NCT03971487

Ocrelizumab for Psychosis by Autoimmunity

Ocrelizumab for Psychoses Possibly Caused by Synaptic Autoimmunity

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Psychosis and cognitive assessments	Administration of MINI, PANSS and Quality of Living scales
BEHAVIORAL	Physical and neuro-cognitive evaluations	Physical, neurological and cognitive evaluations.
DIAGNOSTIC_TEST	Safety labs and electrocardiogram	Metabolic panel, CBC and differential, urinalysis, ECG, recreational drugs. CD19+ B-cell count.
BIOLOGICAL	Ocrelizumab infusion	Two IV infusions of 300 mg of ocrelizumab 2 weeks apart

Timeline

• Start date: 2019-10-01
• Primary completion: 2028-06-30
• Completion: 2028-10-30
• First posted: 2019-06-03
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study