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| ID | Type | Description | Link |
|---|---|---|---|
| U01MH137298 | U.S. NIH Grant/Contract | View source | |
| U24MH137171 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Foundation for the National Institutes of Health | OTHER |
| Accelerating Medicines Partnership (AMP) | OTHER |
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The goal of this clinical trial is to learn how tests undertaken by people at high risk of developing psychosis (aged 17 to 30 years old) change when those people are given the study drug MT1988 daily for 8 weeks. This will help identify tests that could be used in later trials developing treatments for symptoms in people at high risk of developing psychosis, to measure whether those new treatments are effective.
The main question this trial aims to answer is:
Can any of the tests (biomarkers) used in this study detect changes in participants dosed with one of two different dose levels of MT1988?
Researchers will compare the results from two dose levels of MT1988 to a placebo group. Researchers do not expect to see the test results change in participants taking placebo and this will be compared to changes expected in test results in participants taking MT1988.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT1988 Low Dose | Experimental |
| |
| MT1988 High Dose | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT1988 Low Dose | Drug | Oral dosing MT1988; dose level 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 8 in test of verbal memory (List Learning Task) as measured by the Penn Computerized Neurobehavioral Battery (PennCNB) test battery | Day 56 | |
| Change from baseline to week 8 in attenuated positive symptoms as measured by PSYCHS-CT total score | PSYCHS-CT: Positive Symptoms and Diagnostic Criteria for the Comprehensive Assessment of At-Risk Mental States (CAARMS) Harmonized with the Structured Interview for Pyschosis-risk Syndromes (SIPS) - Clinical Trials version. Total score of 0-90 across maximum 15 domain; where a higher score indicates more severe symptoms | Day 56 |
| Change from baseline to week 8 in negative symptoms as measured by the Negative Symptom Inventory - Psychosis Risk (NSI-PR) total score | Total score of 0-44 across 11 domains; where a higher score indicates more severe symptoms | Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety & tolerability as measured by number of treatment related adverse events | The total number of treatment related adverse events reported per study arm (high dose MT1988, low dose MT1988, placebo) will be compared | Day 1 to Day 84 |
| Safety & tolerability as measured by proportion of participants with treatment related adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheryl Caswell | Contact | +447539430768 | info@monumenttx.com |
| Name | Affiliation | Role |
|---|---|---|
| Scott Woods, M.D. | Yale University of Medicine | Principal Investigator |
| Martha E Shenton, PhD | Massachusetts General Brigham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Recruiting | Irvine | California | 92697 | United States |
All clinical and phenotypic data will be shared with the NIMH National Data Archive (NDA). All data will be de-identified prior to receipt by the NDA, but the information needed to generate a global unique identifier for the NDA will be collected for each participant. Phenotypic and clinical data will be collected and deposited in the NDA using the data dictionaries available in NDA. Audio files will be transcribed using HIPAA-compliant services. Only pseudo-anonymized transcripts will be sent to the NDA.
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| MT1988 High Dose |
| Drug |
Oral dosing MT1988; dose level 2 |
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| Placebo | Drug | Oral Placebo; blinded to match MT1988 all doses |
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The proportion of participants in each study arm (high dose MT1988, low dose MT1988, placebo) experiencing treatment related adverse events will be compared |
| Day 1 to Day 84 |
| Change from baseline to week 4 in test of verbal memory (List learning task) as measured by PennCNB battery | Day 28 |
| Change from baseline to weeks 4 and 8 in overall composite score of cognitive performance as measured by PennCNB test battery | Composite includes Continuous Performance Test, Fractal N-Back, Digit-Symbol Substitution Test, Digit Symbol Recall, Visual Object Learning Test, Emotion Recognition Test, Finger Tapping Test, Motor Praxis | Day 28 and Day 56 |
| Change from baseline to weeks 4 and 8 in a cognitive test of working memory and executive function as measured by CANTAB SWM test. | Day 28 and Day 56 |
| Change from baseline to weeks 4 and 8 in a cognitive test of sustained attention as measured by CANTAB RVP test. | Day 28 and Day 56 |
| Change from baseline to weeks 4 and 8 in neurophysiology (EEG) as measured by mismatch negativity; auditory oddball P300. | Day 28 and Day 56 |
| Change from baseline to week 4 in attenuated positive symptoms, as measured by the PSYCHS-CT total score. | PSYCHS-CT: Positive Symptoms and Diagnostic Criteria for the Comprehensive Assessment of At-Risk Mental States (CAARMS) Harmonized with the Structured Interview for Pyschosis-risk Syndromes (SIPS) - Clinical Trials version. Total score of 0-90 across maximum 15 domain; where a higher score indicates more severe symptoms | Day 28 |
| Change from baseline to week 4 in negative symptoms as measured by the NSI-PR total score. | Total score of 0-44 across 11 domains; where a higher score indicates more severe symptoms | Day 28 |
| Change from baseline to weeks 4 and 8 in overall psychopathology as measured by the Positive And Negative Symptoms Scale (PANSS) total score. | Total PANSS score between 30 and 120; where a higher score indicates more severe symptoms | Day 28 and Day 56 |
