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Monoclonal Antibodies

Ocrelizumab for Psychosis (OPA Trial)

Phase 1 & 2
Recruiting
Led By Joseph C Masdeu, MD, PhD
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals of either sex, 18-35 years of age
Having an active psychotic disorder meeting DSM-5 criteria, including a duration of at least six months, for Schizophrenia Spectrum Disorder, as defined by the Mini International Neuropsychiatric Interview (MINI)
Must not have
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
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights
All Individual Drugs Already Approved

Summary

This trial is investigating whether some people diagnosed with schizophrenia or bipolar disorder may actually have a brain disease caused by auto-antibodies. These auto-antibodies attack brain receptors, leading to symptoms

Who is the study for?
This trial is for individuals aged 18-35 who have been diagnosed with an active psychotic disorder, such as schizophrenia or schizoaffective disorder. They should have had normal academic performance until age 15 and no psychiatric symptoms before then. Participants must score a certain level on the PANSS, which measures psychosis severity.
What is being tested?
The study tests Ocrelizumab, a drug that may suppress auto-antibodies causing brain disease leading to hallucinations and other psychosis symptoms. It includes physical evaluations, safety labs, ECGs, and cognitive assessments. Patients are compared to those receiving a placebo (a non-active treatment).
What are the potential side effects?
Ocrelizumab can cause side effects like infusion reactions (symptoms related to the administration of the drug), increased risk of infections due to immune suppression, potential liver issues, and possibly others not yet known.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 35 years old.
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I have been diagnosed with a long-term psychotic disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had a live vaccine in the last 4 weeks or any vaccine in the last 2 weeks before my ocrelizumab infusion.
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My antipsychotic medication dose hasn't changed in the last 2 weeks.
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I haven't taken immune-suppressing drugs, except for pain or fever meds, in the last 6 months.
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I do not have any active infections or a history of chronic infections like hepatitis, HIV, syphilis, TB, or PML.
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I do not have severe heart, kidney disease, or brain disorders caused by liver failure.
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I cannot tolerate or am not allowed to take corticosteroids.
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I have a history of brain tumor, stroke, severe head injury, or multiple sclerosis.
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I have a history of or currently have a weak immune system.
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I need to take steroids or immunosuppressants regularly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Score on the Positive and Negative Syndrome Scale (PANSS)
Secondary study objectives
Antipsychotic-equivalent medication ordered by patient's psychiatrist
Score on NIH Cognitive Toolbox
Score on quality of life scales for psychiatric patients

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: OcrelizumabActive Control4 Interventions
Two doses of 300 mg of ocrelizumab will be administered as an intravenous infusion two weeks apart.
Group II: PlaceboPlacebo Group3 Interventions
Two placebo intravenous infusions will be administered two weeks apart.

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor
285 Previous Clinical Trials
81,646 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,560 Previous Clinical Trials
569,394 Total Patients Enrolled
1 Trials studying Schizophrenia
557 Patients Enrolled for Schizophrenia
Joseph C Masdeu, MD, PhDPrincipal InvestigatorHOUSTON METHODIST NEUROLOGICAL INSTITUTE
~4 spots leftby Jun 2025
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