Cognitive Strategies in Early Psychosis 2

This study aims to understand how two medications, modafinil and d-serine, affect decision-making in people with psychosis spectrum disorders, such as schizophrenia. Participants will be between 18 and 35 years old and have experienced symptoms of a psychosis spectrum disorder within the last five years. You will play computer-based "brain games" before and after taking a single dose of either modafinil, d-serine, or a placebo (an inactive substance). The researchers will then see if these medications change how you perform on the games. The main goal is to improve our understanding of psychosis to help people in the future.

Study design: This is an interventional study with 24 planned participants. It is a blinded study, meaning neither you nor the study team will know which medication you receive.
What's involved: You will have ten appointments, including an intake, six fMRI (functional Magnetic Resonance Imaging) scans, and three clinical interviews. There will also be three brief clinical check-ins and six phone calls after fMRI appointments.
Compensation: Not stated in the trial record.
Follow-up: Your performance on the "brain games" will be measured at baseline, Day 7, and Day 36.

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 2

Recruiting

PHASE3Ages 18–35InterventionalBasic science

University of Minnesota

~24 participants

Updated 2026-07-23 on ClinicalTrials.gov

What's tested:ModafinilD-serine solutionPlacebo

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

+45 more outcomes measured

Conditions

Psychosis

Schizophrenia Disorder

Schizoaffective Disorder

Major Depressive Disorder With Psychotic Features

Bipolar Disorder With Psychotic Features

Psychosis NOS

Schizophreniform Disorder

Psychotic Disorder

Cognition

Where it's being run

1 sites across 1 states

Minnesota1

Study leadership

Sophia Vinogradov, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota Department of Psychiatry and Behavioral Sciences
Caroline Demro, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Minnesota Department of Psychiatry and Behavioral Sciences

Who to contact

Freddie Holmberg Kohler, MBS, CCRP

[email protected]

612-772-2201

Email the study team

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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.

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Eligibility criteria

Inclusion

Between the ages of 18 and 35

Onset of a psychosis spectrum illness (schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis) within 5 years of enrollment

Estimated IQ of 70 or above

Proficient at English as determined through interactions with the study team

No change in psychiatric medication within a week of enrollment or MRI study visits

No clinically significant change in any medications for at least 1 month prior to study participation or MRI study visits, as determined by PI/Co-Is

Participants may have minor adjustments in medication doses in the past 30 days, per PI discretion, but may not have had major increases or decreases in doses, or additions or removal of medication within the past 30 days.

Participants are to have no changes to medications in the past 7 days before drug 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 a clinically significant head injury with or without prolonged unconsciousness

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, or endorsement of history of or of cardiac symptoms at intake:

Dyspnea

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

Taking a medication or supplement that has a major drug interaction with any study drugs (e.g., ketamine, MAOIs, clomipramine, diazepam, propranolol, warfarin)

Allergies to study drugs

Is pregnant, planning to become pregnant, or is breastfeeding

Cannot pass the visual acuity test

Cannot pass the CMRR Subject Safety Screen due to MRI contraindications

Meets criteria for a severe substance or alcohol use disorder within 3 months of enrollment

Lifetime history of a stimulant use disorder

Current manic episode as determined by the MINI

History of psychiatric hospitalization within 3 months of enrollment

Meets criteria for clinical risk of suicidal behavior, as defined by:

Clinician judgment

A suicide attempt within 3 months of enrollment

Active suicidal ideation at screening or baseline, as indicated by the C-SSRS Screener

Previous intent to act on suicidal ideation with a specific plan and/or preparatory acts within 3 months of enrollment, as indicated by the C-SSRS Screener

Symptom severity scores in the severe (6) or extremely severe (7) range on the BPRS for the following items: suicidality, disorientation, bizarre behavior, excitement, elevated mood

