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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05820230

Acronym

3BECT

Enrollment

Registered

2023-04-19

Start date

2023-02-17

Completion date

2024-11-25

Last updated

2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Denmark

Outcome results