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

难治性抑郁症的速效治疗（RAPID）

• 批准号: 8947343
• 负责人: MAURIZIO FAVA
• 金额: $ 10.94万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-15 至 2015-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8947343
• 关键词: Adult; Age; Area; Award; Certificate of Confidentiality; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Computer Systems; Consent Forms; Contractor; Contracts; Data Analyses; Depressed mood; Development; Diagnosis; Documentation; Enrollment; Frequencies; Government Programs; Hour; Human; Individual; Information Systems; Institutional Review Boards; Intervention; Intramural Research Program; Ketamine Hydrochloride; Magnetism; Mental Depression; Monitor; National Institute of Mental Health; Patients; Pharmaceutical Preparations; Phase; Preparation; Protocols documentation; Randomized Clinical Trials; Reporting; Research Infrastructure; Resistance; Site; Sleep Deprivation; Testing; Time; Training; cohort; data management; database design; member; non-drug; performance site; treatment-resistant depression

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.

任务领域 - 第1阶段（启动/准备）活动包括建立基础架构，包括分包商绩效站点，开发和完成协议，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委员会，并响应数据安全委员会，以及最终确定与第三方供应商以及FDA的互动，并获得FDA以及获得访问和批准的文档。任务领域2�第2阶段：进行概念临床试验的行为验证活动包括：开始招募和进行概念证明（药物或非药物试验）试验，根据批准的最终确定协议，进行临床监测，临时数据和最终数据分析，并在研究中进行临床监控，临时数据和最终报告，并根据批准的最终监控，临时监测，临时和最终数据进行管理和协调所有临床试验。快速合同的方法和主要对象的描述随之而来。这种不确定的无限量（IDIQ）合同计划所需的一般方法是首先建立一个小型的临床试验地点团队，然后在人类的概念试验验证验证验证验证验证验证验证验证验证验证验证验证验证验证验证验证。在团队的成员（包括NIMH壁内研究计划）确定有希望的干预措施后，将开始试验，并获得快速指导委员会和NIMH签约官员（COR）的批准（以前称为政府项目官员）。该合同的主要目标是：建立一个小组的临床试验站点团队来研究抑郁症的快速作用治疗方法（即快速团队），该治疗将着重于识别和测试承诺的干预措施（药理和/或非药理），这些干预措施（药理和/或非药理学）在初始给药的72小时内产生了实质性的抗抑郁效应。 �进行随机临床试验测试这种承诺的干预措施（盐酸氯胺酮或睡眠剥夺（总或部分）除外），以诊断为耐药抑郁症的成年受试者（18-60岁）的成年受试者（18-60岁）。