A Study to Explore Changes in Cognitive, Clinical, Biological and Digital Measures Following 8 Weeks of Twice-daily Dosing of MT1988 and to Evaluate Safety & Tolerability of MT1988, in Participants at Clinical High Risk (CHR) for Psychosis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 15
- 主要终点
- 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
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Clinically significant medical disorder or laboratory test abnormality at Day
- •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.
研究组 & 干预措施
MT1988 Low Dose
干预措施: MT1988 Low Dose (Drug)
MT1988 High Dose
干预措施: MT1988 High Dose (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
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
时间窗: Day 56
Change from baseline to week 8 in attenuated positive symptoms as measured by PSYCHS-CT total score
时间窗: Day 56
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
时间窗: Day 56
Total score of 0-44 across 11 domains; where a higher score indicates more severe symptoms
次要结局
- Change from baseline to week 8 in screen state (screen on/off timestamps) assessed by the mindLAMP app(Day -7 to Day 56)
- Safety & tolerability as measured by number of treatment related adverse events(Day 1 to Day 84)
- Safety & tolerability as measured by proportion of participants with treatment related adverse events(Day 1 to Day 84)
- Change from baseline to week 4 in test of verbal memory (List learning task) as measured by PennCNB battery(Day 28)
- Change from baseline to weeks 4 and 8 in overall composite score of cognitive performance as measured by PennCNB test battery(Day 28 and Day 56)
- Change from baseline to weeks 4 and 8 in a cognitive test of working memory and executive function as measured by CANTAB SWM test.(Day 28 and Day 56)
- Change from baseline to weeks 4 and 8 in a cognitive test of sustained attention as measured by CANTAB RVP test.(Day 28 and Day 56)
- Change from baseline to weeks 4 and 8 in neurophysiology (EEG) as measured by mismatch negativity; auditory oddball P300.(Day 28 and Day 56)
- Change from baseline to week 4 in attenuated positive symptoms, as measured by the PSYCHS-CT total score.(Day 28)
- Change from baseline to week 4 in negative symptoms as measured by the NSI-PR total score.(Day 28)
- Change from baseline to weeks 4 and 8 in overall psychopathology as measured by the Positive And Negative Symptoms Scale (PANSS) total score.(Day 28 and Day 56)
- Change from baseline to weeks 4 and 8 in symptoms of anxiety as measured by the Overall Anxiety Severity and Impairment Scale (OASIS).(Day 28 and Day 56)
- Change from baseline to weeks 4 and 8 in symptoms of depression as measured by the Calgary Depression Scale for Schizophrenia (CDSS).(Day 28 and Day 56)
- Change from baseline to weeks 4 and 8 in symptoms of stress as measured by the Perceived Stress Scale (PSS).(Day 28 and Day 56)
- Change from baseline to weeks 4 and 8 in sleep disturbance as measured by the Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS-SD).(Day 28 and Day 56)
- Change from baseline to week 8 in biospecimen assays (levels of inflammation) as measured by blood samples (ELISA).(Day 56)
- Change from baseline to week 8 in cortisol levels, indicative of stress response, as measured by saliva collection (ELISA).(Day 56)
- Change from baseline to week 8 in physical/sedentary behavior as measured by a phone accelerometer and assessed by the mindLAMP app(Day -7 to Day 56)
- Change from baseline to week 8 in roaming/movement behavior as measured by a phone GPS and assessed by the mindLAMP app(Day -7 to Day 56)
- Correlation between latent inhibition score and cognitive change from baseline to weeks 4 and 8 as measured by CANTAB SWM.(Day 28 and Day 56)
- Correlation between latent inhibition score and cognitive change from baseline to weeks 4 and 8 as measured by CANTAB RVP.(Day 28 and Day 56)
- Correlation between the polygenic risk score (as measured by plasma isolated-DNA samples) and PennCNB score change at week 8.(Day 56)
- Correlation between the polygenic risk score (as measured by plasma isolated-DNA samples) and PYSCHS-CT score change at week 8.(Day 56)
- Correlation between the polygenic risk score (as measured by plasma isolated-DNA samples) and NSI-PR score change at week 8.(Day 56)