| Change from baseline to weeks 4 and 8 in symptoms of anxiety as measured by the Overall Anxiety Severity and Impairment Scale (OASIS). | The OASIS (Overall Anxiety Severity and Impairment Scale) ranges from 0 to 20. Higher scores indicate greater severity and impairment due to anxiety symptoms. | Day 28 and Day 56 |
| Change from baseline to weeks 4 and 8 in symptoms of depression as measured by the Calgary Depression Scale for Schizophrenia (CDSS). | The Calgary Depression Scale for Schizophrenia (CDSS) ranges from 0 to 27. Higher scores indicate more severe depressive symptoms in individuals with schizophrenia. | Day 28 and Day 56 |
| Change from baseline to weeks 4 and 8 in symptoms of stress as measured by the Perceived Stress Scale (PSS). | The Perceived Stress Scale (PSS) ranges from 0 to 40. Higher scores indicate greater levels of perceived stress | Day 28 and Day 56 |
| Change from baseline to weeks 4 and 8 in sleep disturbance as measured by the Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS-SD). | The PROMIS-SD scale ranges from 8 to 40. Higher scores indicate greater severity of recent sleep disturbance. | Day 28 and Day 56 |
| Change from baseline to week 8 in biospecimen assays (levels of inflammation) as measured by blood samples (ELISA). | Day 56 |
| Change from baseline to week 8 in cortisol levels, indicative of stress response, as measured by saliva collection (ELISA). | Day 56 |
| Change from baseline to week 8 in physical/sedentary behavior as measured by a phone accelerometer and assessed by the mindLAMP app | Day -7 to Day 56 |
| Change from baseline to week 8 in roaming/movement behavior as measured by a phone GPS and assessed by the mindLAMP app | Day -7 to Day 56 |
| Change from baseline to week 8 in screen state (screen on/off timestamps) assessed by the mindLAMP app | Day -7 to Day 56 |
| Correlation between latent inhibition score and cognitive change from baseline to weeks 4 and 8 as measured by CANTAB SWM. | The data will be explored to determine whether the score on the latent inhibition assessment tool ("positive", "negative") correlates with cognitive change from baseline to weeks 4 and 8 as measured by CANTAB SWM, using Pearson's correlation coefficient. | Day 28 and Day 56 |
| Correlation between latent inhibition score and cognitive change from baseline to weeks 4 and 8 as measured by CANTAB RVP. | The data will be explored to determine whether the score on the latent inhibition assessment tool ("positive", "negative") correlates with cognitive change from baseline to weeks 4 and 8 as measured by CANTAB RVP, using Pearson's correlation coefficient. | Day 28 and Day 56 |
| Correlation between the polygenic risk score (as measured by plasma isolated-DNA samples) and PennCNB score change at week 8. | Polygenic risk scores serve to modestly improve psychosis risk prediction. The data will be examined for correlation between individual genetic risk prediction for psychosis and any changes between baseline and Day 56 for each individual biomarker, using Pearson's correlation coefficient. | Day 56 |
| Correlation between the polygenic risk score (as measured by plasma isolated-DNA samples) and PYSCHS-CT score change at week 8. | Polygenic risk scores serve to modestly improve psychosis risk prediction. The data will be examined for correlation between individual genetic risk prediction for psychosis and any changes between baseline and Day 56 for each individual biomarker, using Pearson's correlation coefficient. | Day 56 |
| Correlation between the polygenic risk score (as measured by plasma isolated-DNA samples) and NSI-PR score change at week 8. | Polygenic risk scores serve to modestly improve psychosis risk prediction. The data will be examined for correlation between individual genetic risk prediction for psychosis and any changes between baseline and Day 56 for each individual biomarker, using Pearson's correlation coefficient. | Day 56 |
| University of California | Recruiting | Los Angeles | California | 90095 | United States |
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| University of California, San Francisco | Recruiting | San Francisco | California | 94107 | United States |
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| Yale University Conneticut Mental Health Center | Recruiting | New Haven | Connecticut | 06519 | United States |
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| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02115 | United States |
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| Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
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| Northwell Health | Recruiting | Glen Oaks | New York | 11004 | United States |
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| Columbia University | Recruiting | New York | New York | 10032 | United States |
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| Icahan School of Medicine at Mount Sinai | Recruiting | New York | New York | 10128 | United States |
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| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
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| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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| Prevention Science Institute | Recruiting | Eugene | Oregon | 97403 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Temple University | Recruiting | Philadelphia | Pennsylvania | 19122 | United States |
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| University of Pittsburgh School of Medicine | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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