Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing Ocrelizumab infusion for Schizo-Affective Type of Psychosis

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.

Official registry: https://clinicaltrials.gov/study/NCT03971487 · The Methodist Hospital Research Institute · enrollment listed as 40

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Psychosis and cognitive assessments, Physical and neuro-cognitive evaluations, or Safety labs and electrocardiogram. The registry lists allocation as randomized. Some people who have what doctors currently call schizophrenia or bipolar disease may actually have a brain disease caused by auto-antibodies.

They plan to enroll about 40 people at Houston. Taking part typically means an infusion or injection of a biologic, following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

Ocrelizumab for Psychoses Possibly Caused by Synaptic Autoimmunity

Interventions: Psychosis and cognitive assessments, Physical and neuro-cognitive evaluations, Safety labs and electrocardiogram, Ocrelizumab infusion

Primary outcome (registry wording): Score on the Positive and Negative Syndrome Scale (PANSS)

Who it is for (from inclusion criteria)

  • Ages 18 Years to 35 Years
  • 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

Public study contact (from the registry)

Joseph C Masdeu, MD, PhD

202-255-7899

jcmasdeu@houstonmethodist.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT03971487 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT03971487?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT03971487?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary