
Research Square (Research Square), Journal Year: 2023, Volume and Issue: unknown
Published: Oct. 6, 2023
Abstract Background: The role of inflammation in the aetiology schizophrenia has gained wide attention and research on association shows an exponential growth last 15 years. Autoimmune diseases severe infections are risk factors for later development schizophrenia, elevated inflammatory markers childhood or adolescence associated with a greater adulthood, individuals have increased levels pro-inflammatory cytokines compared to healthy controls, autoimmune overrepresented schizophrenia. However, treatments anti-inflammatory agents so far doubtful clinical relevance. primary objective this study is test whether monoclonal antibody rituximab, directed against B-cell antigen CD20 ameliorates psychotic symptoms adults schizoaffective disorder examine potential mechanisms. A secondary characteristics inflammation-associated psychosis identify pre-treatment biochemical rituximab responders. third interview subset patients informants their experiences trial obtain insights that rating scales may not capture. Methods: proof-of-concept employing randomised, parallel-group, double-blind, placebo-controlled design testing effect depletion psychosis. 120 participants diagnosis spectrum disorders (SSD) (ICD-10 codes F20, F25) will receive either one intravenous infusion (1000 mg) saline. Psychiatric measures blood samples be collected at baseline, week 12, 24 post-infusion. Brief assessments also made weeks 2 7. Neuroimaging lumbar puncture, both optional, performed baseline endpoints. Approximately 40 interviewed qualitative analyses perceived changes well-being emotional qualities, addition views research. Discussion: This first RCT investigating add-on treatment unselected SSD patients. If helpful, it transform disorders. It heighten awareness immune-psychiatric reduce stigma. Trial registration: NCT05622201, EudraCT-nr 2022-000220-37 version 2.1. registered 14 th October 2022.
Language: Английский