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

Covid-19 Clinical Trial

— COVID-M-ECT  

Official title:

Impact of Covid-19 Pandemic on Patients With Unipolar Depressive Disorder: Effects of Discontinuing Continuation or Maintenance Electroconvulsive Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05633368
• Other study ID #: BC-07543
• Status: Completed
• Start date: March 31, 2020
• Est. completion date: June 19, 2020

Study information

• Verified date: November 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 19, 2020
• Est. primary completion date: June 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Covid-19
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Electroconvulsive Therapy
• Major Depressive Disorder

Intervention

Other:
• 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

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent	East-Flanders
Belgium	AZ Groeninge	Kortrijk	West-Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depressive symptoms (PHQ-9)	Change in depressive symptoms as measured by the patient health questionnaire via phone or through direct participant contact. The PHQ is a 9-question instrument to screen for the presence and severity of depression. The minimum score is 0 and the maximum score is 27, with a higher score indicating more depressive symptoms.	From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
Primary	Change in depressive symptoms, subjective score, scaling question	Change in depressive symptoms as measured by the following scaling question: How would you rate your depressive symptoms on a scale from 0 to 10 with 0 indicating no depressive symptoms and 10 indicating extremely severe depressive symptoms'.	From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
Primary	Change in depressive symptoms, subjective score	Change in depressive symptoms as measured by the patient-rated question: 'How would you describe the severity of your depressive symptoms?'. No depressive symptoms equals a score of 0 and severe depressive symptoms equals a score of 3.	From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
Primary	Change in depressive symptoms (CGI)	Change in depressive symptoms as measured by the Clinical Global impression Scale. This is a clinician-rated scale to assess severity and change in symptomatology with a score of 1 indicating normal or no illness or very much improved and 7 severly ill or very much deteriorated.	From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
Primary	Relapse, depression	During every study contact the need for restart of electroconvulsive treatment or hospital admission will be evaluated by the investigator. If ECT restart or hospital admission is advised, this will be an indication of relapse.	From time of inclusion until maximum 9 months (or sooner if resumption of ECT)