Immune Mechanisms of Antipsychotic Treatment Response (IMAT)

March 24, 2026 updated by: King's College London

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Contact Backup

Study Locations

  • United Kingdom
    • United Kingdom
      • London, United Kingdom, United Kingdom, SE5 8AB
        • Recruiting
        • South London and Maudsley NHS Foundation Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control Participants
Participants with psychosis symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral Immune Phenotype
Time Frame: 4 +/-2 weeks
Change in the flow cytometric peripheral immune phenotype following treatment with antipsychotic medication.
4 +/-2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

University of Oxford
South London and Maudsley NHS Foundation Trust
McPin Foundation
Francis Crick Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2025

Primary Completion (Estimated)

July 1, 2031

Study Completion (Estimated)

July 1, 2031

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 331728

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psychosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe