Clinical trial NCT05633368: Impact of Covid-19 Pandemic on Patients Receiving Continuation or Maintenance Electroconvulsive Therapy
Official title: Impact of Covid-19 Pandemic on Patients With Unipolar Depressive Disorder: Effects of Discontinuing Continuation or Maintenance Electroconvulsive Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Electroconvulsive Therapy
Major Depressive Disorder
Covid-19
Keywords: Electroconvulsive therapy
Maintenance ECT
Continuation ECT
Major depressive disorder
Covid-19
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients receiving continuation or maintenance ECT for unipolar depressieve disorder in two ECT clinics in Belgium at the time of the start of the study (31/03/2020).

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in depressive symptoms (PHQ-9)
timeFrame: From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
measure: Change in depressive symptoms, subjective score, scaling question
timeFrame: From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
measure: Change in depressive symptoms, subjective score
timeFrame: From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
measure: Change in depressive symptoms (CGI)
timeFrame: From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
measure: Relapse, depression
timeFrame: From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: East-Flanders
city: Kortrijk
country: Belgium
facility: AZ Groeninge
state: West-Flanders
Study officials:
affiliation: University Hospital, Ghent
name: Nele Van de Velde
role: PRINCIPAL_INVESTIGATOR
References: