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RecruitingNCT06687694IMATUpdated Mar 25, 2026

Immune Mechanisms of Antipsychotic Treatment Response

An observational study in Psychosis, sponsored by King's College London. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-25.

Sponsored by King's College London · Observational

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Psychosis

Keywords

  • Psychosis
  • Antipsychotic
  • Neuroimmunology
  • Inflammation
  • Autoantibody
  • Schizophrenia
  • Schizotypal disorder
  • Persistent delusional disorders
  • Acute and transient psychotic disorders
  • Induced delusional disorder
  • Schizoaffective disorders
  • Other nonorganic psychotic disorders
  • Unspecified nonorganic psychosis
  • Manic episode
  • Bipolar affective disorder
  • Depressive episode
  • Recurrent depressive disorder
  • Persistent mood [affective] disorders
  • Other mood [affective] disorders
  • Unspecified mood [affective] disorder
03

In context

Psychotic Disorders

1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.

This study's planned enrollment of 500 is above the median of 123 across 221 observational studies indexed under Psychotic Disorders.

Browse Psychotic Disorders studies →

Lead sponsor

King's College London is the lead sponsor of 520 studies on the registry; 126 are open to participants now.

Browse King's College London studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 disorder.
  • No history of psychosis symptoms.

Exclusion criteria

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. , 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.
  • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Participants with psychosis symptoms
  • Control Participants
06

What researchers measure

Primary outcomes

  1. Peripheral Immune Phenotype

    Change in the flow cytometric peripheral immune phenotype following treatment with antipsychotic medication.

    Time frame: 4 +/-2 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Jul 2031, 71 months after the start.

Of 74 non-industry observational studies under Psychotic Disorders, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 124. This study's planned 71 months is above that.

Counting every sponsor, half of 76 studies reached it within 64 months; a quarter within 35 and three quarters within 124.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 12, 2024
First posted
Nov 13, 2024
StartActual
Aug 6, 2025
Primary completionEst.
Jul 2031
CompletionEst.
Jul 2031
Last update
Mar 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06687694
Lead sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust, University of Oxford, McPin Foundation, Francis Crick Institute
Responsible party
Sponsor
First posted
Nov 13, 2024
Start date
Aug 6, 2025
Primary completion
Jul 2031 (estimated)
Completion
Jul 2031 (estimated)
Last update
Mar 25, 2026

Study contacts

Thomas Pollak (Chief Investigator), PhD
Contact
IMATStudy@kcl.ac.uk
+442078485288
Amy Aldridge (Project Manager)
Contact
IMATStudy@kcl.ac.uk
+442078485288

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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