PsychosisPhase 3COSTEP 2NCT07263022
Cognitive Strategies in Early Psychosis 2
A Phase 3 study testing Modafinil and D-serine solution in people with Psychosis and Schizophrenia Disorder, run by University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Psychosis, Schizophrenia Disorder, Schizoaffective Disorder
- What is being tested?
- Modafinil and D-serine solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2026to 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
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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:
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- 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
- 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
- Illiteracy
- Has 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.
Ariel Currie contact
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Ariel Currie, MBS, CCRP, curri105@umn.edu
About this study
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?
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.
- 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.
- Play brain games on a computer that measure decision making, thinking, and problem solving skills
Read the detailed description
Participants will be asked to complete ten appointments in this study: An intake appointment, 6 functional Magnetic Resonance Imaging (fMRI) appointments, and 3 clinical interview appointments. In addition, there will be 3 brief clinical check ins, and 6 phone call check ins after fMRI appointments.
Intake Appointment:
The first appointment is the Intake appointment. This visit will take between 1.75-2.75 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 100 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. They will collect demographics, as well as information on the person's social life and quality of life. Participants will also provide a blood sample for clinical safety screening. The investigators will collect one 3mL tube, which is less than 2/3 of a teaspoon. If pregnancy is a physical possibility, they will also collect a urine sample for pregnancy testing.
fMRI Appointments: The second appointment is an fMRI + study agent appointment. Participants will come in person to the University of Minnesota Center for Magnetic Resonance Research. This visit will take about 7-7.5 hours.
First, the investigators will complete safety screening measures. This will include:
- A screening questionnaire to make sure the participant can enter the fMRI machine safely
- A blood pressure reading.
- A vision test.
- 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, participants will complete the brain games on a computer. Afterwards, the participant will enter the fMRI machine. The very first fMRI scan will last 2 hours, as the investigators will get additional pictures for the structure of the brain before the scan that measures brain activity.
After this, the participant will take a single dose of the study agent. Neither the participant nor the study team will know which study agent the participant is taking. They will be randomly assigned to one of six schedules (for example, one participant will have A > B > C, and another will have A > C > B, and so on). The participant will be provided with a meal while the study agent metabolizes. Afterwards, the investigators 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 a second fMRI scan. This scan will last 90 minutes. Afterwards, they will play the same brain games on the computer. The investigators will take another vital sign 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.
The remaining 5 fMRI visits will be the same, except that the first scan of the day will be only 90 minutes long. fMRI appointments will be scheduled approximately one month apart.
Clinical Interview Appointments:
Between fMRIs 1 and 2, 3 and 4, and 5 and 6, the investigators will interview participants to ask questions about their current mental health symptoms, their quality of life, and their social life. Participants will also complete self-report questionnaires which cover the same topics. These appointments will take about 90 minutes. The appointment can be completed in person at the University of Minnesota or remotely via Zoom.
Between fMRIs 2 and 3, and 4 and 5, participants will be asked a brief series of questions about their recent mental health symptoms. This will be a remote visit conducted via Zoom or by phone. These calls should take about 20 minutes.
- Conditions
- Psychosis, Schizophrenia Disorder, Schizoaffective Disorder, Major Depressive Disorder With Psychotic Features, Bipolar Disorder With Psychotic Features, Psychosis NOS
- Being tested
- Modafinil, D-serine solution, Placebo
- Keywords
- Cognition, Decision Making, fMRI, Psychosis spectrum disorders
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
Single dose of modafinil capsule, 200 mg. Participants will also receive an oral placebo solution to maintain the blind.
D-serine solutionDrug
Single dose of oral solution of d-serine, 100 mg/kg. Participants will also receive a placebo capsule to maintain the blind.
PlaceboDrug
Single dose of oral placebo, in both capsule and oral solution
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Modafinil > d-serine > placebo | Experimental | Participants will take single doses three study medications in the following order: modafinil (200 mg); d-serine (100 mg/kg); and placebo. All medications will be taken 2 times (A>B>C>A>B>C).
