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New treatment option for Clinical High Risk for Psychosis (CHR)
Official title A Study Exploring Changes in a Variety of Biomarkers Following Dosing With MT1988 in Participants at Clinical High Risk for Psychosis
ClinicalTrials.gov ID: NCT07226895
What this study is testing
What is MT1988 Low Dose?
MT1988 Low Dose is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for clinical high risk for psychosis (chr).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 17 to 30
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- New Haven, Connecticut, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Glen Oaks, New York, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Columbus, Ohio, United States
- Eugene, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 17 years to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; Los Angeles, California, United States; San Francisco, California, United States; New Haven, Connecticut, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.