Rituximab for Schizophrenia Spectrum Disorder (RITS-PS-2019)

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the addition of rituximab to 12 patients diagnosed with treatment resistant schizophrenia spectrum disorder in an open trial.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Region Örebro County
• Collaborators: Örebro University; Örebro University, Sweden
• Treatments: Rituximab

Criteria

Inclusion Criteria (Swedish citizens):

1. patient ages 18 to 40 years

2. a duration of illness exceeding 2 years

3. correspond to "Markedly ill", "Severely ill" or "Among the most extremely ill patients" on the Clinical Global Impression - Severity scale (CGI-S)

4. Global Assessment of Functioning below 50

5. Schizophrenia spectrum disorder according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).

6. treatment resistance, i.e. failing to remit despite adequate treatments

7. if female and with any risk for pregnancy, willing to use contraceptives

8. if antipsychotic treatment is prescribed the plasma concentrations of the drug must be tested and shown to be within therapeutic interval.

9. subjects should be judged by the investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent.

10. immunoglobulin levels within the normal range

Exclusion Criteria:

1. on-going immunomodulatory treatment

2. pregnancy or breast-feeding

3. weight below 40 kg

4. clinically relevant on-going infection

5. chronic infections

6. positive screening test for hepatitis B, C, HIV or tuberculosis

7. any change of psychotropic medication within the previous 4 weeks

8. "much" or "very much improved" already at baseline according to CGI-I i.e. scores of 1 or 2 by the clinician

9. severe heart failure (NYHA grade IV) or other severe heart disease or history of cardiac arrhythmia or myocardial infarction

10. unable to make an informed decision to consent to the trial

11. in compulsory treatment

12. treatment with clozapine within the last 2 months

13. previous treatments with immunosuppressive agents

14. malignancy currently or within 2 years prior to inclusion