Actively Recruiting
Ocrelizumab for Psychosis by Autoimmunity
Led by The Methodist Hospital Research Institute · Updated on 2026-04-01
40
Participants Needed
1
Research Sites
473 weeks
Total Duration
On this page
Sponsors
T
The Methodist Hospital Research Institute
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Some people who have what doctors currently call schizophrenia or bipolar disease may actually have a brain disease caused by auto-antibodies. Auto-antibodies are produced when the normal defense mechanism of the body goes wrong and begins to attack the body, similar to "friendly fire." Auto-antibodies attack brain receptors and then the person who has this problem begins to have hallucinations and other manifestations of schizophrenia, like feeling that people can see what they are thinking and also feeling that other people do not like them. If this disease is caused by auto-antibodies, typically the person is well until they are 15 years of age or older, but seldom older than 35 years. Then, in a matter of a few months they begin to have hallucinations and the other symptoms. Doctors still do not know whether some people with schizophrenia or bipolar disease have auto-antibodies attacking their brain. For this reason, in this study some of these patients will receive a treatment that suppresses the auto-antibodies and their symptoms after treatment will be compared with the symptoms of a group of similar patients who are given a preparation that looks like the real treatment, but it is not.
CONDITIONS
Official Title
Ocrelizumab for Psychosis by Autoimmunity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals of either sex, 18-35 years of age.
- Active psychotic disorder meeting DSM-5 criteria for Schizophrenia Spectrum Disorder lasting at least six months.
- Total PANSS score of 60 or higher and score of 4 or higher on at least 2 PANSS positive symptoms.
- Normal academic performance until at least age 15 and no psychiatric symptoms before age 15.
- Ability to consent or assent and participate in study testing procedures.
You will not qualify if you...
- Change in antipsychotic medication dose less than two weeks before baseline PANSS testing.
- Treatment with immune-suppressing medication other than standard analgesics or antipyretics in the past six months.
- Vaccination with live-attenuated vaccine less than 4 weeks before infusion or non-live vaccine less than 2 weeks before infusion.
- Active infection or history of recurrent or chronic infections such as hepatitis B or C, HIV, syphilis, tuberculosis, or PML.
- History of brain tumor, stroke, severe head trauma, or multiple sclerosis.
- Active cancer, metabolic encephalopathy, severe cardiovascular or kidney disease.
- Psychosis related to substance abuse or metabolic disorders as judged by the principal investigator.
- Pregnancy or lactation.
- Requirement for chronic systemic corticosteroids or immunosuppressants during the study.
- History or presence of primary or secondary immunodeficiency.
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
- Contraindications or intolerance to oral or IV corticosteroids.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Houston Methodist Research Institute
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Joseph C Masdeu, MD, PhD
CONTACT
H
Haroon Shahid, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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