NCT06687694 Immune Mechanisms of Antipsychotic Treatment Response
| NCT ID | NCT06687694 |
| Status | Recruiting |
| Phase | — |
| Sponsor | King's College London |
| Condition | Psychosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-08-06 |
| Primary Completion | 2031-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-08-06 with a primary completion date of 2031-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06687694 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Psychosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06687694 currently recruiting?
Yes, NCT06687694 is actively recruiting participants. Contact the research team at IMATStudy@kcl.ac.uk for enrollment information.
Where is the NCT06687694 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06687694 clinical trial?
NCT06687694 is sponsored by King's College London. The trial plans to enroll 500 participants.