Could an Immune-Suppressing drug treat some forms of schizophrenia?
NCT ID NCT03971487
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether ocrelizumab, a drug that suppresses certain immune cells, can reduce psychosis symptoms in people whose schizophrenia or bipolar disorder may be caused by auto-antibodies attacking brain receptors. Forty participants aged 18–35 will receive either ocrelizumab or a placebo, and their symptoms will be measured using standard psychiatric scales. The goal is to see if targeting the immune system can improve outcomes for this specific subgroup.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ocrelizumab
- What this could lead to
- If it works, this could point toward a new treatment for some people with schizophrenia or bipolar disorder whose illness is caused by auto-antibodies attacking the brain.
- What could go wrong
- This is an early-phase trial with only 40 people, so results may not apply to everyone. Ocrelizumab suppresses the immune system, which can increase infection risk, and it is not yet proven to help psychosis.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2019
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 35 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Houston Methodist Research Institute
RECRUITINGHouston, Texas, 77030, United States
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