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NCT Number: NCT05946486

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

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).

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Key information

Conditions

Mental Disorder Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Bordeaux, Bordeaux, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Developmental disorder related to a genetic disease.
  • Co-existing disorder of severe neurological disease.
  • Chronic psychotic disorders receiving ongoing neuroleptic treatment with efficacy.
  • Hypersensitivity to the active substance (rituximab) or to murine proteins, or to any of the other excipients
  • Blood platelets < 75x109/L
  • Neutrophils < 1.5x109/L
  • Neoplastic pathology,
  • 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
  • Pregnant or breastfeeding women
  • 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.
  • Patients with a history of recurring or chronic infections or with underlying conditions which may further predispose them to serious infection (e.g. hypogammaglobulinemia).
  • Recent vaccination with live viral vaccine (within 3 months).
  • Any other medical illness or disability that, in the opinion of the investigator, would compromise effective trial participation.

Treatment and study plan

immunomodulatory treatment by rituximab

Drug

1g for adults or 375 mg/m2 for children, renewed at 14 days (+/- 3 days)

Primary outcomes

  1. Adult patients : the remission of psychiatric symptoms at 3 months

    Time frame: 3 months after randomization

    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).

  2. Minor patients : the remission of psychiatric symptoms at 3 months

    Time frame: 3 months after randomization

    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.

Secondary outcomes

  1. Adult Patients : the remission of psychiatric symptoms at 12 months

    Time frame: 12 months after randomization

    the remission of psychiatric symptoms defined as:

    • For adult patients: 20% decrease from baseline of Brief psychiatric rating scale-Extended (BPRS-E scale).

  2. Adult Patients : the remission of psychiatric symptoms at 6 months

    Time frame: 6 months after randomization

    the remission of psychiatric symptoms defined as:

    • For adult patients: 20% decrease from baseline of Brief psychiatric rating scale-Extended (BPRS-E scale).

  3. Adult Patients : the remission of psychiatric symptoms at 1 month

    Time frame: 1 month after randomization

    the remission of psychiatric symptoms defined as:

    • For adult patients: 20% decrease from baseline of Brief psychiatric rating scale-Extended (BPRS-E scale).

  4. Minor patients : the remission of psychiatric symptoms at 12 months

    Time frame: 12 months after randomization

    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.

  5. Minor patients : the remission of psychiatric symptoms at 6 months

    Time frame: 6 months after randomization

    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. Minor patients : the remission of psychiatric symptoms at 1 month

    Time frame: 1 month after randomization

    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.

  7. Adult patients : general functioning at 1 month

    Time frame: 1 month after randomization

    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.

  8. Adult patients : general functioning at 3 months

    Time frame: 3 months after randomization

    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.

  9. Adult patients : general functioning at 6 months

    Time frame: 6 months after randomization

    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.

  10. Adult patients : general functioning at 12 months

    Time frame: 12 months after randomization

    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.

  11. Minor patients : Child behaviour check list (CBCL) /6-18 scale at 1 month

    Time frame: 1 month after randomization

    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. Minor patients : Child behaviour check list (CBCL) /6-18 scale at 3 months

    Time frame: 3 months after randomization

    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.

  13. Minor patients : Child behaviour check list (CBCL) /6-18 scale at 6 months

    Time frame: 6 months after randomization

    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.

  14. Minor patients : Child behaviour check list (CBCL) /6-18 scale at 12 months

    Time frame: 12 months after randomization

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aurore Capelli, PhD

CONTACT

[email protected]

0557820877

Frédéric VILLEGA, MD, PhD

CONTACT

[email protected]

+33 (0)5 56 79 56 41

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Phase III Randomized, Multicenter Open Label Study to Evaluate the Efficacy of Immunomodulatory Therapy in Case of Psychiatric Disorders With Proven Dysimmunity.

Acronym: TIM-DePisT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2023
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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