RecruitingOBSERVATIONAL

Immune Mechanisms of Antipsychotic Treatment Response

This study is investigating if there's a link between your immune system and psychosis, and how this might affect how well antipsychotic medicines work. Researchers want to collect blood and a small amount of fluid from around your spinal cord (only if you agree) from people experiencing psychosis who are starting or changing their medication. They'll also compare these samples to those from people without neuropsychiatric conditions. The aim is to find biological markers that could help doctors diagnose psychosis sooner, predict who might respond best to certain treatments, and tailor care more effectively. Ultimately, this research hopes to improve treatments for psychosis by understanding the immune system's role.

At a glance

Status

Recruiting

Sponsor

King's College London

Enrolment target

500

Start

06 Aug 2025

Estimated completion

01 Jul 2031

Psychosis

What is this study about?

Imagine your body has its own private army against germs and illnesses – that's your immune system. This study wants to understand if there's a connection between this army and symptoms of psychosis. Psychosis is a serious mental health condition where people can have thoughts and experiences that aren't based in reality, like hearing voices or having strong, unusual beliefs.

Researchers think that the immune system might play a part in why some people develop psychosis or why certain treatments work better for some than others. By looking closely at blood samples and, for some, a small amount of fluid from around the spine, they hope to find certain clues. These clues could be like hidden messages that tell us more about psychosis and how the body responds to medicines. They're also comparing these findings with people who don't have these conditions to see the differences.

The main goal of this research is to find better ways to help people with psychosis. If they can understand the immune system's role, it might lead to new and more personalised treatments. This could mean doctors could choose the best medicine for you more quickly, or even develop completely new types of treatments that focus on your immune system.

Key takeaways

Looks at the link between your immune system and psychosis.
Aims to find clues (biomarkers) to improve diagnosis and treatment.
Involves two visits, blood tests, and an optional spinal fluid test.
Recruiting people with psychosis and healthy volunteers.
Your regular medical care and medication won't change.
Could help develop new, targeted treatments for psychosis in the future.

Who may be eligible?

This study is looking for two main groups of people. Firstly, they need people between 18 and 65 years old who are currently experiencing symptoms of psychosis and are about to start a new antipsychotic medication or change their current one. A specialist doctor involved in your care will confirm if you meet this. Your psychosis symptoms should be those typically managed by mental health services.

Secondly, they need healthy volunteers, also between 18 and 65, who do not have any mental health conditions or serious autoimmune diseases. These volunteers will help serve as a comparison group.

There are also some reasons why you wouldn't be able to join. For anyone, if joining the study might put you or the study team at risk, or if you can't have blood tests, you wouldn't be eligible. Also, if you're taking medications that strongly affect your immune system, such as certain steroids or other specific drugs, you wouldn't be able to participate.

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 between 18 and 65 years old?
Are you currently experiencing symptoms of psychosis?
Are you about to start a new or change your current antipsychotic medication?
Are you generally well and not taking certain strong immune-affecting medications?
Are you able to have blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, there will be two main visits. The first visit will happen when you're just starting or changing your antipsychotic medication. The second visit will be about four weeks later (it could be a couple of weeks earlier or later, depending on timing).

At both visits, you'll have assessments to understand your symptoms and general health. You'll also be asked to provide blood samples. Additionally, for some participants, there's an optional procedure called a lumbar puncture, where a small amount of fluid is taken from around your spinal cord. This is entirely optional and would only happen if you agree and meet additional health checks. The study team will explain everything in detail, and you can always say no to the lumbar puncture if you change your mind. Your medication will be managed by your usual care team.

Potential risks and benefits

Taking part in this study won't directly improve your health, but the information collected could help improve treatments for people with psychosis in the future. The main risks involve the blood tests, which might cause some discomfort or bruising, and the optional lumbar puncture, which carries slight risks like headaches. The research team will explain all potential risks in detail. Remember, your participation is completely voluntary; you can withdraw at any time without affecting your medical care.

Locations (1)

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

South London and Maudsley NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is psychosis?

Psychosis is a mental health condition where a person experiences a distorted view of reality, such as hearing or seeing things that aren't there, or having strong, unusual beliefs.

What is the immune system?

Your immune system is your body's natural defence against infections and illnesses, like an army protecting your body from harm.

Will my regular medication change?

No, your regular doctor will decide your medication, not the study. This study simply observes people who are starting or changing their usual antipsychotic treatment.

What is a lumbar puncture?

A lumbar puncture (also called a 'spinal tap') is a medical procedure to collect a small amount of fluid from around your spinal cord. It's optional for this study and extra checks are done first.

What happens to my samples?

Your blood and fluid samples will be used by the researchers to look for clues about how the immune system might be linked to psychosis and treatment responses. They are kept private and coded.

How to find out more

Thomas Pollak (Chief Investigator), PhD

imatstudy@kcl.ac.uk +442078485288 Official trial record

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