Phase 2 Schizophrenia Trial, Recruiting NCT03971487 Sponsor: The Methodist Hospital Research Institute Condition: Schizophrenia
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Phase 2 Schizophrenia Trial, Recruiting

NCT03971487
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People of any gender between 18 and 35 years old.
  • People who have been diagnosed with a Schizophrenia Spectrum Disorder (a type of psychotic illness) lasting at least six months, confirmed using a standard psychiatric interview tool.
  • People whose symptom scores on a standard rating scale (called the PANSS) meet a certain level of severity, including having at least two notably elevated positive symptoms (such as hallucinations or delusions).
  • People who had normal school performance up to at least age 15 and had no psychiatric symptoms before that age.
  • People who are able to give their agreement to take part in the study and complete the required tests.

Who may not be able to join:

  • People whose antipsychotic medication dose was changed less than two weeks before the first assessment visit.
  • People who have been treated with immune-suppressing medications (other than standard pain relief or fever-reducing medicines) in the six months before joining the trial.
  • People who received a live vaccine less than four weeks before the study infusion, or a non-live vaccine less than two weeks before the infusion.
  • People who have an active infection, or a history of recurring or long-term infections such as hepatitis B or C, HIV, syphilis, tuberculosis, or a condition called PML.
  • People with a history of brain tumour, stroke, severe head injury, or multiple sclerosis.
  • People with active cancer, a metabolic brain condition, or severe heart or kidney disease.
  • People whose psychosis the lead researcher believes is caused by substance use or a metabolic disorder.
  • People who are pregnant or breastfeeding.
  • People who would need ongoing steroid or immune-suppressing treatment throughout the study period.
  • People who have a current or past history of a condition where the immune system does not work properly (primary or secondary immunodeficiency).
  • People who have had a severe allergic or anaphylactic reaction to a type of laboratory-made antibody treatment (called humanized or murine monoclonal antibodies).
  • People for whom steroid medications (taken by mouth or by drip) are not suitable or not tolerated.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Joseph C Masdeu, MD, PhD, HOUSTON METHODIST NEUROLOGICAL INSTITUTE

Phone: 202-255-7899

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
The Methodist Hospital Research Institute
Registry
ClinicalTrials.gov
Start date
1 October 2019
Est. completion
30 June 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Score on the Positive and Negative Syndrome Scale (PANSS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov