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

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Jul 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for certain mental health disorders, specifically psychosis and bipolar disorder, in patients who have been found to have specific autoimmune markers in their blood. Researchers want to see if using a medication called rituximab, which helps modulate the immune system, can improve the management of these psychiatric conditions compared to standard treatments alone. This trial is in the advanced phase III stage and is designed to determine if this immunomodulatory therapy is more effective for these patients.

To participate in the trial, individuals must either be adults experiencing their first episode or a relapse of psychotic disorders or children over 6 years old with similar conditions. They also need to have a confirmed biological diagnosis of certain autoantibodies in their blood. Participants will be closely monitored throughout the study, and women who can become pregnant will need to use effective contraception during and for a year after treatment. It's important to note that the trial is not yet recruiting participants, and there are several health conditions and factors that could prevent someone from being eligible, such as certain severe diseases or recent treatments that could interfere with the study.

Gender

ALL

Eligibility criteria

• 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.