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
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.
Parallel
MT1988 Low Dose
DrugOral dosing MT1988; dose level 1
MT1988 High Dose
DrugOral dosing MT1988; dose level 2
Placebo
DrugOral Placebo; blinded to match MT1988 all doses
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
Change from baseline to week 8 in attenuated positive symptoms as measured by PSYCHS-CT total score
PSYCHS-CT: Positive Symptoms and Diagnostic Criteria for the Comprehensive Assessment of At-Risk Mental States (CAARMS) Harmonized with the Structured Interview for Pyschosis-risk Syndromes (SIPS) - Clinical Trials version. Total score of 0-90 across maximum 15 domain; where a higher score indicates more severe symptoms
Change from baseline to week 8 in negative symptoms as measured by the Negative Symptom Inventory - Psychosis Risk (NSI-PR) total score
Total score of 0-44 across 11 domains; where a higher score indicates more severe symptoms
Safety & tolerability as measured by number of treatment related adverse events
The total number of treatment related adverse events reported per study arm (high dose MT1988, low dose MT1988, placebo) will be compared
Safety & tolerability as measured by proportion of participants with treatment related adverse events
The proportion of participants in each study arm (high dose MT1988, low dose MT1988, placebo) experiencing treatment related adverse events will be compared
Change from baseline to week 4 in test of verbal memory (List learning task) as measured by PennCNB battery
Change from baseline to weeks 4 and 8 in overall composite score of cognitive performance as measured by PennCNB test battery
Composite includes Continuous Performance Test, Fractal N-Back, Digit-Symbol Substitution Test, Digit Symbol Recall, Visual Object Learning Test, Emotion Recognition Test, Finger Tapping Test, Motor Praxis
Click on the lead sponsor to view all of their trials.
Monument Therapeutics Limited
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Foundation for the National Institutes of Health
Collaborator
Accelerating Medicines Partnership (AMP)
Collaborator
