IGF::OT::IGF Double-Blind, Placebo-Controlled, Proof-of-Concept (POC) Trial of LY

IGF::OT::IGF 双盲、安慰剂对照、概念验证 (POC) LY 试验

• 批准号: 8759327
• 负责人: X X
• 金额: $ 323.66万
• 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 2015-05-11
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8759327
• 关键词: Adult; Age; Area; Authorization documentation; Budgets; Clinical; Clinical Trials; Contractor; Contracts; Development; Diagnosis; Double-Blind Method; Government; Government Programs; Hour; Human; Intervention; Intramural Research Program; Ketamine Hydrochloride; Mental Depression; National Institute of Mental Health; Placebo Control; Procedures; Randomized Clinical Trials; Resistance; Site; Sleep Deprivation; Testing; cohort; cost; efficacy trial; member; response

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临床试验中心团队，然后在充分把握度的人类概念验证试验中测试已确定的干预措施（药理学和/或非药理学）。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后启动，并由RAPID指导委员会和NIMH合同官员的技术代表（COTR）（有时也称为政府项目官员）批准。 如果根据本合同或在该领域确定的任何化合物/干预措施被证明是有前途的，政府可以选择使用该化合物/干预措施进行更大规模的疗效试验，以代替其他较小的概念验证试验（见任务4和5）。 下文概述的每个任务领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发出任务订单请求，承包商对请求的响应/建议（包括技术方法和预算），以及NIMH对开始任务订单的最终批准。在任务订单获得批准之前，不得产生或报销费用。核定费用总额是一个上限，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（药物或非药物）。