(Note: This order is not necessarily reflective of the actual randomization schedule used in the protocol, as the procedure is double-blinded) Receives: Drug: Modafinil; Drug: D-serine solution; Drug: Placebo |
| Arm 2: Modafinil > placebo > d-serine | Experimental | Participants will take single doses of three study medications in the following order: modafinil (200 mg); placebo; and d-serine (100 mg/kg). All medications will be taken 2 times (A>B>C>A>B>C).
(Note: This order is not necessarily reflective of the actual randomization schedule used in the protocol, as the procedure is double-blinded) Receives: Drug: Modafinil; Drug: D-serine solution; Drug: Placebo |
| Arm 3: D-serine > modafinil > placebo | Experimental | Participants will take single doses of three study medications in the following order: d-serine (100 mg/kg); modafinil (200 mg); and placebo. All medications will be taken 2 times (A>B>C>A>B>C).
(Note: This order is not necessarily reflective of the actual randomization schedule used in the protocol, as the procedure is double-blinded) Receives: Drug: Modafinil; Drug: D-serine solution; Drug: Placebo |
| Arm 4: D-serine > placebo > modafinil | Experimental | Participants will take single doses of three study medications in the following order: d-serine (100 mg/kg); placebo; and modafinil (200 mg). All medications will be taken 2 times (A>B>C>A>B>C).
(Note: This order is not necessarily reflective of the actual randomization schedule used in the protocol, as the procedure is double-blinded) Receives: Drug: Modafinil; Drug: D-serine solution; Drug: Placebo |
| Arm 5: Placebo > modafinil > d-serine | Experimental | Participants will take single doses of three study medications in the following order: placebo; modafinil (200 mg); and d-serine (100 mg/kg). All medications will be taken 2 times (A>B>C>A>B>C).
(Note: This order is not necessarily reflective of the actual randomization schedule used in the protocol, as the procedure is double-blinded) Receives: Drug: Modafinil; Drug: D-serine solution; Drug: Placebo |
| Arm 6: Placebo > d-serine > modafinil | Experimental | Participants will take single doses of three study medications in the following order: placebo; d-serine (100 mg/kg); and modafinil (200 mg). All medications will be taken 2 times (A>B>C>A>B>C).
(Note: This order is not necessarily reflective of the actual randomization schedule used in the protocol, as the procedure is double-blinded) Receives: Drug: Modafinil; Drug: D-serine solution; Drug: Placebo |
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 (fMRI 1)
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 36 (fMRI 2)
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 63 (fMRI 3)
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 91 (fMRI 4)
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 119 (fMRI 5)
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 147 (fMRI 6)
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 (fMRI 1)
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 36 (fMRI 2)
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 63 (fMRI 3)
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 91 (fMRI 4)
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 119 (fMRI 5)
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 147 (fMRI 6)
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 (fMRI 1)
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 36 (fMRI 2)
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 63 (fMRI 3)
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 91 (fMRI 4)
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 119 (fMRI 5)
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 147 (fMRI 6)
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 (fMRI 1)
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 36 (fMRI 2)
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 63 (fMRI 3)
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 91 (fMRI 4)
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 119 (fMRI 5)
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 147 (fMRI 6)
Resting-state functional connectivity
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
Measured: Day 7 (fMRI 1)
Resting-state functional connectivity
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
Measured: Day 36 (fMRI 2)
Resting-state functional connectivity
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
Measured: Day 63 (fMRI 3)
Resting-state functional connectivity
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
Measured: Day 91 (fMRI 4)
Resting-state functional connectivity
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
Measured: Day 119 (fMRI 5)
Resting-state functional connectivity
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
Measured: Day 147 (fMRI 6)
Dot Pattern Expectancy variation (TOPX) task performance
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.
Measured: Day 7 (fMRI 1)
Dot Pattern Expectancy variation (TOPX) task performance
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.
Measured: Day 36 (fMRI 2)
Dot Pattern Expectancy variation (TOPX) task performance
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.
