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

治疗难治性抑郁症的新型速效疗法 (RAPID)

• 批准号: 8562506
• 金额: $ 401.76万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-03-21 至 2017-12-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8562506
• 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

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。