At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 71 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years to 65 Years
- Who
- All
- Number of participants
- 500
- Started
- 2025-08-06
- Last checked
- 2025-08
Plain English Summary
What is this study?
- • Testing a new treatment for psychosis
- • Clinical study - 500 participants
- • The aim of this study is to investigate the role of the immune system in psychotic symptoms and their response to treatment
Who can take part?
- • Ages 18 Years to 65 Years
- • Diagnosed with psychosis
Where?
- • London - South London and Maudsley NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 65 Years
- Who can join: All genders
What the study is looking for
- ✓Inclusion Criteria
- ✓Participants with psychosis symptoms:
- ✓Age 18-65
- ✓Currently experiencing psychosis symptoms warranting treatment by secondary care mental health services, as...
- ✓Psychosis symptoms likely to be attributable to a disorder represented by ICD codes F20-F39, in the opinion of the...
See the full criteria
Where Is This Study? (1 UK site)
South London and Maudsley NHS Foundation Trust
London SE5 8AB, United Kingdom
How to Get in Touch
Thomas Pollak (Chief Investigator), PhD
Sponsor contactCONTACT
Amy Aldridge (Project Manager)
Sponsor contactCONTACT
