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

Korábbi kezelés

• Chronic psychotic disorders receiving ongoing neuroleptic treatment with efficacy.
• 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.
• Recent vaccination with live viral vaccine (within 3 months).

Más betegség

• Developmental disorder related to a genetic disease.
• Co-existing disorder of severe neurological disease.
• Hypersensitivity to the active substance (rituximab) or to murine proteins, or to any of the other excipients
• 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
• Patients with a history of recurring or chronic infections or with underlying conditions which may further predispose them to serious infection (e.g. hypogammaglobulinemia).
• Any other medical illness or disability that, in the opinion of the investigator, would compromise effective trial participation.

Laborértékek

• Blood platelets < 75x109/L
• Neutrophils < 1.5x109/L

Egyéb

• Neoplastic pathology,
• Pregnant or breastfeeding women

• 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.