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RecruitingPhase 1 / Phase 2

Ocrelizumab for Psychosis by Autoimmunity

Ocrelizumab for Psychoses Possibly Caused by Synaptic Autoimmunity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 35 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ocrelizumab for adults ages 18–35 with schizophrenia-related illness. It asks whether a treatment that reduces antibodies that attack the body can improve symptoms, such as seeing or hearing things that are not there. Researchers will compare it with a look-alike treatment that has no active medicine.

Some people who have what doctors currently call schizophrenia or bipolar disease may actually have a brain disease caused by auto-antibodies. Auto-antibodies are produced when the normal defense mechanism of the body goes wrong and begins to attack the body, similar to "friendly fire." Auto-antibodies attack brain receptors and then the person who has this problem begins to have hallucinations and other manifestations of schizophrenia, like feeling that people can see what they are thinking and also feeling that other people do not like them. If this disease is caused by auto-antibodies, typically the person is well until they are 15 years of age or older, but seldom older than 35 years. Then, in a matter of a few months they begin to have hallucinations and the other symptoms. Doctors still do not know whether some people with schizophrenia or bipolar disease have auto-antibodies attacking their brain. For this reason, in this study some of these patients will receive a treatment that suppresses the auto-antibodies and their symptoms after treatment will be compared with the symptoms of a group of similar patients who are given a preparation that looks like the real treatment, but it is not.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–35, of any sex.
  • Have a current schizophrenia-related disorder lasting at least 6 months, confirmed by a study interview.
  • Score at least 60 on the PANSS symptom rating scale, with scores of at least 4 on two symptoms such as hallucinations or false beliefs.
  • Had normal school performance through at least age 15 and no mental health symptoms before age 15.
  • Can agree to join the study and take part in its tests.

Who can't join

  • Changed the dose of medicine for psychosis within 2 weeks before the starting symptom test.
  • Used medicine to weaken the immune system in the past 6 months, except standard pain or fever medicines; or need ongoing whole-body steroid or immune-suppressing treatment during the study.
  • Received a live, weakened vaccine less than 4 weeks before ocrelizumab, or a non-live vaccine less than 2 weeks before it.
  • Have a current, repeated, or long-lasting infection, or have ever had a condition that weakens the immune system.
  • Have a history of brain tumor, stroke, severe head injury, or multiple sclerosis; or have active cancer, brain problems caused by a chemical imbalance, or severe heart, blood vessel, or kidney disease.
  • The lead study doctor believes the psychosis is caused by substance use or problems with the body's chemical processes.
  • Are pregnant or breastfeeding.
  • Have had a severe allergic reaction to certain antibody medicines made using human or mouse proteins, or cannot safely take or tolerate steroids by mouth or through a vein.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

TX