Ongoing, recruitingTherapeutic use (Phase IV)Interventional

PRECISER; Prediction of ECT treatment response and reduction of Cognitive Side-effects using EEG and Rivastigmine

This research, called PRECISER, is focused on improving treatment for depression, specifically electroconvulsive therapy (ECT). ECT can be very effective for severe depression, but sometimes causes memory and thinking problems. This study is testing a medication called rivastigmine, given as a skin patch, to see if it can help prevent or lessen these memory issues. Researchers are also using brain wave measurements (EEG) and other information to create a way to accurately predict who will benefit most from ECT and who might experience side effects. The goal is to make ECT a more tailored and comfortable experience for patients by improving its effectiveness and reducing unwanted side effects on memory and thinking. It's in the 'Phase IV' stage, meaning it's looking at how well a treatment already in use works in real-world settings.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Universitair Medisch Centrum Groningen

Enrolment target

100

Start

16 Dec 2024

Depression

What is this study about?

This study, named PRECISER, is looking into ways to make a treatment for severe depression called Electroconvulsive Therapy (ECT) even better. ECT can be a very helpful treatment when other options haven't worked, but people sometimes worry about its effects on memory and thinking.

The main idea behind this research is two-fold. Firstly, it's testing whether a medicine called rivastigmine, given as a patch on the skin, can help protect memory and thinking skills during and after ECT. Researchers want to see if this medicine can reduce any memory problems that might occur. Secondly, the study is working on developing clever ways, using information from brain activity scans (like EEG) and other measurements, to predict who will respond well to ECT and who might be more likely to experience side effects. This could help doctors choose the best treatment for each person.

Ultimately, the PRECISER study aims to improve the experience of people undergoing ECT. By finding ways to reduce memory side effects and by predicting who will benefit most, the hope is to make ECT a more effective and less worrying treatment for individuals living with depression in the UK.

Key takeaways

This study aims to make ECT treatment for depression better and safer.
It's testing a medicine called rivastigmine to reduce memory problems from ECT.
Researchers are using brain scans (EEG) to predict who will respond best to ECT.
The study includes adults aged 18 and over, both men and women.
You might receive the active medicine or a placebo, and regular checks will be done.
Participation could help improve future depression treatments.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 or over. There is no upper age limit, so people of any adult age can consider joining.

Both men and women are welcome to participate in this research. The study doesn't have any restrictions based on whether you are male or female.

Apart from these general rules, your doctors will carefully check your overall health and your specific situation with depression to make sure this study is safe and suitable for you. They will explain everything in detail.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you male or female?
Are you currently being treated for depression?
Are you scheduled to receive ECT treatment?
Can you attend regular appointments for assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be receiving ECT for your depression as planned. In addition, you would either receive the rivastigmine medication via an adhesive skin patch or a similar-looking patch that contains no active medication (a placebo). You would regularly attend appointments for assessments of your memory, thinking skills, and depression symptoms. Researchers would also record your brain activity using EEG scans, collect blood samples, and ask you about your quality of life and how you are feeling. The exact number of visits and the full duration of your participation would be explained by the study team, typically covering the period of your ECT treatment and some time afterwards for follow-up.

Potential risks and benefits

Taking part might offer the potential benefit of closer monitoring of your condition and could help future patients by improving ECT treatment. While rivastigmine is generally well-tolerated, like all medicines, it can have side effects which would be fully explained. The study also involves scans and blood tests, which carry minimal risks. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is ECT?

ECT, or Electroconvulsive Therapy, is a medical treatment for severe mental health conditions, like depression, when other treatments haven't worked. It involves a brief, controlled electrical stimulation of the brain while you are asleep under general anaesthetic.

What is rivastigmine?

Rivastigmine is a medication often used to help with memory and thinking in conditions like Alzheimer's disease. In this study, it's being tested to see if it can help reduce memory problems that can sometimes happen after ECT.

What is 'Phase IV' in a study?

Phase IV means the study is looking at a treatment that is already approved and in use. Researchers want to learn more about its long-term effects, how it works in different groups of people, or new benefits.

What does 'EEG' mean?

EEG stands for Electroencephalogram. It's a test that measures brain activity by placing small sensors on your scalp. It's harmless and painless, and helps researchers understand how your brain is working.

Will I know if I'm getting the real medicine or the placebo?

No, in this type of study, neither you nor your doctors will know if you're receiving the active rivastigmine patch or a placebo (an inactive patch). This is to ensure the results are as fair and unbiased as possible.