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| Name | Class |
|---|---|
| Glostrup University Hospital, Copenhagen | OTHER |
| Amager Hospital | OTHER |
| Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital | OTHER |
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The main purpose of this study is to determine whether electroconvulsive therapy (ECT) causes any structural or functional brain changes and thus indicating its mechanism of action. The second aim is to find predictors of an immediate response, sustained remission, relapse and side-effects. Thirdly, this study aims to explore whether ECT causes any changes in blood-brain barriers permeability and whether these changes correlate to memory problems. The fourth objective is to examine whether ECT causes any brain tissue damage.
ECT has been the most effective treatment of depression for decades. Despite of this, neither the mechanism of action or side-effects are fully elucidated. The reason why some patients relapse shortly after remission is still not completely understood. Thus, there is a need to find predictors of the favourable clinical effect, relapse and side-effects. ECT is considered by professionals to be a safe procedure. However, this view is based on rather old and small studies. Additionally, many patients do not consent to this treatment because they fear a permanent loss of memory or that they will contract a brain damage after the completed ECT series. Therefore, it is very important to examine whether ECT might have negative effects on the structure or function of the brain, using state of the art Magnetic Resonance Imaging (MRI) techniques on a greater study population.
The study consists of 60 inpatients, diagnosed with depression, admitted to one of the recruiting Mental Health Centres, and scheduled to ECT. The most modern MRI sequences examining brain structure and function are used at 3 time points: at baseline (just before ECT series), the second examination (just after ECT series) and the third (follow-up) examination (6 months after ECT series). Blood samples (measurements of Brain-Derived Neurotrophic Factor - BDNF, Vascular Endothelial Growth Factor - VEGF along with the marker of brain injury - S100B-protein) and the evaluation of clinical effect and side-effects to ECT are performed at the same time points.
The study has 4 main hypotheses. The first hypothesis assumes that the immediate and sustained response to ECT can be predicted by combining neuroimaging findings and blood-samples results. The second hypothesis is based on the assumption that ECT modulates the microstructure and connectivity in the fronto-limbic pathways (FLPs) and that this modulation correlates with the clinical effect. Thus, the altered microstructure of the FLPs in depression is normalised by an ECT series. Furthermore, the depression-associated increased resting state connectivity in FLPs is normalised by ECT. The third hypothesis is that ECT will induce changes in blood-brain barrier (BBB) permeability, which will correlate with the severity of memory problems. The last hypothesis assumes that ECT does not cause any brain tissue damage (including brain atrophy and white matter lesions - WMLs).
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| Measure | Description | Time Frame |
|---|---|---|
| Volumetric changes in the hippocampus. | This outcome will be measured by means of voxel-based morphometry (VBM). | at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) |
| Changes in BDNF concentration in the blood. | at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) | |
| Changes in regional cerebral blood flow (rCBF) in the frontal lobes. | Pseudo-continuous arterial spin-labelling (PSCAL) will be used to measure this outcome. | at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) |
| Measure | Description | Time Frame |
|---|---|---|
| The number of WMLs in the brain. | FLAIR sequences of MRI will be used to measure this outcome. | at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) |
| Changes in water diffusion in the brain. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of the inpatients admitted to one of the recruiting Mental Health Centres (MHC) in the Capital Region of Denmark (Mental Health Centre Glostrup or Amager or Copenhagen or others), diagnosed with either depression according to the 10th version of the International Classification of Diseases (ICD-10) or major depression according to the Diagnostic and Statistical Manual of Mental Disorders, 4th ed (DSM-IV) and scheduled to ECT series.
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| Name | Affiliation | Role |
|---|---|---|
| Poul Videbech, Professor | Glostrup University Hospital, Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mental Health Centre Glostrup | Glostrup Municipality | The Capital Region | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24381234 | Background | Abbott CC, Gallegos P, Rediske N, Lemke NT, Quinn DK. A review of longitudinal electroconvulsive therapy: neuroimaging investigations. J Geriatr Psychiatry Neurol. 2014 Mar;27(1):33-46. doi: 10.1177/0891988713516542. Epub 2013 Dec 30. | |
| 24800688 | Background | Andrade C, Bolwig TG. Electroconvulsive therapy, hypertensive surge, blood-brain barrier breach, and amnesia: exploring the evidence for a connection. J ECT. 2014 Jun;30(2):160-4. doi: 10.1097/YCT.0000000000000133. |
| Label | URL |
|---|---|
| Sundhedsstyrelsen: Referenceprogram for Unipolar Depression hos voksne. 2007. | View source |
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There is no plan to share Individual Patient Data.
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Whole blood samples are kept in the biobank until the last enrolled patient has been examined. They will be then analysed for S100B-protein concentration and destroyed. Whole blood, serum and plasma samples are kept in the biobank until the last enrolled patient has been examined. They will then be analysed for concentrations of BDNF and VEGF and destroyed. Extra whole blood samples are stored in the psychiatric biobank for the future research (as part of another protocol - PSV-2001-04, I-Suite 00422 - ID nr 2001-54-798)
Diffusion-weighted imaging (DWI) will be used to measure this outcome. |
| at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) |
| Changes in the level of fractional anisotropy (FA) in the brain. | Diffusion tensor imaging (DTI) will be used to measure this outcome. | at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) |
| Changes in the level of intrinsic connectivity pattern in fronto-limbic pathways in the brain. | Resting state functional MRI will be used to measure this outcome. | at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) |
| Changes in the glucose metabolism in the brain. | Cerebral Metabolic Rate of Oxygen ( CMRO2) will be used to measure this outcome. | at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) |
| Changes in blood-brain barrier (BBB) permeability. | Dynamic Contrast Enhanced (DCE)T1-weighted imaging will be used to measure this outcome. | at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) |
| Changes in S100B-protein concentration in the blood. | at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) |
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