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

Inclusion Criteria7

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 Criteria12

pregnancy or breast-feeding
weight below 40 kg
clinically relevant ongoing infection at the discretion of the physician
chronic infections
positive test for hepatitis B, hepatitis C, HIV, or tuberculosis
malignancy currently or within 2 years prior to inclusion
current severe heart failure (NYHA grade IV) or any other severe heart disease (e.g. or history of cardiac arrhythmia or myocardial infarction)
any change of antipsychotic medication within the previous 4 weeks
unable to make an informed decision to consent to the trial
ongoing clozapine treatment
ongoing immunomodulatory treatment
treatments with monoclonal antibodies within 1 year before the inclusion