Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05622201 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Randomized Controlled Trial With Rituximab for Psychotic Disorder in Adults

Study acronym: RCT-RITS
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 24, 2026 (before its estimated August 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruitingv10 Show 5 more changesShow less
    • Enrollment target: estimated 120 to confirmed 123
    • Primary completion date: Jun 30, 2026 to Aug 30, 2026
    • Secondary endpoints: 12 to 13
    • Study description expanded, about 595 words
    • Site details revised
  2. Primary endpoint revised
    • Secondary endpoints: 11 to 12
    v9
  3. Study description expanded, about 8 wordsv8
  4. Study description expanded, about 15 wordsv7
  5. Enrollment target: 104 to 120
    • Study description expanded, about 22 words
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Eligibility criteria revised
    • Study description expanded, about 88 words
    • Study title shortened, about 2 words
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 15, 2023 to Mar 21, 2023
    • Site details revised
    v3
  4. Secondary endpoints: details revised at 1 of 11 entries
    • Eligibility criteria shortened, about 3 words
    • Study description expanded, about 1 word
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Immunological factors are assumed to be determinants for some psychiatric disorders, thus anti-inflammatory drugs may be helpful. However, studies on such treatments are scarce. An inflammatory modulating drug rituximab, cluster of differentiation antigen 20 antibodies (anti-CD20 antibodies), is a standard treatment for e.g. multiple sclerosis. The investigators aim to test rituximab in a randomised placebo-controlled double-blinded, add-on treatment trial in 120 participants (18-55 years) with schizophrenia spectrum disorder. Sampling from blood for analyses of inflammatory mediators are investigated at gene and protein levels and resting state functional magnetic resonance imaging (rsfMRI) and lumbar puncture are optional. Biomarkers will be investigated in relation to treatment response. Family member(s) to the patient and the patient (separate) will be asked to participate in a qualitative interview by an independent researcher after 3 months.
Trial Details
NCT Number NCT05622201
Lead Sponsor Region Örebro County
Conditions
(from sponsor)		 Schizophrenia Spectrum and Other Psychotic Disorders
Related terms Psychotic Disorders, Schizophrenia Spectrum and Other Psychotic Disorders
Enrollment 123 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov