Changes in the Blood-brain Barrier During Maintenance ECT... | NCT05820230

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

NCT05820230

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Nov 27, 2024Actual

Enrollment

7Actual

Phase

Not provided

Conditions

Depression

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2023Actual

Primary Completion Date

Feb 1, 2024Actual

Completion Date

Nov 25, 2024Actual

First Submitted Date

Mar 24, 2023

First Submission Date that Met QC Criteria

Apr 18, 2023

First Posted Date

Apr 19, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2024

Last Update Posted Date

Nov 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

7Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Poul Videbech, Professor	University of Copenhagen & Mental Health Centre Glostrup	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mental Health Services of the Capital Region of Denmaark		Copenhagen		2100	Denmark

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior