Ocrelizumab for Psychosis by Autoimmunity
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-35
SponsorThe Methodist Hospital Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Psychosis and cognitive assessments
BehavioralAdministration of MINI, PANSS and Quality of Living scales
Physical and neuro-cognitive evaluations
BehavioralPhysical, neurological and cognitive evaluations.
Safety labs and electrocardiogram
Diagnostic testMetabolic panel, CBC and differential, urinalysis, ECG, recreational drugs. CD19+ B-cell count.
Ocrelizumab infusion
Biological/VaccineTwo IV infusions of 300 mg of ocrelizumab 2 weeks apart
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: OcrelizumabActive comparator 4 interventions
Group B: PlaceboPlacebo comparator 3 interventions
Trial outcomes
Primary outcomes
1
Score on the Positive and Negative Syndrome Scale (PANSS)
It measures symptoms of psychosis
Time frame
Six monthsSecondary outcomes
1
Score on quality of life scales for psychiatric patients
(modified to include input by caregivers)
Time frame
Six months2
Score on NIH Cognitive Toolbox
Tablet-implemented tool testing cognitive abilities, including working memory
Time frame
Six months3
Antipsychotic-equivalent medication ordered by patient's psychiatrist
Dose of medications for psychosis transformed to a standard equivalent
Time frame
Six monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Methodist Hospital Research Institute
Lead sponsor
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov