Impact of Covid-19 Pandemic on Patients Receiving Continuation or Maintenance Electroconvulsive Therapy

NCT ID: NCT05633368

Last Updated: 2022-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-31

Study Completion Date

2020-06-19

Brief Summary

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Electroconvulsive therapy is a safe and effective therapeutic strategy in patients with treatment resistant depression. As relapse after successful ECT is significant even with adequate pharmacological strategies, continuation (up to 6 months after completion of index-ECT) or maintenance ECT (more than 6 months after index-ECT) is often necessary to maintain remission. During the current Covid-19 pandemic hospitals redirected resources and closed or significantly diminished ECT services. In this study we aim to assess the impact of discontinuing maintenance electroconvulsive therapy in patients diagnosed with unipolar depressive disorder.

Detailed Description

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During the height of the Covid-19 pandemic in Belgium all patients receiving continuation or maintenance electroconvulsive therapy (ECT) for major depressive disorder in two ECT centers in Belgium will be included. Due to differences in Covid-19 infection rates and hospital management decisions, one ECT-service temporarily halted all electroconvulsive treatments, where as the other ECT-service continued continuation and maintenance treatments. Depressive symptomatology and relapse rates will be assessed during the diminished accessibility of electroconvulsive treatment.

Conditions

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Electroconvulsive Therapy Major Depressive Disorder Covid-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Discontinuation of C/M-ECT

Participants with major depressive disorder who are unable to continue maintenance (M-ECT) or continuation electroconvulsive therapy (C-ECT) due to hospital restrictions during Covid-19 or due to personal preference.

Questionnaires

Intervention Type OTHER

Participants will be contacted every three weeks to assess depressive symptomatology and possible relapse.

* Patient Health Questionnaire (PHQ-9)
* Clinical Global Impression (CGI)
* Scaling question regarding depressive symptomatology

Continuation of C/M-ECT

Participants with major depressive disorder who are able to continue maintenance (M-ECT) or continuation electroconvulsive therapy (C-ECT) during Covid-19.

Questionnaires

Intervention Type OTHER

Participants will be contacted every three weeks to assess depressive symptomatology and possible relapse.

* Patient Health Questionnaire (PHQ-9)
* Clinical Global Impression (CGI)
* Scaling question regarding depressive symptomatology

Interventions

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Questionnaires

Participants will be contacted every three weeks to assess depressive symptomatology and possible relapse.

* Patient Health Questionnaire (PHQ-9)
* Clinical Global Impression (CGI)
* Scaling question regarding depressive symptomatology

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Continuation or maintenance ECT, in treatment at two specified ECT-centers in Belgium
* Unipolar depressive disorder

Exclusion Criteria

* Unable to provide informed consent
* Unable to comply with study requirements (telephone questionnaire)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nele Van de Velde

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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Ghent University Hospital

Ghent, East-Flanders, Belgium

Site Status

AZ Groeninge

Kortrijk, West-Flanders, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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BC-07543

Identifier Type: -

Identifier Source: org_study_id

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