A Randomized Controlled Trial With Rituximab for Psychotic Disorder in Adults (NCT05622201) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Randomized Controlled Trial With Rituximab for Psychotic Disorder in Adults
Sweden123 participantsStarted 2023-03-21
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. ages 18 to 55 years
✓. duration of illness exceeding 1 year
✓. diagnosed with Schizophrenia spectrum disorder (SSD) according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
✓. if female and with any risk for pregnancy, willing to use contraceptives or abstinence if normal and preferred lifestyle.
✓. participants should be judged by the investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent.
✓. insufficiently recovered from previous antipsychotic treatments.
✓. a minimum score of 4 (moderately ill) in Clinical global impression - severity (CGI-S) at baseline.
Exclusion criteria
✕. pregnancy or breast-feeding
✕. weight below 40 kg
✕
What they're measuring
1
Proportion of responders to treatment, rated as much or very much improved with CGI-I