Optimizing ECT for difficult-to-treat depression
Official 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
Run by Universitaire Ziekenhuizen KU Leuven · NCT05923801 · Data updated 2026-11-12
This study is testing whether sticking with one type of electroconvulsive therapy or switching to another can help people with tough-to-treat depression recover faster and with less impact on their thinking.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 196 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Kortenberg) |
| Status | Recruiting |
| Started | June 1, 2023 |
| Main results expected | June 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | May 11, 2026 |
| Trial ID | NCT05923801 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older diagnosed with major depressive disorder or bipolar disorder who have not shown a significant response to initial ECT treatments.
✕Probably not a fit
Patients with contraindications for general anesthesia, non-Dutch speakers, or those with certain psychiatric disorders such as schizophrenia will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial aims to determine whether continuing with right unilateral (RUL) electroconvulsive therapy (ECT) or switching to bitemporal (BT) ECT is more effective in speeding up recovery and minimizing cognitive impact for patients with difficult-to-treat depression who show no early response to treatment. Participants will be assessed for antidepressant efficacy and cognitive performance during the acute ECT course and up to three months post-treatment. The study will involve patients diagnosed with major depressive disorder or bipolar disorder who have not responded adequately after four ECT sessions.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with difficult-to-treat depression, enhancing recovery rates while preserving cognitive function.
How similar studies have gone: Other studies have explored ECT techniques, but this specific comparison of RUL versus BT ECT in early non-responders is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
UPC Kortenberg
Kortenberg, Belgium Recruiting
Study contacts
- Principal investigator: Pascal Sienaert, MD, PhD — UPC KU Leuven
- Study coordinator: Pascal Sienaert, MD,PhD
- Email: pascal.sienaert@upckuleuven.be
- Phone: +322 758 05 11
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.