New, Rapidly-Acting Treatments for Treatment-Resistant Depression (RAPID)

任务区-第一阶段(启动/准备)活动包括建立基础设施，包括分包商履约现场，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，提交并回应数据安全和监测委员会，完成与第三方供应商和FDA的互动，并根据需要获取访问和批准的文件。 任务领域2？阶段2：进行概念验证临床试验活动包括：开始招募和进行概念验证(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，以及准备研究报告草稿和最终报告。 以下是对快速合同的方法和主要目标的说明。 这项不确定交付不确定数量(IDIQ)合同计划所需的一般方法将是首先建立一个临床试验地点的小团队，然后在人体上测试确定的干预措施(药理学和/或非药理学)，进行足够强大的概念验证试验。试验将在团队成员(包括NIMH内科研究计划)确定有希望的干预措施并得到快速指导委员会和NIMH合同官员S代表(以前称为政府项目官员)的批准后开始。 本合同的主要目标是： 建立一个小型的临床试验站点团队，研究抑郁症的快速起效疗法(即快速团队)，重点是确定和测试有希望的干预措施(药理学和/或非药理学)，这些干预措施在首次给药72小时内产生实质性的抗抑郁效果。 进行随机临床试验，测试这些有希望的干预措施(盐酸氯胺酮或睡眠剥夺(完全或部分)除外)在一组特征良好的成年受试者(年龄18-60岁)中被诊断为难治性抑郁症。

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.