Actively Recruiting
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
Eligibility Criteria
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
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
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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