A Phase 3 interventional study of Modafinil and D-serine solution in Psychosis, Schizophrenia Disorder and Schizoaffective Disorder, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by University of Minnesota · Phase 3, Interventional, and Basic science
Among 11 studies testing D-serine zwitterion in Psychotic Disorders — 1 open to participants now, 1 under way, 1 of them phase 3. D-serine zwitterion · Psychotic Disorders.
Among the 11 studies testing D-serine zwitterion in Psychotic Disorders, this one is the 7th largest by planned enrollment, is the only one that started in 2026, is one of 3 in phase 3, and was the 11th registered.
1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.
Browse Psychotic Disorders studies →1 of the 11 studies testing D-serine zwitterion in Psychotic Disorders is open now, in 1 country.
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 205 Psychotic Disorders studies recruiting now, 53 (26%) set no upper age limit and 143 (70%) stop at 75 or younger; 51 take children under 18; 41 take healthy volunteers.
This study: 18 Years to 35 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 6 · Phase 3 3
First in 2002; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 24 is below the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.
Median enrollment 45 across the 11 interventional studies. Of the 6 that completed or were terminated, 3 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 11 has an industry lead sponsor. The 8 most frequent:
University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
19 studies in Psychotic Disorders by University of Minnesota: 4 open now, 6 under way, 2 of them phase 3. Of 12 finished, 5 (42%) have results posted.
Among the 19 studies in Psychotic Disorders by University of Minnesota, this one is the 12th largest by planned enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2026, is one of 2 in phase 3, and was the 17th registered.
University of Minnesota’s Psychotic Disorders studies by the year they started, since 2002.
None of the studies under way reaches primary completion within a year.
Among the 11 studies testing D-serine zwitterion in Psychotic Disorders, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among University of Minnesota’s 19 in Psychotic Disorders:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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:
Participants will:
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
No change in any medications for at least 1 month prior to study participation or MRI study visits, as determined by PI/Co-Is
Exclusion Criteria:
Medical Criteria:
Presence of the following medical concerns as determined by the study PI:
History of any of the following as reported by the participant:
Myocardial infarction or heart disease, or endorsement of history of or of cardiac symptoms at intake:
Abnormal clinical laboratory values:
Mental health criteria:
Meets criteria for clinical risk of suicidal behavior, as defined by:
Other criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Drug: Modafinil · Drug: D-serine solution · Drug: Placebo
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)
Drug: Modafinil · Drug: D-serine solution · Drug: Placebo
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)
Drug: Modafinil · Drug: D-serine solution · Drug: Placebo
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)
Drug: Modafinil · Drug: D-serine solution · Drug: Placebo
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)
Drug: Modafinil · Drug: D-serine solution · Drug: Placebo
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)
Drug: Modafinil · Drug: D-serine solution · Drug: Placebo
Single dose of modafinil capsule, 200 mg. Participants will also receive an oral placebo solution to maintain the blind.
Single dose of oral solution of d-serine, 100 mg/kg. Participants will also receive a placebo capsule to maintain the blind.
Single dose of oral placebo, in both capsule and oral solution
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 147 (fMRI 6)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 133 (Clinical E)
Abbreviated Quality of Life Scale (aQLS) - Global Score
Clinician-administered rating scale to assess functioning in schizophrenia. Individual items range from 0 (virtually absent) to 6 (Little or no deficit); global scores range from 0 to 54.
Time frame: Day 21 (Clinical A)
Abbreviated Quality of Life Scale (aQLS) - Global Score
Clinician-administered rating scale to assess functioning in schizophrenia. Individual items range from 0 (virtually absent) to 6 (Little or no deficit); global scores range from 0 to 54.
Time frame: Day 77 (Clinical C)
Abbreviated Quality of Life Scale (aQLS) - Global Score
Clinician-administered rating scale to assess functioning in schizophrenia. Individual items range from 0 (virtually absent) to 6 (Little or no deficit); global scores range from 0 to 54.
Time frame: Day 133 (Clinical E)
Global Functioning - Social Scale (GFS)
Clinician-administered rating scale to assess social functioning. Scores range from 1 (extreme social isolation) to 10 (Superior social/interpersonal functioning)
Time frame: Clinical A
Global Functioning - Social Scale (GFS)
Clinician-administered rating scale to assess social functioning. Scores range from 1 (extreme social isolation) to 10 (Superior social/interpersonal functioning)
Time frame: Day 77 (Clinical C)
Global Functioning - Social Scale (GFS)
Clinician-administered rating scale to assess social functioning. Scores range from 1 (extreme social isolation) to 10 (Superior social/interpersonal functioning)
Time frame: Day 133 (Clinical E)
Global Functioning - Role Scale (GFR)
Clinician-administered rating scale to assess occupational functioning. Scores range from 1 (Extreme role dysfunction) to 10 (Superior role functioning)
Time frame: Day 21 (Clinical A)
Global Functioning - Role Scale (GFR)
Clinician-administered rating scale to assess occupational functioning. Scores range from 1 (Extreme role dysfunction) to 10 (Superior role functioning)
Time frame: Day 77 (Clinical C)
Global Functioning - Role Scale (GFR)
Clinician-administered rating scale to assess occupational functioning. Scores range from 1 (Extreme role dysfunction) to 10 (Superior role functioning)
Time frame: Day 133 (Clinical E)
Plan to share: Yes — Data will be shared with the National Institutes of Mental Health Data Archive (collection ID pending).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be shared 1 year following study completion. There is no end date for data sharing.
Access criteria: Users who register with the NIMH Data Archive will be able to access the data.
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Apr 2030, 45 months after the start.
Of 26 phase 3 interventional studies under Psychotic Disorders, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 72. This study's planned 45 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Modafinil · D-serine zwitterion