BridgeMD
Phase III randomized, multicenter open label clinical trial to evaluate the efficacy of immunomodulatory therapy in case of psychiatric disorders with proven dysimmunity. TIM-DePisT
EU CTIS ID: 2024-518259-49-00
What this study is testing
To evaluate the efficacy at 3 months of immunotherapy for patients with psychotic symptoms and proven auto-immunity added to ongoing psychiatric care (with or without standard psychotropic treatment).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- For step 1 : For Adult and Adolescent (who reached 17 years old): First acute or relapse of psychotic disorders defined by the PANSS scale with or without standard pharmacological treatment.
- For Step 1 : For Children: Child aged between 6 and 16 years old with a first acute or relapse of psychotic disorders defined by the Kiddie sads-PL scale with or without standard pharmacological treatment.
- Informed consent concerning the step 1 of the patient or his legal representatives.
- For step 2 : Patient for whom inclusion criteria for step 1 of the trial are present with or without standard pharmacological treatment.
- For step 2 : Biological diagnosis of pathogenic CNS autoantibodies in the blood.
- For step 2 : MDC scale score >3 is required for inclusion in step 2.
You likely can't join if
- For the first step of the clinical trial (diagnostic) : Developmental disorder related to a genetic disease.
- For the second step: Contraindication to immunosuppressant treatment (active severe infection, severely immunocompromised state).
- for the second step: Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
- for the second step: Pregnant or breastfeeding women at the randomization visit.
- for the second step: 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.
- for the second step: Previous treatment with rituximab in the past 12 months.
See the full eligibility criteria
Who can join
- For step 1 : For Adult and Adolescent (who reached 17 years old): First acute or relapse of psychotic disorders defined by the PANSS scale with or without standard pharmacological treatment.
- For Step 1 : For Children: Child aged between 6 and 16 years old with a first acute or relapse of psychotic disorders defined by the Kiddie sads-PL scale with or without standard pharmacological treatment.
- Informed consent concerning the step 1 of the patient or his legal representatives.
- For step 2 : Patient for whom inclusion criteria for step 1 of the trial are present with or without standard pharmacological treatment.
- For step 2 : Biological diagnosis of pathogenic CNS autoantibodies in the blood.
- For step 2 : MDC scale score >3 is required for inclusion in step 2.
- For step 2, Normal ECG in case of previous heart disease.
- For step 2, Informed consent concerning the step 2 of the patient or his legal representatives
- For step 2, Effective contraception for women of childbearing potential during the clinical trial and for at least 12 months after the last rituximab administration.
What rules you out
- For the first step of the clinical trial (diagnostic) : Developmental disorder related to a genetic disease.
- For the second step: Contraindication to immunosuppressant treatment (active severe infection, severely immunocompromised state).
- for the second step: Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
- for the second step: Pregnant or breastfeeding women at the randomization visit.
- for the second step: 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.
- for the second step: Previous treatment with rituximab in the past 12 months.
- for the second step: Patients with a history of recurring or chronic infections or with underlying conditions which may further predispose them to serious infection (e.g. hypogammaglobulinemia).
- for the second step: Recent vaccination with live viral vaccine (within 3 months).
- for the second step: Any other medical illness or disability that, in the opinion of the investigator, would compromise effective trial participation.
- For the first step :Co-existing disorder of severe neurological disease.
- For the first step :Chronic psychotic disorders receiving ongoing neuroleptic treatment with efficacy.
- For the first step: Pregnant or breastfeeding women.
- For the second step of the clinical trial (Intervention): Hypersensitivity to the active substance (rituximab) or to murine proteins, or to any of the other excipients
- For the second step : Blood platelets < 75x109/L
- For the second step: Neutrophils < 1.5x109/L
- For the second step: Neoplastic pathology
- For the second step: Hepatitis B or HIV infection
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.