Phase 3 Schizophrenia Trial, Recruiting NCT07231497 Sponsor: University of Minnesota Condition: Schizophrenia
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Phase 3 Schizophrenia Trial, Recruiting

NCT07231497
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:

  • You are comfortable reading, speaking, and understanding English
  • Your score on a thinking and memory test suggests an IQ of 70 or above
  • You have been living in the community (not in a hospital or inpatient facility) for at least one month before joining the study
  • Your medications have been at a stable dose for at least one month before joining, with no major changes in the past 30 days and no changes at all in the 7 days before taking the study drug

Who may not be able to join:

  • You have a major brain or nervous system disorder (such as epilepsy or multiple sclerosis)
  • You have had a head injury at any point in your life, with or without losing consciousness
  • You have any serious medical condition that the study doctor believes could put you at risk or make it hard to participate
  • You have a history of kidney problems, kidney disease, or kidney injury
  • You have a history of liver problems, liver disease, or liver injury
  • You have a history of heart attack or heart disease
  • You have heart-related symptoms — such as shortness of breath, a racing or fluttering heartbeat, difficulty breathing when lying down, swollen feet or ankles, severe dizziness, fainting, or leg pain when walking — that the study doctor believes could put you at risk
  • You have a low white blood cell count, or have been diagnosed with a condition affecting white blood cells (such as leukopenia, neutropenia, or agranulocytosis)
  • Your blood pressure is uncontrolled and above 140/90, or your resting heart rate is above 100 beats per minute
  • Your blood or urine lab results fall outside the normal ranges set by the study (confirm with trial site for specific values)
  • You are currently pregnant, trying to become pregnant, or breastfeeding
  • You cannot pass a basic vision test (needing to see at least 20/25 with or without glasses)
  • You currently take certain medications or supplements that could interact dangerously with the study drug, modafinil — for example, ketamine, certain antidepressants (MAOIs), diazepam, propranolol, warfarin, amphetamines, methylphenidate, or clomipramine (confirm with trial site for a full list)
  • You are allergic to modafinil
  • You are already taking modafinil as a prescribed medication
  • You have previously had a severe skin reaction called Stevens-Johnson syndrome after taking any medication
  • You have had a significant problem with alcohol or drug use in the past 3 months
  • You have ever had a stimulant use disorder (such as a serious problem with amphetamines or cocaine) at any point in your life
  • You are currently considered at clinical risk for suicide, have active thoughts of suicide, have made a plan to act on suicidal thoughts in the past 6 months, or have made a suicide attempt in the past 6 months
  • You have been experiencing a depressive episode in the past month, as identified through a diagnostic interview or assessment
  • You have been diagnosed with, or meet the criteria for, a psychotic disorder, bipolar disorder, or autism spectrum disorder
  • You have a parent, sibling, or child who has been diagnosed with a psychotic disorder, bipolar disorder, or autism spectrum disorder
  • You currently take any psychiatric medications or supplements that affect mood or thinking (such as nootropics)
  • You have any other mental health symptoms or conditions that, in the study doctor's opinion, could put you at risk or affect your ability to participate
  • You are unwilling or unable to give informed consent to take part in the study
  • You are unable to show that you can make an informed decision about joining the study, in the judgment of the study staff
  • You are unable to read or write
  • You have taken part in significant brain training or cognitive training programs in the past year, in the opinion of the study doctor (confirm with trial site)

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 22 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

Phone: 612-403-4585

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
31 October 2025
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 - Verbal Paired Associates Memory; Test My Brain - Verbal Paired Associates Memory; Test My Brain - Matrix Reasoning; Test My Brain - Matrix Reasoning; Test My Brain - Multiracial Emotion Identification; Test My Brain - Multiracial Emotion Identification; Electroencaphalography (EEG) - Resting alpha synchrony; Electroencaphalography (EEG) - Oscillatory frontal gamma synchrony; Electroencaphalography (EEG) - Task-related reward positivity/P900; Electroencaphalography (EEG) - N1 amplitude; Dot Pattern Expecta...

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: 22 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