CompletedPhase 2

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

Sweden9 participantsStarted 2019-08-07

Plain-language summary

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

Age range18 Years – 40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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

Positive and Negative Syndrome Scale (PANSS)

Timeframe: week 20

NCT IDNCT03983018

SponsorRegion Örebro County

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-31

Results submitted2024-11-19