Actively Recruiting
Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine
Led by UMC Utrecht · Updated on 2024-05-10
100
Participants Needed
1
Research Sites
222 weeks
Total Duration
On this page
Sponsors
U
UMC Utrecht
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Clinical indication for ECT as determined by the treating psychiatrist
- Diagnosis of unipolar or bipolar depression
- Fluent in Dutch
You will not qualify if you...
- Receiving or having received ECT within 6 months before study start
- Current use of rivastigmine, galantamine, or donepezil
- Pregnancy or breastfeeding
- Suspicion or diagnosis of neurodegenerative disorders
- Contraindications for ECT such as recent heart attack, stroke, brain surgery, pheochromocytoma, or unstable angina
- Contraindications for rivastigmine including bradycardia or certain heart conduction disorders (excluding first degree AV-block)
- Known allergy to rivastigmine
- Cognitive disorder not explained by depression
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UMC Utrecht
Utrecht, Netherlands
Actively Recruiting
Research Team
J
Jasper O. Nuninga, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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