Mental and behavioral disorders (F00-F99)
Conditions
Interventions
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria are common for the two steps - For Adult patient: • First acute or relapse of psychiatric disorder (most often psychotic diseases or bipolar disorders) defined by the BPRS-E scale. - For Children patient: • Child over 6 years old with a first acute or relapse of psychiatric disorder defined by the Kiddie sads-PL scale. - For all patients: • Informed consent of the patient or his legal representatives • Effective contraception for women of childbearing potential Are the trial subjects under 18? yes Number of subjects for this age range: 200 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 800 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For the first step of the study (diagnostic) • Developmental disorder related to a genetic disease. • Co-existing disorder of severe neurological disease. • Chronic psychiatric disorders receiving ongoing neuroleptic treatment with efficacy. • Absence of consent from the patient or their legal representatives for the first step of the study • Pregnant or breastfeeding women. For the second step of the study (Intervention): • Patient for whom a diagnosis of autoimmune disease would not be made or for whom participation in step 2 would not be validated by the multidisciplinary concertation (MDC) • Absence of consent from the patient or their legal representatives for the second step of the study • 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 • Pregnancy at the randomization visit. • Concurrent enrolment in another pharmacological trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To evaluate the efficacy at 3 months of immunotherapy for patients with psychiatric symptoms and proven auto-immunity (added to ongoing psychotropic treatment). ;Secondary Objective: Secondary objectives: -To assess the efficacy at 1, 6 and 12 months of immunotherapy added to ongoing psychotropic treatment, -To evaluate the prevalence of auto-immune psychosis in France, -To assess the safety of immunotherapy in case of psychiatric symptoms, -To evaluate the kinetic of auto-Ab at 3 months. ;Primary end point(s): The primary outcome is the remission of psychiatric symptoms at 3 months, defined as: - For adult patients: 20% decrease from baseline of BPRS-E scale - 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. ;Timepoint(s) of evaluation of this end point: 3 months after treatement initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints linked with the secondary objectives are: - The remission of psychiatric symptoms in each group of participants to the Step 2 of the trial, at month 1, 6 and 12 - For adults patients: • Evaluation of severity CGI-S, CGI-I • Cognitive scales (GAF, MOCA) • Neurologic scales (KREBS, BUSH) • Psychiatric scales (BPRS-E, MINI) • Scale for psychosis evaluation PANSS • Scales for bipolar symptoms (MADRS, YMRS) • CBCL (only if they are included at adolescent age on step 2 inclusion visit and reach legal age during the step 2 of the study) - For children patients: • Evaluation of severity CGI-S, CGI-I • CBCL - Persistence rate of autoimmunity in psychiatric disorder at baseline for all participants to the Step 1 of the trial. - Level of NMDAr-Ab at 3 months in each group of participants to the Step 2 of the trial. - Frequency of serious and non-serious adverse events in each arm. - Frequency of infections in each arm. ;Timepoint(s) of evaluation of this end point: at month 1, 6 and 12 after treatment initiation | — |
Countries
France
Contacts
Public ContactCAPELLI Aurore
CHU de Bordeaux
Outcome results
None listed