RITUXIMAB for Psychotic disorders|Autoimmune psychosis

Inclusion criteria

• {"criterion_text":"- For step 1 : For Adult and Adolescent (who reached 17 years old): First acute or relapse of psychotic disorders defined by the PANSS scale with or without standard pharmacological treatment."}
• {"criterion_text":"- For Step 1 : For Children: Child aged between 6 and 16 years old with a first acute or relapse of psychotic disorders defined by the Kiddie sads-PL scale with or without standard pharmacological treatment."}
• {"criterion_text":"- Informed consent concerning the step 1 of the patient or his legal representatives."}
• {"criterion_text":"- For step 2 : Patient for whom inclusion criteria for step 1 of the trial are present with or without standard pharmacological treatment."}
• {"criterion_text":"- For step 2 : Biological diagnosis of pathogenic CNS autoantibodies in the blood."}
• {"criterion_text":"- For step 2 : MDC scale score >3 is required for inclusion in step 2."}
• {"criterion_text":"- For step 2, Normal ECG in case of previous heart disease."}
• {"criterion_text":"- For step 2, Informed consent concerning the step 2 of the patient or his legal representatives"}
• {"criterion_text":"- For step 2, Effective contraception for women of childbearing potential during the clinical trial and for at least 12 months after the last rituximab administration."}

Exclusion criteria

• {"criterion_text":"- For the first step of the clinical trial (diagnostic) : Developmental disorder related to a genetic disease."}
• {"criterion_text":"- For the first step :Co-existing disorder of severe neurological disease."}
• {"criterion_text":"- For the first step :Chronic psychotic disorders receiving ongoing neuroleptic treatment with efficacy."}
• {"criterion_text":"- For the first step: Pregnant or breastfeeding women."}
• {"criterion_text":"- For the second step of the clinical trial (Intervention): Hypersensitivity to the active substance (rituximab) or to murine proteins, or to any of the other excipients"}
• {"criterion_text":"- For the second step : Blood platelets < 75x109/L"}
• {"criterion_text":"- For the second step: Neutrophils < 1.5x109/L"}
• {"criterion_text":"- For the second step: Neoplastic pathology"}
• {"criterion_text":"- For the second step: Hepatitis B or HIV infection"}
• {"criterion_text":"- For the second step: Contraindication to immunosuppressant treatment (active severe infection, severely immunocompromised state)."}
• {"criterion_text":"- For the second step: Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease"}
• {"criterion_text":"- for the second step: Pregnant or breastfeeding women at the randomization visit."}
• {"criterion_text":"- for the second step: 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."}
• {"criterion_text":"- for the second step: Previous treatment with rituximab in the past 12 months."}
• {"criterion_text":"- for the second step: Patients with a history of recurring or chronic infections or with underlying conditions which may further predispose them to serious infection (e.g. hypogammaglobulinemia)."}
• {"criterion_text":"- for the second step: Recent vaccination with live viral vaccine (within 3 months)."}
• {"criterion_text":"- for the second step: Any other medical illness or disability that, in the opinion of the investigator, would compromise effective trial participation."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint outcome is the remission of psychiatric symptoms at 3 months, defined as: \tFor adult and adolescent patients (who reached 17 years old at step 1 inclusion visit) : 20% decrease from baseline of BPRS-E scale. For children patients aged between 6 and 16 years old at step 1 inclusion visit: 25% decrease from baseline of ABC (Aberrant Behavior Checklist) scale.","definition_or_measurement_approach":"Remission at 3 months defined by a 20% decrease from baseline on the BPRS-E for adults/adolescents (>=17 at inclusion) and a 25% decrease from baseline on the ABC scale for children (6-16 at inclusion)."}

Secondary endpoints

• {"endpoint_text":"- for adults and adolescents : general functioning measurement with the GAF scale","definition_or_measurement_approach":"Measured using the GAF (Global Assessment of Functioning) scale."}
• {"endpoint_text":"- for adults and adolescents : cognitive assessment thanks to the MOCA scale","definition_or_measurement_approach":"Measured using the MOCA (Montreal Cognitive Assessment) scale."}
• {"endpoint_text":"- for adults and adolescents : neurologic evaluation with the 2 scales KREBS and BUSH","definition_or_measurement_approach":"Neurologic evaluation using KREBS and BUSH scales."}
• {"endpoint_text":"- for adults and adolescents : psychotic disorders measurement with the PANSS scale","definition_or_measurement_approach":"Measured using the PANSS (Positive and Negative Syndrome Scale)."}
• {"endpoint_text":"- for adults and adolescents : assessment of the evolution of depressive and manic disorders thanks to the MADRS and YMRS scales.","definition_or_measurement_approach":"Measured using MADRS (depression) and YMRS (mania) scales."}
• {"endpoint_text":"- for children (aged between 6 and 16 years old at step 1 inclusion visit) :psychotic disorders measurement with the PANSS scale","definition_or_measurement_approach":"Measured using the PANSS scale for children 6-16."}
• {"endpoint_text":"- for children : assessment of the evolution of depressive and manic disorders thanks to the CDRS and YMRS scales","definition_or_measurement_approach":"Measured using CDRS (Children's Depression Rating Scale) and YMRS (Young Mania Rating Scale)."}
• {"endpoint_text":"- for children : neurologic evaluation BUSH scale","definition_or_measurement_approach":"Neurologic evaluation using the BUSH scale."}
• {"endpoint_text":"- for all: Persistence rate of autoimmunity in psychiatric disorder at baseline for all participants to the Step 1 of the trial","definition_or_measurement_approach":"Measured as persistence rate of auto-immune antibodies at baseline for Step 1 participants."}
• {"endpoint_text":"- for all: Remission of psychiatric symptoms in each group of participants to the Step 2 of the trial, at M1, M6 and M12","definition_or_measurement_approach":"Remission measured in each randomized group at months 1, 6 and 12 using the study scales (per protocol definitions)."}
• {"endpoint_text":"- for all: Evaluation of severity and improvement with CGI-S and CGI-I","definition_or_measurement_approach":"Measured using CGI-S (Clinical Global Impression - Severity) and CGI-I (Improvement) scales."}
• {"endpoint_text":"- for all: Level of autoimmune Abs at 3 months in each group of participants to the Step 2 of the trial","definition_or_measurement_approach":"Measured level/titers of autoimmune antibodies at 3 months in each randomized arm."}
• {"endpoint_text":"- for all: Frequency and nature of serious and non-serious adverse events as well as infections in each arm.","definition_or_measurement_approach":"Safety assessed by recording frequency and nature of serious and non-serious adverse events and infections per arm."}

Methods

• Patients will be recruited in 10 hospital units (psychiatric units for adults and children and neuropediatrics) across participating French centres; recruitment is site-based in the listed hospital sites.

France

Latest Decision Or Authorization Date

03-10-2025

Number Of Sites

10

Number Of Participants

1000

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Bordeaux

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France