How the immune system affects response to antipsychotic medicines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational biomarker study enrolling adults with psychosis who are due to start or change regular antipsychotic medication, alongside age- and sex-matched healthy controls. Investigators collect blood and cerebrospinal fluid at two main timepoints: baseline (week 0, at medication start/change) and follow-up around 4 ± 2 weeks. Clinical measures of symptoms and treatment response will be compared with immune, inflammatory, and autoantibody profiles to identify signals linked to diagnosis, prognosis, treatment selection, and response tracking. No investigational drug is administered; the study examines biological mechanisms associated with routine antipsychotic treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• South London and Maudsley NHS Foundation Trust
  London, United Kingdom, United Kingdom Recruiting

Study contacts

• Study coordinator: Thomas Pollak (Chief Investigator), PhD
• Email: IMATStudy@kcl.ac.uk
• Phone: +442078485288

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.