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

Conditions

• Clinical High Risk for Psychosis (CHR)

Eligibility Criteria

Sex

ALL

Age

17 Years - 30 Years

Healthy Volunteers

Not accepted

Interventions

• MT1988 Low Dose — DRUG
  Oral dosing MT1988; dose level 1
• MT1988 High Dose — DRUG
  Oral dosing MT1988; dose level 2
• Placebo — DRUG
  Oral Placebo; blinded to match MT1988 all doses

Study Details

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

Key Dates

Start date

Mar 3, 2026

Status verified

Jun 2026

Primary completion

Sep 30, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: MT1988 Low Dose
• Experimental: MT1988 High Dose
• Placebo Comparator: Placebo

Primary Outcome Measure

Change from baseline to week 8 in test of verbal memory (List Learning Task) as measured by the Penn Computerized Neurobehavioral Battery (PennCNB) test battery [ Time Frame: Day 56 ]

Central Contacts

• Sheryl Caswell
  +447539430768
  [email protected]

Locations (15)

Find similar trials in Irvine, CA

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