NCT07226895 · Monument Therapeutics Limited
A Study Exploring Changes in a Variety of Biomarkers Following Dosing With MT1988 in Participants at Clinical High Risk for Psychosis
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Irvine, California
- Los Angeles, California
- San Francisco, California
- New Haven, Connecticut
- Boston, Massachusetts
- St Louis, Missouri
- Glen Oaks, New York
- New York, New York
- Chapel Hill, North Carolina
- Columbus, Ohio
- Eugene, Oregon
- Philadelphia, Pennsylvania
And 1 more location — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations