Recruiting

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

ClinicalTrials.gov IDNCT05923801

PhaseNA

Enrollment196

SponsorUniversitaire Ziekenhuizen KU Leuven

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Depression

About this study

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.

Interventions

Device: switch to BT electrode position — use of different electrode positions of ECT device
Device: continue with RUL electrode position — use of different electrode positions of ECT device

Primary outcomes

Change form baseline Depressive Symptom Severity (after 4 ECT sessions (2 weeks))
Change form baseline Depressive Symptom Severity (after 8 ECT sessions (4 weeks))
Depressive Symptom Severity (at the end of acute ECT course (up to 7 weeks))
Depressive Symptom Severity (3 months post-acute course)
Autobiographical Memory (after 4 ECT sessions (2 weeks))
Autobiographical Memory (after 8 ECT sessions (4 weeks))
Autobiographical Memory (at the end of acute ECT course (up to 7 weeks))
Autobiographical Memory (3 months post-acute course)

Eligibility information

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

Study locations

UPC Kortenberg, Kortenberg, Belgium

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.