MGT SVCS/CONTRACT & PROCUREMENT SUP

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Administrative Task Administrative Task Description: of the Base IDIQ contract will consist of the effort needed to support contract start-up and management, including developing draft protocols, communication with NIH and other components of the RAPID effort, and preparation of Minutes, Quarterly Administrative Task Reports, the Final Administrative Task Report, and all other required reports and deliverables listed in the Reporting Requirements/Deliverables attachment. Study 1 Abstract: The focus of the RAPID initiative is to leverage the development of rapidly-acting treatments (demonstrable clinical improvement within 72 hours of initial administration) for subjects with treatment-resistant depression (TRD). This Study Task Order shall evaluate the kappa opioid receptor antagonist LY2456302 as a rapidly-acting antidepressant treatment in patients with TRD, when added to ongoing, stable, and adequate antidepressant therapy. The clinical trial is a randomized, placebo-controlled study in 90 subjects with TRD, testing two (2) doses (10 mg/day and 20 mg/day) of oral LY2456302, using a sequential parallel comparison design. Study 2 Abstract: The focus of the RAPID initiative is to leverage the development of rapidly-acting treatments (demonstrable clinical improvement within 72 hours of initial administration) for subjects with treatment-resistant depression (TRD). The study shall be a double-blind, placebo-controlled study of the acute efficacy of ketamine for the treatment of adults with treatment-resistant depression. The primary objective will be to demonstrate that multiple doses of i.v. ketamine are superior to placebo therapy in the acute treatment of patients with TRD, and to evaluate the dose-response range of the antidepressant effect of ketamine in humans. The study is a randomized, placebo-controlled, study in 100 subjects with TRD, using an active placebo (i.e., midazolam).