A Study Exploring Changes in a Variety of Biomarkers Following Dosing With MT1988 in Participants at Clinical High Risk for Psychosis

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Clinical High Risk for Psychosis (CHR)

In brief

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

Key facts

Study ID

NCT07226895

Run by

Monument Therapeutics Limited

People needed

150

Starts

2026-03-03

Expected to finish

2027-10-01

Last updated by the study team

2026-06-08

Who can join

Age: 17 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of California, Irvine — Irvine, California, United States (enrolling)
• University of California — Los Angeles, California, United States (enrolling)
• University of California, San Francisco — San Francisco, California, United States (enrolling)
• Yale University Conneticut Mental Health Center — New Haven, Connecticut, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• Northwell Health — Glen Oaks, New York, United States (enrolling)
• Columbia University — New York, New York, United States (enrolling)
• Icahan School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• Prevention Science Institute — Eugene, Oregon, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Temple University — Philadelphia, Pennsylvania, United States (enrolling)
• University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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