Phase 4 Schizophrenia Trial, Recruiting NCT05208190 Sponsor: New York State Psychiatric Institute Condition: Schizophrenia
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Phase 4 Schizophrenia Trial, Recruiting

NCT05208190
Recruiting Phase 4

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 who have been formally diagnosed with schizophrenia or schizoaffective disorder using a structured clinical interview
  • People who have committed at least one act of violence (minor or serious) in the past six months, as measured by a specific assessment tool
  • People who are willing and able to give informed consent to participate
  • People who a doctor considers to be medically stable
  • People who a doctor considers suitable for treatment with either clozapine or standard care, and who are currently not taking any medication, or are taking an antipsychotic other than clozapine or a long-acting injectable given less than every 30 days

Who may not be able to join:

  • People with an unstable or serious medical or neurological condition, including certain blood or bone marrow disorders (confirm with trial site)
  • People who have previously had a serious reaction or allergy to clozapine, such as a dangerous drop in white blood cells, bowel blockage, or heart inflammation
  • People with a history of intellectual disability
  • Women who are pregnant or breastfeeding, or women who are capable of becoming pregnant but are not willing to use effective birth control
  • People who have experienced significant suicidal thoughts in the past month, any suicidal behaviour in the past three months, or who a doctor considers to be at too high a risk of suicide to safely participate in this type of trial
  • People who have previously tried clozapine and either could not tolerate it or did not benefit from a full course of treatment

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 14 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Ragy Girgis, MD, New York State Psychiatric Institute

Phone: 646-774-5553

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 4
Sponsor
New York State Psychiatric Institute
Registry
ClinicalTrials.gov
Start date
17 March 2022
Est. completion
30 June 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Effectiveness outcome: Violent acts; Target engagement outcome: Excitement Factor of 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: 14 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