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CompletedNCT058202303BECTUpdated Nov 27, 2024

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

An observational study in Depression, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by University of Copenhagen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Depression

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03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 7 is below the median of 160 across 1,084 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Permeability

    Change in permeability measured as Ki in the units of ml/100g/min in the right and left hippocampus

    Time frame: Permeability is measured before a single ECT and 0-8 hours after a single ECT

07

Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05820230
Lead sponsor
University of Copenhagen
Responsible party
Poul Videbech (Professor Poul Videbech, University of Copenhagen) — Principal investigator
First posted
Apr 19, 2023
Start date
Feb 17, 2023
Primary completion
Feb 1, 2024
Completion
Nov 25, 2024
Last update
Nov 27, 2024

Study contacts

Poul Videbech, Professor
principal investigator · University of Copenhagen & Mental Health Centre Glostrup

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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