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Monoclonal Antibodies

Ocrelizumab for Schizoaffective Disorder (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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights

OPA Trial 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.Check my eligibility
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).See study design
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.

OPA Trial 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.

OPA Trial 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

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

OPA 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
275 Previous Clinical Trials
80,505 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
567,990 Total Patients Enrolled
Joseph C Masdeu, MD, PhDPrincipal InvestigatorHOUSTON METHODIST NEUROLOGICAL INSTITUTE
~7 spots leftby Jun 2025
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