1. To investigate neuropsychological deficits during an ECT course in relationship to cortisol levels 2. To investigate the underlying neural correlates, i.e. functional connectivity, structural connectivity, and amygdala reactivity, that are…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Mood (categorical DSM-IV diagnose, severity assessed with observer rated
questionaire)
- A detail neuropsychological examination (focus on memory and executive
functioning).
- Neuroimaging, i.e. functional connectivity (fMRI), structural connectivity
(DTI), and amygdale reactivity (fMRI: Hariri paradigm)
- Hypothalamic-pituitary-adrenal axis functioning (dexamethason suppression
test) by nine cortisol measures in saliva.
Secondary outcome
N.A.
Background summary
Electroconvulsive therapy (ECT) is the most effective treatment for depressive
disorder, although the underlying mechanisms are poorly understood. Moreover,
patient and clinical acceptance are limited by significant cognitive
side-effects.
Study objective
1. To investigate neuropsychological deficits during an ECT course in
relationship to cortisol levels
2. To investigate the underlying neural correlates, i.e. functional
connectivity, structural connectivity, and amygdala reactivity, that are
involved in successful electroconvulsive treatment of depression.
Study design
Observational study of patients who receive ECT will be assessed additionally
before and after the ECT course.
Study burden and risks
In addition to the normal procedure and measures for ECT treatment, an
additional burden will be placed on patients due to the neuroimaging part
(estimated at 20 minutes), a detailed neuropsychological testing (estimated at
60 minutes), and 9 cortisol measures in saliva, incl. one after 0.5 mg
dexamethason ingestion, before and after ECT. The risks for these additional
measurements are almost nihil.
Reinier Postlaan 10
6525 GC Nijmegen
NL
Reinier Postlaan 10
6525 GC Nijmegen
NL
Listed location countries
Age
Inclusion criteria
- Males and females above 18 years of age
- Unipolar major depressive disorder with and without psychotic features, first and recurrent episode
Exclusion criteria
- Presence of a current or past relevant somatic or neurological disorder
- Comorbid diagnosis of bipolar depression, schizophrenia or substance dependence.
- MRI-related exclusion criteria like claustrophobia, metal in body, pacemaker, pregnancy, etc.
- ECT course within the past year
- Use of antidepressants (according to good clinical practice, antidepressants have to be withdrawn before an ECT course, so this will not be a major issue).
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 | NL17318.091.07 |