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Completed

NCT Number: NCT02715986

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

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.

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Key information

Conditions

Severe Depression Behavior Behavioral Symptoms Depression

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Toulouse, Hôpital de psychiatrie

Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3T MRI

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  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.

    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.

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    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.

  9. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ECT-IM

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 22, 2016
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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