Badanie długoterminowych wyników i bezpieczeństwa powtarzanych dawek rituximabu u pacjentów z schizofrenią

Enrollment and baseline Assessment

After you join the study, you provide informed consent and undergo an initial evaluation that includes medical history, psychiatric Assessment, and laboratory tests to establish baseline measurements.

First rituximab infusion

You receive the first rituximab infusion. The medication is administered intravenously at a dose of 100 mg. the infusion is performed under medical supervision and monitoring for any immediate reactions.

Second rituximab infusion

A second rituximab infusion, also 100 mg given intravenously, is administered according to the study schedule after the first infusion. The procedure is identical to the first infusion and is performed under medical supervision.

Post‑infusion monitoring and follow‑up visits

Following each infusion you are observed for a short period to detect any adverse effects.

Subsequent visits are scheduled to evaluate clinical status, functional abilities, and self‑reported health. During these visits standardized scales such as the clinical Global Impression of improvement (CGI‑i), severity (CGI‑s), personal and social performance (PSP), visual analogue Scale of health (VAS‑health), self‑Assessment of Negative symptoms (sns), and cross‑cutting symptom measure (ccsm) are completed.

Blood samples may be taken to assess peripheral biomarkers.

Primary outcome Assessment (approximately 4 months after second infusion)

Around four months (plus or minus one month) after the second rituximab infusion, a comprehensive evaluation is performed. The primary measure is the proportion of participants rated as more than minimally improved on the CGI‑i Scale (score ≤ 2.5).

Study completion and data collection

After the final Assessment, all study data are compiled. You may be asked to complete additional questionnaires regarding satisfaction and overall experience with the treatment.