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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

a study on Clinical High Risk for Psychosis (CHR)

Summary

Eligibility
for people ages 17-30 (full criteria)
Location
at San Francisco 5391959, California 5332921 and other locations
Dates
study started
study ends around

Description

Summary

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

Official Title

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

Keywords

Clinical High Risk for Psychosis (CHR), MT1988 Low Dose, MT1988 High Dose

Eligibility

You can join if…

Open to people ages 17-30

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCSF
    San Francisco 5391959 California 5332921 94107 United States
  • University of California
    Los Angeles 5368361 California 5332921 90095 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Monument Therapeutics Limited
ID
NCT07226895
Phase
Phase 1/2 Clinical High Risk for Psychosis (CHR) Research Study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated