Brain Changes in Severely Depressed Patients Before and After Treatment With Electroconvulsive Therapy

Study Overview
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Brief Summary
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Electroconvulsive therapy (ECT) is a non-pharmacological treatment used in resistant depression whose effectiveness has been demonstrated. However, the brain mechanisms underlying this therapeutic effect remain unclear. Many animal studies show a neurotrophic action of ECT on the hippocampus: increased neurogenesis, synaptogenesis, proliferation of glial cells. In addition, functional imaging of resting state type have shown, among depressed patients after ECT, increased functional connectivity . These results were reinforced by the recent work of Perrin (2012). In view of this a priori contradictory, it seems appropriate to continue research neuroanatomical correlates subtending neurofunctional processes responsible at the same time improving the clinical depressive. The investigators suggest using an original technique never used in this type of population: Functional magnetic resonance imaging (fMRI) or multimodal structural-functional. This method will allow us to study the impact of ECT on brain structures involved in major depressive disorder: hippocampus.

Official Title
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Structural-functional Brain Changes in Severely Depressed Patients Before and After Treatment With Electroconvulsive Therapy: an Exploratory Study

Conditions
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Severe Depression

Intervention / Treatment
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* Device: 3T MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnostic and Statistical Manual of Mental Disorders-V (DSM) diagnosis of major depressive disorder indication of ECT and signing the consent for conducting a ECT right-handed be of French mother tongue belong to a social security scheme sign an informed consent Exclusion Criteria: against indication for MRI against indication to anesthesia processes brain expensive pregnant woman refuse to be informed of an abnormality detected during MRI Patients holders of stimulation electrodes presence history of neurological disease presence history of head injury Mini-Mental State Examination (MMSE) <15/30 presence of neurodegenerative disease patients who have had ECT treatment in the last 6 months

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Severly depressed patients<br>Recruitment of twenty depressive subjects will be conducted within the hospital service adult psychiatry.These patients are referred for indication of ECT sessions for severe resistant depression. Four MRI evaluations (3T MRI examination) are programmed in such patients to analyze structural changes in the hippocampus. | Device: 3T MRI<br>* Four visits will be conducted during the prospective follow during which will be carried out a 3T MRI examination, assessment of assessment of depressive symptomatology and anterograde memory: within 7 days prior to the first session of ECT, within 48 hours after the first ECT session, within 48 hours after the first effective ECT session and within 10 days of the last session of ECT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphological changes in the hippocampus between baseline and after the first ECT effective session as assessed by volume measure in multimodal MRI. | Visit 3 will take place within 48 hours after the first ECT session effective. | Within 48 hours after the first effective ECT session. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional connectivity changes of the hippocampus-related networks between baseline and after the first effective ECT session as assessed by measure of connectivity in multimodal MRI. | Visit 3 will take place within 48 hours after the first ECT session effective. | Within 48 hours after the first effective ECT session. | 
| Morphological changes of the hippocampus-related networks between baseline and after the first ECT session as assessed by measure of volume in multimodal MRI. | Visit 2 will take place within 48 hours after the first ECT session | Within 48 hours after the first ECT session. | 
| Morphological changes of the hippocampus-related networks between baseline and after the first ECT session as assessed by average diffusivity in multimodal MRI. | Visit 2 will take place within 48 hours after the first ECT session | Within 48 hours after the first ECT session. | 
| Functional changes of the hippocampal-related networks between baseline and after the first ECT session as assessed by measure of connectivity in multimodal MRI. | Visit 2 will take place within 48 hours after the first ECT session | Within 48 hours after the first ECT session. | 
| Morphological changes in the hippocampus and hippocampal-related networks related to ECT between baseline and after remission as assessed by measure of volume in multimodal MRI | Remission is defined by a score of 7 or less on Hamilton Depression Rating | Within 10 days after remission. | 
| Morphological changes in the hippocampus and hippocampal-related networks related to ECT between baseline and after remission as assessed by | Remission is defined by a score of 7 or less on Hamilton Depression Rating | Within 10 days after remission. | 
| Functional changes in the hippocampus and hippocampal-related networks related to ECT after remission as assessed by measure of connectivity in multimodal MRI. | Remission is defined by a score of 7 or less on Hamilton Depression Rating Scale (HDRS). | Within 10 days after remission | 
| Evolution of Real Life/Real Impact-16 (RLRI-16) score after the first ECT, after ECT first effective and after remission | RLRI-16 test will be realised during all visits, after ECT. | Within 7 days before first ECT, after the first ECT, within 48 hours after the first effective ECT and within 10 days after remission | 
| Changes in the intensity of depressive symptoms score (Hamilton Depression Rating Scale) after the first ECT, ECT first effective and after remission | Hamilton Depression Rating Scale will be realised during all visits, after ECT. | Within 7 days before first ECT, after the first ECT, within 48 hours after the first effective ECT and within 10 days after remission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECT, Diffusion Tensor Imaging (DTI), fMRI