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

ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

Contra-indication for general anesthesia

Non-Dutch speaking

Diagnosis of schizoaffective disorder or schizophrenia

Diagnosis of substance use disorder in the past six months

Trial design

Treatments tested in this trial

  • switch to BT electrode position
  • continue with RUL electrode position

Treatment groups

196 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Universiteit Antwerpen

Collaborator

AZ Sint-Jan AV

Collaborator

General Hospital Groeninge

Collaborator