MGT SVCS/CONTRACT & PROCUREMENT SUP - New Experimental Medicine Studies: Fast-Fail Trials in Mood and Anxiety

MGT SVCS/合同

• 批准号: 8919169
• 负责人: ANDREW D KRYSTAL
• 金额: $ 42.67万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-29 至 2015-06-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8919169
• 关键词: Aftercare; Anhedonia; Anxiety; Certificate of Confidentiality; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Communication; Communities; Contracts; Controlled Clinical Trials; Development; Dimensions; Disease; Enrollment; Future; Goals; Information Systems; Informed Consent; Institutional Review Boards; Intervention; Manuscripts; Medicine; Molecular; Moods; National Institute of Mental Health; Patients; Placebo Control; Preparation; Protocols documentation; Psychopathology; Publications; Randomized; Registries; Reporting; Research Infrastructure; Schedule; Site; Support Contracts; Teleconferences; Testing; Training; United States National Institutes of Health; United States National Library of Medicine; Writing; base; cognitive function; healthy volunteer; hedonic; novel; protocol development; receptor; response; reward circuitry; social

Administrative Task Description: The Second Administrative Task for the Base IDIQ contract will consist of the effort needed to support contract start-up and management, including developing draft protocols, communication with NIH and other components of the FAST-MAS 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: This initiative seeks to expeditiously test and analyze a novel intervention (i.e., compound) and its molecular and/or clinical targets for treating clinical dimensions of psychopathology (e.g., anhedonia, cognitive function, social engagement) associated with traditional mood and anxiety spectrum disorders. The overall goal of this project is to receptor effects after treatment with the compound. The study shall be a study healthy volunteers receiving 2 weeks treatment with the compound. Receptor occupancy shall be assessed. Exploratory aims include assessment of the engagement of reward circuitry and assessment of anhedonia. Study 2 Description: 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 mood and anxiety spectrum disorders. The overall goal of this project shall be to determine whether a specific receptor has utility as a treatment for patients with mood and anxiety spectrum disorders. This study is a randomized, placebo-controlled clinical trial in subjects with anhedonia. The primary aim is to evaluate if receptor antagonist engages neurocircuits related to the hedonic response.

管理任务描述：基础IDIQ合同的第二项管理任务将包括支持合同启动和管理所需的工作，包括制定方案草案、与NIH和FAST-MAS工作的其他组成部分进行沟通，以及编写会议记录、季度报告和最终任务订单报告，以及报告要求/附件中列出的所有其他报告和可交付成果。 研究1描述：该倡议旨在迅速测试和分析一种新的干预措施（即，化合物）及其用于治疗精神病理学临床方面的分子和/或临床靶点（例如，快感缺乏、认知功能、社会参与）与传统的情绪和焦虑谱系障碍相关。该项目的总体目标是研究化合物治疗后的受体效应。本研究应为接受2周化合物治疗的健康志愿者。应评估受体占用率。探索性的目的包括奖励回路的参与评估和快感缺乏的评估。 研究2描述：该倡议旨在迅速测试和分析一种新的干预措施（即，化合物）和它们用于治疗精神病理学临床方面的分子和/或临床靶点（例如，快感缺乏、认知功能、社会参与）与传统的情绪和焦虑谱系障碍相关。本项目的总体目标是确定特定受体是否可用于治疗情绪和焦虑谱系障碍患者。本研究是一项在快感缺失受试者中进行的随机、安慰剂对照临床试验。主要目的是评估受体拮抗剂是否参与与享乐反应相关的神经回路。