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

NCT05768126 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-05-10

No results posted yet for this study

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.

Conditions

  • Depressive Disorder

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.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • St. Antonius Hospital

    collaborator OTHER

  • Tergooi Hospital

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Iris EC Sommer, PhD, MD · UMC Groningen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-29
Primary Completion
2025-12-31
Completion
2026-01-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05768126 on ClinicalTrials.gov