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Ocrelizumab for Psychosis by Autoimmunity (OPA)

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Schizophrenia / Bipolar Disease

Over 1% of the population suffer from chronic psychotic diseases, commonly known as schizophrenia or bipolar disease. Many of these individuals are homeless, because their hallucinations and paranoia keep them away from other people. About 5% end up by committing suicide. These diseases begin typically in people who are in their adolescence or early adulthood, often in their twenties. Researchers at several hospitals in Houston, led by Dr. Joseph C. Masdeu, believe that many people with psychosis may have a disease caused by antibodies produced by their own body that attack their own brain. By lowering the antibodies, the psychosis may disappear. However, doctors still do not know whether this is correct. To find out, in a treatment trial conducted in Houston, 20 people with psychosis are being given a medication to lower antibodies and another 20 are being given a look-alike inert placebo.
People 18 to 35 years of age who have been diagnosed with schizophrenia or bipolar disease may be candidates for this treatment trial. They need to have been vaccinated against COVID.

Ocrelizumab for Psychoses by Autoimmunity (OPA trial)

  • Study director (local PI): Joseph C. Masdeu, MD, PhD 
  • Sponsor: Houston Methodist Research Institute with support (medication) from Genentech
  • STATUS: Recruiting
  • Official study title: Ocrelizumab for psychoses possibly caused by synaptic autoimmunity.
  • ClinicalTrials.gov identifier: NCT03971487
  • Conditions studied: Schizophrenia-spectrum psychosis
  • Intervention Drugs: Ocrelizumab in comparison with placebo
  • Phase: Phase 1
  • Duration of participation: The expected time the subject will be in the study is between 18 to24 months
  • IRB #:  PR00014773 and  Pro00021901
  • IRB approval date: 7/30/2019
  • Download the OPA flyer

Study Contact

Eligibility

Inclusion criteria: 
  • Individuals of either sex, 18-35 years of age.
  • Having an active psychotic disorder meeting DSM-5 criterion, including a duration of at least six months, for Schizophrenia Spectrum Disorder, as defined by the Mini International Neuropsychiatric Interview (MINI).
  • A total PANSS ≥ 60 and a score ≥ 4 on at least 2 of the PANSS positive symptoms.
  • Normal academic performance at least until the age of 15 years and absence of psychiatric symptoms before the same age.
  • Ability to assent or consent to the performance of the study and participate in testing procedures.
  • Participants must have received a full COVID-19 vaccine at least three weeks before the first infusion of the study drug.

Exclusion criteria: 

  • The dose of antipsychotic medication (if they are on one) has been changed less than two weeks prior to baseline PANSS testing (Visit 2, see below).
  • Patient treated with a medication designed to suppress the immune system, other than standard analgesics or antipyretics, in the six months prior to randomization.
  • Vaccinated with a live-attenuated vaccine less than 4 weeks before ocrelizumab infusion or with a non-live vaccine less than 2 weeks before infusion.
  • Active infection, or history of or known presence of recurrent or chronic infection (for example, hepatitis B or C, Human Immunodeficiency Virus, syphilis, tuberculosis, PML).
  • History of brain tumor, stroke, severe head trauma or multiple sclerosis.
  • Active cancer, metabolic encephalopathy, severe cardiovascular or renal disease.
  • In the judgment of the PI, psychosis related to substance abuse or metabolic disorders.
  • Pregnancy or lactation.
  • Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
  • History of or currently active primary or secondary immunodeficiency.
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
  • Contraindications to or intolerance of oral or IV corticosteroids.
What is involved?
  • Testing and Procedures: History, Clinical and Neurological Examination,  Psychological testing, questionnaires about your quality of life, ECGs (electrocardiograms), EEGs (Electroencephalograms – to check the electrical activity of the brain), blood and urine specimen collection, vital signs, and study drug administrations (total 2 intravenous infusions).
  • Frequency of visits:
  • Costs: No costs will be charged for any of the study procedures. To compensate the time and involvement, you will receive $350 once all the procedures requiring your participation have been completed.


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