A Randomized Controlled Trial With Rituximab for Psychotic Disorder in Adults

Launched by REGION ÖREBRO COUNTY · Nov 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called rituximab for adults diagnosed with schizophrenia spectrum disorders. Researchers believe that some mental health issues may be linked to inflammation in the body, and rituximab, an anti-inflammatory drug typically used for conditions like multiple sclerosis, could help improve symptoms in people who haven't responded well to other treatments. The study will involve 120 participants between the ages of 18 and 55 years, who have been living with their condition for over a year.

To be eligible for this trial, participants must be diagnosed with schizophrenia spectrum disorder and have not fully recovered from previous treatments. They also need to be stable and able to understand the study requirements. If someone joins the study, they will receive either rituximab or a placebo (a substance with no active medication) along with their regular treatment. Throughout the trial, researchers will collect blood samples and may perform additional tests to better understand how the treatment is working. After three months, both the participant and a family member will have the chance to share their experiences in an interview. This trial is currently recruiting participants, and it’s important to note that individuals who are pregnant, breastfeeding, or have certain medical conditions won’t be able to take part.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. ages 18 to 55 years
• • 2. duration of illness exceeding 1 year
• • 3. diagnosed with Schizophrenia spectrum disorder (SSD) according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
• • 4. if female and with any risk for pregnancy, willing to use contraceptives or abstinence if normal and preferred lifestyle.
• • 5. participants should be judged by the investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent.
• • 6. insufficiently recovered from previous antipsychotic treatments.
• • 7. a minimum score of 4 (moderately ill) in Clinical global impression - severity (CGI-S) at baseline.
• Exclusion Criteria:
• • 1. pregnancy or breast-feeding
• • 2. weight below 40 kg
• • 3. clinically relevant ongoing infection at the discretion of the physician
• • 4. chronic infections
• • 5. positive test for hepatitis B, hepatitis C, HIV, or tuberculosis
• • 6. malignancy currently or within 2 years prior to inclusion
• • 7. current severe heart failure (NYHA grade IV) or any other severe heart disease (e.g. or history of cardiac arrhythmia or myocardial infarction)
• • 8. any change of antipsychotic medication within the previous 4 weeks
• • 9. unable to make an informed decision to consent to the trial
• • 10. ongoing clozapine treatment
• • 11. ongoing immunomodulatory treatment
• • 12. treatments with monoclonal antibodies within 1 year before the inclusion