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NCT Number: NCT05923801

Changing Tactics? Optimizing ECT in 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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPC Kortenberg

Kortenberg, Belgium

Location status: Recruiting

Location contact

Pascal Sienaert, MD, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

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

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).

Exclusion criteria

  • Contra-indication for general anesthesia
  • Non-Dutch speaking
  • Diagnosis of schizoaffective disorder or schizophrenia
  • Diagnosis of substance use disorder in the past six months
  • 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

Treatment and study plan

switch to BT electrode position

Device

use of different electrode positions of ECT device

continue with RUL electrode position

Device

use of different electrode positions of ECT device

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. Depressive Symptom Severity

    Time frame: 3 months post-acute course

    mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)

  5. Autobiographical Memory

    Time frame: after 4 ECT sessions (2 weeks)

    Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)

  6. Autobiographical Memory

    Time frame: after 8 ECT sessions (4 weeks)

    Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)

  7. 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)

  8. Autobiographical Memory

    Time frame: 3 months post-acute course

    Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)

Secondary outcomes

  1. 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

  2. number of ECT treatments needed to achieve response/remission

    Time frame: at the end of acute ECT course (up to 7 weeks)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

Other outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Pascal Sienaert, MD,PhD

CONTACT

[email protected]

+322 758 05 11

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • AZ Sint-Jan AV
  • General Hospital Groeninge
  • Universiteit Antwerpen

Registry information

Official study title

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

Acronym: ChaT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 28, 2023
Registry last updated
May 11, 2026

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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