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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-17

Study Completion Date

2024-11-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Poul Videbech

Professor Poul Videbech

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Poul Videbech, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen & Mental Health Centre Glostrup

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mental Health Services of the Capital Region of Denmaark

Copenhagen, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-22039168

Identifier Type: -

Identifier Source: org_study_id