A Randomized Controlled Trial With Rituximab for Psychotic Disorder in Adults (RCT-RITS)
Schizophrenia Spectrum and Other Psychotic Disorders
About this trial
This is an interventional treatment trial for Schizophrenia Spectrum and Other Psychotic Disorders focused on measuring RCT, immunomodulatory treatment, psychosis, rituximab, CD20 antibodies
Eligibility Criteria
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 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
Sites / Locations
- Örebro university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Rituximab
Placebo
Rituximab 1000 mg, infusion
Saline infusion