MGT SVCS/CONTRACT & PROCUREMENT SUP

MGT SVCS/合同

• 批准号: 8738841
• 负责人: X X
• 金额: $ 634.73万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-15 至 2014-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8738841
• 关键词: Acute; Adult; Antidepressive Agents; Certificate of Confidentiality; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Communication; Communities; Contracts; Development; Dose; Double-Blind Method; Enrollment; Future; Hour; Human; Information Systems; Informed Consent; Institutional Review Boards; Ketamine; Manuscripts; Mental Depression; Midazolam; National Institute of Mental Health; Oral; Patients; Placebos; Preparation; Protocols documentation; Publications; Registries; Reporting; Research Infrastructure; Resistance; Schedule; Site; Support Contracts; Teleconferences; Testing; Training; United States National Institutes of Health; United States National Library of Medicine; Writing; abstracting; base; design; kappa opioid receptors; placebo controlled study; protocol development; randomized placebo controlled trial; response

Administrative Task Administrative Task Description: of 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 RAPID effort, and preparation of Minutes, Quarterly Administrative Task Reports, the Final Administrative Task Report, and all other required reports and deliverables listed in the Reporting Requirements/Deliverables attachment. Study 1 Abstract: The focus of the RAPID initiative is to leverage the development of rapidly-acting treatments (demonstrable clinical improvement within 72 hours of initial administration) for subjects with treatment-resistant depression (TRD). This Study Task Order shall evaluate the kappa opioid receptor antagonist LY2456302 as a rapidly-acting antidepressant treatment in patients with TRD, when added to ongoing, stable, and adequate antidepressant therapy. The clinical trial is a randomized, placebo-controlled study in 90 subjects with TRD, testing two (2) doses (10 mg/day and 20 mg/day) of oral LY2456302, using a sequential parallel comparison design. Study 2 Abstract: The focus of the RAPID initiative is to leverage the development of rapidly-acting treatments (demonstrable clinical improvement within 72 hours of initial administration) for subjects with treatment-resistant depression (TRD). The study shall be a double-blind, placebo-controlled study of the acute efficacy of ketamine for the treatment of adults with treatment-resistant depression. The primary objective will be to demonstrate that multiple doses of i.v. ketamine are superior to placebo therapy in the acute treatment of patients with TRD, and to evaluate the dose-response range of the antidepressant effect of ketamine in humans. The study is a randomized, placebo-controlled, study in 100 subjects with TRD, using an active placebo (i.e., midazolam).

管理任务 管理任务描述：基础IDIQ合同的内容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RAPID工作的其他组成部分进行沟通、准备会议记录、季度管理任务报告、最终管理任务报告以及报告要求/可提交文件附件中列出的所有其他所需报告和可交付成果。 研究1摘要： RAPID计划的重点是为难治性抑郁症（TRD）受试者开发速效治疗（首次给药后72小时内可证明临床改善）。本研究任务指令应评价κ阿片受体拮抗剂LY 2456302作为TRD患者的速效抗抑郁药治疗（添加至正在进行的、稳定和充分的抗抑郁药治疗中）。该临床试验是一项在90例TRD受试者中进行的随机化、安慰剂对照研究，采用序贯平行比较设计测试两种剂量（10 mg/天和20 mg/天）的口服LY 2456302。 研究2摘要： RAPID计划的重点是为难治性抑郁症（TRD）受试者开发速效治疗（首次给药后72小时内可证明临床改善）。本研究是一项双盲、安慰剂对照研究，旨在评价氯胺酮治疗成人难治性抑郁症的急性疗效。主要目的是证明氯胺酮多次静脉给药在TRD患者的急性治疗中上级安慰剂治疗，并评价氯胺酮在人体中抗抑郁作用的剂量-反应范围。该研究是一项随机、安慰剂对照研究，在100例TRD受试者中使用活性安慰剂（即，咪达唑仑）。