RecruitingPhase 2NCT05622201

A Randomized Controlled Trial With Rituximab for Psychotic Disorder in Adults

Sponsor

Region Örebro County

Enrollment

120 participants

Start Date

Mar 21, 2023

Study Type

INTERVENTIONAL

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing rituximab — a drug that depletes certain immune cells (B-cells) — as an add-on treatment to standard antipsychotic therapy in adults with schizophrenia spectrum disorders that have not responded well to prior treatments, based on the hypothesis that immune abnormalities may drive some cases. **You may be eligible if...** - You are between 18 and 55 years old with a DSM-5 diagnosis of a schizophrenia spectrum disorder (such as schizophrenia) - Your illness has lasted more than one year and has not responded adequately to antipsychotic treatment - Your symptoms are at least moderately severe on a clinical rating scale - You are alert and oriented at the time of consent - If you are a woman with pregnancy risk, you are willing to use contraception **You may NOT be eligible if...** - You are pregnant or breastfeeding - You weigh less than 40 kg - You have a current serious infection or chronic infection - You have tested positive for hepatitis B, hepatitis C, HIV, or tuberculosis - You have active cancer or have had cancer within the past 2 years - You have severe heart disease or a history of heart attack - Your antipsychotic medication has changed in the past 4 weeks - You are currently treated with clozapine or other immunomodulatory drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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