Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 35

Cognitive strategies for early psychosis.

Official title: Cognitive Strategies in Early Psychosis 1

Run by University of Minnesota · NCT07231497 · Data updated 2026-11-12

This will try a single dose of modafinil in people without psychosis to see if it changes how they play decision-making brain games and their brain activity.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 35 Years
SexAll
Enrollment103 (estimated)
SponsorUniversity of Minnesota
Academic / other
Locations1 site (Minneapolis, Minnesota)
StatusRecruiting
StartedOctober 31, 2025
Main results expectedApril 30, 2030
Study endsApril 30, 2030
Registry record updatedFebruary 17, 2026
Trial IDNCT07231497 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults who do not have psychosis, speak English, have estimated IQ ≥70, can attend two in-person visits, and have been clinically stable on any medications per study rules are the intended participants.

Probably not a fit

People with major neurological disorders, certain medical contraindications to modafinil, unstable psychiatric status, or who cannot travel to Minneapolis likely would not benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants complete two in-person visits roughly one week apart: an intake visit with interviews and questionnaires, and a longer EEG + medication visit at the University of Minnesota. At the EEG visit participants undergo safety screening (blood draw, urine drug test, breathalyzer), wear an EEG cap, complete computerized decision-making tasks, and receive a single dose of modafinil with repeat task/EEG recordings. Visits take about 30 minutes to 2.5 hours for intake (shorter if they participated in a sister study) and about 4–4.5 hours for the EEG/medication visit. The design compares task performance and EEG signals before and after the single modafinil dose to see acute drug-related changes.

Why it matters

Potential benefit: If successful, the results could improve understanding of decision-making brain processes relevant to psychosis and inform future treatment or cognitive interventions.

How similar studies have gone: Prior studies of modafinil for cognition and EEG have shown mixed but sometimes positive effects, so this approach builds on existing but not definitive evidence.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • University of Minnesota
    Minneapolis, Minnesota, United States
    Recruiting

Study contacts

  • Principal investigator: Sophia Vinogradov, MD — University of Minnesota
  • Study coordinator: Kaylee Enevold
  • Email: costep1@umn.edu
  • Phone: 612-403-4585

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.