Biomarker changes after MT1988 dosing in young people at 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

This will test whether two doses of MT1988 taken twice daily for 8 weeks change biomarker tests in 17–30-year-olds at high risk for psychosis compared with placebo.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 17 Years to 30 Years
• Sex: All
• Sponsor: Monument Therapeutics Limited (industry)
• Locations: 15 sites (Irvine, California and 14 other locations)
• Trial ID: NCT07226895 on ClinicalTrials.gov

What this trial studies

Participants aged 17–30 who meet criteria for Clinical High Risk for Psychosis will be assigned to low-dose MT1988, high-dose MT1988, or placebo and will take the study medication twice daily for 8 weeks. The trial will collect a variety of laboratory and clinical biomarker measures at baseline and during regular clinic visits every two weeks to track change over time. Results from the two active dose groups will be compared with placebo to see which tests change in response to MT1988. The goal is to identify reliable biomarkers that can be used in later trials to measure treatment effects in people at high risk for psychosis.

Who should consider this trial

Good fit: Ideal candidates are 17–30-year-olds who meet criteria for Clinical High Risk for Psychosis, can give informed consent, are not pregnant or nursing if female of childbearing potential, and can attend regular clinic visits.

Not a fit: People with a current or past diagnosis of schizophrenia or another established psychotic disorder, significant medical problems, or on medications that interfere with the study are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the trial could identify biomarkers that show drug effects and help speed development of treatments that prevent or reduce psychosis.

How similar studies have performed: Using biomarker changes to guide early-phase psychosis treatment development is an established approach, though MT1988 itself is a novel compound with limited prior clinical data.

Eligibility criteria

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.

Where this trial is running

Irvine, California and 14 other locations

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

Study contacts

• Principal investigator: Scott Woods, M.D. — Yale University of Medicine
• Study coordinator: Sheryl Caswell

Conditions: Clinical High Risk for Psychosis