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OpenTrials
Completed

NCT Number: NCT05820230

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mental Health Services of the Capital Region of Denmaark

Copenhagen, 2100, Denmark

About this study

Primary hypothesis

  • The BBB permeability to Gadovist (measured as Ki) temporarily increases in the right and left hippocampus (HC) after a single ECT.

Secondary hypothesises

  • The volume of the right and left HC increases after a single ECT and the volume increase is positively correlated with the BBB permeability
  • A larger post-ECT increase in systolic blood pressure correlates with a larger increase in BBB permeability in the right and left HC.
  • A larger increase in serum S100-B compared to baseline values is correlated with increased BBB permeability in the right and left HC.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Schizophrenia
  • Psychotic symptoms
  • Any substance use (other than cigarette smoking and alcohol consumption within the recommendations of the Danish National Health Authority) within the last 3 months
  • Risk of suicide making transport or participation in the study hazardous
  • Claustrophobia or severe restlessness
  • 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)
  • Somatic illness potentially confounding results (e.g., any central nervous system diseases or cancers)
  • Lack of consent to being informed of potential medically important findings on MRI or blood tests

Treatment and study plan

Primary outcomes

  1. Permeability

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Acronym: 3BECT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2023
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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