Measured: Day 63 (fMRI 3)
Dot Pattern Expectancy variation (TOPX) task performance
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.
Measured: Day 91 (fMRI 4)
Dot Pattern Expectancy variation (TOPX) task performance
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.
Measured: Day 119 (fMRI 5)
Dot Pattern Expectancy variation (TOPX) task performance
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.
Measured: Day 147 (fMRI 6)
Translational Bandit Task (TBT) Performance
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.
Measured: Day 7 (fMRI 1)
Translational Bandit Task (TBT) Performance
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.
Measured: Day 36 (fMRI 2)
Translational Bandit Task (TBT) Performance
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.
Measured: Day 63 (fMRI 3)
Translational Bandit Task (TBT) Performance
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.
Measured: Day 91 (fMRI 4)
Translational Bandit Task (TBT) Performance
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.
Measured: Day 119 (fMRI 5)
Translational Bandit Task (TBT) Performance
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.
Measured: Day 147 (fMRI 6)
Secondary outcomes (9)
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
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: Day 21 (Clinical A)
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: Day 49 (Brief Clinical B)
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: Day 77 (Clinical C)
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: Day 105 (Brief Clinical D)
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: Day 133 (Clinical E)
Scale for Assessment of Negative Symptoms/Scale for Assessment of Positive Symptoms (SANS/SAPS) - Global score
The SANS (25 items) and SAPS (34 items) are clinician-administered scales that assess negative and positive symptoms of schizophrenia. Individual items are rated from 0 (symptoms not present) to 5 (Marked symptoms); global scores range from 0 to 295.
Measured: Day 21 (Clinical A)
Scale for Assessment of Negative Symptoms/Scale for Assessment of Positive Symptoms (SANS/SAPS) - Global score
The SANS (25 items) and SAPS (34 items) are clinician-administered scales that assess negative and positive symptoms of schizophrenia. Individual items are rated from 0 (symptoms not present) to 5 (Marked symptoms); global scores range from 0 to 295.
Measured: Day 77 (Clinical C)
Scale for Assessment of Negative Symptoms/Scale for Assessment of Positive Symptoms (SANS/SAPS) - Global score
The SANS (25 items) and SAPS (34 items) are clinician-administered scales that assess negative and positive symptoms of schizophrenia. Individual items are rated from 0 (symptoms not present) to 5 (Marked symptoms); global scores range from 0 to 295.
Measured: Day 133 (Clinical E)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start17 Jul 2026
- 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 PsychosisStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will take a single dose of each drug 2 times. There will be 6 different orders of administration (e.g., A\>B\>C, A\>C\>B).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 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 Minnesota Department of Psychiatry and Behavioral SciencesCaroline Demro, Ph.D., Principal investigator, University of Minnesota Department of Psychiatry and Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263022
- Sponsor's protocol ID
- STUDY00025575
- Other IDs
- P50MH119569
- Acronym
- COSTEP 2
- Status last verified
- Jul 2026
- First submitted
- 25 Aug 2025
- Last updated
- 23 Jul 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 National Institutes of Mental Health Data Archive (collection ID pending).
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Strategies in Early Psychosis 2
- ClinicalTrials.gov ID
- NCT07263022
- Acronym / sponsor ID
- COSTEP 2 / STUDY00025575
- Conditions
- Psychosis, Schizophrenia Disorder, Schizoaffective Disorder, Major Depressive Disorder With Psychotic Features, Bipolar Disorder With Psychotic Features, Psychosis NOS
- Keywords
- Cognition, Decision Making, fMRI, Psychosis spectrum disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 4 Dec 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 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.
- Play brain games on a computer that measure decision making, thinking, and problem solving skills
Detailed description
Participants will be asked to complete ten appointments in this study: An intake appointment, 6 functional Magnetic Resonance Imaging (fMRI) appointments, and 3 clinical interview appointments. In addition, there will be 3 brief clinical check ins, and 6 phone call check ins after fMRI appointments.
