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：Base IDIQ 合同的第二个管理任务将包括支持合同启动和管理所需的工作，包括制定协议草案、与 NIH 和 FAST-MAS 工作的其他组成部分的沟通以及会议记录的准备、季度和最终任务订单报告，以及报告要求/可交付成果附件中列出的所有其他报告和可交付成果。 研究 1 描述：该计划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，用于治疗与传统情绪和精神障碍相关的精神病理学临床维度（例如快感缺乏、认知功能、社会参与）。焦虑谱系障碍。该项目的总体目标是化合物治疗后的受体效应。该研究应是一项健康志愿者接受该化合物治疗两周的研究。应评估受体占用率。探索性目标包括评估奖励回路的参与和评估快感缺乏。 研究 2 描述：该计划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，用于治疗与传统情绪和情绪相关的精神病理学临床维度（例如快感缺乏、认知功能、社会参与）。焦虑谱系障碍。该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。本研究是一项针对快感缺失受试者的随机、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。