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

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

• 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 [Срок оценки: Day 56]
• Change from baseline to week 8 in attenuated positive symptoms as measured by PSYCHS-CT total score [Срок оценки: Day 56]
• Change from baseline to week 8 in negative symptoms as measured by the Negative Symptom Inventory - Psychosis Risk (NSI-PR) total score [Срок оценки: Day 56]

Вторичные конечные точки (12)

• Safety & tolerability as measured by number of treatment related adverse events [Срок оценки: Day 1 to Day 84]
• Safety & tolerability as measured by proportion of participants with treatment related adverse events [Срок оценки: Day 1 to Day 84]
• Change from baseline to week 4 in test of verbal memory (List learning task) as measured by PennCNB battery [Срок оценки: Day 28]
• Change from baseline to weeks 4 and 8 in overall composite score of cognitive performance as measured by PennCNB test battery [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Day 28 and Day 56]
• Change from baseline to weeks 4 and 8 in neurophysiology (EEG) as measured by mismatch negativity; auditory oddball P300. [Срок оценки: Day 28 and Day 56]
• Change from baseline to week 4 in attenuated positive symptoms, as measured by the PSYCHS-CT total score. [Срок оценки: Day 28]
• Change from baseline to week 4 in negative symptoms as measured by the NSI-PR total score. [Срок оценки: 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. [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: Day 28 and Day 56]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 15 центров

• University of California, Irvine — Irvine
• University of California — Los Angeles
• University of California, San Francisco — San Francisco
• Yale University Conneticut Mental Health Center — New Haven
• Beth Israel Deaconess Medical Center — Boston
• Washington University — St Louis
• Northwell Health — Glen Oaks
• Columbia University — New York
• … и ещё 7 центров

Идентификаторы

NCT: NCT07226895 · AMP SCZ MT1988 / SCZ201 · U01MH137298 · U24MH137171

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