๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-04

A Study Exploring Changes in a Variety of Biomarkers Following Dosing With MT1988 in Participants at Clinical High Risk for Psychosis (NCT07226895)

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

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Monument Therapeutics Limited

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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

Who can join: Review the eligibility criteria below.

Location: University of California, Irvine โ€” Irvine, California

Age range: 17 Years to 30 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (15 Sites)

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

๐Ÿ“ž Contact the Study Coordinator

Phone: +447539430768

Email: info@monumenttx.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—