ECT-IM: Brain Changes in Severely Depressed Patients Before and After Treatment With Electroconvulsive Therapy

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Completed
CT.gov ID
NCT02715986
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France (Other)
17
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27
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: 3T MRI
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Structural-functional Brain Changes in Severely Depressed Patients Before and After Treatment With Electroconvulsive Therapy: an Exploratory Study
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Jul 1, 2018
Actual Study Completion Date :
Jul 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Severly depressed patients

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
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.

Outcome Measures

Primary Outcome Measures

  1. Morphological changes in the hippocampus between baseline and after the first ECT effective session as assessed by volume measure in multimodal MRI. [Within 48 hours after the first effective ECT session.]

    Visit 3 will take place within 48 hours after the first ECT session effective.

Secondary Outcome Measures

  1. 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. [Within 48 hours after the first effective ECT session.]

    Visit 3 will take place within 48 hours after the first ECT session effective.

  2. Morphological changes of the hippocampus-related networks between baseline and after the first ECT session as assessed by measure of volume in multimodal MRI. [Within 48 hours after the first ECT session.]

    Visit 2 will take place within 48 hours after the first ECT session

  3. Morphological changes of the hippocampus-related networks between baseline and after the first ECT session as assessed by average diffusivity in multimodal MRI. [Within 48 hours after the first ECT session.]

    Visit 2 will take place within 48 hours after the first ECT session

  4. Functional changes of the hippocampal-related networks between baseline and after the first ECT session as assessed by measure of connectivity in multimodal MRI. [Within 48 hours after the first ECT session.]

    Visit 2 will take place within 48 hours after the first ECT session

  5. 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 [Within 10 days after remission.]

    Remission is defined by a score of 7 or less on Hamilton Depression Rating

  6. Morphological changes in the hippocampus and hippocampal-related networks related to ECT between baseline and after remission as assessed by [Within 10 days after remission.]

    Remission is defined by a score of 7 or less on Hamilton Depression Rating

  7. Functional changes in the hippocampus and hippocampal-related networks related to ECT after remission as assessed by measure of connectivity in multimodal MRI. [Within 10 days after remission]

    Remission is defined by a score of 7 or less on Hamilton Depression Rating Scale (HDRS).

  8. Evolution of Real Life/Real Impact-16 (RLRI-16) score after the first ECT, after ECT first "effective" and after remission [Within 7 days before first ECT, after the first ECT, within 48 hours after the first effective ECT and within 10 days after remission]

    RLRI-16 test will be realised during all visits, after ECT.

  9. Changes in the intensity of depressive symptoms score (Hamilton Depression Rating Scale) after the first ECT, ECT first "effective" and after remission [Within 7 days before first ECT, after the first ECT, within 48 hours after the first effective ECT and within 10 days after remission]

    Hamilton Depression Rating Scale will be realised during all visits, after ECT.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Toulouse, Hôpital de psychiatrie Toulouse France

Sponsors and Collaborators

  • University Hospital, Toulouse
  • Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Christophe ARBUS, CHU Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT02715986
Other Study ID Numbers:
  • RC31/15/7733
  • 15 7733 02
First Posted:
Mar 22, 2016
Last Update Posted:
Jul 29, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University Hospital, Toulouse
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2020