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Could an Immune-Suppressing drug treat some forms of schizophrenia?

NCT ID NCT03971487

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2019

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 35 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Houston Methodist Research Institute

    RECRUITING

    Houston, Texas, 77030, United States

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