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| ID | Type | Description | Link |
|---|---|---|---|
| P50MH119569 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| 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) |
|
| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modafinil | Drug | Single dose of modafinil capsule, 200 mg. Participants will also receive an oral placebo solution to maintain the blind. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. | Day 119 (fMRI 5) |
| Test My Brain - Digit Symbol Coding |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 21 (Clinical A) |
| Abbreviated Quality of Life Scale (aQLS) - Global Score |
Inclusion Criteria:
Between the ages of 18 and 35
Onset of a psychosis spectrum illness (schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis) within 5 years of enrollment
Estimated IQ of 70 or above
Proficient at English as determined through interactions with the study team
No change in psychiatric medication within a week of enrollment or MRI study visits
No clinically significant change in any medications for at least 1 month prior to study participation or MRI study visits, as determined by PI/Co-Is
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:
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:
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:
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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Freddie Holmberg Kohler | Contact | 612-772-2201 | costep2@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sophia Vinogradov, MD | University of Minnesota Department of Psychiatry and Behavioral Sciences | Principal Investigator |
| Caroline Demro, Ph.D. | University of Minnesota Department of Psychiatry and Behavioral Sciences |
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Data will be shared with the National Institutes of Mental Health Data Archive (collection ID pending).
Data will be shared 1 year following study completion. There is no end date for data sharing.
Users who register with the NIMH Data Archive will be able to access the data.
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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).
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|
| 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) |
|
| 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) |
|
| D-serine solution | Drug | Single dose of oral solution of d-serine, 100 mg/kg. Participants will also receive a placebo capsule to maintain the blind. |
|
| Placebo | Drug | Single dose of oral placebo, in both capsule and oral solution |
|
A computerized cognitive assessment measuring processing speed. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 |
| 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 | 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 | 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 | 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 | 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. | 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. | 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. | Day 133 (Clinical E) |
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. |
| 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. | 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) | 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) | 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) | 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) | 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) | 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) | Day 133 (Clinical E) |
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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