Using rituximab to treat psychotic disorders in adults
A Randomized Controlled Trial With Rituximab for Psychotic Disorder in Adults
This study is testing if adding rituximab, an anti-inflammatory drug, can help adults with schizophrenia feel better and improve their daily functioning.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Region Örebro County Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Örebro) |
| Trial ID | NCT05622201 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of rituximab, an anti-inflammatory drug, as an add-on treatment for adults aged 18-55 with schizophrenia spectrum disorder. The study is designed as a randomized, placebo-controlled, double-blinded trial involving 120 participants. It aims to assess the impact of rituximab on psychotic symptoms and overall disability, while also exploring potential biomarkers related to treatment response through blood sampling and optional imaging techniques. Participants will be evaluated at multiple time points over a 24-week period to determine the efficacy of the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-55 with a diagnosis of schizophrenia spectrum disorder who have not adequately responded to previous antipsychotic treatments.
Not a fit: Patients who are pregnant, breastfeeding, or have certain chronic infections or malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve psychotic symptoms and overall functioning in patients with schizophrenia spectrum disorder.
How similar studies have performed: Previous small pilot trials have shown promising results with rituximab in treatment-resistant schizophrenia, suggesting potential for success in this larger study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ages 18 to 55 years 2. duration of illness exceeding 1 year 3. diagnosed with Schizophrenia spectrum disorder (SSD) according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). 4. if female and with any risk for pregnancy, willing to use contraceptives or abstinence if normal and preferred lifestyle. 5. participants should be judged by the investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent. 6. insufficiently recovered from previous antipsychotic treatments. 7. a minimum score of 4 (moderately ill) in Clinical global impression - severity (CGI-S) at baseline. Exclusion Criteria: 1. pregnancy or breast-feeding 2. weight below 40 kg 3. clinically relevant ongoing infection at the discretion of the physician 4. chronic infections 5. positive test for hepatitis B, hepatitis C, HIV, or tuberculosis 6. malignancy currently or within 2 years prior to inclusion 7. current severe heart failure (NYHA grade IV) or any other severe heart disease (e.g. or history of cardiac arrhythmia or myocardial infarction) 8. any change of antipsychotic medication within the previous 4 weeks 9. unable to make an informed decision to consent to the trial 10. ongoing clozapine treatment 11. ongoing immunomodulatory treatment 12. treatments with monoclonal antibodies within 1 year before the inclusion
Where this trial is running
Örebro
- Örebro university hospital — Örebro, Sweden (Recruiting)
Study contacts
- Principal investigator: Susanne Bejerot, MD, PhD — Region Örebro län
- Study coordinator: Susanne Bejerot, MD,PhD
- Email: susanne.bejerot@oru.se
- Phone: 0701655102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.