Phase 2
Completed N=9
Rituximab for Schizophrenia Spectrum Disorder (RITS-PS-2019)
Schizophrenia Spectrum and Other Psychotic Disorders · Schizophrenia
Source: ClinicalTrials.gov NCT03983018 ↗
Enrolled (actual)
9
Serious AEs
11.1%
Results posted
Mar 2025
Primary outcomePrimary: Positive and Negative Syndrome Scale (PANSS) — 72.9 score on a scale
Summary
This study evaluates the addition of rituximab to 12 patients diagnosed with treatment resistant schizophrenia spectrum disorder in an open trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive and Negative Syndrome Scale (PANSS) |
— | — |
| SECONDARY Personal and Social Performance Scale (PSP) |
— | — |
| SECONDARY Clinical Global Impression-Severity (CGI-S) Scale |
— | — |
| SECONDARY Clinical Global Impression-Improvement (CGI-I) in Relation to Inflammatory Markers |
— | — |
| SECONDARY Clinical Global Impression-Improvement (CGI-I). Proportion of Responders. |
— | — |
| SECONDARY Clinical Global Impression-Improvement (CGI-I). |
— | — |
| SECONDARY Adverse Event: Any Adverse Reactions (AAR). Safety and Tolerability of Rituximab |
— | — |
Eligibility Criteria
Inclusion Criteria (Swedish citizens):
- patient ages 18 to 40 years
- a duration of illness exceeding 2 years
- correspond to "Markedly ill", "Severely ill" or "Among the most extremely ill patients" on the Clinical Global Impression - Severity scale (CGI-S)
- Global Assessment of Functioning below 50
- Schizophrenia spectrum disorder according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- treatment resistance, i.e. failing to remit despite adequate treatments
- if female and with any risk for pregnancy, willing to use contraceptives
- if antipsychotic treatment is prescribed the plasma concentrations of the drug must be tested and shown to be within therapeutic interval.
- subjects should be judged by the investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent.
- immunoglobulin levels within the normal range
Exclusion Criteria
- on-going immunomodulatory treatment
- pregnancy or breast-feeding
- weight below 40 kg
- clinically relevant on-going infection
- chronic infections
- positive screening test for hepatitis B, C, HIV or tuberculosis
- any change of psychotropic medication within the previous 4 weeks
- "much" or "very much improved" already at baseline according to CGI-I i.e. scores of 1 or 2 by the clinician
- severe heart failure (NYHA grade IV) or other severe heart disease or history of cardiac arrhythmia or myocardial infarction
- unable to make an informed decision to consent to the trial
- in compulsory treatment
- treatment with clozapine within the last 2 months
- previous treatments with immunosuppressive agents
- malignancy currently or within 2 years prior to inclusion
Data sourced from ClinicalTrials.gov (NCT03983018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.