Phase 4 Schizophrenia Trial, Recruiting NCT06969755 Sponsor: Northwell Health Condition: Schizophrenia
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Phase 4 Schizophrenia Trial, Recruiting

NCT06969755
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 aged 18 to 35
  • People who have been diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder, as confirmed by a structured clinical interview (called the SCID-5)
  • People who are currently experiencing moderate or higher levels of certain symptoms, such as unusual thoughts, disorganised thinking, hallucinations, or suspiciousness, as measured by a standard rating scale
  • People whose brain scan (MRI) shows preserved connectivity in a specific brain region called the striatum
  • People whose genetic testing does not show a specific high-risk gene variant called MC4R
  • People whose genetic testing does not show a specific high-risk gene variant called HLA-DQB1
  • People who are in an early stage of illness, meaning they have taken antipsychotic medications for a total of 4 weeks or less over their lifetime (small doses used for other purposes, such as sleep, may be an exception — confirm with trial site)
  • People who are able to give informed consent to participate

Who may not be able to join:

  • People who have a serious neurological or hormonal (endocrine) condition that the investigator believes could affect the trial results
  • People who have an abnormal heart tracing (ECG/EKG) at screening that the investigator believes could affect the trial results
  • People who have a medical condition that requires them to take medication with effects on mood, thinking, or behaviour
  • People who are assessed as having a significant risk of suicidal or violent behaviour, based on specific standardised safety rating scales
  • People who have cognitive difficulties or any other factor that would prevent them from giving informed consent
  • People who cannot safely have an MRI scan (for example, people with a pacemaker)
  • People who have a moderate or severe substance use disorder for any substance (other than nicotine) within the past 3 months, or a mild substance use disorder for substances other than cannabis, alcohol, or nicotine in the past 3 months, or a positive drug screen at baseline for substances other than nicotine, alcohol, or cannabis
  • People where an intellectual disability is suspected, based on clinical interview or a reading/IQ screening test showing a score below 71
  • People who have previously had brain surgery (psychosurgery)
  • People who are pregnant (based on self-report)
  • People who have a seizure disorder (based on self-report)

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 28 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

Phone: 904-302-0811

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
Northwell Health
Registry
ClinicalTrials.gov
Start date
30 September 2025
Est. completion
30 July 2030

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

Total change in BPRS Symptoms

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: 28 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