drugset / Trial / NCT05946486

Evaluation of the Efficacy of Immunomodulatory Therapy in Case of Psychiatric Disorders With Proven Dysimmunity.

NCT05946486 ↗

Phase 3 Not yet recruiting 174 enrolled University Hospital, Bordeaux
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open phase III randomized clinical trial studying the superiority of management by immunomodulator treatment of psychiatric disorders (psychosis and bipolar disorders) for patients previously identified as carriers of autoimmunity such as as the presence of a pathogenic anti-glutamatergic NMDA receptor antibody (NMDAr-Ac).

Timeline

Start
2023-10-15
Primary completion
2026-01-15
Completion
2026-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 375 mg/m2 —
Subject Rituximab Monoclonal antibody 1 g —

Indications