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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Cognitive Strategies in Early Psychosis 1

Cognitive Strategies in Early Psychosis 1 (NCT07231497) is a Phase 3 interventional studying Cognition and Healthy Participants, sponsored by University of Minnesota. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this clinical is to learn more about decision making in psychosis spectrum disorders, like schizophrenia. The investigators will ask people who do not have psychosis to take a single dose of modafinil and then complete some brain games on the computer that measure decision making. They hope to improve our understanding of psychosis to help people in the future. The main research questions are: Does a single dose of modafinil change how people play the brain games? Does a single dose of modafinil change brain activity? Participants will: Complete an interview and self-report questionnaires. Complete safety screening activities, like a blood draw, a urine drug test, and an alcohol breathalyzer test. Take a single dose of modafinil. Complete brain games while wearing an electroencephalography (EEG) cap, before and after taking the single dose of modafinil. EEG measures electrical activity in the brain.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Cognition, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 103 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Cognition subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - English proficiency, as determined by staff observation and participant self-report - Estimated IQ at or above 70, as estimated by the cognitive assessments - Is clinical stable, defined as outpatient status for at least one month prior to study participation - Has clinically stable doses of medication for at least one month prior to study participation as determined by the PI - Participants may have minor adjustments in medication doses in the past 30 days, per PI discretion, but may not have major increases or decreases in dosses, or additions or removal of medications in the past 30 days - Participants are to have no changes to medications in the past 7 days before study medication administration (i.e., must have been on a stable dose for at least 7 days prior to receiving the study drug). Who Should NOT Join This Trial: Medical criteria: - Presence of the following medical concerns, as determined by the study PI: - Major neurological disorder - History of head injury with or without prolonged consciousness - Any major medical condition that, in the opinion of the PI, would impede participation in the study or would put the participant at additional risk by participating - History of any of the following as reported by the participant: - Renal impairment, injury, or disease - Hepatic impairment, injury, or disease - Myocardial infarction or heart disease. - The following cardiac symptoms requiring medical follow-up that, in the opinion of the investigator, would impede participation in the study or would put the participant at additional risk by participating - Dsypnea - Palpitations - Orthopnea - Pedal oedema - Significant dizziness - Syncope - Claudication ---Low white blood cell count, or is diagnosed with leukopenia, neutropenia, or agranulocytosis - Presence of unmanaged hypertension (\>140/90) or elevated resting heart rate (\>100 bpm) - Abnormal clinical laboratory values: - uACR \> 30 mg/g - creatinine level \>0/95 mg/dL ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * English proficiency, as determined by staff observation and participant self-report * Estimated IQ at or above 70, as estimated by the cognitive assessments * Is clinical stable, defined as outpatient status for at least one month prior to study participation * Has clinically stable doses of medication for at least one month prior to study participation as determined by the PI * Participants may have minor adjustments in medication doses in the past 30 days, per PI discretion, but may not have major increases or decreases in dosses, or additions or removal of medications in the past 30 days * Participants are to have no changes to medications in the past 7 days before study medication administration (i.e., must have been on a stable dose for at least 7 days prior to receiving the study drug). Exclusion Criteria: Medical criteria: * Presence of the following medical concerns, as determined by the study PI: * Major neurological disorder * History of head injury with or without prolonged consciousness * Any major medical condition that, in the opinion of the PI, would impede participation in the study or would put the participant at additional risk by participating * History of any of the following as reported by the participant: * Renal impairment, injury, or disease * Hepatic impairment, injury, or disease * Myocardial infarction or heart disease. * The following cardiac symptoms requiring medical follow-up that, in the opinion of the investigator, would impede participation in the study or would put the participant at additional risk by participating * Dsypnea * Palpitations * Orthopnea * Pedal oedema * Significant dizziness * Syncope * Claudication ---Low white blood cell count, or is diagnosed with leukopenia, neutropenia, or agranulocytosis * Presence of unmanaged hypertension (\>140/90) or elevated resting heart rate (\>100 bpm) * Abnormal clinical laboratory values: * uACR \> 30 mg/g * creatinine level \>0/95 mg/dL * AST or ALT \>50 U/L * Bilirubin \>1.2 mg/dL * Total Protein \<6 g/dL * Participant is pregnant, planning to become pregnant, or is breastfeeding * Participant cannot pass the visual acuity test (e.g., a score lower than 20/25 on the Snellen) * Takes medications or supplements that have major interactions with modafinil (e.g., ketamine, MAOIs, clomipramine, diazepam, propranolol, warfarin, amphetamine or dextroamphetamine, dexmethylphenidate or methylphenidate) * Has an allergy to modafinil * Is currently taking modafinil as a prescription * Has previously experienced Stevens-Johnson syndrome in response to taking a medication Mental health criteria: * Meets criteria for severe substance or alcohol use disorder within 3 months of enrollment * Lifetime history of stimulant use disorder * Meets criteria for clinical risk of suicidal behavior, as defined by: * Clinician judgment * Active suicidal ideation at screening or other appointments * Previous intent to act on suicidal ideation with a specific plan and/or preparatory acts within 6 months of enrollment * A suicide attempt within 6 months of enrollment * Meets criteria for a depressive episode within the past month as determined by the diagnostic interview or for a severe or extremely severe depressive episode in the abbreviated battery within the past month * Meets DSM-5 criteria for, or reports professional diagnosis of, a psychotic, bipolar, or autism spectrum disorder * Has a family history (1st degree relative) of psychotic, bipolar, or autism spectrum disorder * Is prescribed psychotropic medications or takes supplements with psychotropic effects (e.g., Nootropics) * Any other psychiatric symptoms or conditions that, in the opinion of the PI, would impede participation in the study or put the participant at additional risk by participating Other Criteria: * Unable or unwilling to provide informed consent * Unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in the research study * Participant is illiterate * Have engaged in significant cognitive training, in the opinion of the PI, in the last year

Treatments Being Tested

DRUG

Modafinil

Single dose of 200mg

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Minnesota
Minneapolis, Minnesota, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07231497), the sponsor (University of Minnesota), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07231497 clinical trial studying?

The goal of this clinical is to learn more about decision making in psychosis spectrum disorders, like schizophrenia. The investigators will ask people who do not have psychosis to take a single dose of modafinil and then complete some brain games on the computer that measure decision making. They hope to improve our understanding of psychosis to help people in the future. The main research questions are: Does a single dose of modafinil change how people play the brain games? Does a single dose of modafinil change brain activity? Participants will: Complete an interview and self-report ques… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07231497?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07231497?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07231497. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07231497. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.