Cognitive Effects Associated With Hippocampal Neurogenesis Induced by ECT in the Treatment of Depression (CONHECT)

October 25, 2024 updated by: Centre Hospitalier St Anne

Cognitive Effects Associated With Hippocampal Neurogenesis Induced by Electroconvulsive Therapy in the Treatment of Depression

Electroconvulsive therapy (ECT) is the treatment of choice for drug-resistant depression (30% of patients), or when there is a short-term risk to the patient's life. Despite its robust efficacy and rapid onset of action, its use is limited both by the limited range of treatment available and by the cognitive effects sometimes induced. The present study focuses on the links between the efficacy of ECT, its cognitive effects and the formation of new neurons in the hippocampus (hippocampal neurogenesis) associated with this treatment.

Study Overview

Study Type

Observational

Enrollment (Actual)

87

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

      • Paris, France, 75014
        • Sainte-Anne Hospital (GHU Paris Psychiatrie et Neurosciences)

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This study focuses on a population of adult patients suffering from unipolar or bipolar depression and treated with electroconvulsive therapy.

In order to monitor the impact of depression on cognitive functions, including memory, and on biological markers and brain imaging, 35 depressed subjects treated without ECT will be recruited.

And to monitor the effect of time on memory, 35 healthy volunteers will be recruited.

Description

Inclusion Criteria:

  1. Study population: depressed subjects treated with ECT

    • Male or female over 18 years of age
    • Hospitalised at the Centre Hospitalier Sainte-Anne
    • Suffering from a unipolar or bipolar major depressive episode, according to DSM5 criteria
    • Indication for ECT treatment
    • Patient has given informed written consent
    • Beneficiary of a social security scheme
  2. Control population: depressed subjects treated without ECT

    • Male or female over 18 years of age
    • Hospitalised at the Centre Hospitalier Sainte-Anne
    • Suffering from a unipolar or bipolar major depressive episode, according to DSM5 criteria
    • Patient who has given informed written consent
    • Beneficiary of a social security scheme
  3. Control population: healthy volunteers

    • Male or female over 18 years of age
    • Patient with written informed consent
    • Beneficiary of a social security scheme

Exclusion Criteria:

  1. Study population: depressed subjects with ECT

    • Psychiatric comorbidity: schizophrenia, pervasive developmental disorder, dependence on a substance other than tobacco
    • Neurological comorbidity: Parkinson's disease, dementia
    • ECT treatment in the 6 months prior to inclusion
    • Compulsory care
    • Protected adults, persons under court protection measures
    • Persons deprived of liberty by judicial or administrative decision;
    • Refusal of consent to ECT treatment
    • Contraindications to ECT (HTIC, recent history of stroke, severe uncontrolled arterial hypertension, contraindication to anaesthesia)
    • Contraindications to MRI (patients with metal prostheses, claustrophobia)
    • Pregnant or breast-feeding women
  2. Control population: depressed subjects without ECT

    • Psychiatric comorbidity: schizophrenia, pervasive developmental disorder, dependence on any substance other than tobacco
    • Neurological comorbidity: Parkinson's disease, dementia
    • ECT treatment in the 6 months prior to inclusion
    • Compulsory care
    • Protected adults, persons under court protection measures
    • Persons deprived of liberty by judicial or administrative decision;
    • Pregnant or breast-feeding women
  3. Control population: healthyvolunteers

    • Protected adults, persons under legal protection,
    • Persons deprived of their liberty by judicial or administrative decision ;
    • persons hospitalised for purposes other than research
    • Clear psychiatric history
    • Dependence on any substance other than tobacco
    • Neurological history: Parkinson's disease, dementia
    • Pregnant or breast-feeding women

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

Cohorts and Interventions

Group / Cohort
Depressed patient treated with electroconvulsivotherapy
The indication for ECT treatment is established by the department's medical team. Participants are not assigned to ECT as part of this observational study.
Depressed patient treated without electroconvulsivotherapy
The indication for antidepressant treatment is established by the department's medical team. Participants are not assigned to ECT as part of this observational study.
Healthy volunteers
Age- and sex-matched healthy volunteers free of psychiatric disorders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between increased hippocampal volume and post-ECT retrograde amnesia
Time Frame: After a course of ECT, up to 3 months
After a course of ECT, up to 3 months

Collaborators and Investigators

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

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)

June 6, 2018

Primary Completion (Actual)

May 14, 2024

Study Completion (Actual)

May 14, 2024

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Major Depressive Disorder (MDD)

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