NCT05515159

Brief Summary

The present multi-disciplinary study will assess blood biomarkers to investigate putative mechanisms of action of ECT. Laboratory findings will be correlated to clinical parameters, cognitive measures and psychometric outcome measures. The aim is to elucidate the underlying mechanisms for both treatment effects and cognitive side effects of ECT.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
42mo left

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Oct 2019Oct 2029

Study Start

First participant enrolled

October 1, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

10 years

First QC Date

August 23, 2022

Last Update Submit

October 8, 2024

Conditions

Electroconvulsive TherapyDepressionBlood Biomarkers

Outcome Measures

Primary Outcomes (1)

  • change in levels of blood biomarkers

    6 months

Study Arms (2)

ECT group

patients undergoing electroconvulsive therapy for depression

Other: electroconvulsive therapy

control group

healthy controls; patients undergoing electroconversion for atrial fibrillation

Interventions

electroconvulsive therapyOTHER

electrical stimulation of the brain while the patient is under anesthesia.

ECT group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients (age \> 18) referred to the ECT-unit and accepted for treatment.

You may qualify if:

  • Patients (age \> 18) referred to the ECT-unit and accepted for treatment.

You may not qualify if:

  • Patients unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Depression

Interventions

Electroconvulsive Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Convulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2022

First Posted

August 25, 2022

Study Start

October 1, 2019

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

October 10, 2024

Record last verified: 2024-10

Locations

NO(1)