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Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine - Trial NCT05768126

Access comprehensive clinical trial information for NCT05768126 through Pure Global AI's free database. This Phase 4 trial is sponsored by UMC Utrecht and is currently Recruiting. The study focuses on Depressive Disorder. Target enrollment is 100 participants.

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NCT05768126
Phase 4
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05768126
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Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine

Study Focus

Depressive Disorder

Rivastigmine Transdermal Product

Interventional

drug

Sponsor & Location

UMC Utrecht

Utrecht, Netherlands

Timeline & Enrollment

Phase 4

Sep 29, 2021

Jan 01, 2026

100 participants

Primary Outcome

The effect of rivastigmine on scores of the verbal fluency test.,The effect of rivastigmine on scores of the Rey auditory verbal learning test,The effect of rivastigmine on changes in scores on the Montreal Cognitive Assessment,The effect of rivastigmine on changes in scores on the Columbia University Autobiographical Memory Interview short form,Changes in resting-state EEG peak frequency,Treatment response,Treatment response,Treatment response,Treatment response,Remission,Remission,Remission,Remission

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.

ICD-10 Classifications

Depressive conduct disorder
Recurrent depressive disorder, unspecified
Recurrent depressive disorder
Other recurrent depressive disorders
Recurrent depressive disorder, currently in remission

Data Source

ClinicalTrials.gov

NCT05768126

Non-Device Trial