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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocrelizumab | Active Comparator | Two doses of 300 mg of ocrelizumab will be administered as an intravenous infusion two weeks apart. |
|
| Placebo | Placebo Comparator | Two placebo intravenous infusions will be administered two weeks apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosis and cognitive assessments | Behavioral | Administration of MINI, PANSS and Quality of Living scales |
|
| Measure | Description | Time Frame |
|---|---|---|
| Score on the Positive and Negative Syndrome Scale (PANSS) | It measures symptoms of psychosis | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Score on quality of life scales for psychiatric patients | (modified to include input by caregivers) | Six months |
| Score on NIH Cognitive Toolbox | Tablet-implemented tool testing cognitive abilities, including working memory |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph C Masdeu, MD, PhD | Contact | 202-255-7899 | jcmasdeu@houstonmethodist.org | |
| Haroon Shahid, MD | Contact | 713-441-1150 | mhshahid@houstonmethodist.org |
| Name | Affiliation | Role |
|---|---|---|
| Joseph C Masdeu, MD, PhD | HOUSTON METHODIST NEUROLOGICAL INSTITUTE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Research Institute | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27130657 | Background | 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. | |
| 28234799 | Background | 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. |
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It is possible that anonymized data could be shared with other researchers at the conclusion of the study.
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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Randomized placebo-controlled therapeutic trial
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| Physical and neuro-cognitive evaluations | Behavioral | Physical, neurological and cognitive evaluations. |
|
| Safety labs and electrocardiogram | Diagnostic Test | Metabolic panel, CBC and differential, urinalysis, ECG, recreational drugs. CD19+ B-cell count. |
|
| Ocrelizumab infusion | Biological | Two IV infusions of 300 mg of ocrelizumab 2 weeks apart |
|
| Six months |
| Antipsychotic-equivalent medication ordered by patient's psychiatrist | Dose of medications for psychosis transformed to a standard equivalent | Six months |
| D006334 |
| Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |