Neuroimmune profiling for psychosis study: NIPPY
Research type
Research Study
Full title
Establishing and testing neuroimmune profiling for clinical trials of novel immune-based therapies in schizophrenia: a feasibility study.
IRAS ID
338523
Contact name
Inti Qurashi
Contact email
Sponsor organisation
Mersey Care NHS Foundation Trust
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
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.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
24/SC/0256
Date of REC Opinion
12 Dec 2024
REC opinion
Further Information Favourable Opinion