eligibility_summary
Inclusion: Adults 18–55 with ≥1‑year DSM‑5 schizophrenia spectrum disorder, insufficient response to antipsychotics, CGI‑S ≥4, lucid/oriented and able to consent, females at risk use contraception/abstinence. Exclusion: pregnant/breastfeeding, weight <40 kg, active/chronic infection or HBV/HCV/HIV/TB positive, cancer ≤2 yrs, severe heart disease/arrhythmia/MI, antipsychotic change <4 wks, clozapine, immunomodulators, or mAb in past year, unable to consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 randomized, double-blind, placebo-controlled add-on trial in adults with schizophrenia spectrum disorder tests rituximab (1000 mg IV infusion, chimeric anti-CD20 monoclonal antibody) versus saline. Mechanism: rituximab binds CD20 on pre‑B and mature B lymphocytes, depleting B cells via complement-dependent cytotoxicity, antibody‑dependent cellular cytotoxicity, and apoptosis, this lowers autoantibody production, antigen presentation, and pro‑inflammatory signaling. Targeted cells/pathways: CD20+ B cells, humoral immune pathways including B‑cell receptor signaling, cytokine/chemokine outputs, and putative CNS immune activation. Biomarkers (blood ± CSF, gene/protein) and rsfMRI assess immune–brain correlates of response.