Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05923801

Changing Tactics? Optimizing ECT in Difficult-to-treat Depression

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-05-11

196

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

U

Universitaire Ziekenhuizen KU Leuven

Lead Sponsor

U

Universiteit Antwerpen

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Changing Tactics? Optimizing ECT in Difficult-to-treat Depression

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary written informed consent has been obtained
  • Age 18 or older
  • Diagnosis of major depressive disorder or bipolar disorder with a depressive episode
Not Eligible

You will not qualify if you...

  • Contraindication 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 with MoCA score below 23
  • Previous ECT course in the past three months
  • Participation in an interventional trial with an investigational medicinal product or device
  • Pregnancy

AI-Screening

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Trial Site Locations

Total: 1 location

1

UPC Kortenberg

Kortenberg, Belgium

Actively Recruiting

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Research Team

P

Pascal Sienaert, MD,PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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