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Immune Mechanisms of Antipsychotic Treatment Response

Sponsor: King's College London

NCT ID: NCT06687694

View on ClinicalTrials.gov ↗

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.

Psychosis

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What we know so far

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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
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 Is This Study? (1 UK site)

South London and Maudsley NHS Foundation Trust

London SE5 8AB, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Thomas Pollak (Chief Investigator), PhD

Sponsor contact

CONTACT

+442078485288 IMATStudy@kcl.ac.uk

Amy Aldridge (Project Manager)

Sponsor contact

CONTACT

+442078485288 IMATStudy@kcl.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-08