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

NCT06661616 | Completed

• 1 other identifier: D17-P018
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder (MDD); Bipolar Disorder Depression

Outcome Measures

Primary Outcomes (1)

• Correlation between increased hippocampal volume and post-ECT retrograde amnesia

  After a course of ECT, up to 3 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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
• Control population: healthy volunteers
• Male or female over 18 years of age

You may not qualify if:

• 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
• 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
• 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
• Compulsory care
• Protected adults, persons under court protection measures

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

Sainte-Anne Hospital (GHU Paris Psychiatrie et Neurosciences)

Paris, 75014, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Collection of blood plasma and peripheral blood mononuclear cell (PBMC)

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: June 6, 2018
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-09

Locations

FR (1)