Ocrelizumab for Psychosis by Autoimmunity

This study is exploring if ocrelizumab, given as two intravenous (IV) infusions two weeks apart, can help people with certain types of psychosis. Researchers believe that some cases of psychosis, like schizophrenia or schizo-affective disorder, might be caused by the body's immune system mistakenly attacking the brain (auto-antibodies). This study is for individuals aged 18 to 35 who have been diagnosed with a psychotic disorder for at least six months and meet specific symptom criteria. The main goal is to see if ocrelizumab can improve symptoms of psychosis, measured by the Positive and Negative Syndrome Scale (PANSS) score, after six months.

Study design: This is an interventional study with a planned enrollment of 40 participants. The study does not specify if it is randomized or blinded.
What's involved: You would undergo psychosis and cognitive assessments, physical and neuro-cognitive evaluations, and safety lab tests including an electrocardiogram. You would also receive two IV infusions of ocrelizumab, two weeks apart.
Compensation: Not stated in the trial record.
Follow-up: Your symptoms will be measured at six months after the intervention to assess the study's primary goal.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Ocrelizumab for Psychosis by Autoimmunity

Recruiting

PHASE1Ages 18–35InterventionalTreatment

The Methodist Hospital Research Institute

~40 participants

Updated 2026-04-01 on ClinicalTrials.gov

What's tested:Psychosis and cognitive assessmentsPhysical and neuro-cognitive evaluationsSafety labs and electrocardiogramOcrelizumab infusion

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Score on the Positive and Negative Syndrome Scale (PANSS)

Measured over Six months

Conditions

Schizo-Affective Type of Psychosis

Schizophrenia

Where it's being run

1 sites across 1 states

Texas1

Study leadership

Joseph C Masdeu, MD, PhD · PRINCIPAL_INVESTIGATOR · HOUSTON METHODIST NEUROLOGICAL INSTITUTE

Who to contact

Joseph C Masdeu, MD, PhD

[email protected]

202-255-7899

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

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).

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.

Exclusion

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 this trial measures

Score on the Positive and Negative Syndrome Scale (PANSS)Six months
It measures symptoms of psychosis

Trialytics