Changing Tactics? Optimizing ECT in Difficult-to-treat Depression (ChaT)

June 19, 2023 updated by: Universitaire Ziekenhuizen KU Leuven

Changing Tactics? Optimizing ECT in Difficult-to-treat Depression: A Randomized Trial Comparing Continuation of Right Unilateral ECT and Switching to Bitemporal ECT in Case of Early Non-response During an Acute Course of ECT for Difficult-to-treat Depression

The goal of this randomized controlled trial is to address which treatment strategy (continue right unilateral (RUL) ECT or switch to bitemporal (BT) ECT speeds up recovery and has the least impact on memory function, in case of early non-response during an acute course of ECT for difficult-to-treat depression.

The main questions it aims to answer are:

  • Assess the antidepressant efficacy and cognitive impact of the continuation of an ongoing treatment with RUL ECT compared to switching the treatment technique to BT ECT, in patients failing to show an early response to an acute course of ECT for major depression;
  • Assess group and subject-specific trajectories of depressive symptom severity and neurocognitive performance during the acute ECT course and up to 3 months post-treatment.

Participants treated with ECT for depression, showing no 'response' (≥50 percent decrease in depressive symptom severity compared to baseline) after 4 treatment sessions, will be randomized to either switch to BT ECT or continue with RUL ECT. Mood and neurocognitive assessments will be performed at baseline, after 4 ECT sessions (before randomization), after 8 ECT sessions, at the end of the acute course and 3 month after the acute course.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Kortenberg, Belgium
        • Recruiting
        • UPC Kortenberg
        • Contact:
          • Pascal Sienaert, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
  • Age 18 or older
  • Diagnosis of major depressive disorder (DSM-5 296.21-30) or bipolar disorder, depressed (DSM-5 296.51-54; 296.84), confirmed by MINI (Mini International Neuropsychiatric Interview)

Exclusion Criteria:

  • Contra-indication for general anesthesia
  • Non-Dutch speaking
  • Diagnosis of schizoaffective disorder or schizophrenia, confirmed by MINI
  • Diagnosis of substance use disorder in the past six months, confirmed by MINI
  • Diagnosis of neurocognitive disorder or intellectual disability alongside a MoCA score <23
  • Previous ECT course in the past three months
  • Participation in an interventional Trial with an investigational medicinal product or device
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BT ECT
Participants showing no response will be switched to BT ECT until remission is achieved.
Device: switch to BT electrode position
use of different electrode positions of ECT device
Active Comparator: RUL ECT
Participants showing no response will continue with RUL ECT until remission is achieved.
Device: continue with RUL electrode position
use of different electrode positions of ECT device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change form baseline Depressive Symptom Severity
Time Frame: after 4 ECT sessions (2 weeks)
mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)
after 4 ECT sessions (2 weeks)
Change form baseline Depressive Symptom Severity
Time Frame: after 8 ECT sessions (4 weeks)
mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)
after 8 ECT sessions (4 weeks)
Depressive Symptom Severity
Time Frame: at the end of acute ECT course (up to 7 weeks)
mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)
at the end of acute ECT course (up to 7 weeks)
Depressive Symptom Severity
Time Frame: 3 months post-acute course
mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)
3 months post-acute course
Autobiographical Memory
Time Frame: after 4 ECT sessions (2 weeks)
Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)
after 4 ECT sessions (2 weeks)
Autobiographical Memory
Time Frame: after 8 ECT sessions (4 weeks)
Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)
after 8 ECT sessions (4 weeks)
Autobiographical Memory
Time Frame: at the end of acute ECT course (up to 7 weeks)
Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)
at the end of acute ECT course (up to 7 weeks)
Autobiographical Memory
Time Frame: 3 months post-acute course
Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)
3 months post-acute course

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response/remission status
Time Frame: at the end of acute ECT course (up to 7 weeks)
number of participants with an 50 percent decrease in IDS-score/ IDS-score < 12
at the end of acute ECT course (up to 7 weeks)
number of ECT treatments needed to achieve response/remission
Time Frame: at the end of acute ECT course (up to 7 weeks)
at the end of acute ECT course (up to 7 weeks)
Neurocognitive performance (RAVLT)
Time Frame: after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course
mean scores on RAVLT (Rey Auditory Verbal Learning Test)
after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course
Neurocognitive performance (MoCA)
Time Frame: after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course
mean scores on MoCA (Montreal Cognitive Assessment)
after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course
Neurocognitive performance (COWAT)
Time Frame: after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course
mean scores on COWAT (Controlled Oral Word Association Test)
after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course
Neurocognitive performance (WMS-R)
Time Frame: after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course
mean scores on WMS-R (Wechsler Memory Scale) (Cijferreeksen)
after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical characteristics (CORE)
Time Frame: after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course
mean scores on CORE
after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course
Clinical characteristics (PDAS)
Time Frame: after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course
mean scores on PDAS
after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

AZ Sint-Jan AV
General Hospital Groeninge
Universiteit Antwerpen

Investigators

  • Principal Investigator: Pascal Sienaert, MD, PhD, UPC KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

June 19, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S67329

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Details on methodology are noted in the protocol. Questionnaires will be used as stated in their manuals. Data of assessments (informed consent, answers to questionnaires,...) are documented on paper and entered in a data platform (Redcap). When access is provided, or data is exported (using a certain standard format such as .xls or .cvs) it can be reused by other researchers. All data is provided with a clear nomenclature, referring to the scores of standardized questionnaires,cognitive assessment tools, ECT parameters,...

Further, published articles by the involved researchers will contain all details necessary to reveal context of data collection, collection methodology, analytical and procedural information, etc.

The pseudonymized data can be made available upon request, after permission is granted by the principal investigator and the head researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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