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

Current guardianship

Is under civil commitment or under a stay of civil commitment

Illiteracy

Has 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 (fMRI 1)
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 36 (fMRI 2)
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 63 (fMRI 3)
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 91 (fMRI 4)
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 119 (fMRI 5)
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 147 (fMRI 6)
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 (fMRI 1)
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 36 (fMRI 2)
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 63 (fMRI 3)
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 91 (fMRI 4)
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 119 (fMRI 5)
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 147 (fMRI 6)
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 (fMRI 1)
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 36 (fMRI 2)
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 63 (fMRI 3)
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 91 (fMRI 4)
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 119 (fMRI 5)
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 147 (fMRI 6)
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 (fMRI 1)
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 36 (fMRI 2)
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 63 (fMRI 3)
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 91 (fMRI 4)
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 119 (fMRI 5)
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 147 (fMRI 6)
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.
Resting-state functional connectivityDay 7 (fMRI 1)
Resting state connectivity in the brain is measured with fMRI. The primary outcome will be changes in resting-state functional connectivity before and after study agent administration
Resting-state functional connectivityDay 36 (fMRI 2)
Resting state connectivity in the brain is measured with fMRI. The primary outcome will be changes in resting-state functional connectivity before and after study agent administration
Resting-state functional connectivityDay 63 (fMRI 3)
Resting state connectivity in the brain is measured with fMRI. The primary outcome will be changes in resting-state functional connectivity before and after study agent administration
Resting-state functional connectivityDay 91 (fMRI 4)
Resting state connectivity in the brain is measured with fMRI. The primary outcome will be changes in resting-state functional connectivity before and after study agent administration
Resting-state functional connectivityDay 119 (fMRI 5)
Resting state connectivity in the brain is measured with fMRI. The primary outcome will be changes in resting-state functional connectivity before and after study agent administration
Resting-state functional connectivityDay 147 (fMRI 6)
Resting state connectivity in the brain is measured with fMRI. The primary outcome will be changes in resting-state functional connectivity before and after study agent administration
Dot Pattern Expectancy variation (TOPX) task performanceDay 7 (fMRI 1)
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 and response time. The primary outcome will be differences in task performance before and after modafinil administration.
Dot Pattern Expectancy variation (TOPX) task performanceDay 36 (fMRI 2)
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 and response time. The primary outcome will be differences in task performance before and after modafinil administration.
Dot Pattern Expectancy variation (TOPX) task performanceDay 63 (fMRI 3)
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 and response time. The primary outcome will be differences in task performance before and after modafinil administration.
Dot Pattern Expectancy variation (TOPX) task performanceDay 91 (fMRI 4)
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 and response time. The primary outcome will be differences in task performance before and after modafinil administration.
Dot Pattern Expectancy variation (TOPX) task performanceDay 119 (fMRI 5)
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 and response time. The primary outcome will be differences in task performance before and after modafinil administration.
Dot Pattern Expectancy variation (TOPX) task performanceDay 147 (fMRI 6)
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 and response time. The primary outcome will be differences in task performance before and after modafinil administration.
Translational Bandit Task (TBT) PerformanceDay 7 (fMRI 1)
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 accuracy, response time, and behavior of reward seeking. The primary outcome will be differences in task performance before and after modafinil administration.
Translational Bandit Task (TBT) PerformanceDay 36 (fMRI 2)
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 accuracy, response time, and behavior of reward seeking. The primary outcome will be differences in task performance before and after modafinil administration.
Translational Bandit Task (TBT) PerformanceDay 63 (fMRI 3)
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 accuracy, response time, and behavior of reward seeking. The primary outcome will be differences in task performance before and after modafinil administration.
Translational Bandit Task (TBT) PerformanceDay 91 (fMRI 4)
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 accuracy, response time, and behavior of reward seeking. The primary outcome will be differences in task performance before and after modafinil administration.
Translational Bandit Task (TBT) PerformanceDay 119 (fMRI 5)
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 accuracy, response time, and behavior of reward seeking. The primary outcome will be differences in task performance before and after modafinil administration.
Translational Bandit Task (TBT) PerformanceDay 147 (fMRI 6)
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 accuracy, response time, and behavior of reward seeking. The primary outcome will be differences in task performance before and after modafinil administration.

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