Depression Clinical Trial
— 3BECTOfficial title:
Changes in the Blood-brain Barrier During Maintenance ECT in Formerly Depressed Patients
NCT number | NCT05820230 |
Other study ID # | H-22039168 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 17, 2023 |
Est. completion date | May 2024 |
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Mental Health Services of the Capital Region of Denmaark | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Permeability | Change in permeability measured as Ki in the units of ml/100g/min in the right and left hippocampus | Permeability is measured before a single ECT and 0-8 hours after a single ECT |
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