Schizophrenia Study Testing Novel Immunological Approach Cleared to Continue Despite Recruitment Challenges
Stockholm, Sweden – A pivotal clinical trial investigating rituximab, a drug typically used to treat autoimmune diseases, as a potential treatment for schizophrenia has received the green light to proceed following a positive interim analysis. Led by Susanne Bejerot,the randomized study aims to determine if the promising results observed in a smaller pilot study can be replicated in a broader patient population.
The interim analysis, based on data from the first 64 patients, confirmed that at least 25 percent of those receiving active treatment were deemed ”very improved” according to the clinical Global Impression Improvement (CGI-I) scale – a key criterion for continuing the trial. Though, Bejerot emphasized the analysis provides no information regarding the response of patients receiving a placebo.
Rituximab works by eliminating B cells, a type of white blood cell, and is currently used in the treatment of conditions like multiple sclerosis, lymphoma, and rheumatoid arthritis. A previous, smaller study without a control group showed improvement in 7 out of 9 patients with therapy-resistant schizophrenia after receiving rituximab alongside thier standard antipsychotic medication.
This current study focuses on less severely ill patients and will follow participants for six months. The primary outcome measure is the proportion of patients achieving “very improved” status on the CGI-I scale.Preliminary results are anticipated in the second half of 2026. The study is funded by the Swedish Research Council, the Torsten Söderberg Foundation, and the Brain Fund.
Despite the positive interim data, recruitment has proven challenging. Bejerot attributes this to patient hesitancy, an overburdened psychiatric system lacking time and incentives for research participation, and intricate regulations surrounding drug testing. “Many colleagues do not ask their patients to a sufficient extent,” she stated.”In addition,the regulations on drug tests are indescribably complicated,wich scares many from helping.”
Bejerot believes a successful outcome coudl fundamentally change the understanding and treatment of psychosis. “It opens the door to seriously think about immunological deviations in psychosis illness,” she explained. “Rituximab is a cheap drug given half-yearly. For today’s patients, it would of course mean a lot, but above all, the open door for intensified immunological research would.”
Following the current study, researchers plan a three-year open-label study to evaluate the long-term effects of rituximab treatment. Bejerot is actively seeking to enroll 100 participants and is urging colleagues across Sweden to refer eligible patients before the recruitment deadline at the turn of the year. “I need more patients,” she said.
