Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05946486
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-14
First Post:
2023-07-07
Brief Title:
Evaluation of the Efficacy of Immunomodulatory Therapy in Case of Psychiatric Disorders With Proven Dysimmunity
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
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
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIM-DePisT
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None