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NCT03971487 · ClinicalTrials.gov registry record · Phase 1
Ocrelizumab for Psychosis by Autoimmunity
A Phase 1 study, sponsored by The Methodist Hospital Research Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT03971487: Recruiting Phase 1 study, sponsored by The Methodist Hospital Research Institute.
NCT03971487 is a Phase 1 study that is actively recruiting participants, run by The Methodist Hospital Research Institute. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03971487, a Phase 1 study, is actively recruiting participants, sponsored by The Methodist Hospital Research Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study 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 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.
Primary Outcome
It measures symptoms of psychosis
Interventions
- BEHAVIORAL Psychosis and cognitive assessments
- BEHAVIORAL Physical and neuro-cognitive evaluations
- DIAGNOSTIC_TEST Safety labs and electrocardiogram
- BIOLOGICAL Ocrelizumab infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2028-10-30 |
| Phase | Phase 1 |
What NCT03971487 shows while recruiting
NCT03971487 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 4 interventions - of which Psychosis and cognitive assessments is the first listed.
NCT03971487 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03971487 about?
NCT03971487 is a clinical study titled "Ocrelizumab for Psychosis by 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-antibod...
What is the current status of trial NCT03971487?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2019-10-01. Estimated completion is 2028-10-30.
What interventions are being tested in trial NCT03971487?
The interventions under investigation include: Psychosis and cognitive assessments (BEHAVIORAL), Physical and neuro-cognitive evaluations (BEHAVIORAL), Safety labs and electrocardiogram (DIAGNOSTIC_TEST), Ocrelizumab infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT03971487?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03971487's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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