Changes in the Blood-brain Barrier During Maintenance ECT in Formerly Depressed Patients (3BECT)

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.

Study Overview

• Status: Completed
• Conditions: Depression

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 Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Mental Health Services of the Capital Region of Denmaark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with a series of ECT or maintenance ECT in a hospital at the Mental health services in the Capital Region of Denmark

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Investigators: Principal Investigator: Poul Videbech, Professor, University of Copenhagen & Mental Health Centre Glostrup

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): November 25, 2024

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: H-22039168

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No