NCT05622201CompletedPhase 2
A randomized controlled trial with Rituximab for Psychotic disorder in adults
Source: EU CTIS (euclinicaltrials.eu) · Last updated 11 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 14 Aug 2024
- Start date
- 27 Aug 2024
- Lead sponsor
- Region Oerebro Laen
- Diseases
- Schizophrenia
- NCT number
- NCT05622201
- EU CT number
- 2024-512408-20-00
- EudraCT number
- 2022-000220-37
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 120
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- treatments with monoclonal antibodies within 1 year prior to the inclusion
- positive test for hepatitis B, hepatitis C, HIV, or TB prior to treatment
- malignancy currently or within 2 years prior to inclusion
- any change of antipsychotic medication within the previous 4 weeks
Other illness
- clinically relevant ongoing infection at the discretion of the physician
- chronic infections
- current severe heart failure (NYHA grade IV) or any other severe heart disease (e.g. or history of cardiac arrhythmia or myocardial infarction)
Other
- pregnancy or breast-feeding
- ongoing clozapine treatment
- ongoing immunomodulatory treatment
- weight below 40 kg
- unable to make an informed decision to consent to the trial
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Goteborg | Sweden | Completed |
| Region Skane Helsingborg Hospital Coordinator of this site? Confirm its status | Helsingborg | Sweden | Completed |
| Region Vaermland Coordinator of this site? Confirm its status | Karlstad | Sweden | Completed |
| Vrinnevisjukhuset I Norrkoeping Region Oestergoetland Coordinator of this site? Confirm its status | Norrkoping | Sweden | Completed |
| Region Soermland Coordinator of this site? Confirm its status | Nykoping | Sweden | Completed |
| Region Oerebro Laen Coordinator of this site? Confirm its status | Orebro | Sweden | Completed |
| Region Stockholm – SLSO Coordinator of this site? Confirm its status | Stockholm | Sweden | Completed |
| Region Vaesterbotten Coordinator of this site? Confirm its status | Umea | Sweden | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.