Evaluation of the Efficacy of Immunomodulatory Therapy in Case of Psychiatric Disorders With Proven Dysimmunity.

Sponsor
University Hospital, Bordeaux
Study ID
NCT05946486
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Mental Disorder

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Oct 15, 2023
Status verified
Jul 2023
Primary completion
Jan 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
174 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: control group
    continuation of ongoing psychiatric care (with or without standard treatment as usual (i.e. antipsychotics, mood stabilisers, antidepressants and/or anxiolytics)).
  • Experimental: experimental group
    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.

Primary Outcome Measure

Adult patients : the remission of psychiatric symptoms at 3 months [ Time Frame: 3 months after randomization ]

Central Contacts

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