Using Ocrelizumab to treat psychosis caused by autoimmunity

Ocrelizumab for Psychoses Possibly Caused by Synaptic Autoimmunity

This study tests if the medication Ocrelizumab can help young adults with schizo-affective psychosis and schizophrenia caused by autoimmune issues feel better.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 35 Years
• Sex: All
• Sponsor: The Methodist Hospital Research Institute (other)
• Drugs / interventions: ocrelizumab
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT03971487 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18-35 with a diagnosis of schizophrenia spectrum disorder and specific symptom criteria.

Not a fit: Patients with a history of significant psychiatric symptoms before age 15 or those on certain immunosuppressive medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with psychosis linked to autoimmune mechanisms.

How similar studies have performed: While the approach of targeting auto-immunity in psychosis is novel, similar studies exploring autoimmune links in psychiatric conditions have shown promise.

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.

Where this trial is running

Houston, Texas

• 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

Conditions: Schizo-Affective Type of Psychosis, Schizophrenia, schizo-affective psychosis, schizophrenia