Recruiting
Phase 1
Phase 2

Ocrelizumab

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT03971487

Conditions

Schizo-Affective Type of Psychosis

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

Interventions

Psychosis and cognitive assessments

Physical and neuro-cognitive evaluations

Safety labs and electrocardiogram

Ocrelizumab infusion

Study Details

Brief summary:

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.

Conditions

Schizo-Affective Type of Psychosis

Schizophrenia

Study ID

NCT03971487

Start date

Oct 1, 2019

Status verified date

Mar, 2026

Completion date

Oct 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Ocrelizumab

Two doses of 300 mg of ocrelizumab will be administered as an intravenous infusion two weeks apart.

placebo comparator: Placebo

Two placebo intravenous infusions will be administered two weeks apart.

Interventions

Psychosis and cognitive assessments

Administration of MINI, PANSS and Quality of Living scales

Physical and neuro-cognitive evaluations

Physical, neurological and cognitive evaluations.

Safety labs and electrocardiogram

Metabolic panel, CBC and differential, urinalysis, ECG, recreational drugs. CD19+ B-cell count.

Ocrelizumab infusion

Two IV infusions of 300 mg of ocrelizumab 2 weeks apart

Primary outcome measure

  • Score on the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Six months ]

Central Contacts and Locations

Central contacts

Joseph C Masdeu, MD, PhD

202-255-7899jcmasdeu@houstonmethodist.org

Haroon Shahid, MD

713-441-1150mhshahid@houstonmethodist.org

Locations

Houston Methodist Research Institute

Recruiting

Houston, Texas, United States, 77030

Contacts

Nilene M Crisci, RN

281-222-1782ncrisci@houstonmethodist.org

Maushami Gurung, CCRP

713-441-4889mgurung@houstonmethodist.org

Principal Investigator:

Joseph C Masdeu, MD, PhD

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • schizo-affective psychosis
  • schizophrenia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2026-04-01.