Intake Appointment:
The first appointment is the Intake appointment. This visit will take between 1.75-2.75 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 100 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. They will collect demographics, as well as information on the person's social life and quality of life. Participants will also provide a blood sample for clinical safety screening. The investigators will collect one 3mL tube, which is less than 2/3 of a teaspoon. If pregnancy is a physical possibility, they will also collect a urine sample for pregnancy testing.
fMRI Appointments: The second appointment is an fMRI + study agent appointment. Participants will come in person to the University of Minnesota Center for Magnetic Resonance Research. This visit will take about 7-7.5 hours.
First, the investigators will complete safety screening measures. This will include:
- A screening questionnaire to make sure the participant can enter the fMRI machine safely
- A blood pressure reading.
- A vision test.
- 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, participants will complete the brain games on a computer. Afterwards, the participant will enter the fMRI machine. The very first fMRI scan will last 2 hours, as the investigators will get additional pictures for the structure of the brain before the scan that measures brain activity.
After this, the participant will take a single dose of the study agent. Neither the participant nor the study team will know which study agent the participant is taking. They will be randomly assigned to one of six schedules (for example, one participant will have A > B > C, and another will have A > C > B, and so on). The participant will be provided with a meal while the study agent metabolizes. Afterwards, the investigators 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 a second fMRI scan. This scan will last 90 minutes. Afterwards, they will play the same brain games on the computer. The investigators will take another vital sign 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.
The remaining 5 fMRI visits will be the same, except that the first scan of the day will be only 90 minutes long. fMRI appointments will be scheduled approximately one month apart.
Clinical Interview Appointments:
Between fMRIs 1 and 2, 3 and 4, and 5 and 6, the investigators will interview participants to ask questions about their current mental health symptoms, their quality of life, and their social life. Participants will also complete self-report questionnaires which cover the same topics. These appointments will take about 90 minutes. The appointment can be completed in person at the University of Minnesota or remotely via Zoom.
Between fMRIs 2 and 3, and 4 and 5, participants will be asked a brief series of questions about their recent mental health symptoms. This will be a remote visit conducted via Zoom or by phone. These calls should take about 20 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Each participant will take a single dose of each drug 2 times. There will be 6 different orders of administration (e.g., A>B>C, A>C>B).
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Modafinil > d-serine > placebo | Experimental | Drug: Modafinil, Drug: D-serine solution, Drug: PlaceboParticipants will take single doses three study medications in the following order: modafinil (200 mg); d-serine (100 mg/kg); and placebo. All medications will be taken 2 times (A>B>C>A>B>C). (Note: This order is not necessarily reflective of the actual randomization schedule used in the protocol, as the procedure is double-blinded) |
| Arm 2: Modafinil > placebo > d-serine | Experimental | Drug: Modafinil, Drug: D-serine solution, Drug: PlaceboParticipants will take single doses of three study medications in the following order: modafinil (200 mg); placebo; and d-serine (100 mg/kg). All medications will be taken 2 times (A>B>C>A>B>C). (Note: This order is not necessarily reflective of the actual randomization schedule used in the protocol, as the procedure is double-blinded) |
| Arm 3: D-serine > modafinil > placebo | Experimental | Drug: Modafinil, Drug: D-serine solution, Drug: PlaceboParticipants will take single doses of three study medications in the following order: d-serine (100 mg/kg); modafinil (200 mg); and placebo. All medications will be taken 2 times (A>B>C>A>B>C). (Note: This order is not necessarily reflective of the actual randomization schedule used in the protocol, as the procedure is double-blinded) |
