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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
274 Previous Clinical Trials
80,495 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,103 Total Patients Enrolled
Joseph C Masdeu, MD, PhDPrincipal InvestigatorHOUSTON METHODIST NEUROLOGICAL INSTITUTE

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How large is the sample size for this particular investigation?

"Indeed, the details available on clinicaltrials.gov affirm that this research is actively pursuing eligible participants. The study was initially listed on October 1st, 2019 and last revised on February 6th, 2024. Recruitment aims to enroll a total of 40 individuals at a single investigational site."

Answered by AI

Are there any ongoing efforts to enroll participants for this clinical trial at the moment?

"Affirmative. Records from clinicaltrials.gov indicate that this investigation is actively seeking volunteers. This study was initially disclosed on October 1st, 2019 and underwent its latest revision on February 6th, 2024. The trial aims to enroll a total of 40 participants across one designated location."

Answered by AI

Which individuals are eligible to partake in this experimental study?

"This clinical research endeavor aims to recruit 40 individuals diagnosed with schizoaffective disorder aged between 18 and 35. Essential inclusion criteria include: Being of either gender within the specified age range, Presenting an active psychotic condition aligning with DSM-5 standards for Schizophrenia Spectrum Disorder as per the Mini International Neuropsychiatric Interview (MINI), Demonstrating a total PANSS score of ≥60 along with a minimum score of ≥4 on at least two PANSS positive symptoms, Displaying normal academic achievements until reaching the age of 15 without any psychiatric manifestations before that period, Possessing the capacity to provide informed ass"

Answered by AI

Could individuals who are younger than 18 years of age participate in this research?

"Eligibility requirements for this study dictate that participants must be between 18 and 35 years old. Notably, there are a total of 140 trials catering to individuals under the age of 18 and 385 studies focusing on patients above the age of 65."

Answered by AI

Can you provide information on previous medical studies that have investigated Ocrelizumab?

"At present, there are 5 ongoing clinical investigations exploring Ocrelizumab. Among these, 2 trials are in the advanced Phase 3 stage. While a significant number of research endeavors on Ocrelizumab are centered in Cincinnati, Ohio, there is an extensive network of 303 sites globally conducting studies with this therapeutic agent."

Answered by AI

Is this particular study setting a new precedent in the field?

"Currently, there are 5 ongoing investigations on Ocrelizumab being conducted in a vast network of 115 urban areas spanning across 28 nations. The initial clinical exploration involving this drug commenced in the year 2018 under the sponsorship of Roche Pharma AG. In its Phase III progression for regulatory endorsement, this investigation successfully engaged 51 individuals. Subsequently, after its initiation in 2018, a total of seven research initiatives have reached completion status."

Answered by AI
~8 spots leftby Jun 2025