A Study Exploring Changes in a Variety of Biomarkers Following Dosing With MT1988 in Participants at Clinical High Risk for Psychosis
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
3 other identifiers
interventional
150
1 country
15
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2026
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2025
CompletedFirst Posted
Study publicly available on registry
November 12, 2025
CompletedStudy Start
First participant enrolled
March 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
April 2, 2026
April 1, 2026
1.5 years
October 24, 2025
April 1, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (24)
Safety & tolerability as measured by number of treatment related adverse events
Day 1 to Day 84
Safety & tolerability as measured by proportion of participants with treatment related adverse events
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
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
- +19 more secondary outcomes
Study Arms (3)
MT1988 Low Dose
EXPERIMENTALMT1988 High Dose
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Aged 17 to 30 years at time of consent.
- 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.
You may not qualify if:
- Clinically significant medical disorder or laboratory test abnormality at Day 1.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Monument Therapeutics Limitedlead
- National Institute of Mental Health (NIMH)collaborator
- Foundation for the National Institutes of Healthcollaborator
- Accelerating Medicines Partnership (AMP)collaborator
Study Sites (15)
University of California, Irvine
Irvine, California, 92697, United States
University of California
Los Angeles, California, 90095, United States
University of California, San Francisco
San Francisco, California, 94107, United States
Yale University Conneticut Mental Health Center
New Haven, Connecticut, 06519, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Washington University
St Louis, Missouri, 63110, United States
Northwell Health
Glen Oaks, New York, 11004, United States
Columbia University
New York, New York, 10032, United States
Icahan School of Medicine at Mount Sinai
New York, New York, 10128, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Ohio State University
Columbus, Ohio, 43210, United States
Prevention Science Institute
Eugene, Oregon, 97403, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Temple University
Philadelphia, Pennsylvania, 19122, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Woods, M.D.
Yale University of Medicine
- PRINCIPAL INVESTIGATOR
Martha E Shenton, PhD
Massachusetts General Brigham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2025
First Posted
November 12, 2025
Study Start
March 3, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
April 2, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.