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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).
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). The aim is to assess the clinical efficacy of this treatment associated with the usual recommended psychotropic treatment. To meet this objective, we will use, via a National Center for Scientific Research (CNRS) Research laboratory in Bordeaux, a very sensitive diagnostic platform to detect and demonstrate the pathogenesis of antibodies in patient serum. This platform is operational only within the framework of validation of the results by the reference center for neurological autoimmune diseases in Lyon
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | continuation of ongoing psychiatric care (with or without standard treatment as usual (i.e. antipsychotics, mood stabilisers, antidepressants and/or anxiolytics)). | |
| experimental group | Experimental | immunomodulatory treatment by rituximab, 1g for adults or 375 mg/m2 for children, renewed at 14 days (+/- 3 days), added to stable ongoing psychiatric care (with or without standard treatment as usual ( i.e. antipsychotic, mood stabiliser, antidepressant and/or anxiolytic)). The rituximab is the best immunomodulatory treatment recommended for neurologic encephalitis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immunomodulatory treatment by rituximab | Drug | 1g for adults or 375 mg/m2 for children, renewed at 14 days (+/- 3 days) |
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| Measure | Description | Time Frame |
|---|---|---|
| Adult patients : the remission of psychiatric symptoms at 3 months | The primary endpoint outcome is the remission of psychiatric symptoms at 3 months, defined as: - For adult patients: 20% decrease from baseline of Brief psychiatric rating scale-Extended (BPRS-E scale). | 3 months after randomization |
| Minor patients : the remission of psychiatric symptoms at 3 months | The primary endpoint outcome is the remission of psychiatric symptoms at 3 months, defined as: - 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. | 3 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Adult Patients : the remission of psychiatric symptoms at 12 months | the remission of psychiatric symptoms defined as: - For adult patients: 20% decrease from baseline of Brief psychiatric rating scale-Extended (BPRS-E scale). | 12 months after randomization |
| Adult Patients : the remission of psychiatric symptoms at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frédéric VILLEGA, MD, PhD | Contact | +33 (0)5 56 79 56 41 | frederic.villega@chu-bordeaux.fr | |
| Aurore Capelli, PhD | Contact | 0557820877 | aurore.capelli@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Frédéric VILLEGA, MD, PhD | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Charles Perrens | Bordeaux | France |
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the remission of psychiatric symptoms defined as: - For adult patients: 20% decrease from baseline of Brief psychiatric rating scale-Extended (BPRS-E scale). |
| 6 months after randomization |
| Adult Patients : the remission of psychiatric symptoms at 1 month | the remission of psychiatric symptoms defined as: - For adult patients: 20% decrease from baseline of Brief psychiatric rating scale-Extended (BPRS-E scale). | 1 month after randomization |
| Minor patients : the remission of psychiatric symptoms at 12 months | The primary endpoint outcome is the remission of psychiatric symptoms at 12 months, defined as: - 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. | 12 months after randomization |
| Minor patients : the remission of psychiatric symptoms at 6 months | The primary endpoint outcome is the remission of psychiatric symptoms, defined as: - 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. | 6 months after randomization |
| Minor patients : the remission of psychiatric symptoms at 1 month | The primary endpoint outcome is the remission of psychiatric symptoms, defined as: - 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. | 1 month after randomization |
| Adult patients : general functioning at 1 month | for Global assessment of functioning scale (GAF scale), a mean score of 60 and above is expected to be achieved indicating patients experiencing mild to moderate symptoms and functioning pretty well in daily life. | 1 month after randomization |
| Adult patients : general functioning at 3 months | for Global assessment of functioning scale (GAF scale), a mean score of 60 and above is expected to be achieved indicating patients experiencing mild to moderate symptoms and functioning pretty well in daily life. | 3 months after randomization |
| Adult patients : general functioning at 6 months | for Global assessment of functioning scale (GAF scale), a mean score of 60 and above is expected to be achieved indicating patients experiencing mild to moderate symptoms and functioning pretty well in daily life. | 6 months after randomization |
| Adult patients : general functioning at 12 months | for Global assessment of functioning scale (GAF scale), a mean score of 60 and above is expected to be achieved indicating patients experiencing mild to moderate symptoms and functioning pretty well in daily life. | 12 months after randomization |
| Minor patients : Child behaviour check list (CBCL) /6-18 scale at 1 month | For children>6 years old with an acute first episode or relapse of psychotic disorders: clinically significant difference ≤3 from baseline of CBCL/6-18 (Child Behavior Checklist) scale. | 1 month after randomization |
| Minor patients : Child behaviour check list (CBCL) /6-18 scale at 3 months | For children>6 years old with an acute first episode or relapse of psychotic disorders: clinically significant difference ≤3 from baseline of CBCL/6-18 (Child Behavior Checklist) scale. | 3 months after randomization |
| Minor patients : Child behaviour check list (CBCL) /6-18 scale at 6 months | For children>6 years old with an acute first episode or relapse of psychotic disorders: clinically significant difference ≤3 from baseline of CBCL/6-18 (Child Behavior Checklist) scale. | 6 months after randomization |
| Minor patients : Child behaviour check list (CBCL) /6-18 scale at 12 months | For children>6 years old with an acute first episode or relapse of psychotic disorders: clinically significant difference ≤3 from baseline of CBCL/6-18 (Child Behavior Checklist) scale. | 12 months after randomization |
| CHU de Bordeaux | Bordeaux | France |
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| Centre hospitalier le Vinatier | Bron | France |
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| CHU de Clermond Ferrand | Clermont-Ferrand | France |
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| APHP Louis Mourier | Colombes | France |
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| APHP Henri Mondor | Créteil | France |
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| APHP Kremlin Bicetre | Le Kremlin-Bicêtre | France |
|
| CHU de Montpellier | Montpellier | France |
|
| CHU de Strasbourg | Strasbourg | France |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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