| Arm 4: D-serine > placebo > modafinil | Experimental | Drug: Modafinil, Drug: D-serine solution, Drug: PlaceboParticipants will take single doses of three study medications in the following order: d-serine (100 mg/kg); placebo; and modafinil (200 mg). All medications will be taken 2 times (A>B>C>A>B>C). (Note: This order is not necessarily reflective of the actual randomization schedule used in the protocol, as the procedure is double-blinded) |
| Arm 5: Placebo > modafinil > d-serine | Experimental | Drug: Modafinil, Drug: D-serine solution, Drug: PlaceboParticipants will take single doses of three study medications in the following order: placebo; modafinil (200 mg); and d-serine (100 mg/kg). All medications will be taken 2 times (A>B>C>A>B>C). (Note: This order is not necessarily reflective of the actual randomization schedule used in the protocol, as the procedure is double-blinded) |
| Arm 6: Placebo > d-serine > modafinil | Experimental | Drug: Modafinil, Drug: D-serine solution, Drug: PlaceboParticipants will take single doses of three study medications in the following order: placebo; d-serine (100 mg/kg); and modafinil (200 mg). All medications will be taken 2 times (A>B>C>A>B>C). (Note: This order is not necessarily reflective of the actual randomization schedule used in the protocol, as the procedure is double-blinded) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
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:
- Presence of unmanaged hypertension (>140/90) or elevated resting heart rate (>100 bpm)
- Abnormal clinical laboratory values:
- Taking a medication or supplement that has a major drug interaction with any study drugs (e.g., ketamine, MAOIs, clomipramine, diazepam, propranolol, warfarin)
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 modafinil capsule, 200 mg. Participants will also receive an oral placebo solution to maintain the blind. | Drug | Arm 1: Modafinil > d-serine > placebo, Arm 2: Modafinil > placebo > d-serine, Arm 3: D-serine > modafinil > placebo, Arm 4: D-serine > placebo > modafinil, Arm 5: Placebo > modafinil > d-serine, Arm 6: Placebo > d-serine > modafinil |
| D-serine solutionSingle dose of oral solution of d-serine, 100 mg/kg. Participants will also receive a placebo capsule to maintain the blind. | Drug | Arm 1: Modafinil > d-serine > placebo, Arm 2: Modafinil > placebo > d-serine, Arm 3: D-serine > modafinil > placebo, Arm 4: D-serine > placebo > modafinil, Arm 5: Placebo > modafinil > d-serine, Arm 6: Placebo > d-serine > modafinil |
| PlaceboSingle dose of oral placebo, in both capsule and oral solution | Drug | Arm 1: Modafinil > d-serine > placebo, Arm 2: Modafinil > placebo > d-serine, Arm 3: D-serine > modafinil > placebo, Arm 4: D-serine > placebo > modafinil, Arm 5: Placebo > modafinil > d-serine, Arm 6: Placebo > d-serine > modafinil |
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 (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.
9 secondary outcomes
Brief Psychiatric Rating Scale (BPRS) - Global Score
Time frame: Baseline
Brief Psychiatric Rating Scale (BPRS) - Global Score
Time frame: Day 21 (Clinical A)
Brief Psychiatric Rating Scale (BPRS) - Global Score
Time frame: Day 49 (Brief Clinical B)
Brief Psychiatric Rating Scale (BPRS) - Global Score
Time frame: Day 77 (Clinical C)
Brief Psychiatric Rating Scale (BPRS) - Global Score
Time frame: Day 105 (Brief Clinical D)
Brief Psychiatric Rating Scale (BPRS) - Global Score
Time frame: Day 133 (Clinical E)
Scale for Assessment of Negative Symptoms/Scale for Assessment of Positive Symptoms (SANS/SAPS) - Global score
Time frame: Day 21 (Clinical A)
Scale for Assessment of Negative Symptoms/Scale for Assessment of Positive Symptoms (SANS/SAPS) - Global score
Time frame: Day 77 (Clinical C)
Scale for Assessment of Negative Symptoms/Scale for Assessment of Positive Symptoms (SANS/SAPS) - Global score
Time frame: Day 133 (Clinical E)
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 23 Jul 2026.
- Individual participant dataSharing planned: Yes. Data will be shared with the National Institutes of Mental Health 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.
Ariel Currie contact
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
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 and D-serine solution in people with Psychosis and Schizophrenia Disorder, 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 8 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 23 Jul 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 Freddie Holmberg Kohler, MBS, CCRP (612-772-2201, costep2@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 46 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 23 Jul 2026.