Table 2 Outline of the RCT-RITS study

Enrolment

Eligibility screen, Consent form, Demographics, Treatment history, Infection history, Physical examination, Routine blood tests, Immunoglobulins, Test of hepatitis B and C, HIV, and TB. Pregnancy test and Drug screen in urine

40 min

x

Intervention: Rituximab or Saline infusion and auxiliary drugs

4.5 h

x

Assessments: M.I.N.I. interview, psychosis section

10 min

x

Positive and Negative Syndrome Scale (PANSS), Personal and Social Performance Scale (PSP)

40 min

x

x

x

CGI-S (clinician rated severity)

5 min

x

x

x

CGI-I (clinician rated improvement)

10 min

x

x

CGI-I (informant evaluated improvement)

5 min

x

x

x

x

PGE (patient evaluated improvement)

5 min

x

x

x

x

Patient evaluated health (VAS-health), Level 1 Cross-cutting symptom global symptom severity, MAP-SR

10 min

x

x

x

Adverse Event assessment: open check-up questions

5 min

x

x

x

x

Adverse Event assessment: AAR-R

10 min

x

x

x

Blood test security: leukocyte count/5 part, SR, CRP

10 min

x

x

x

Self-assessment of Negative Symptoms (SNS, patient-rated), Weight

5 min

x

Blood sample for analyses of PBMC, proteins and gene expression (optional)

15 min

x

x

x

Cerebrospinal fluid tap and fMRI (optional)

40/60 min

x

x

x

Five to Fifteen brief (FTF-brief) filled out by a parent (optional)

5–10 min

x

Qualitative interview with an informant after 12 weeks (optional)

45–60 min

x

Qualitative interview with participant after 12 weeks (optional)

45–60 min

x