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Study on Improving ECT Response and Reducing Cognitive Side Effects in Depression Patients Using Rivastigmine

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for depression, specifically targeting patients who undergo Electroconvulsive Therapy (ECT). The treatment being tested is a medication called Rivastigmine, which is delivered through a transdermal patch, meaning it is applied to the skin. The study aims to see if Rivastigmine can help improve cognitive functions, such as memory and thinking skills, after ECT, making the therapy more acceptable and easier to tolerate for patients.

The trial will also explore whether it is possible to predict how well a patient will respond to ECT using clinical characteristics and EEG (a test that measures electrical activity in the brain). This could help avoid unnecessary ECT treatments for those unlikely to benefit from it. Participants in the study will receive either the Rivastigmine patch or a placebo patch, which looks the same but contains no active medication. The study will monitor changes in cognitive abilities and other health measures over time to assess the effectiveness of Rivastigmine.

By participating in this study, researchers hope to develop a method to predict ECT response and reduce its cognitive side effects, potentially improving the quality of life for patients with severe depression. The study will also investigate various factors, such as speech patterns and changes in blood and DNA, to see if they can predict the effects of ECT and Rivastigmine. The ultimate goal is to create a comprehensive prediction method to enhance treatment outcomes for depression.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age over 18 years, a clinical indication for electroconvulsive therapy (ECT), and a diagnosis of uni- or bipolar depression.

    The study is conducted in Dutch, so proficiency in the language is required.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate cognitive and memory-related measures. This assessment serves as a baseline for future comparisons.

  3. Step 3

    Medication administration

    The medication rivastigmine is administered via a transdermal patch. This means the medication is delivered through the skin.

    The dosage and frequency of the patch application are determined by the study protocol and are monitored throughout the trial.

  4. Step 4

    Ongoing assessments

    Regular assessments are conducted to monitor cognitive and memory-related measures. These assessments help determine the effect of rivastigmine compared to a placebo.

    The assessments also include evaluating the quality of life and any changes in cognitive function.

  5. Step 5

    Electroconvulsive therapy (ECT)

    ECT sessions are conducted as part of the treatment plan. The response to ECT is monitored to develop a prediction method for treatment outcomes.

    The study aims to predict who will respond to ECT using clinical and EEG characteristics.

  6. Step 6

    Final assessment

    A final assessment is conducted to compare cognitive and memory-related measures from the beginning of the study.

    The effectiveness of rivastigmine in reducing cognitive side effects and improving treatment response is evaluated.

  7. Step 7

    Completion of the study

    The study is estimated to conclude by July 31, 2025. Participants complete their involvement after the final assessments are conducted.

Who can join the trial?

4 criteria

  • Must be **over 18 years old**.
  • Must have a **clinical indication for ECT**. This means a doctor or psychiatrist has recommended ECT as a treatment.
  • Must have **uni- or bipolar depression**. This means the person has been diagnosed with either one type of depression or both types by a psychiatrist.
  • Must speak **Dutch as their first language**.

Who cannot join the trial?

5 criteria

  • Patients who do not have **depression** cannot participate. **Depression** is a mental health condition that affects mood and can cause feelings of sadness and loss of interest.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not part of the specified clinical trial groups cannot participate. This refers to specific categories or groups of patients that the study is focusing on.
  • Patients who are not male or female cannot participate. The study includes both male and female participants.
  • Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection or consideration in research.
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Investigated drugs

Rivastigmine is a medication used in this study to help improve cognitive function after Electroconvulsive Therapy (ECT). It is commonly used to treat symptoms of memory loss and confusion, which are often seen in conditions like Alzheimer's disease. In this trial, Rivastigmine is being tested to see if it can reduce the cognitive side effects that some patients experience after undergoing ECT.

What is already known about the treatment

Rivastigmine – Rivastigmine is administered orally or via a transdermal patch. It is currently used in medicine primarily for treating symptoms of Alzheimer's disease and Parkinson's disease dementia, but it is being studied for its potential to improve cognitive function in patients undergoing electroconvulsive therapy (ECT) for severe depression. The medication works by inhibiting the breakdown of acetylcholine, a neurotransmitter important for memory and learning, thereby enhancing cholinergic function in the brain. Rivastigmine is classified as a cholinesterase inhibitor.

Investigated diseases

Depression – Depression is a mental health disorder characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It can affect how a person thinks, feels, and handles daily activities, such as sleeping, eating, or working. The condition may lead to emotional and physical problems, impacting a person's ability to function at work and home. Symptoms can vary from mild to severe and may include changes in appetite, sleep disturbances, fatigue, and difficulty concentrating. Depression can occur at any age, but it often begins in adulthood. The progression of depression can be chronic or episodic, with periods of remission and recurrence.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518047-37-01Protocol code202000842Estimated enrolment100 patientsSponsorUniversitair Medisch Centrum Groningen

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