eligibility_summary
Incl: Adults or children >6 with first/relapse psychosis (BPRS-E/Kiddie-SADS), blood CNS autoantibody+, MDC>3, WOCBP contraception x12 mo post-RTX. Excl: genetic developmental/severe neuro disease, controlled chronic psychosis, RTX/murine allergy, plt<75, neut<1.5 (x10^9/L), cancer, HBV/HIV, immunosuppression contraindicated, severe/uncontrolled heart disease, pregnant/lactating, recent investigational Rx, RTX in last 12 mo, recurrent infections/hypogammaglobulinemia, live vaccine <3 mo.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05946486. Interventions: Rituximab added to usual psychiatric care vs usual care alone. Rituximab is a chimeric monoclonal antibody (drug) targeting CD20, dose 1 g for adults or 375 mg/m2 for children, repeated after ~14 days. Mechanism: depletes CD20+ B cells to reduce pathogenic CNS autoantibodies. Targeted cells/pathways: B-cell–mediated humoral immunity producing autoantibodies (notably anti–glutamatergic NMDA receptor antibodies). Intended effect: lower autoantibody burden, attenuate immune-driven neuroinflammation, and mitigate antibody-mediated disruption of NMDA receptor signaling in psychosis/bipolar disorders with proven dysimmunity.