Ocrelizumab for Psychosis by Autoimmunity

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT03971487
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 1, 2019
Status verified
Mar 2026
Primary completion
Jun 30, 2028
Completion
Oct 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist Research InstituteHoustonTexas77030
Nilene M Crisci, RN
[email protected]
281-222-1782
Maushami Gurung, CCRP
[email protected]
713-441-4889
Joseph C Masdeu, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Houston Methodist Research Institute· Houston, TX

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