A Randomized Controlled Trial With Rituximab - for Schizophrenia Spectrum Disorder in Adults

• Status: Not yet recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Immunological factors are assumed to be determinants for some psychiatric disorders, thus anti-inflammatory drugs may be helpful. However, studies on such treatments are scarce. An inflammatory modulating drug rituximab, cluster of differentiation antigen 20 antibodies (anti-CD20 antibodies), is a standard treatment for e.g. multiple sclerosis.

We aim to test rituximab in a randomised placebo-controlled double-blinded, add-on treatment trial in 104 patients (18-51 years) with schizophrenia spectrum disorder. Sampling from blood for analyses of inflammatory mediators are investigated at gene and protein levels and resting state functional magnetic resonance imaging (rsfMRI) and lumbar puncture are optional. Biomarkers will be investigated in relation to treatment response.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Region Örebro County
• Treatments: Rituximab

Criteria

Inclusion Criteria:

1. patient ages 18 to 51 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. subjects 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 to treatment

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