Recipient organisationNIHR Royal Liverpool & Broadgreen University Clinical Research Facility
NIHR supportRecorded as supported by this research centre
PeriodJan 2025 — Ongoing
In plain English
AI plain-English summary
Around a third of people with psychosis do not respond to standard antipsychotic drugs, and inflammation may be part of the reason. This feasibility study will recruit 15 people experiencing their first episode of psychosis (before they start medication), 10 people with treatment-resistant schizophrenia (before they begin clozapine), and a group of healthy volunteers. Researchers will take blood samples to measure immune markers, track who agrees to participate and stays in the study, and identify practical barriers to recruitment and retention. Why this matters: current treatments fail many patients, and immune-based therapies could offer a new option—but only if trials can reliably identify which patients have the right immune profile. Without this groundwork, larger trials risk wasting resources on the wrong participants. If successful, this study will provide the recruitment rates, cost estimates, and immune-marker variability needed to design a definitive clinical trial testing anti-inflammatory drugs for psychosis. That trial could eventually lead to a new class of treatments for people who currently have few alternatives. For now, the research is a necessary feasibility step—it does not test any therapy itself, but without it, the larger trial cannot happen.
View original technical description
Current drug treatments for psychosis do not work in approximately 30% of patients. Non-response in some patients with psychosis appears to be associated with abnormalities in markers of inflammation, but the specific mechanism in psychosis is not well understood. This study aims to assess whether it is feasible to recruit and retain two groups of patients with schizophrenia (treatment-resistant and antipsychotic-naïve) and healthy controls to assess and compare clinical symptoms and immune signatures. Immune signatures from blood tests will be obtained at baseline. The findings will inform a future study with anti-inflammatory properties to see if symptoms of psychosis can be improved in patients with pre-selected immune signatures. As a necessary prior step the objectives of this feasibility study are:1.To recruit two groups of patients who meet criteria for i) First Episode Psychosis (FEP) (n=15) and before commencement of antipsychotic treatment ii) Treatment Resistant Schizophrenia (TRS) (n=10) before commencement of clozapine therapy and healthy volunteers.2.Establish the rates at which patients with FEP and TRS consent to participate and use this information to inform design and costings for a future interventional trial. 3.Identify aspects of the study least acceptable to participants and use this information to modify future study design.4.Assess the acceptability of participants to take part and remain in the trial.5.Identify the research and personal factors in those who decline to participate or do not compete the trial and identify remediable obstacles to participation.6.To demonstrate capability to a future funding body ability to obtain, process, store, retrieve and analyse 40 blood samples from the 3 groups using existing infrastructure, data processing and analytics and required human resource. 7. Determine within and between group variability of the immune markers for initial power calculations to determine sample sizes in designing a definitive study and clinical trial.
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