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Mental Disorder

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

Sponsored by University Hospital, Bordeaux

About this trial

Last updated 2 years ago

Study ID

CHUBX 2019/59

Status

Not yet recruiting

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
6+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial about?

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).

What are the participation requirements?

Yes

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.

No

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

Location

Status