RAPIDLY-ACTING TREATMENTS FOR TREATMENT-RESISTANT DEPRESSION (RAPID)

任务领域-第1阶段（启动/准备）活动包括建立基础设施，包括分包商绩效站点，开发和最终确定协议，设计数据库，计算机系统和数据管理计划，提交和响应数据安全和监测委员会，最终确定与第三方供应商和FDA的互动，并获得所需的访问和批准文件。第2阶段：进行概念验证临床试验活动包括：开始招募并进行概念验证（药物或非药物）试验，根据批准的最终方案管理和协调所有临床试验，进行临床监测，中期和最终数据分析，准备研究草案和最终报告。以下是RAPID合同的方法和主要目标的描述。这项不确定交付不确定数量（IDIQ）合同倡议所需的一般方法将是首先建立一个小型临床试验团队，然后在充分支持的人体概念验证试验中测试确定的干预措施（药理学和/或非药理学）。在团队成员（包括NIMH内部研究项目）确定有希望的干预措施，并得到RAPID指导委员会和NIMH合同官员代表（COR）（以前称为政府项目官员）的批准后，将启动试验。该合同的主要目标是：“建立一个小型临床试验团队来研究“抑郁症的快速作用治疗”（即“RAPID-team”），该团队将专注于识别和测试有希望的干预措施（药物和/或非药物），这些干预措施在初始给药72小时内产生实质性的抗抑郁效果。在一组被诊断为难治性抑郁症的成年受试者（18-60岁）中进行随机临床试验，测试这些有希望的干预措施（除了盐酸氯胺酮或睡眠剥夺（全部或部分））。

Task Area - Phase 1 (Start-up/Preparation) activities include establishing the infrastructure including subcontractor performance sites, developing and finalizing the protocol, designing the database, computer system, and data management plans, submitting and responding to the Data Safety and Monitoring Board, and finalizing interaction with the 3rd party suppliers and the FDA and obtain documentation of access and approvals as required. Task area 2 � Phase 2: Conduct Proof of Concept Clinical Trials activities include: beginning recruitment and conducting Proof of Concept (either drug or non-drug) trials, managing and coordinating all clinical trials according to the approved finalized protocols, performing clinical monitoring, interim and final data analysis, and preparing of draft and final reports on the study. The description of the approach and primary objectives of the RAPID Contract follows. The general approach required for this Indefinite Delivery Indefinite Quantity (IDIQ) Contract initiative will be to first establish a small team of clinical trial sites and subsequently to test identified interventions (pharmacologic and/or non-pharmacologic) in adequately powered Proof of Concept trials in humans. Trials will be initiated after promising interventions are identified by members of the team (including the NIMH Intramural Research Program), and approved by the RAPID steering committee and the NIMH Contracting Officer�s Representative (COR) (previously referred to as the Government Program Officer). The primary objectives of this contract are: � To establish a small team of clinical trials sites to study �Rapidly-Acting Treatments for Depression� (i.e., the �RAPID-team�) that will focus on identifying and testing promising interventions (pharmacologic and/or non-pharmacological) that produce a substantial anti-depressant effect within 72 hours of initial administration. � To perform randomized clinical trials testing such promising interventions (other than Ketamine Hydrochloride or sleep deprivation (total or partial)) in a well-characterized cohort of adult subjects (age 18-60) diagnosed with treatment-resistant depression.