CognitionPhase 3COSTEP 1NCT07231497
Cognitive Strategies in Early Psychosis 1
A Phase 3 study testing Modafinil in people with Cognition and Healthy Participants, run by University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition, Healthy Participants
- What is being tested?
- Modafinil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2025to 30 Apr 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 cannot join
- 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:
Show all 48Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Ariel Currie, 612-626-7261, curri015@umn.edu
About this study
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?
Read more
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.
Read the detailed description
Participants will be asked to complete two appointments in this study. These appointments will ideally be about 1 week apart, but can be up to 1 month apart if needed.
The first appointment is the Intake and Clinical appointment. This visit will take between 30 minutes to 2.5 hours, depending on how many study tasks are needed. Participants in this study may have participated in a sister study, called "State Representation in Early Psychosis 2 (STEP 2)." If so, they will not need to complete many of the intake questionnaires, and it is expected to take about 30 minutes for them to complete this appointment. If they did not participate in STEP 2, participants will need to complete the full intake battery.
During the interview, the investigators will ask questions about a participant's medical and psychiatric history, and current and past mental health symptoms. The investigators will collect demographics, as well as information on the person's social life and quality of life. After the interview, they will complete brain games on their computer.
The second appointment is the EEG + Medication appointment. Participants will come in person to the MHealth Fairview Riverside Campus. The visit will take place in the University of Minnesota Department of Psychiatry. This visit will take about 4-4.5 hours.
First, the investigators will complete safety screening measures. This will include:
- A blood draw for lab testing. They will collect one 3mL tube, which is less than ⅔ of a teaspoon.
- A blood pressure reading.
- A breathalyzer to test for the presence of alcohol.
- A urine drug test to screen for the presence of substances.
- If pregnancy is a physical possibility, a urine pregnancy test will be required.
After screening measures are successfully completed, the investigators will fit an EEG cap onto the participant's head. While this is happening, the participant will complete self-report questionnaires. Once the cap is in place, the participant will play some brain games.
After this, the participant will take a single dose of modafinil. The participant will be provided with a meal while the modafinil metabolizes. Afterwards, they will monitor the participant's vital signs and ask whether they are experiencing any adverse effects.
After the observation period is completed, the participant will complete the same brain games on the computer. The investigators will take another vital signs measurement and ask about adverse effects.
The following day, the investigators will contact the participant via phone to ask whether they experienced any adverse effects after leaving the study appointment. This call should last about 5 minutes.
- Conditions
- Cognition, Healthy Participants
- Being tested
- Modafinil
- Keywords
- Cognition, Decision making, Electroencephalography (EEG), Psychosis
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
Single dose of 200mg
| Study group | Role | What they receive |
|---|---|---|
| COSTEP 1 | Experimental | Not described Receives: Drug: Modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test My Brain - Digit Symbol Coding
A computerized cognitive assessment measuring processing speed. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.
Measured: Baseline
Test My Brain - Digit Symbol Coding
A computerized cognitive assessment measuring processing speed. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.
Measured: Day 7 (EEG + Modafinil Appointment)
Test My Brain - Verbal Paired Associates Memory
A computerized cognitive assessment measuring verbal memory. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.
Measured: Baseline
Test My Brain - Verbal Paired Associates Memory
A computerized cognitive assessment measuring verbal memory. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.
Measured: Day 7 (EEG + Modafinil Appointment)
Test My Brain - Matrix Reasoning
A computerized cognitive assessment measuring problem solving. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.
Measured: Baseline
Test My Brain - Matrix Reasoning
A computerized cognitive assessment measuring problem solving. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.
Measured: Day 7 (EEG + Modafinil Appointment)
Test My Brain - Multiracial Emotion Identification
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.
Measured: Baseline
Test My Brain - Multiracial Emotion Identification
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.
Measured: Day 7 (EEG + Modafinil Appointment)
Electroencaphalography (EEG) - Resting alpha synchrony
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.
Measured: Day 7 (EEG + Modafinil Appointment)
Electroencaphalography (EEG) - Oscillatory frontal gamma synchrony
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
Measured: Day 7 (EEG + Modafinil Appointment)
Electroencaphalography (EEG) - Task-related reward positivity/P900
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
Measured: Day 7 (EEG + Modafinil Appointment)
Electroencaphalography (EEG) - N1 amplitude
The EEG will measure N1 amplitude in the brain. The primary outcome will be differences in EEG activity before and after modafinil administration
Measured: Day 7 (EEG + Modafinil Appointment)
Dot Pattern Expectancy variation (TOPX) Task - Accuracy
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.
Measured: Day 7 (EEG + Modafinil Appointment)
Dot Pattern Expectancy variation (TOPX) Task - Response Time
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.
Measured: Day 7 (EEG + Modafinil Appointment)
Translational Bandit Task (TBT) - Accuracy
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.
Measured: Day 7 (EEG + Modafinil Appointment)
Translational Bandit Task (TBT) - Response time
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.
Measured: Day 7 (EEG + Modafinil Appointment)
Translational Bandit Task (TBT) - Reward Seeking Behavior
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.
Measured: Day 7 (EEG + Modafinil Appointment)
Secondary outcomes (1)
Brief Psychiatric Rating Scale (BPRS) - Global Score
Clinician-administered rating scale to assess psychiatric symptoms such as depression, anxiety, hallucinations, and unusual behavior. Scores on individual items range from 1 (not present) to 7 (extremely severe); global scores range from 24 to 168.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start31 Oct 2025
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sophia Vinogradov, MD, Principal investigator, University of MinnesotaCaroline Demro, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231497
- Sponsor's protocol ID
- STUDY00025500
- Other IDs
- P50MH119569
- Acronym
- COSTEP 1
- Status last verified
- Feb 2026
- First submitted
- 21 Aug 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with the NIMH Data Archive (collection ID pending).
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Strategies in Early Psychosis 1
- ClinicalTrials.gov ID
- NCT07231497
- Acronym / sponsor ID
- COSTEP 1 / STUDY00025500
- Conditions
- Cognition, Healthy Participants
- Keywords
- Cognition, Decision making, Electroencephalography (EEG), Psychosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be asked to complete two appointments in this study. These appointments will ideally be about 1 week apart, but can be up to 1 month apart if needed.
The first appointment is the Intake and Clinical appointment. This visit will take between 30 minutes to 2.5 hours, depending on how many study tasks are needed. Participants in this study may have participated in a sister study, called "State Representation in Early Psychosis 2 (STEP 2)." If so, they will not need to complete many of the intake questionnaires, and it is expected to take about 30 minutes for them to complete this appointment. If they did not participate in STEP 2, participants will need to complete the full intake battery.
During the interview, the investigators will ask questions about a participant's medical and psychiatric history, and current and past mental health symptoms. The investigators will collect demographics, as well as information on the person's social life and quality of life. After the interview, they will complete brain games on their computer.
The second appointment is the EEG + Medication appointment. Participants will come in person to the MHealth Fairview Riverside Campus. The visit will take place in the University of Minnesota Department of Psychiatry. This visit will take about 4-4.5 hours.
First, the investigators will complete safety screening measures. This will include:
- A blood draw for lab testing. They will collect one 3mL tube, which is less than ⅔ of a teaspoon.
- A blood pressure reading.
- A breathalyzer to test for the presence of alcohol.
- A urine drug test to screen for the presence of substances.
- If pregnancy is a physical possibility, a urine pregnancy test will be required.
After screening measures are successfully completed, the investigators will fit an EEG cap onto the participant's head. While this is happening, the participant will complete self-report questionnaires. Once the cap is in place, the participant will play some brain games.
After this, the participant will take a single dose of modafinil. The participant will be provided with a meal while the modafinil metabolizes. Afterwards, they will monitor the participant's vital signs and ask whether they are experiencing any adverse effects.
After the observation period is completed, the participant will complete the same brain games on the computer. The investigators will take another vital signs measurement and ask about adverse effects.
The following day, the investigators will contact the participant via phone to ask whether they experienced any adverse effects after leaving the study appointment. This call should last about 5 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COSTEP 1 | Experimental | Drug: Modafinil |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (48 listed)
- Presence of the following medical concerns, as determined by the study PI:
- History of any of the following as reported by the participant:
- 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
- Presence of unmanaged hypertension (>140/90) or elevated resting heart rate (>100 bpm)
- Abnormal clinical laboratory values:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ModafinilSingle dose of 200mg | Drug | COSTEP 1 |
Primary outcome
Test My Brain - Digit Symbol Coding
Time frame: Baseline
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 Coding
Time frame: Day 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 Memory
Time frame: Baseline
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 Memory
Time frame: Day 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 Reasoning
Time frame: Baseline
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 Reasoning
Time frame: Day 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 Identification
Time frame: Baseline
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 Identification
Time frame: Day 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 synchrony
Time frame: Day 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 synchrony
Time frame: Day 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/P900
Time frame: Day 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 amplitude
Time frame: Day 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 - Accuracy
Time frame: Day 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 Time
Time frame: Day 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) - Accuracy
Time frame: Day 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 time
Time frame: Day 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 Behavior
Time frame: Day 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.
1 secondary outcome
Brief Psychiatric Rating Scale (BPRS) - Global Score
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes. Data will be shared with the NIMH Data Archive (collection ID pending).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophia Vinogradov, MD principal investigator
University of Minnesota
Caroline Demro, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Modafinil in people with Cognition and Healthy Participants, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaylee Enevold (612-403-4585, costep1@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test My Brain - Digit Symbol Coding (time frame: Baseline). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.