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

RecruitingPhase 1, Phase 2Ages 17 Years - 30 YearsAllMonument Therapeutics Limited
NCT07226895 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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: * t

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📋 Eligibility rules (as published)
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.
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What it tests

  • MT1988 Low Dose
  • MT1988 High Dose
  • Placebo
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Where

15 sites
University of California, Irvine
Irvine, United States
University of California
Los Angeles, United States
University of California, San Francisco
San Francisco, United States
Yale University Conneticut Mental Health Center
New Haven, United States
Beth Israel Deaconess Medical Center
Boston, United States
Washington University
St Louis, United States
Northwell Health
Glen Oaks, United States
Columbia University
New York, United States

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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