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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-29

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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Electroconvulsive therapy (ECT) is the most potent psychiatric treatment, with an effect size of 1.5 for severe and refractory unipolar and bipolar depression. ECT convincingly outperforms pharmacotherapy such as tricyclic antidepressants and monoamine oxidase inhibitors and any form of psychotherapy. Despite its outstanding performance in reducing depressive symptoms up to the point of full remission, it is used only marginally. One reason for its infrequent use may be that the response to ECT is largely unpredictable, while cognitive side-effects occur frequently.

In a previous study, the researchers found that multiple cognitive tests showed a significant decline immediately post-ECT, which resolved within 6 months after the last ECT session without further treatment. Even though cognitive side-effects are mostly short-lasting, both patients and doctors see this as a great drawback of ECT. If these disturbing side-effects could be prevented, more patients and psychiatrists would choose ECT as a treatment option. This would lead to a more effective treatment and hence shorter duration of chronic severe depression and improvement in quality of life, while costs for health care and loss of productivity would decrease. A potential way of ameliorating side effects, could be to add a cholinesterase inhibitor to ECT treatment. Rodent studies show that the loss of cholinergic fibers specifically correlated to the cognitive side effects of rodents after electroconvulsive stimulation (ECS). The researchers selected rivastigmine (a cholinesterase inhibitor) as a potential candidate in counteracting cognitive side effects induced by cholinergic fiber loss due to ECT. Rivastigmine patches are very well tolerated and widely used for Alzheimer's and Parkinson's dementia.

Tailoring treatment to patients that are likely to respond while cognitive side-effects are unlikely to occur, would be another important improvement for depressed patients. Currently, ECT outcome is unpredictable. Factors that favor response include older age, psychotic depression, shorter duration of the depressive episode, and smaller volumes of the dentate gyrus (a part of the hippocampus). However, these predictors do not provide enough accuracy to make individual response profiles. Accurately classifying specifically non-responders will prevent application of ineffective treatment with potential iatrogenic damage, while more accurately predicted response will increase the applicability of ECT as treatment option. A potentially powerful way that is easy to implement in the clinic is prediction of ECT response using resting state EEG characteristics in addition to clinical information.

Conditions

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Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rivastigmine

Rivastigmine, transdermal administration with a dosage of 4.6 and 9.6mg. The patches will be administered daily. The duration will equate to the duration of ECT treatment (that will be clinically determined)

Group Type EXPERIMENTAL

Rivastigmine Transdermal Product

Intervention Type DRUG

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

Sham

Non-active patches will be administered daily. The duration will equate to the duration of ECT treatment (that will be clinically determined)

Group Type SHAM_COMPARATOR

Sham

Intervention Type OTHER

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

Interventions

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Rivastigmine Transdermal Product

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

Intervention Type DRUG

Sham

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No