Image

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

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

Recruiting
17-30 years
All
Phase 1/2

Powered by AI

Overview

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

Eligibility

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.

Study details
    Clinical High Risk for Psychosis (CHR)

NCT07226895

Monument Therapeutics Limited

13 May 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.