A Randomized Controlled Trial With Rituximab for Psychotic Disorder in Adults

Sponsor
Region Örebro County
Study ID
NCT05622201
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Schizophrenia Spectrum and Other Psychotic Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 21, 2023
Status verified
Feb 2026
Primary completion
Aug 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
123 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    Rituximab 1000 mg, infusion
  • Placebo Comparator: Placebo
    Saline infusion

Primary Outcome Measure

Proportion of responders to treatment, rated as much or very much improved with CGI-I [ Time Frame: Baseline up to week 12 ]

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