Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine

• Status: Recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical trial is to test the beneficial effects of rivastigmine administration, and predict the treatment outcome with electroencephalography (EEG), in patients with severe depression treated with electroconvulsive therapy (ECT). The study has two main objectives:

• to study whether rivastigmine would ameliorate the side-effect profile of ECT

• to develop an outcome prediction model based on resting state EEG for both the response to treatment as well as its side effect

Participants will be assessed by:

• Cognitive tests

• Questionnaires of clinical symptoms

• Questionnaires of depressive symptoms

• Bloodsample

• Resting state and task-based EEG

Researchers will compare patients with a depressive disorder treated with ECT receiving rivastigmine to placebo patches to see if rivastigmine reduces cognitive side effects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Collaborators: St. Antonius Hospital; Tergooi Hospital; ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Rivastigmine

Criteria

Inclusion Criteria:

• Age over 18 years

• Clinical indication for ECT (as indicated by the treating physician/psychiatrist)

• Uni- or bipolar depression (as assessed by the treating psychiatrist)

• Fluent in Dutch

Exclusion Criteria:

• Currently receiving, or having received ECT 6 months prior to the start of the treatment/study.

• Currently using rivastigmine, galantamine, donepezil (all cholinesterase inhibitors for mild to moderate Alzheimer's Disease).

• Pregnancy and/or lactation/breast feeding

• Suspicion of neurodegenerative disorders (as diagnosed earlier)

• Contraindications for ECT (recent myocardial infarction, recent cerebrovascular accident, recent intracranial surgery, pheochromocytoma and instable angina pectoris)

• Contraindications for rivastigmine (bradycardia or atrioventricular (AV) conduction disorders (first degree AV-block excluded)

• Patients who have had an allergic reaction to rivastigmine

• Cognitive disorder not explained by the depressive episode