RECRUITING

Ocrelizumab for Psychosis by Autoimmunity

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Conditions

Schizo-Affective Type of PsychosisSchizophreniaschizo-affective psychosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Ocrelizumab for Psychoses Possibly Caused by Synaptic Autoimmunity

Quick Facts

Study Start:2019-10-01
Study Completion:2025-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03971487

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 35 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals of either sex, 18-35 years of age.
  2. * 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).
  3. * A total PANSS ≥ 60 and a score ≥ 4 on at least 2 of the PANSS positive symptoms.
  4. * Normal academic performance at least until the age of 15 years and absence of psychiatric symptoms before the same age.
  5. * Ability to assent or consent to the performance of the study and participate in testing procedures.
  1. * 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).
  2. * Patient treated with a medication designed to suppress the immune system, other than standard analgesics or antipyretics, in the six months prior to randomization.
  3. * 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.
  4. * 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).
  5. * History of brain tumor, stroke, severe head trauma or multiple sclerosis.
  6. * Active cancer, metabolic encephalopathy, severe cardiovascular or renal disease.
  7. * In the judgment of the PI, psychosis related to substance abuse or metabolic disorders.
  8. * Pregnancy or lactation.
  9. * Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
  10. * History of or currently active primary or secondary immunodeficiency.
  11. * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
  12. * Contraindications to or intolerance of oral or IV corticosteroids.

Contacts and Locations

Study Contact

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

Principal Investigator

Joseph C Masdeu, MD, PhD
PRINCIPAL_INVESTIGATOR
HOUSTON METHODIST NEUROLOGICAL INSTITUTE

Study Locations (Sites)

Houston Methodist Research Institute
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The Methodist Hospital Research Institute

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-01
Study Completion Date2025-10-30

Study Record Updates

Study Start Date2019-10-01
Study Completion Date2025-10-30

Terms related to this study

Keywords Provided by Researchers

  • schizo-affective psychosis
  • schizophrenia

Additional Relevant MeSH Terms

  • Schizo-Affective Type of Psychosis
  • Schizophrenia