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NCT05946486Not yet recruitingPhase 3

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.

Source: ClinicalTrials.gov · Last updated 14 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
174 (estimated)
First submitted
7 Jul 2023
Start date
15 Oct 2023
Primary completion date
15 Jan 2026
Lead sponsor
University Hospital, Bordeaux
NCT number
NCT05946486

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 174
  • From 15 Oct 2023 to the primary completion date, 15 Jan 2026
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Chronic psychotic disorders receiving ongoing neuroleptic treatment with efficacy.
  • Currently receiving an investigational drug or received an investigational drug or device within 30 days (or 5 half-lives for drugs, whichever is longer) prior to screening.
  • Previous treatment with rituximab in the past 12 months.
  • Recent vaccination with live viral vaccine (within 3 months).

Other illness

  • Developmental disorder related to a genetic disease.
  • Co-existing disorder of severe neurological disease.
  • Hypersensitivity to the active substance (rituximab) or to murine proteins, or to any of the other excipients
  • 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
  • Patients with a history of recurring or chronic infections or with underlying conditions which may further predispose them to serious infection (e.g. hypogammaglobulinemia).
  • Any other medical illness or disability that, in the opinion of the investigator, would compromise effective trial participation.

Lab values

  • Blood platelets \< 75x109/L
  • Neutrophils \< 1.5x109/L

Other

  • Neoplastic pathology,
  • Pregnant or breastfeeding women

Who the study is looking for

  • For Adult: First acute or relapse of psychotic disorders defined by the BPRS-E scale with or without standard pharmacological treatment.
  • For Children: Child over 6 years old with a first acute or relapse of psychotic disorders defined by the Kiddie sads-PL scale with or without standard pharmacological treatment.
  • Biological diagnosis of pathogenic CNS autoantibodies in the blood.
  • MDC scale score \>3 is required for inclusion in step 2.
  • Normal ECG in case of previous heart disease.
  • Informed consent of the patient or his legal representatives.
  • Effective contraception for women of childbearing potential during the study and for at least 12 months after the last rituximab administration.

Age in the registry: 6 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU de Bordeaux
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BordeauxFranceUnknown status
Centre Hospitalier Charles Perrens
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BordeauxFranceUnknown status
Centre Hospitalier Le Vinatier
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BronFranceUnknown status
CHU de Clermond Ferrand
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Clermont-FerrandFranceUnknown status
APHP Louis Mourier
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ColombesFranceUnknown status
APHP Henri Mondor
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CréteilFranceUnknown status
Aphp Kremlin Bicetre
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Le Kremlin-BicêtreFranceUnknown status
CHU de Montpellier
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MontpellierFranceUnknown status
CHU de Strasbourg
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StrasbourgFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.