Immune clues could revolutionize psychosis care
NCT ID NCT06687694
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study investigates how the immune system influences psychotic symptoms and response to antipsychotic medication. Researchers will collect blood and spinal fluid from 500 participants, including those starting or changing antipsychotics and healthy controls. The goal is to find biomarkers that help diagnose, predict, and track treatment response, potentially leading to targeted immune-based therapies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to immune-based treatments for psychosis and better ways to choose the right antipsychotic for each patient.
- What could go wrong
- This is an observational study, not a treatment trial. It is early-stage research, and findings may not directly lead to new therapies or apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2025
- Expected to finish
-
Jul 2031
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants with psychosis symptoms will be recruited from clinical services at participating sites. Control participants may be recruited via online and offline channels. This may include posting on social media platforms, sharing information with local research networks or databases and displaying adverts on notice boards in public places in collaborating universities and NHS facilities.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria Participants with psychosis symptoms: * Age 18-65 * Currently experiencing psychosis symptoms warranting treatment by secondary care mental health services, as confirmed by a psychiatrist involved in their treatment. * Psychosis symptoms likely to be attributable to a disorder represented by ICD codes F20-F39, in the opinion of the treating clinical team. * Due to start or change to a new regular antipsychotic medication. (Participants who are initiating antipsychotic treatment for the first time, transitioning to a different antipsychotic medication, or resuming a formerly prescribed antipsychotic medication that was discontinued for a minimum of two weeks may be recruited.) Control Participants * Age 18-65 * No active autoimmune disorder. * No history of psychosis symptoms. Exclusion Criteria Participants with psychosis symptoms: * Unacceptable risk of harm to participant or study staff due to risk of behavioural disturbance. * Currently taking or having taken in the last four weeks any medication known to grossly affect the production or function of immune cells (e.g. corticosteroids, methotrexate, cyclophosphamide, mycophenolate mofetil, rituximab or other monoclonal antibody therapies). * Inability to have blood tests. Control participants: * Unacceptable risk of harm to participant or study staff due to risk of behavioural disturbance. * Currently taking or having taken in the last four weeks any medication known to grossly affect the production or function of immune cells (e.g. corticosteroids, methotrexate, cyclophosphamide, mycophenolate mofetil, rituximab or other monoclonal antibody therapies). * Inability to have blood tests. Optional lumbar puncture only: * Significant lower spinal deformity (such as spina bifida), injury (such as stenosis) or previous lower spinal surgery. * Antiplatelet or anticoagulant therapy within the 14 days prior to Lumbar Puncture procedure. * Known or suspected clotting disorder. * Clinically significant abnormality in full blood count. * Known or suspected raised intracranial pressure, assessed by study clinician. * Known or suspected allergy to local anaesthetic agent or an ingredient of the anaesthetic solution. * History of chronic or recurrent headaches, in the opinion of the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Psychosis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
-
Contact
Email: •••••@•••••
Locations
-
South London and Maudsley NHS Foundation Trust
RECRUITINGLondon, United Kingdom, SE5 8AB, United Kingdom
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Scientists build a computer model of the brain to explain hearing voices
- Can schools catch teen mental health struggles before they escalate?
- Can a phone app curb cannabis use in early psychosis?
- Can a nasal insulin spray rev up brain energy and sharpen thinking in psychosis?
- Can virtual reality from home sharpen social skills in schizophrenia?
- Can DBT skills ease emotional distress after a first psychotic episode?