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

严重难治性抑郁症的速效治疗（RAPID）

• 批准号: 9261423
• 负责人: MAURIZIO FAVA
• 金额: $ 176.83万
• 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: 2013-09-12 至 2016-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9261423
• 关键词: Adult; Age; Area; Authorization documentation; Budgets; Clinical; Clinical Trials; Contractor; Contracts; Development; Diagnosis; Government; Government Programs; Hour; Human; Intervention; Intramural Research Program; Mental Depression; National Institute of Mental Health; Procedures; Randomized Clinical Trials; Site; Sleep Deprivation; Testing; antidepressant effect; cohort; cost; efficacy trial; member; response; treatment-resistant depression

The general approach required for this 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 Technical Representative (COTR) (sometimes also referred to as the Government Program Officer (GPO)). If any compound/intervention identified under this contract or in the field proves to be promising, the Government may choose to conduct a larger efficacy trial with that compound/intervention in lieu of other smaller Proof of Concept trials (see Tasks 4 and 5). All efforts within each task area outlined below will be controlled by task order procedures outlined in more detail in the contract. These procedures require the issuance of a task order request by NIMH, the Contractor�s response/proposal to a request (including a technical approach and budget), and final NIMH approval to begin the task order. Costs shall not be incurred or reimbursed until a task order has been approved. The approved total cost is a ceiling that cannot be exceeded without further authorization. The emphasis and objective in this contract is to identify and test the most promising interventions for treatment resistant depression (either pharmacologic or non-pharmacologic).

该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，然后在人类中有能力的概念试验验证证明中测试确定的干预措施（药理和/或非药物）。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签约官员技术代表（COTR）的批准（有时也称为政府计划官员（GPO））。 如果根据本合同或在该领域确定的任何复合/干预措施是有希望的，则政府可以选择使用该化合物/干预措施进行更大的效率试验，以代替其他较小的概念验证验证试验（请参阅任务4和5）。 下面概述的每个任务区域内的所有工作将由合同中更详细概述的任务订单程序控制。这些程序要求NIMH发布任务订单请求，承包商对请求的响应/建议（包括技术方法和预算）以及最终的NIMH批准，以开始任务订单。在批准任务命令之前，不得产生或偿还费用。批准的总成本是未经​​进一步授权就无法超过的上限。 本合同的重点和目标是确定和测试抗治疗抑郁症（药理学或非药物）的最有希望的干预措施。