Schizo-Affective Type of PsychosisPhase 1/2OPANCT03971487
Ocrelizumab for Psychosis by Autoimmunity
A Phase 1/2 study testing Psychosis and cognitive assessments, Physical and neuro-cognitive evaluations and Safety labs and electrocardiogram in people with Schizo-Affective Type of Psychosis and Schizophrenia, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizo-Affective Type of Psychosis, Schizophrenia
- What is being tested?
- Psychosis and cognitive assessments, Physical and neuro-cognitive evaluations and Safety labs and electrocardiogram
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 30 Oct 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Research Institute
Houston, Texas, 77030
Nilene M Crisci, RN, 281-222-1782, ncrisci@houstonmethodist.org
Maushami Gurung, CCRP, 713-441-4889, mgurung@houstonmethodist.org
About this study
Official title: Ocrelizumab for Psychoses Possibly Caused by Synaptic Autoimmunity
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.
- Conditions
- Schizo-Affective Type of Psychosis, Schizophrenia
- Being tested
- Psychosis and cognitive assessments, Physical and neuro-cognitive evaluations, Safety labs and electrocardiogram, Ocrelizumab infusion
- Keywords
- schizo-affective psychosis, schizophrenia
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosis and cognitive assessmentsBehavioural
Administration of MINI, PANSS and Quality of Living scales
Physical and neuro-cognitive evaluationsBehavioural
Physical, neurological and cognitive evaluations.
Safety labs and electrocardiogramDiagnostic test
Metabolic panel, CBC and differential, urinalysis, ECG, recreational drugs. CD19+ B-cell count.
Ocrelizumab infusionBiological
Two IV infusions of 300 mg of ocrelizumab 2 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| Ocrelizumab | Active comparator | Two doses of 300 mg of ocrelizumab will be administered as an intravenous infusion two weeks apart. Receives: Behavioral: Psychosis and cognitive assessments; Behavioral: Physical and neuro-cognitive evaluations; Diagnostic Test: Safety labs and electrocardiogram; Biological: Ocrelizumab infusion |
| Placebo | Placebo comparator | Two placebo intravenous infusions will be administered two weeks apart. Receives: Behavioral: Psychosis and cognitive assessments; Behavioral: Physical and neuro-cognitive evaluations; Diagnostic Test: Safety labs and electrocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the Positive and Negative Syndrome Scale (PANSS)
It measures symptoms of psychosis
Measured: Six months
Secondary outcomes (3)
Score on quality of life scales for psychiatric patients
(modified to include input by caregivers)
Measured: Six months
Score on NIH Cognitive Toolbox
Tablet-implemented tool testing cognitive abilities, including working memory
Measured: Six months
Antipsychotic-equivalent medication ordered by patient's psychiatrist
Dose of medications for psychosis transformed to a standard equivalent
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Oct 2019
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Schizo-Affective Type of PsychosisStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo-controlled therapeutic trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Joseph C Masdeu, MD, PhD, Principal investigator, HOUSTON METHODIST NEUROLOGICAL INSTITUTE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971487
- Sponsor's protocol ID
- Pro00021901
- Acronym
- OPA
- Status last verified
- Mar 2026
- First submitted
- 30 May 2019
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: It is possible that anonymized data could be shared with other researchers at the conclusion of the study.
Publications
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.
PubMed 27130657Masdeu 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.
PubMed 28234799
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocrelizumab for Psychoses Possibly Caused by Synaptic Autoimmunity
- ClinicalTrials.gov ID
- NCT03971487
- Acronym / sponsor ID
- OPA / Pro00021901
- Conditions
- Schizo-Affective Type of Psychosis, Schizophrenia
- Keywords
- schizo-affective psychosis, schizophrenia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled therapeutic trial
| Arm | Type | Receives |
|---|---|---|
| Ocrelizumab | Active comparator | Behavioral: Psychosis and cognitive assessments, Behavioral: Physical and neuro-cognitive evaluations, Diagnostic Test: Safety labs and electrocardiogram, Biological: Ocrelizumab infusionTwo doses of 300 mg of ocrelizumab will be administered as an intravenous infusion two weeks apart. |
| Placebo | Placebo comparator | Behavioral: Psychosis and cognitive assessments, Behavioral: Physical and neuro-cognitive evaluations, Diagnostic Test: Safety labs and electrocardiogramTwo placebo intravenous infusions will be administered two weeks apart. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosis and cognitive assessmentsAdministration of MINI, PANSS and Quality of Living scales | Behavioural | Ocrelizumab, Placebo |
| Physical and neuro-cognitive evaluationsPhysical, neurological and cognitive evaluations. | Behavioural | Ocrelizumab, Placebo |
| Safety labs and electrocardiogramMetabolic panel, CBC and differential, urinalysis, ECG, recreational drugs. CD19+ B-cell count. | Diagnostic test | Ocrelizumab, Placebo |
| Ocrelizumab infusionTwo IV infusions of 300 mg of ocrelizumab 2 weeks apart | Biological | Ocrelizumab |
Primary outcome
Score on the Positive and Negative Syndrome Scale (PANSS)
Time frame: Six months
It measures symptoms of psychosis
3 secondary outcomes
Score on quality of life scales for psychiatric patients
Time frame: Six months
Score on NIH Cognitive Toolbox
Time frame: Six months
Antipsychotic-equivalent medication ordered by patient's psychiatrist
Time frame: Six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Background: PubMed 27130657Masdeu 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.
- Background: PubMed 28234799Masdeu 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.
- Individual participant dataSharing planned: No. It is possible that anonymized data could be shared with other researchers at the conclusion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph C Masdeu, MD, PhD principal investigator
HOUSTON METHODIST NEUROLOGICAL INSTITUTE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Psychosis and cognitive assessments, Physical and neuro-cognitive evaluations and Safety labs and electrocardiogram in people with Schizo-Affective Type of Psychosis and Schizophrenia, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph C Masdeu, MD, PhD (202-255-7899, jcmasdeu@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the Positive and Negative Syndrome Scale (PANSS) (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03971487, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.