Actively Recruiting
Immune Mechanisms of Antipsychotic Treatment Response
Led by King's College London · Updated on 2026-03-25
500
Participants Needed
1
Research Sites
307 weeks
Total Duration
On this page
Sponsors
K
King's College London
Lead Sponsor
S
South London and Maudsley NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this study is to investigate the role of the immune system in psychotic symptoms and their response to treatment. The investigators will collect blood and cerebrospinal fluid samples from participants with psychosis symptoms who are about to start or change to a new regular antipsychotic treatment as well as a control group for comparison. Participants will be assessed at two main timepoints, at visit 1 (Week 0) and at visit 2 (4 +/-2 weeks). For participants with psychosis symptoms visit 1 will take place at the start or change of antipsychotic medication. The studies goal is to identify biomarkers that can aid in diagnosis, prognosis, treatment selection, and tracking treatment response. The investigators aim to recruit participants from the following groups: 1. Individuals with psychosis symptoms presenting to acute or outpatient services who are due to be started on or change to a new regular antipsychotic medication. 2. Age- and sex-matched control participants without neuropsychiatric disease. Findings could potentially impact the treatment of psychotic illnesses by offering mechanistic insights into targeted immune-based interventions for these disorders through high-resolution immunophenotyping techniques alongside targeted immunological assays. Ultimately, the research aims to contribute valuable resources for future studies exploring the connection between immune processes and neuropsychiatric conditions.
CONDITIONS
Official Title
Immune Mechanisms of Antipsychotic Treatment Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Experiencing psychosis symptoms requiring treatment by secondary mental health services confirmed by a psychiatrist
- Psychosis symptoms likely related to disorders classified by ICD codes F20-F39
- About to start, change, or resume a regular antipsychotic medication (including first-time treatment, switching medications, or restarting after at least two weeks off)
- Control participants aged 18 to 65 years
- Control participants have no active autoimmune disorders
- Control participants have no history of psychosis symptoms
You will not qualify if you...
- Risk of harm to participant or study staff due to behavioral disturbance
- Currently taking or taken in the last 4 weeks any medication that strongly affects immune cell production or function (e.g., corticosteroids, methotrexate, cyclophosphamide, mycophenolate mofetil, rituximab, or other monoclonal antibodies)
- Unable to have blood tests
- Significant lower spinal deformity, injury, or previous lower spinal surgery (for optional lumbar puncture)
- Use of antiplatelet or anticoagulant therapy within 14 days before lumbar puncture
- Known or suspected clotting disorder
- Clinically significant abnormal blood count
- Known or suspected raised intracranial pressure
- Known or suspected allergy to local anesthetic or its ingredients
- History of chronic or recurrent headaches as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
South London and Maudsley NHS Foundation Trust
London, United Kingdom, United Kingdom, SE5 8AB
Actively Recruiting
Research Team
T
Thomas Pollak (Chief Investigator), PhD
CONTACT
A
Amy Aldridge (Project Manager)
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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