Phase 3 Schizophrenia Trial, Recruiting NCT07263022 Sponsor: University of Minnesota Condition: Schizophrenia
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Phase 3 Schizophrenia Trial, Recruiting

NCT07263022
Recruiting Phase 3

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 are between 18 and 35 years old
  • People who have been diagnosed with a psychosis-related illness (such as schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis not otherwise specified, bipolar disorder with psychosis, or major depressive disorder with psychosis) within the last 5 years
  • People with an estimated IQ of 70 or above
  • People who are sufficiently fluent in English, as determined by the study team through normal interactions
  • People whose psychiatric medications have not changed in the week before enrolling or attending MRI visits
  • People whose overall medications have been stable for at least one month before joining the study, with no major dose changes, new medications added, or medications removed in the past 30 days (minor dose adjustments may be considered at the principal investigator's discretion)
  • People who have been on the same medication dose for at least 7 days before receiving the study drug

Who may not be able to join:

  • People with a major neurological disorder, as determined by the principal investigator
  • People with a history of a significant head injury, with or without loss of consciousness
  • People with any major medical condition that, in the opinion of the principal investigator, could interfere with participation or create additional health risks
  • People with a personal history of kidney disease, damage, or impairment
  • People with a personal history of liver disease, damage, or impairment
  • People with a personal history of heart attack or heart disease, or who report symptoms such as shortness of breath, heart palpitations, difficulty breathing while lying flat, ankle swelling, significant dizziness, fainting, or leg pain while walking
  • People with a history of a low white blood cell count, or who have been diagnosed with leukopenia, neutropenia, or agranulocytosis (conditions involving abnormally low levels of certain immune cells)
  • People with uncontrolled high blood pressure (above 140/90) or a resting heart rate above 100 beats per minute
  • People whose blood or urine lab results fall outside acceptable ranges for kidney function, liver function, or protein levels (confirm with trial site for specific values)
  • People currently taking a medication or supplement that has a known major interaction with the study drugs, such as ketamine, MAOIs, clomipramine, diazepam, propranolol, or warfarin (confirm with trial site)
  • People with known allergies to any of the study drugs
  • People who are pregnant, planning to become pregnant, or currently breastfeeding
  • People who are unable to pass a standard vision test
  • People who are unable to pass a safety screening for MRI scans (for example, due to metal implants or other MRI-related concerns)
  • People who meet the criteria for a severe substance use disorder or severe alcohol use disorder within the past 3 months
  • People with a lifetime history of a stimulant use disorder
  • People currently experiencing a manic episode, as identified through a structured clinical interview
  • People who have been hospitalised for a psychiatric reason within the past 3 months
  • People considered to be at clinical risk of suicidal behaviour, including those with a recent suicide attempt, active suicidal thoughts at screening, or recent planning or preparatory actions related to suicide within the past 3 months
  • People whose scores on a psychiatric symptom assessment reach the severe or extremely severe range for items including suicidality, disorientation, unusual behaviour, agitation, or elevated mood
  • People with any other psychiatric symptoms or conditions that, in the opinion of the principal investigator, could interfere with participation or create additional risk
  • People who are unable or unwilling to give informed consent
  • People who, in the judgment of study staff, do not have sufficient capacity to make an informed decision about participating
  • People who are currently under legal guardianship
  • People who are under a civil commitment order (a legal order relating to psychiatric care)
  • People who are unable to read
  • People who have engaged in significant structured cognitive training in the past year, as determined by the principal investigator

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 26 July 2026
Phase 3: approximately ~65% 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: Sophia Vinogradov, MD, University of Minnesota Department of Psychiatry and Behavioral Sciences

Phone: 612-772-2201

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 3
Registry
ClinicalTrials.gov
Start date
17 July 2026
Est. completion
30 April 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Test My Brain - Digit Symbol Coding; Test My Brain - Digit Symbol Coding; Test My Brain - Digit Symbol Coding; Test My Brain - Digit Symbol Coding; Test My Brain - Digit Symbol Coding; Test My Brain - Digit Symbol Coding; Test My Brain - Digit Symbol Coding; Test My Brain - Verbal Paired Associates Memory; Test My Brain - Verbal Paired Associates Memory; Test My Brain - Verbal Paired Associates Memory; Test My Brain - Verbal Paired Associates Memory; Test My Brain - Verbal Paired Associates Memory; Test My Brain - Verbal Paired Associates Memory; Test My Brain - Verbal Paired Associates Memory...

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: 26 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