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NOT YET RECRUITING
NCT05946486
PHASE3

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

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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

DRUG

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