotion regulation task and a repeated resting-state scan after a sad mood
induction will be made.
Neurobiological/Neuroendocrine tests consist of blood collection for
polyunsaturated fatty acids and brain derived neurotrophic factor, analysis of
genetic polymorphisms and salivary cortisol measurements
Secondary outcome
Not applicable
Background summary
Major depressive disorder (MDD) is a highly prevalent and disabling disease,
especially because its symptoms tend to return. In general antidepressants
reduce the risk of recurrence 2-fold, but after cessation this risk appears to
increase again. For prediction of recurrence, the number of previous episodes
is amongst the strongest predictors, together with residual symptoms, *daily
hassles* and coping style. Recurrence of MDD has been considered from
neuropsychological, brain network dysfunction, neurochemical and
psychoneuroendocrine perspectives which have not yet been integrated.
Therefore, despite these perspectives of neurobiological substrates for
recurrent depression, the underlying mechanisms of recurrence remain poorly
understood, which will be improved by a multimodal approach in which
neuroimaging will be combined with neuropsychological and
neurobiological/neuroendocrine measurements in patients with recurrent
depression.
Study objective
With this research-protocol we aim to investigate six important issues
regarding recurrences of MDD-episodes:
1. The differences between healthy controls and patients with recurrent
MDD-episodes with respect to structural (sMRI) and functional (fMRI)-scans
2. The differences in changes in resting state activations and HPA-axis
activity after mood-induction between remitted MDD-patients and controls
3. The differences in the relations between HPA-axis functioning, fatty acid
status and neuroimaging findings between remitted MDD-patients and controls
4. The predictive value of sMRI/fMRI, changes in resting state activations and
HPA-axis activity after mood-induction, fatty acid status and their
interactions for the occurrence of new relapse/recurrences
5. The association between sMRI/fMRI, changes in resting state activations and
HPA-axis activity after mood-induction and fatty acid status with the number of
previous episodes
6. What changes occur in brain functions, psychoneuroendocrinological measures
and their interaction when patients have a recurrence of their depression
Study design
Prospective and retrospective cohort design, with a healthy control comparison
group, and an age and sex matched controlled repeated measurements design in
case of future (non-) recurrence in the next 2.5 years
Study burden and risks
Not applicable
Meibergdreef 5
1105 AZ Amsterdam
NL
Meibergdreef 5
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Remitted MDD-patients:
- Age 35-65 yr
- both sexes
- *2 MDD episodes according to a structured interview for DSM-IV (SCID)
- in stable remission defined as a Hamilton depression rating scale (HDRS) *7 and Inventory for depressive symptomatology (IDS-SR) *14 for at least 10 weeks.;Healthy controls:
Controls will be matched with patients on age (±3 years), sex and estimated intelligence with the Dutch adult reading test (DART).
- matched for age, sex and years of education
- IDS-SR *14
Exclusion criteria
Remitted MDD-patients:
- current diagnosis of alcohol or drug dependence, psychotic or bipolar disorder, predominant anxiety disorder
- standard fMRI exclusion criteria (claustrophobia, implanted metal objects in the bodies)
- electroconvulsive therapy within two months before scanning
- a history of head trauma or neurological disease, severe general physical illness ;Healthy controls:
- Personal (assessed by SCID) or 1st degree relative with psychiatric disorder
- current diagnosis of alcohol or drug dependence
- standard fMRI exclusion criteria (claustrophobia, implanted metal objects in the bodies)
- a history of head trauma or neurological disease, severe general physical illness
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 | NL35858.018.11 |