Cognitive Strategies in Early Psychosis 1 Study

This study aims to understand how a medication called modafinil affects decision-making in people who do not have psychosis (a mental health condition that affects how a person thinks, feels, and behaves). Researchers will give a single 200mg dose of modafinil to healthy volunteers and then ask them to play computer brain games that measure decision-making. The main goals are to see if modafinil changes how people play these games and if it changes their brain activity. This research could help improve our understanding of psychosis for future treatments. They plan to enroll 103 participants aged 18 to 35 years old who are fluent in English and have an estimated IQ of 70 or higher. The study is currently unclear on its recruitment status.

Study design: This is an interventional study, meaning participants will receive a specific treatment (modafinil). It is designed to enroll 103 healthy participants.
What's involved: You would attend two appointments, ideally about one week apart. The first visit, lasting 30 minutes to 2.5 hours, includes interviews, questionnaires, and brain games. The second visit, lasting 4-4.5 hours, involves safety screenings, taking modafinil, and brain activity measurements (EEG).
Compensation: Not stated in the trial record.
Follow-up: Your ability to complete brain games will be measured at baseline and again on Day 7 (EEG + Modafinil Appointment).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Cognitive Strategies in Early Psychosis 1

Recruiting

PHASE3Ages 18–35InterventionalBasic science

University of Minnesota

~103 participants

Updated 2026-02-17 on ClinicalTrials.gov

What's tested:Modafinil

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Test My Brain - Digit Symbol Coding

Measured over Baseline

+16 more outcomes measured

Conditions

Cognition

Healthy Participants

Where it's being run

1 sites across 1 states

Minnesota1

Study leadership

Sophia Vinogradov, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota
Caroline Demro, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Kaylee Enevold

[email protected]

612-403-4585

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

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

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

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

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

What this trial measures

Test My Brain - Digit Symbol CodingBaseline
A computerized cognitive assessment measuring processing speed. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.
Test My Brain - Digit Symbol CodingDay 7 (EEG + Modafinil Appointment)
A computerized cognitive assessment measuring processing speed. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.
Test My Brain - Verbal Paired Associates MemoryBaseline
A computerized cognitive assessment measuring verbal memory. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.
Test My Brain - Verbal Paired Associates MemoryDay 7 (EEG + Modafinil Appointment)
A computerized cognitive assessment measuring verbal memory. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.
Test My Brain - Matrix ReasoningBaseline
A computerized cognitive assessment measuring problem solving. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.
Test My Brain - Matrix ReasoningDay 7 (EEG + Modafinil Appointment)
A computerized cognitive assessment measuring problem solving. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.
Test My Brain - Multiracial Emotion IdentificationBaseline
A computerized cognitive assessment measuring social cognition and emotion recognition skills. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.
Test My Brain - Multiracial Emotion IdentificationDay 7 (EEG + Modafinil Appointment)
A computerized cognitive assessment measuring social cognition and emotion recognition skills. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.
Electroencaphalography (EEG) - Resting alpha synchronyDay 7 (EEG + Modafinil Appointment)
The EEG will measure resting state alpha synchrony in the brain. The primary outcome will be differences in EEG activity before and after modafinil administration.
Electroencaphalography (EEG) - Oscillatory frontal gamma synchronyDay 7 (EEG + Modafinil Appointment)
The EEG will measure oscillatory frontal gamma synchrony in the brain. The primary outcome will be differences in EEG activity before and after modafinil administration
Electroencaphalography (EEG) - Task-related reward positivity/P900Day 7 (EEG + Modafinil Appointment)
The EEG will measure task-related reward positivity/P900 activity in the brain. The primary outcome will be differences in EEG activity before and after modafinil administration
Electroencaphalography (EEG) - N1 amplitudeDay 7 (EEG + Modafinil Appointment)
The EEG will measure N1 amplitude in the brain. The primary outcome will be differences in EEG activity before and after modafinil administration
Dot Pattern Expectancy variation (TOPX) Task - AccuracyDay 7 (EEG + Modafinil Appointment)
The TOPX task consists of a series of pattern sequences. One pattern is designated the "A" cue, and another the "X" cue, which requires one response (AX, 60-70% of trials, e.g. respond with the left button), while other sequences require a different response (AY or BX, 12-15% of trials each, or BY, 6-10% of trials, e.g. respond with the right button). Given the strong expectation that X's evokes a valid response, BX trials place demands on the fidelity (stability, memory) of the "B" cue state representation to overcome this tendency. Performance is assessed based on accuracy of responses. The primary outcome will be differences in task accuracy before and after modafinil administration.
Dot Pattern Expectancy variation (TOPX) Task - Response TimeDay 7 (EEG + Modafinil Appointment)
The TOPX task consists of a series of pattern sequences. One pattern is designated the "A" cue, and another the "X" cue, which requires one response (AX, 60-70% of trials, e.g. respond with the left button), while other sequences require a different response (AY or BX, 12-15% of trials each, or BY, 6-10% of trials, e.g. respond with the right button). Given the strong expectation that X's evokes a valid response, BX trials place demands on the fidelity (stability, memory) of the "B" cue state representation to overcome this tendency. Response time performance is assessed based on the delay in the presentation of the stimuli and the selection of the response. The primary outcome will be differences in response times before and after modafinil administration.
Translational Bandit Task (TBT) - AccuracyDay 7 (EEG + Modafinil Appointment)
This is a task variant that uses choice options (neutral images) that are rewarded probabilistically. The rewarded stimulus with the highest reward is changed over time. State learning associated with staying or switching stimuli too quickly (lose-switching) can be evaluated. Performance is assessed based on selection of the option that will yield the highest reward. The primary outcome will be differences in task performance before and after modafinil administration.
Translational Bandit Task (TBT) - Response timeDay 7 (EEG + Modafinil Appointment)
This is a task variant that uses choice options (neutral images) that are rewarded probabilistically. The rewarded stimulus with the highest reward is changed over time. State learning associated with staying or switching stimuli too quickly (lose-switching) can be evaluated. Performance is assessed based on the delay between the presentation of stimuli and the selection of the response. The primary outcome will be differences in task performance before and after modafinil administration.
Translational Bandit Task (TBT) - Reward Seeking BehaviorDay 7 (EEG + Modafinil Appointment)
This is a task variant that uses choice options (neutral images) that are rewarded probabilistically. The rewarded stimulus with the highest reward is changed over time. State learning associated with staying or switching stimuli too quickly (lose-switching) can be evaluated. Performance is assessed based on the behavior of reward seeking-whether participants "explore" to find new reward scenarios, or if they stay to "exploit" a known reward scenario. The primary outcome will be differences in reward seeking behavior before and after modafinil administration.

Trialytics