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Ocrelizumab for Psychosis by Autoimmunity (OPA)

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ClinicalTrials.gov Identifier: NCT03971487
Recruitment Status : Not yet recruiting
First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
The Methodist Hospital System

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.

Condition or disease Intervention/treatment Phase
Schizo-Affective Type of Psychosis Schizophrenia Behavioral: Psychosis and cognitive assessments Behavioral: Physical and neuro-cognitive evaluations Diagnostic Test: Safety labs and electrocardiogram Biological: Ocrelizumab infusion Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized placebo-controlled therapeutic trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Ocrelizumab for Psychoses Possibly Caused by Synaptic Autoimmunity
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : September 2021


Arm Intervention/treatment
Active Comparator: Ocrelizumab
Two doses of 300 mg of ocrelizumab will be administered as an intravenous infusion two weeks apart.
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

Placebo Comparator: Placebo
Two placebo intravenous infusions will be administered two weeks apart.
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.




Primary Outcome Measures :
  1. Score on the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Six months ]
    It measures symptoms of psychosis


Secondary Outcome Measures :
  1. Score on quality of life scales for psychiatric patients [ Time Frame: Six months ]
    (modified to include input by caregivers)

  2. Score on NIH Cognitive Toolbox [ Time Frame: Six months ]
    Tablet-implemented tool testing cognitive abilities, including working memory

  3. Antipsychotic-equivalent medication ordered by patient's psychiatrist [ Time Frame: Six months ]
    Dose of medications for psychosis transformed to a standard equivalent



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971487


Contacts
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Contact: Joseph C Masdeu, MD, PhD 202-255-7899 jcmasdeu@houstonmethodist.org
Contact: Haroon Shahid, MD 713-441-1150 mhshahid@houstonmethodist.org

Locations
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United States, Texas
Houston Methodist Research Institute Not yet recruiting
Houston, Texas, United States, 77030
Contact: Jennifer M Garrett, RN, CCRP    281-222-9983    jmgarrett@houstonmethodist.org   
Contact: Rejani Nair, RN, CCRP    713-441-1150 ext Masdeu    jcmasdeu@houstonmethodist.org   
Principal Investigator: Joseph C Masdeu, MD, PhD         
Sponsors and Collaborators
The Methodist Hospital System
Genentech, Inc.
Investigators
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Principal Investigator: Joseph C Masdeu, MD, PhD HOUSTON METHODIST NEUROLOGICAL INSTITUTE

Publications:
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Responsible Party: The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT03971487     History of Changes
Other Study ID Numbers: Pro00021901
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is possible that anonymized data could be shared with other researchers at the conclusion of the study.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by The Methodist Hospital System:
schizo-affective psychosis
schizophrenia

Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Mental Disorders
Autoimmune Diseases
Schizophrenia Spectrum and Other Psychotic Disorders
Immune System Diseases
Ocrelizumab
Immunologic Factors
Physiological Effects of Drugs