Changes in the Blood-brain Barrier During Maintenance ECT in Formerly Depressed Patients

Completed

• Conditions: Depression

• Registration Number: NCT05820230
• Lead Sponsor: University of Copenhagen

Brief Summary

The aim of the study is to examine the effect of electroconvulsive therapy (ECT) on the blood-brain barrier (BBB) in patients who had suffered from depression. We will study the BBB with dynamic contrast enhanced (DCE) MRI before and after treatment with a single ECT in patients currently undergoing ECT. The study is an observational (naturalistic) longitudinal study.

Detailed Description

Primary hypothesis

1. The BBB permeability to Gadovist (measured as Ki) temporarily increases in the right and left hippocampus (HC) after a single ECT.

Secondary hypothesises

2. The volume of the right and left HC increases after a single ECT and the volume increase is positively correlated with the BBB permeability

3. A larger post-ECT increase in systolic blood pressure correlates with a larger increase in BBB permeability in the right and left HC.

4. A larger increase in serum S100-B compared to baseline values is correlated with increased BBB permeability in the right and left HC.

Study Timeline

• Study Start: 2023-02-17
• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-19
• Primary Completion: 2024-02-01
• Status Verified: 2024-11
• Study Completion: 2024-11-25
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• We will include patients (age 18-75) currently treated with a series of ECT or maintenance ECT referred to the treatment due to moderate to severe depression according to ICD-10.

Exclusion Criteria

1. Schizophrenia
2. Psychotic symptoms
3. Any substance use (other than cigarette smoking and alcohol consumption within the recommendations of the Danish National Health Authority) within the last 3 months
4. Risk of suicide making transport or participation in the study hazardous
5. Claustrophobia or severe restlessness
6. Contraindications to DCE-MRI (e.g., metallic implants, increased body temperature, reduced kidney function (estimated Global Filtration Rate (eGFR) of <40 ml/min/1.73 m2), pregnancy)
7. Somatic illness potentially confounding results (e.g., any central nervous system diseases or cancers)
8. Lack of consent to being informed of potential medically important findings on MRI or blood tests

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Permeability	Permeability is measured before a single ECT and 0-8 hours after a single ECT	Change in permeability measured as Ki in the units of ml/100g/min in the right and left hippocampus

Trial Locations

Locations (1)

Mental Health Services of the Capital Region of Denmaark; 🇩🇰 Copenhagen, Denmark