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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

Monument Therapeutics Limited · with National Institute of Mental Health (NIMH), Foundation for the National Institutes of Health · NCT07226895

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 17–30 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
150
US sites recruiting
15
Study start
March 3, 2026
Record last updated
June 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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. 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

Being studied: MT1988 Low Dose; MT1988 High Dose; Placebo

Conditions: Clinical High Risk for Psychosis (CHR)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • University of California, Irvine

    Irvine, CA 92697

    Site contact: Jason Schiffman · 443-722-7768 · jason.schiffman@uci.edu

  • University of California

    Los Angeles, CA 90095

    Site contact: Carrie Bearden · 310-206-3466 · cbearden@mednet.ucla.edu

  • University of California, San Francisco

    San Francisco, CA 94107

    Site contact: Daniel Mathalon · 415-221-4810 · daniel.mathalon@ucsf.edu

  • Yale University Conneticut Mental Health Center

    New Haven, CT 06519

    Site contact: Scott Woods · 203-200-8997 · scott.woods@yale.edu

  • Beth Israel Deaconess Medical Center

    Boston, MA 02115

    Site contact: William Stone · 508-740-2050 · wstone@bidmc.harvard.edu

  • Washington University

    St Louis, MO 63110

    Site contact: Daniel Mamah · 314-273-4329 · mamahd@wustl.edu

  • Northwell Health

    Glen Oaks, NY 11004

    Site contact: Ricardo Carrion · 347-502-1909 · RCarrion@northwell.edu

  • Columbia University

    New York, NY 10032

    Site contact: Ragy Girgis · 646-774-5553 · ragy.girgis@nyspi.columbia.edu

  • Icahan School of Medicine at Mount Sinai

    New York, NY 10128

    Site contact: Cheryl Corcoran · 212-659-1671 · cheryl.corcoran@mssm.edu

  • University of North Carolina at Chapel Hill

    Chapel Hill, NC 27514

    Site contact: Diana Perkins · 877-774-6319 · PRIME@med.unc.edu

  • Ohio State University

    Columbus, OH 43210

    Site contact: Nicholas Breitborde · 614-398-2991 · nicholas.breitborde@osumc.edu

  • Prevention Science Institute

    Eugene, OR 97403

    Site contact: Fred Sabb · 310-844-6458 · fws@uoregon.edu

  • University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Daniel Wolf · 215-662-3692 · danwolf@pennmedicine.upenn.edu

  • Temple University

    Philadelphia, PA 19122

    Site contact: Lauren Ellman · 215-204-1571 · ellman@temple.edu

  • University of Pittsburgh School of Medicine

    Pittsburgh, PA 15213

    Site contact: Leslie Horton · 412-864-7006 · hortonle2@upmc.edu

Study contacts (from the official record)

  • Sheryl Caswell · +447539430768 · info@monumenttx.com
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