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RECRUITING
NCT07226895
PHASE1/PHASE2

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

Sponsor: Monument Therapeutics Limited

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

17 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-03-03

Completion Date

2027-10

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DRUG

MT1988 Low Dose

Oral dosing MT1988; dose level 1

DRUG

MT1988 High Dose

Oral dosing MT1988; dose level 2

DRUG

Placebo

Oral Placebo; blinded to match MT1988 all doses

Locations (15)

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