Using Ocrelizumab to treat psychosis caused by autoimmunity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of Ocrelizumab, a medication that targets auto-antibodies, in patients diagnosed with schizo-affective type of psychosis and schizophrenia. The study aims to determine if these conditions, which often present with hallucinations and other psychotic symptoms, may be linked to an autoimmune response affecting the brain. Participants will undergo various assessments, including psychosis and cognitive evaluations, to monitor the effects of the treatment. The trial focuses on individuals aged 18-35 who have experienced active psychotic symptoms for at least six months.

Why it matters

Who can join: the full rules

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.

Where it's running

• Houston Methodist Research Institute
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Joseph C Masdeu, MD, PhD — Houston Methodist Neurological Institute
• Study coordinator: Joseph C Masdeu, MD, PhD
• Email: jcmasdeu@houstonmethodist.org
• Phone: 202-255-7899

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Lumateperone to improve motivation in patients with schizophrenia and psychosis

  This study is testing if Lumateperone can help people with schizophrenia or schizoaffective disorders feel more motivated and less apathetic.

  Recruiting Phase 3 Louisiana State University Health Sciences Center Shreveport · Shreveport, Louisiana · NCT06482554

• Examining the effects of combined therapy for schizophrenia

  This study is testing whether combining two therapies, one for managing thoughts and another for improving cognitive skills, can help people with schizophrenia do better in their daily lives compared to using just one of the therapies.

  Recruiting at 2 sites University of Toronto · Scarborough Village, Ontario and 1 other locations · NCT05731414

• XEP527 in stable schizophrenia: safety and how it behaves in the body

  This small, early-stage study tests the safety and how XEP527 behaves in people with stable schizophrenia who are on a single antipsychotic.

  Recruiting Phase 1 Novartis · Bentonville, Arkansas · NCT07908680

• Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations

  This study tests whether theta-burst transcranial magnetic stimulation can lessen persistent auditory verbal hallucinations in adults with schizophrenia-spectrum or psychotic disorders who have not responded to antipsychotic meds.

  Recruiting Ciusss de L'Est de l'Île de Montréal · Montreal, Quebec · NCT07902518

• Quality of life and safety in quetiapine use for schizophrenia or bipolar disorder

  This study looks at how patients with schizophrenia or bipolar disorder feel and stay safe when treated with quetiapine alone or with other antipsychotics.

  Recruiting Bosnalijek D.D · Sarajevo · NCT07858565

• Neuronavigated rTMS for treatment-resistant auditory hallucinations

  We are testing whether personalized neuronavigated inhibitory rTMS can reduce persistent auditory verbal hallucinations in adults who don’t respond to medication.

  Recruiting Psychiatric University Hospital, Zurich · Zurich · NCT07856368

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.