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

Depression Clinical Trial

— 3BECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05820230
• Other study ID #: H-22039168
• Status: Recruiting
• Start date: February 17, 2023
• Est. completion date: May 2024

Study information

• Verified date: December 2023
• Source: University of Copenhagen
• Contact: Christoffer Lundsgaard
• Phone: +45 38640832
• Email: christoffer.cramer.lundsgaard[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression

Locations

Country	Name	City	State
Denmark	Mental Health Services of the Capital Region of Denmaark	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Permeability	Change in permeability measured as Ki in the units of ml/100g/min in the right and left hippocampus	Permeability is measured before a single ECT and 0-8 hours after a single ECT