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NCT07263022 · University of Minnesota

Cognitive Strategies in Early Psychosis 2

(COSTEP 2)

What this study is about

The goal of this clinical trial is to learn more about decision making in psychosis spectrum disorders, like schizophrenia. Participants will be people who have had symptoms of a psychosis spectrum disorder start within the last five years.

View original scientific description

The goal of this clinical trial is to learn more about decision making in psychosis spectrum disorders, like schizophrenia. Participants will be people who have had symptoms of a psychosis spectrum disorder start within the last five years. The investigators will study how two study agents change decision making in people with psychosis, by asking participants to complete some brain games on the computer before and after taking the study agents. The investigators 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 with psychosis play the brain games? * Does a single dose of d-serine change how people with psychosis play the brain games? * Does a single dose of modafinil change brain activity? * Does a single dose of d-serine 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. * Complete functional Magnetic Resonance Imaging (fMRI) scans. fMRI uses magnets to take pictures of the brain. There will be six scanning appointments in the study, with two scans each. Appointments will be about a month apart. * Take a single dose of a study agent during each scanning appointment. The study agent will be taken after the first fMRI. There are three study agents in total: modafinil, d-serine, and a placebo. Each participant will take each study agent twice during the study.

Interventions

DRUG

Modafinil

Single dose of modafinil capsule, 200 mg. Participants will also receive an oral placebo solution to maintain the blind.

DRUG

D-serine solution

Single dose of oral solution of d-serine, 100 mg/kg. Participants will also receive a placebo capsule to maintain the blind.

DRUG

Placebo

Single dose of oral placebo, in both capsule and oral solution

Primary outcome measures

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 (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 Coding

Time frame: Day 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 Coding

Time frame: Day 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 Coding

Time frame: Day 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 Coding

Time frame: Day 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 Coding

Time frame: Day 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 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 (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 Memory

Time frame: Day 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 Memory

Time frame: Day 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 Memory

Time frame: Day 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 Memory

Time frame: Day 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 Memory

Time frame: Day 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 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 (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 Reasoning

Time frame: Day 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 Reasoning

Time frame: Day 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 Reasoning

Time frame: Day 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 Reasoning

Time frame: Day 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 Reasoning

Time frame: Day 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 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 (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 Identification

Time frame: Day 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 Identification

Time frame: Day 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 Identification

Time frame: Day 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 Identification

Time frame: Day 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 Identification

Time frame: Day 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 connectivity

Time frame: Day 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 connectivity

Time frame: Day 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 connectivity

Time frame: Day 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 connectivity

Time frame: Day 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 connectivity

Time frame: Day 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 connectivity

Time frame: Day 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 performance

Time frame: Day 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 performance

Time frame: Day 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 performance

Time frame: Day 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 performance

Time frame: Day 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 performance

Time frame: Day 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 performance

Time frame: Day 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) Performance

Time frame: Day 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) Performance

Time frame: Day 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) Performance

Time frame: Day 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) Performance

Time frame: Day 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) Performance

Time frame: Day 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) Performance

Time frame: Day 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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • 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 criteria

  • Medical Criteria:
  • 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:
  • Palpitations
  • Pedal oedema
  • Significant dizziness
  • 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 Mental health criteria:
  • 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 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
  • Current guardianship
  • Is under civil commitment or under a stay of civil commitment
  • Has engaged in significant cognitive training, in the opinion of the PI, in the last year

Where

  • Minneapolis, Minnesota

Collaborators

National Institute of Mental Health (NIMH)

Related conditions & keywords

PsychosisSchizophrenia DisorderSchizoaffective DisorderMajor Depressive Disorder With Psychotic FeaturesBipolar Disorder With Psychotic FeaturesPsychosis NOSSchizophreniform DisorderPsychotic DisorderCognitionDecision MakingfMRIPsychosis spectrum disorders

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jul 23, 2026 · Source of record for eligibility and locations

📊
1 of 24 participants interested
4% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Minneapolis

Minnesota

Location available
View Minneapolis location page

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Psychosis Treatment in Minneapolis?

Join others in Minnesota exploring innovative treatment options through clinical research

Psychosis Treatment Options in Minneapolis, Minnesota

If you're searching for Psychosis treatment in Minneapolis, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Minneapolis and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Psychosis. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Minnesota
Now Enrolling
Up to 24 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Psychosis?

Potential Benefits

  • ✓Access to new treatment approaches before public availability
  • ✓Close monitoring by experienced medical professionals
  • ✓Study-related care provided at no cost
  • ✓Contribute to medical research for Psychosis

What to Expect

  • →Initial screening to determine eligibility
  • →Regular check-ups and monitoring visits
  • →Possible compensation for time and travel
  • →You can withdraw at any time

Frequently Asked Questions About This Psychosis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07263022. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.