Trials / Not Yet Recruiting
Not Yet RecruitingNCT05946486
Evaluation of the Efficacy of Immunomodulatory Therapy in Case of Psychiatric Disorders With Proven Dysimmunity.
Phase III Randomized, Multicenter Open Label Study to Evaluate the Efficacy of Immunomodulatory Therapy in Case of Psychiatric Disorders With Proven Dysimmunity.
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 174 (estimated)
- Sponsor
- University Hospital, Bordeaux · Academic / Other
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | immunomodulatory treatment by rituximab | 1g for adults or 375 mg/m2 for children, renewed at 14 days (+/- 3 days) |
Timeline
- Start date
- 2023-10-15
- Primary completion
- 2026-01-15
- Completion
- 2026-12-15
- First posted
- 2023-07-14
- Last updated
- 2023-07-14
Locations
9 sites across 1 country: France
Source: ClinicalTrials.gov record NCT05946486. Inclusion in this directory is not an endorsement.