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

这一倡议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，然后在人体上测试已确定的干预措施(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校内研究计划)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技术代表(有时也称为政府项目官员)的批准后开始。 如果根据本合同或在实地确定的任何化合物/干预措施被证明是有希望的，政府可以选择用该化合物/干预措施进行更大规模的疗效试验，而不是进行其他较小的概念验证试验(见任务4和5)。 以下列出的每个任务区域内的所有工作将由合同中更详细列出的任务订单程序控制。这些程序要求NIMH发出任务订单请求、承包商�S对请求的回应/建议(包括技术方法和预算)，以及NIMH开始任务订单的最终批准。在任务单获得批准之前，不得产生或报销费用。核准的总费用是一个上限，未经进一步授权不得超过。 本合同的重点和目标是确定和测试最有希望的治疗难治性抑郁症的干预措施(无论是药理学的还是非药理学的)。

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).