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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

NCT07226895 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-02

No results posted yet for this study

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

Conditions

  • Clinical High Risk for Psychosis (CHR)

Interventions

DRUG

MT1988 Low Dose

Oral dosing MT1988; dose level 1

DRUG

MT1988 High Dose

Oral dosing MT1988; dose level 2

DRUG

Placebo

Oral Placebo; blinded to match MT1988 all doses

Sponsors & Collaborators

Principal Investigators

  • Scott Woods, M.D. · Yale University of Medicine

  • Martha E Shenton, PhD · Massachusetts General Brigham

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-03
Primary Completion
2027-09-30
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07226895 on ClinicalTrials.gov