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

Phase 3Not Yet RecruitingNCT05946486

University Hospital, Bordeaux174 enrolled

Overview

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). The aim is to assess the clinical efficacy of this treatment associated with the usual recommended psychotropic treatment. To meet this objective, we will use, via a National Center for Scientific Research (CNRS) Research laboratory in Bordeaux, a very sensitive diagnostic platform to detect and demonstrate the pathogenesis of antibodies in patient serum. This platform is operational only within the framework of validation of the results by the reference center for neurological autoimmune diseases in Lyon

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

174

Conditions

Mental Disorder

Interventions

immunomodulatory treatment by rituximabDRUG

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

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

Adult patients : the remission of psychiatric symptoms at 3 months

The primary endpoint outcome is the remission of psychiatric symptoms at 3 months, defined as: \- For adult patients: 20% decrease from baseline of Brief psychiatric rating scale-Extended (BPRS-E scale).

Time frame: 3 months after randomization

Minor patients : the remission of psychiatric symptoms at 3 months

The primary endpoint outcome is the remission of psychiatric symptoms at 3 months, defined as: \- For patients \<18years or adults patients included at adolescent age at 2nd step inclusion visit: clinically significant difference ≤3 from baseline of CBCL/6-18 (Child Behavior Checklist) scale.

Time frame: 3 months after randomization

Secondary Outcomes

Adult Patients : the remission of psychiatric symptoms at 12 months

the remission of psychiatric symptoms defined as: \- For adult patients: 20% decrease from baseline of Brief psychiatric rating scale-Extended (BPRS-E scale).

Time frame: 12 months after randomization

Adult Patients : the remission of psychiatric symptoms at 6 months

the remission of psychiatric symptoms defined as: \- For adult patients: 20% decrease from baseline of Brief psychiatric rating scale-Extended (BPRS-E scale).

Time frame: 6 months after randomization

Adult Patients : the remission of psychiatric symptoms at 1 month

the remission of psychiatric symptoms defined as: \- For adult patients: 20% decrease from baseline of Brief psychiatric rating scale-Extended (BPRS-E scale).

Time frame: 1 month after randomization

Minor patients : the remission of psychiatric symptoms at 12 months

Central Contacts

Frédéric VILLEGA, MD, PhD

CONTACT

+33 (0)5 56 79 56 41 frederic.villega@chu-bordeaux.fr

Aurore Capelli, PhD

CONTACT

0557820877 aurore.capelli@chu-bordeaux.fr

Data from ClinicalTrials.gov

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