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New treatment option for Schizo-Affective Type of Psychosis
Official title Ocrelizumab for Psychosis by Autoimmunity
ClinicalTrials.gov ID: NCT03971487
What this study is testing
What is Ocrelizumab infusion?
Ocrelizumab infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for schizo-affective type of psychosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- 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...
- History of brain tumor, stroke, severe head trauma or multiple sclerosis.
- Active cancer, metabolic encephalopathy, severe cardiovascular or renal disease.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.