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Ocrelizumab for Psychosis by Autoimmunity (OPA)

Primary Purpose

Schizo-Affective Type of Psychosis, Schizophrenia

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Psychosis and cognitive assessments

Physical and neuro-cognitive evaluations

Safety labs and electrocardiogram

Ocrelizumab infusion

About this trial

This is an interventional treatment trial for Schizo-Affective Type of Psychosis focused on measuring schizo-affective psychosis, schizophrenia

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Houston Methodist Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ocrelizumab

Placebo

Arm Description

Two doses of 300 mg of ocrelizumab will be administered as an intravenous infusion two weeks apart.

Two placebo intravenous infusions will be administered two weeks apart.

Outcomes

Primary Outcome Measures

Score on the Positive and Negative Syndrome Scale (PANSS)

It measures symptoms of psychosis

Secondary Outcome Measures

Score on quality of life scales for psychiatric patients

(modified to include input by caregivers)

Score on NIH Cognitive Toolbox

Tablet-implemented tool testing cognitive abilities, including working memory

Antipsychotic-equivalent medication ordered by patient's psychiatrist

Dose of medications for psychosis transformed to a standard equivalent

Full Information

NCT ID

NCT03971487

First Posted

May 30, 2019

Last Updated

December 11, 2019

Sponsor

The Methodist Hospital Research Institute

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03971487

Brief Title

Ocrelizumab for Psychosis by Autoimmunity

Acronym

OPA

Official Title

Ocrelizumab for Psychoses Possibly Caused by Synaptic Autoimmunity

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2019 (Actual)

Primary Completion Date

March 2021 (Anticipated)

Study Completion Date

September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Methodist Hospital Research Institute

Collaborators

Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizo-Affective Type of Psychosis, Schizophrenia

Keywords

schizo-affective psychosis, schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Randomized placebo-controlled therapeutic trial

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ocrelizumab

Arm Type

Active Comparator

Arm Description

Two doses of 300 mg of ocrelizumab will be administered as an intravenous infusion two weeks apart.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Two placebo intravenous infusions will be administered two weeks apart.

Intervention Type

Behavioral

Intervention Name(s)

Psychosis and cognitive assessments

Intervention Description

Administration of MINI, PANSS and Quality of Living scales

Intervention Type

Behavioral

Intervention Name(s)

Physical and neuro-cognitive evaluations

Intervention Description

Physical, neurological and cognitive evaluations.

Intervention Type

Diagnostic Test

Intervention Name(s)

Safety labs and electrocardiogram

Intervention Description

Metabolic panel, CBC and differential, urinalysis, ECG, recreational drugs. CD19+ B-cell count.

Intervention Type

Biological

Intervention Name(s)

Ocrelizumab infusion

Intervention Description

Two IV infusions of 300 mg of ocrelizumab 2 weeks apart

Primary Outcome Measure Information:

Title

Score on the Positive and Negative Syndrome Scale (PANSS)

Description

It measures symptoms of psychosis

Time Frame

Six months

Secondary Outcome Measure Information:

Title

Score on quality of life scales for psychiatric patients

Description

(modified to include input by caregivers)

Time Frame

Six months

Title

Score on NIH Cognitive Toolbox

Description

Tablet-implemented tool testing cognitive abilities, including working memory

Time Frame

Six months

Title

Antipsychotic-equivalent medication ordered by patient's psychiatrist

Description

Dose of medications for psychosis transformed to a standard equivalent

Time Frame

Six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joseph C Masdeu, MD, PhD

Phone

202-255-7899

jcmasdeu@houstonmethodist.org

First Name & Middle Initial & Last Name or Official Title & Degree

Haroon Shahid, MD

Phone

713-441-1150

mhshahid@houstonmethodist.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph C Masdeu, MD, PhD

Organizational Affiliation

HOUSTON METHODIST NEUROLOGICAL INSTITUTE

Official's Role

Principal Investigator

Facility Information:

Facility Name

Houston Methodist Research Institute

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer M Garrett, RN, CCRP

Phone

281-222-9983

jmgarrett@houstonmethodist.org

First Name & Middle Initial & Last Name & Degree

Rejani Nair, RN, CCRP

Phone

713-441-1150

Ext

Masdeu

jcmasdeu@houstonmethodist.org

First Name & Middle Initial & Last Name & Degree

Joseph C Masdeu, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

It is possible that anonymized data could be shared with other researchers at the conclusion of the study.

Citations:

PubMed Identifier

27130657

Citation

Masdeu JC, Dalmau J, Berman KF. NMDA Receptor Internalization by Autoantibodies: A Reversible Mechanism Underlying Psychosis? Trends Neurosci. 2016 May;39(5):300-310. doi: 10.1016/j.tins.2016.02.006. Epub 2016 Apr 26.

Results Reference

background

PubMed Identifier

28234799

Citation

Masdeu JC. Detecting synaptic autoantibodies in psychoses: need for more sensitive methods. Curr Opin Neurol. 2017 Jun;30(3):317-326. doi: 10.1097/WCO.0000000000000447.

Results Reference

background

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Ocrelizumab for Psychosis by Autoimmunity

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