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Could a daily pill prevent psychosis? new trial begins

NCT ID NCT07226895

Disease control Sponsor: Monument Therapeutics Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study is testing an experimental drug called MT1988 in 150 people aged 17 to 30 who are at high risk of developing psychosis. Participants take either a low dose, high dose, or placebo pill twice daily for 8 weeks. The main goal is to see if certain tests (like memory and symptom checklists) can detect changes caused by the drug, which will help design future larger trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MT1988 (an experimental drug taken as a pill twice daily)
What this could lead to
If this trial works, it could point toward a treatment that reduces symptoms and improves thinking in people at high risk for psychosis.
What could go wrong
This is a very early (Phase 1/2) trial with only 150 people. The drug may not work better than placebo, and side effects are unknown. It is designed mainly to find good tests for future studies, not to prove the drug works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

17 to 30 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

psychotic disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clinical high risk for psychosis (CHR)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    15 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Icahan School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10128, United States

  • Northwell Health

    RECRUITING

    Glen Oaks, New York, 11004, United States

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Prevention Science Institute

    RECRUITING

    Eugene, Oregon, 97403, United States

  • Temple University

    RECRUITING

    Philadelphia, Pennsylvania, 19122, United States

  • University of California

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of California, Irvine

    RECRUITING

    Irvine, California, 92697, United States

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94107, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh School of Medicine

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Yale University Conneticut Mental Health Center

    RECRUITING

    New Haven, Connecticut, 06519, United States

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