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

NCT07226895 · tracked via the Priya Life Science USA tracker

Sponsor

Monument Therapeutics Limited

Phase

Phase 1/2

Started

2026-03-03

Last updated

2026-06-08

Condition(s) studied

Clinical High Risk for Psychosis (CHR)

Investigational drug(s) / intervention(s)

MT1988 Low DoseMT1988 High DosePlacebo

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

Study 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

Eligibility

Sex

ALL

Min age

17 Years

Max age

30 Years

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

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 — Day 56
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
Change from baseline to week 8 in negative symptoms as measured by the Negative Symptom Inventory - Psychosis Risk (NSI-PR) total score — Day 56
Total score of 0-44 across 11 domains; where a higher score indicates more severe symptoms

Trial sites (15)

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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07226895 on ClinicalTrials.gov ↗ ← All trials in the USA