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Clinical Trials in France / NCT05946486
Starting soon Phase 3

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

NCT05946486 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2023-10-15
Last updated
2023-07-14

Condition(s) studied

Mental Disorder

Investigational drug(s) / intervention(s)

immunomodulatory treatment by rituximab

immunomodulatory treatment by rituximab: 1g for adults or 375 mg/m2 for children, renewed at 14 days (+/- 3 days)

Study 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).

Eligibility

Sex
ALL
Min age
6 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * For Adult: First acute or relapse of psychotic disorders defined by the BPRS-E scale with or without standard pharmacological treatment. * For Children: Child over 6 years old with a first acute or relapse of psychotic disorders defined by the Kiddie sads-PL scale with or without standard pharmacological treatment. * Biological diagnosis of pathogenic CNS autoantibodies in the blood. * MDC scale score \>3 is required for inclusion in step 2. * Normal ECG in case of previous heart disease. * Informed consent of the patient or his legal representatives. * Effective contraception for women of childbearing potential during the study and for at least 12 months after the last rituximab administration. Exclusion Criteria: * Developmental disorder related to a genetic disease. * Co-existing disorder of severe neurological disease. * Chronic psychotic disorders receiving ongoing neuroleptic treatment with efficacy. * Hypersensitivity to the active substance (rituximab) or to murine proteins, or to any of the other excipients * Blood platelets \< 75x109/L * Neutrophils \< 1.5x109/L * Neoplastic pathology, * Hepatitis B or HIV infection, * Contraindication to immunosuppressant treatment (active severe infection, severely immunocompromised state). * Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease * Pregnant or breastfeeding women * Currently receiving an investigational drug or received an investigational drug or device within 30 days (or 5 half-lives for drugs, whichever is longer) prior to screening. * Previous treatment with rituximab in the past 12 months. * Patients with a history of recurring or chronic infections or with underlying conditions which may further predispose them to serious infection (e.g. hypogammaglobulinemia). * Recent vaccination with live viral vaccine (within 3 months). * Any other medical illness or disability that, in the opinion of the investigator, would compromise effective trial participation.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
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

More University Hospital, Bordeaux trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05946486 on ClinicalTrials.gov ↗ ← All trials in France