A Study Exploring Changes in a Variety of Biomarkers Following Dosing With MT1988 in Participants at Clinical High Risk for Psychosis
NCT ID: NCT07226895
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
150 participants
INTERVENTIONAL
2025-11-30
2027-04-30
Brief Summary
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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:
* take a dose of MT1988 or placebo twice per day for 8 weeks
* attend clinic appointments every two weeks to undertake assessments
* report any side effects they experience to the researchers
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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MT1988 Low Dose
MT1988 Low Dose
Oral dosing MT1988; dose level 1
MT1988 High Dose
MT1988 High Dose
Oral dosing MT1988; dose level 2
Placebo
Placebo
Oral Placebo; blinded to match MT1988 all doses
Interventions
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MT1988 Low Dose
Oral dosing MT1988; dose level 1
MT1988 High Dose
Oral dosing MT1988; dose level 2
Placebo
Oral Placebo; blinded to match MT1988 all doses
Eligibility Criteria
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Inclusion Criteria
* Capacity to provide informed consent. (For patients under 17 years, participants must assent and informed consent provided by one parent or legal guardian).
* Meet diagnostic criteria for Clinical High Risk of Psychosis (CHR).
* For females of reproductive potential - not pregnant or nursing and willing to comply with contraceptive requirements.
Exclusion Criteria
* History of or current condition which may prevent participant from complying with study procedures.
* Past or current schizophrenia, other disorder with symptoms of psychosis, major cognitive disorder resulting from traumatic brain injury.
* Received antipsychotic medication equivalent to a total lifetime haloperidol dose \>50 mg.
* Current use of medications which could interfere with the study endpoints - to be assessed by the Investigator at screening.
* Unable to abstain from nicotine (e.g. cigarettes, vape) for two hours before cognitive testing.
* Unable to abstain from marijuana use on test day prior to test completion.
* History of suicide attempt or behavior in previous 12 months, or risk of suicidal behavior during the study.
17 Years
30 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Foundation for the National Institutes of Health
OTHER
ProCAN
UNKNOWN
CT-DPACC
UNKNOWN
Monument Therapeutics Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Scott Woods, M.D.
Role: PRINCIPAL_INVESTIGATOR
Yale University of Medicine
Martha E Shenton, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Brigham
Locations
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University of California, Irvine
Irvine, California, United States
University of California
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Yale University Conneticut Mental Health Center
New Haven, Connecticut, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Northwell Health
Glen Oaks, New York, United States
Columbia University
New York, New York, United States
Icahan School of Medicine at Mount Sinai
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Prevention Science Institute
Eugene, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Jason Schiffman
Role: primary
Carrie Bearden
Role: primary
Daniel Mathalon
Role: primary
Scott Woods
Role: primary
William Stone
Role: primary
Daniel Mamah
Role: primary
Ricardo Carrion
Role: primary
Ragy Girgis
Role: primary
Joshua Kantrowitz
Role: backup
Cheryl Corcoran
Role: primary
Diana Perkins
Role: primary
Nicholas Breitborde
Role: primary
Fred Sabb
Role: primary
Daniel Wolf
Role: primary
Christian Kohler
Role: backup
Lauren Ellman
Role: primary
Leslie Horton
Role: primary
Other Identifiers
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