Actively Recruiting
A Study Exploring Changes in a Variety of Biomarkers Following Dosing With MT1988 in Participants at Clinical High Risk for Psychosis
Led by Monument Therapeutics Limited · Updated on 2026-04-02
150
Participants Needed
15
Research Sites
82 weeks
Total Duration
On this page
Sponsors
M
Monument Therapeutics Limited
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial 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. 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
CONDITIONS
Official Title
A Study Exploring Changes in a Variety of Biomarkers Following Dosing With MT1988 in Participants at Clinical High Risk for Psychosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 17 to 30 years at time of consent.
- Capacity to provide informed consent.
- 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.
You will not qualify if you...
- Clinically significant medical disorder or laboratory test abnormality at Day 1.
- History of or current condition preventing compliance with study procedures.
- Past or current schizophrenia or other disorder with psychosis symptoms.
- Major cognitive disorder from traumatic brain injury.
- Received antipsychotic medication equivalent to total lifetime haloperidol dose >50 mg.
- Current use of medications interfering with study endpoints.
- Unable to abstain from nicotine for two hours before cognitive testing.
- Unable to abstain from marijuana use on test day prior to testing.
- History of suicide attempt or behavior in previous 12 months, or risk of suicidal behavior during the study.
AI-Screening
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Trial Site Locations
Total: 15 locations
1
University of California, Irvine
Irvine, California, United States, 92697
Not Yet Recruiting
2
University of California
Los Angeles, California, United States, 90095
Not Yet Recruiting
3
University of California, San Francisco
San Francisco, California, United States, 94107
Actively Recruiting
4
Yale University Conneticut Mental Health Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
5
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
6
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
7
Northwell Health
Glen Oaks, New York, United States, 11004
Actively Recruiting
8
Columbia University
New York, New York, United States, 10032
Actively Recruiting
9
Icahan School of Medicine at Mount Sinai
New York, New York, United States, 10128
Actively Recruiting
10
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
11
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
12
Prevention Science Institute
Eugene, Oregon, United States, 97403
Actively Recruiting
13
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
14
Temple University
Philadelphia, Pennsylvania, United States, 19122
Actively Recruiting
15
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
S
Sheryl Caswell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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