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Immune clues could revolutionize psychosis care

NCT ID NCT06687694

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • South London and Maudsley NHS Foundation Trust

    RECRUITING

    London, United Kingdom, SE5 8AB, United Kingdom

    Contact Email: •••••@•••••

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