Immune Mechanisms of Antipsychotic Treatment Response
ConditionPsychosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorKing's College London
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.)
Disqualifiers
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.
Unacceptable risk of harm to participant or study staff due to risk of behavioural disturbance.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 2 trial groupsGroup A: Participants with psychosis symptoms
Group B: Control Participants
Trial outcomes
Primary outcomes
1
Peripheral Immune Phenotype
Change in the flow cytometric peripheral immune phenotype following treatment with antipsychotic medication.
Time frame
4 +/-2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
King's College London
Lead sponsor
South London and Maudsley NHS Foundation Trust
Collaborator
University of Oxford
Collaborator
McPin Foundation
Collaborator
Francis Crick Institute
Collaborator
Source ClinicalTrials.gov