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Evaluation of the Efficacy of Immunomodulatory Therapy in Case of Psychiatric Disorders With Proven Dysimmunity.
Sponsor: University Hospital, Bordeaux
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).
Official title: Phase III Randomized, Multicenter Open Label Study to Evaluate the Efficacy of Immunomodulatory Therapy in Case of Psychiatric Disorders With Proven Dysimmunity.
Key Details
Gender
All
Age Range
6 Years - Any
Study Type
INTERVENTIONAL
Enrollment
174
Start Date
2023-10-15
Completion Date
2026-12-15
Last Updated
2023-07-14
Healthy Volunteers
No
Conditions
Interventions
immunomodulatory treatment by rituximab
1g for adults or 375 mg/m2 for children, renewed at 14 days (+/- 3 days)
Locations (9)
Centre Hospitalier Charles Perrens
Bordeaux, France
CHU de Bordeaux
Bordeaux, France
Centre hospitalier le Vinatier
Bron, France
CHU de Clermond Ferrand
Clermont-Ferrand, France
APHP Louis Mourier
Colombes, France
APHP Henri Mondor
Créteil, France
APHP Kremlin Bicetre
Le Kremlin-Bicêtre, France
CHU de Montpellier
Montpellier, France
CHU de Strasbourg
Strasbourg, France