RecruitingNAINTERVENTIONAL

Metabolomics During ElectroConvulsivoTherapy

This study is investigating how electroconvulsive therapy (ECT) changes the chemicals in your blood when you're being treated for severe depression. ECT is a recognised treatment for very serious or difficult-to-treat depression, but we don't fully understand how it works at a chemical level. Researchers will take blood samples at different times during your ECT course and measure various substances in them. At the same time, they'll check your mood, thinking skills, and how well the treatment is working. The aim is to find out if these blood changes can predict how well someone will respond to ECT and give us a better understanding of the treatment's effects on the body.

At a glance

Status

Recruiting

Phase

Sponsor

Hôpital le Vinatier

Enrolment target

Start

11 Mar 2024

Estimated completion

15 Oct 2026

Major Depressive Episode ECT

What is this study about?

This study is about understanding how a treatment called electroconvulsive therapy (ECT) works for people with severe depression. ECT is a treatment where small, controlled electrical currents are passed through the brain to trigger a brief seizure. This can cause changes in brain chemistry that can quickly improve symptoms of severe depression, especially when other treatments haven't helped or for very serious cases.

While we know ECT can be very effective and safe, especially for severe depression, scientists don't yet fully understand all the ways it works in the body. This study wants to look closely at the "metabolome," which is like a fingerprint of all the small chemicals in your blood. By tracking how these chemicals change during ECT, researchers hope to get clues about the deep biological processes that ECT affects.

The main goals are to see if these blood changes can help predict who will respond well to ECT and to give doctors a clearer picture of how the treatment helps improve depression. This vital information could lead to more personalised and effective treatments in the future.

Key takeaways

The study explores how ECT affects blood chemicals in people with severe depression.
It aims to better understand how ECT works and predict who will respond best.
Participation involves giving blood samples and completing assessments during your regular ECT treatment.
You won't receive extra medication; the study monitors your body's response to ECT.
This research could help develop more targeted depression treatments in the future.

Who may be eligible?

You might be able to join this study if you are an adult, aged 18 or over, and have been diagnosed with a severe depressive episode. This could be part of a major depressive disorder or bipolar disorder, and your doctor has decided that ECT is the right treatment for you because other common treatments like antidepressants haven't worked well enough.

Before you join, you would need to understand what the study involves and give your written permission (consent) to take part. Your depression would also need to be at a certain level based on a standard assessment tool.

However, you wouldn't be able to take part if you have certain other conditions, such as some types of severe mental health problems like schizophrenia, or certain brain conditions like epilepsy or Parkinson's disease. You also wouldn't be able to join if you have certain inflammatory conditions or if you've been told you have extra risks that make ECT unsuitable for you. Also, if you're unable to give consent freely or are in a situation where your freedom is restricted, you wouldn't be able to join.

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?
Do you have a diagnosis of severe depression for which your doctor has recommended ECT?
Have you understood the study and are you able to give your written consent?
Do you have certain serious health conditions (like some types of brain diseases or inflammatory conditions) that would prevent you from joining?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be having ECT as planned for your depression. During this time, the researchers will take several blood samples. These samples will be taken before your very first ECT session, then again after that first session. Further samples will be collected before your 6th, 12th, and final ECT sessions. Along with the blood tests, at each of these time points, you'll also have assessments to check your mood, how well you're thinking (your cognitive skills), and how the treatment is generally affecting you. These assessments might involve answering questionnaires or doing short tests. There are no additional medications or treatments in this study; it focuses on monitoring your body's response to the ECT you are receiving. The total duration will depend on how many ECT sessions your doctors decide you need.

Potential risks and benefits

Taking part in this study could help us better understand how ECT works for depression, which may lead to improved treatments for others in the future. You will be receiving ECT as part of your standard medical care, so you are not exposed to new treatments. The main risks of participating in the study itself are related to the repeated blood samples, which might cause some minor discomfort or bruising. There are no direct benefits to you from the study's research aspect, but your standard ECT treatment aims to improve your depression. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Centre Hospitalier le Vinatier
Verified postcode
Bron, France· Recruiting

Common questions

What is ECT?

ECT (Electroconvulsive Therapy) is a recognised medical treatment for severe depression where small electrical currents are passed through the brain to help improve symptoms.

What are 'metabolites'?

Metabolites are tiny chemical substances found in your blood that are involved in normal body processes. They can give clues about what's happening inside your body.

Will I get extra treatment?

No, you will receive your standard ECT treatment as planned by your doctors. This study only involves taking blood samples and doing assessments during your treatment course.

Will my privacy be protected?

Yes, all your personal information and blood sample results will be kept confidential and anonymised to protect your privacy.

Can I stop participating if I want to?

Yes, you are free to withdraw from the study at any time, for any reason, without it affecting the medical care you receive.

How to find out more

COSTEMALE-LACOSTE Jean-François, PH

jean-francois.costemale-lacoste@ch-le-vinatier.fr (0)4 37 91 54 95 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.