Changing Tactics? Optimizing ECT in Difficult-to-treat Depression (ChaT)

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Depression

Treatments: Device: switch to BT electrode position; Device: continue with RUL electrode position

Study type: Interventional

Funder types: Other

Identifiers

NCT05923801

S67329

Details and patient eligibility

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.

Enrollment: 196 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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), confirmed by MINI (Mini International Neuropsychiatric Interview)

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

196 participants in 2 patient groups

BT ECT

Active Comparator group

Description:

Participants showing no response will be switched to BT ECT until remission is achieved.

Treatment:

Device: switch to BT electrode position

RUL ECT

Active Comparator group

Description:

Participants showing no response will continue with RUL ECT until remission is achieved.

Treatment:

Device: continue with RUL electrode position