Biomarker changes after MT1988 dosing in young people at high risk for psychosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants aged 17–30 who meet criteria for Clinical High Risk for Psychosis will be assigned to low-dose MT1988, high-dose MT1988, or placebo and will take the study medication twice daily for 8 weeks. The trial will collect a variety of laboratory and clinical biomarker measures at baseline and during regular clinic visits every two weeks to track change over time. Results from the two active dose groups will be compared with placebo to see which tests change in response to MT1988. The goal is to identify reliable biomarkers that can be used in later trials to measure treatment effects in people at high risk for psychosis.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of California, Irvine
  Irvine, California, United States Recruiting
• University of California
  Los Angeles, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting
• Yale University Conneticut Mental Health Center
  New Haven, Connecticut, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• Washington University
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Scott Woods, M.D. — Yale University of Medicine
• Study coordinator: Sheryl Caswell
• Email: info@monumenttx.com
• Phone: +447539430768

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Accelerated Brain Stimulation for Young People at Risk of Psychosis

  This study tests a five-day accelerated brain-stimulation treatment to see if it is safe and tolerable for young people at risk for psychosis and to explore biomarkers that might show whether it works.

  Recruiting Douglas Mental Health University Institute · Verdun, Quebec · NCT07786714

• Recovery-oriented suicide prevention for young people at clinical high risk for psychosis

  This program tests a peer-supported, clinician-led suicide prevention group for young people at clinical high risk for psychosis to see if it helps reduce suicidal thoughts and support recovery.

  Recruiting at 2 sites University of California, San Diego · Los Angeles, California and 1 other locations · NCT07756567

• Mindfulness group experiences for young people at high risk for or early in psychosis

  This project tries to understand how group mindfulness sessions feel for French-speaking young people aged 15–30 who are at ultra‑high risk for psychosis or have had a first episode.

  Recruiting at 2 sites Centre Psychothérapique de Nancy · Laxou and 1 other locations · NCT07499934

• Digital DBT for Youth at Risk of Psychosis

  This study tests a self-guided digital DBT program to help young people aged 14–35 who are at clinical high risk for psychosis, comparing it to usual care over eight weeks.

  Recruiting Centre for Addiction and Mental Health · Toronto, Ontario · NCT06928935

• French version of the Schizophrenia Proneness Instrument for children and adolescents (SPI-CY)

  This project will test the French SPI-CY to see if it reliably identifies French-speaking adolescents (ages 12–17) who are at high risk for developing psychosis.

  Recruiting at 2 sites Centre Psychothérapique de Nancy · Lille and 2 other locations · NCT06649552

• Cognitive training and enhanced treatment for youth at high risk of psychosis in Tunisia

  This study is testing two different treatment approaches to see if they can help young people at high risk for psychosis improve their daily functioning over 12 weeks.

  Recruiting University of California, Los Angeles · Tunis · NCT06582901

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.