Ocrelizumab for Psychoses Possibly Caused by Synaptic Autoimmunity

Who is this study for? Patients with Schizo-Affective Type of Psychosis, Schizophrenia
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Biological, Behavioral
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
Houston Methodist Research Institute
RECRUITING
Houston
Contact Information
Primary
Joseph C Masdeu, MD, PhD
jcmasdeu@houstonmethodist.org
202-255-7899
Backup
Haroon Shahid, MD
mhshahid@houstonmethodist.org
713-441-1150
Time Frame
Start Date: 2019-10-01
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Genentech, Inc.
Leads: The Methodist Hospital Research Institute

This content was sourced from clinicaltrials.gov

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