New Experimental Medicine Studies: Fast-Fail Trials in Psychotic Spectrum

管理任务说明： 支持合同启动和管理所需的努力，包括制定协议草案，与NIH和FAST-PS工作的其他组成部分进行沟通，编制会议纪要、季度和最终任务单报告，以及报告要求/交付件附件中列出的所有其他报告和交付成果。 研究1说明/摘要： 这一举措旨在迅速测试和分析一种新的干预措施(即化合物)及其分子和/或临床目标，以治疗与传统精神病谱系障碍相关的精神病理学的临床层面(例如，快感丧失、认知功能、社交参与)。该项目的总体目标应该是评估激动剂逆转健康人类变化的能力。这些模式可以提供有关目标参与程度与代理关联的信息。如果该试剂显著逆转了对测量的影响，它将表明有一种预测性生理标志物的可用性，以评估针对受体的新化合物的靶向参与，并有助于促进未来与该试剂相关的临床开发。这项研究将是初步的第一阶段先导性可行性研究/临床试验，以验证该方案和建议的生物标记物测量工具的可行性、可靠性和可比性，这些工具将用于潜在的POCM临床试验。

Administrative Task Description: The effort needed to support contract start-up and management, including developing draft protocols, communication with NIH and other components of the FAST-PS effort, and preparation of Minutes, Quarterly, and Final Task Order Reports, and all other reports and deliverables listed in the Reporting Requirements/Deliverables attachment. Study 1 Description/abstract: This initiative seeks to expeditiously test and analyze a novel intervention (i.e., compound) and their molecular and/or clinical targets for treating clinical dimensions of psychopathology (e.g., anhedonia, cognitive function, social engagement) associated with traditional psychotic spectrum disorders. The overall goal of this project shall be to evaluate the ability of an agonist to reverse alterations in healthy humans. These modalities could provide information regarding the degree of target engagement association with the agent. If the agent significantly reverses effects on measurements, it would suggest availability of a predictive physiological marker to assess target engagement of novel compounds targeting the receptor and help facilitate future agent related clinical development. The study will be an initial 1st Phase Pilot Feasibility study/clinical trial to validate the feasibility, reliability, and comparability of the protocol and proposed biomarker measure tools to be used in a potential 2nd Phase POCM clinical trial.