A Randomized Controlled Trial With Rituximab for Psychotic Disorder in Adults

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.

Timeline

Start

2023-03-21

Primary completion

2026-08-30

Completion

2026-12-31

Publications

• Bejerot S, Eklund D, Hesser H, Hietala MA, Kariis T, Lange N, Lebedev A, Montgomery S, Nordenskjold A, Petrovic P, Soderbergh A, Thunberg P, Wikstrom S, Humble MB; RCT-Rits study collaboration group. Study protocol for a randomized controlled trial with rituximab for psychotic disorder in adults (RCT-Rits). BMC Psychiatry. 2023 Oct 23;23(1):771. doi: 10.1186/s12888-023-05250-5.

Drugs

Indications