Electroconvulsive TherapyCOVID-M-ECTNCT05633368
Impact of Covid-19 Pandemic on Patients Receiving Continuation or Maintenance Electroconvulsive Therapy
An observational study of Electroconvulsive Therapy and Major Depressive Disorder, run by University Hospital, Ghent at 2 sites in Belgium.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Electroconvulsive Therapy, Major Depressive Disorder, Covid-19
- What is being tested?
- Questionnaires
- How many people
- 47 participants
- Where
- 2 sitesBelgium
- Study dates
- 31 Mar 2020to 19 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- Continuation or maintenance ECT, in treatment at two specified ECT-centers in Belgium
- Unipolar depressive disorder
Who cannot join
- Unable to provide informed consent
- Unable to comply with study requirements (telephone questionnaire)
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ghent University Hospital
Ghent, East-Flanders, 9000
AZ Groeninge
Kortrijk, West-Flanders, 8500
About this study
Official title: Impact of Covid-19 Pandemic on Patients With Unipolar Depressive Disorder: Effects of Discontinuing Continuation or Maintenance Electroconvulsive Therapy
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.
Read the 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.
- Being tested
- Questionnaires
- Keywords
- Electroconvulsive therapy, Maintenance ECT, Continuation ECT, Major depressive disorder, Covid-19
- Medical subject headings
- Depressive Disorder, Major, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaires | |
| 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. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
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'.
Measured: From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
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.
Measured: From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
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.
Measured: From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
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.
Measured: From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start31 Mar 2020
- Primary completion19 Jun 2020
- Study completion19 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electroconvulsive TherapyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nele Van de Velde, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633368
- Sponsor's protocol ID
- BC-07543
- Acronym
- COVID-M-ECT
- Status last verified
- Nov 2022
- First submitted
- 29 Jun 2020
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and/or analyzed during the current study are not publicly available due to confidentiality issues but are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Covid-19 Pandemic on Patients With Unipolar Depressive Disorder: Effects of Discontinuing Continuation or Maintenance Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT05633368
- Acronym / sponsor ID
- COVID-M-ECT / BC-07543
- Keywords
- Electroconvulsive therapy, Maintenance ECT, Continuation ECT, Major depressive disorder, Covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 19 Jun 2020 (actual)
- Study completion
- 19 Jun 2020 (actual)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discontinuation of C/M-ECT | – | Other: QuestionnairesParticipants 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. |
| Continuation of C/M-ECT | – | Other: QuestionnairesParticipants with major depressive disorder who are able to continue maintenance (M-ECT) or continuation electroconvulsive therapy (C-ECT) during Covid-19. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Continuation or maintenance ECT, in treatment at two specified ECT-centers in Belgium
- Unipolar depressive disorder
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- Unable to comply with study requirements (telephone questionnaire)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesParticipants 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 | Other | Continuation of C/M-ECT, Discontinuation of C/M-ECT |
Primary outcome
Change in depressive symptoms (PHQ-9)
Time frame: From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
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.
Change in depressive symptoms, subjective score, scaling question
Time frame: From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
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'.
Change in depressive symptoms, subjective score
Time frame: From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
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.
Change in depressive symptoms (CGI)
Time frame: From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
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.
Relapse, depression
Time frame: From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Individual participant dataSharing planned: No. The datasets generated and/or analyzed during the current study are not publicly available due to confidentiality issues but are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nele Van de Velde principal investigator
University Hospital, Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electroconvulsive Therapy and Major Depressive Disorder, run by University Hospital, Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms (PHQ-9) (time frame: From time of inclusion until maximum 9 months (or sooner if resumption of ECT)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.