Ocrelizumab for Psychosis by Autoimmunity

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

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

Sponsors & Collaborators

• Genentech, Inc.

  collaborator INDUSTRY

• The Methodist Hospital Research Institute

  lead OTHER

Principal Investigators

• Joseph C Masdeu, MD, PhD · HOUSTON METHODIST NEUROLOGICAL INSTITUTE

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-01

Primary Completion

2028-06-30

Completion

2028-10-30

FDA Drug

Yes

Countries

• United States

Study Locations