BridgeMD
A randomized controlled trial with Rituximab for Psychotic disorder in adults
EU CTIS ID: 2024-512408-20-00
What this study is testing
To investigate whether psychiatric patients diagnosed with schizophrenia spectrum disorder (SSD) are improved after an intravenous treatment with the immunomodulatory drug rituximab (anti- CD20 antibodies) in comparison with patients receiving NaCl (placebo). Treatment response in this study is defined as ≥ 30 % improvement in PANSS combined with a clinician rated CGI-I score of 1 or 2, corresponding to very much improved or much improved at week 12.
- Therapeutic exploratory (Phase II)
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
- Age: 18 to 55 years
- Duration of psychiatric illness: exceeding 1 year
- Diagnosed with Schizophrenia spectrum disorder (SSD) according to Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5)
- If female and with any risk for pregnancy: willing to use contraceptives* or abstinence if normal and preferred lifestyle
- Subjects should be judged by the investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent
- Insufficiently recovered from previous antipsychotic treatments
You likely can't join if
- pregnancy or breast-feeding
- ongoing clozapine treatment
- ongoing immunomodulatory treatment
- treatments with monoclonal antibodies within 1 year prior to the inclusion
- weight below 40 kg
- clinically relevant ongoing infection at the discretion of the physician
See the full eligibility criteria
- Age: 18 to 55 years
- Duration of psychiatric illness: exceeding 1 year
- Diagnosed with Schizophrenia spectrum disorder (SSD) according to Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5)
- If female and with any risk for pregnancy: willing to use contraceptives* or abstinence if normal and preferred lifestyle
- Subjects should be judged by the investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent
- Insufficiently recovered from previous antipsychotic treatments
- A minimum score of 4 in CGI-Severity at baseline
- pregnancy or breast-feeding
- ongoing clozapine treatment
- ongoing immunomodulatory treatment
- treatments with monoclonal antibodies within 1 year prior to the inclusion
- weight below 40 kg
- clinically relevant ongoing infection at the discretion of the physician
- chronic infections
- positive test for hepatitis B, hepatitis C, HIV, or TB prior to treatment
- malignancy currently or within 2 years prior to inclusion
- current severe heart failure (NYHA grade IV) or any other severe heart disease (e.g. or history of cardiac arrhythmia or myocardial infarction)
- any change of antipsychotic medication within the previous 4 weeks
- unable to make an informed decision to consent to the trial
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, 18-64 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.