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A Study to Explore Changes in Cognitive, Clinical, Biological and Digital Measures Following 8 Weeks of Twice-daily Dosing of MT1988 and to Evaluate Safety & Tolerability of MT1988, in Participants at Clinical High Risk (CHR) for Psychosis
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: * 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
Age
17 - 30 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
March 1, 2026
Primary Completion Date
March 1, 2027
Completion Date
April 1, 2027
Last Updated
March 20, 2026
150
ESTIMATED participants
MT1988 Low Dose
DRUG
MT1988 High Dose
DRUG
Placebo
DRUG
Lead Sponsor
Monument Therapeutics Limited
Collaborators
NCT05968560
NCT06928935
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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