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Completed

NCT Number: NCT05633368

Impact of Covid-19 Pandemic on Patients Receiving 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.

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Key information

Conditions

Electroconvulsive Therapy COVID-19 Coronaviridae Infections Coronavirus Infections Depressive Disorder Depressive Disorder, Major Infections Lung Diseases Major Depressive Disorder Mental Disorders Mood Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University Hospital, Ghent, East-Flanders, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

questionnaires

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

Primary outcomes

  1. 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.

  2. 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'.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: COVID-M-ECT

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 1, 2022
Registry last updated
Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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