Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05768126
PHASE4

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

Sponsor: UMC Utrecht

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2021-09-29

Completion Date

2026-01

Last Updated

2024-05-10

Healthy Volunteers

No

Interventions

DRUG

Rivastigmine Transdermal Product

The patches will be administered (first four weeks 4.6 mg and then 9.5. mg).

OTHER

Sham

The sham patches will be administered during the same period of time as the rivastigmine.

Locations (1)

UMC Utrecht

Utrecht, Netherlands