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

July 28, 2020 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France
        • CHU Toulouse, Hôpital de Psychiatrie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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.
Time Frame: Within 48 hours after the first effective ECT session.
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.
Time Frame: Within 48 hours after the first effective ECT session.
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.
Time Frame: Within 48 hours after the first ECT session.
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.
Time Frame: Within 48 hours after the first ECT session.
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.
Time Frame: Within 48 hours after the first ECT session.
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
Time Frame: Within 10 days after remission.
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
Time Frame: Within 10 days after remission.
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.
Time Frame: Within 10 days after remission
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
Time Frame: 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.
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
Time Frame: 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.
Within 7 days before first ECT, after the first ECT, within 48 hours after the first effective ECT and within 10 days after remission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Christophe ARBUS, CHU Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2016

Primary Completion (ACTUAL)

July 1, 2018

Study Completion (ACTUAL)

July 1, 2018

Study Registration Dates

First Submitted

December 14, 2015

First Submitted That Met QC Criteria

March 16, 2016

First Posted (ESTIMATE)

March 22, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/15/7733
  • 15 7733 02 (OTHER_GRANT: University Hospital Toulouse, local funding 2015)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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