Trials / Completed
CompletedNCT05820230
Changes in the Blood-brain Barrier During Maintenance ECT in Formerly Depressed Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 7 (actual)
- Sponsor
- University of Copenhagen · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2023-02-17
- Primary completion
- 2024-02-01
- Completion
- 2024-11-25
- First posted
- 2023-04-19
- Last updated
- 2024-11-27
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT05820230. Inclusion in this directory is not an endorsement.