IGF::OT::IGF FAST-PS THIRD ADMINISTRATIVE TASK - New Experimental Medicine Studies: Fast-Fail Trials in Psychotic Spectrum Disorders (FAST-PS)

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Administrative Task Description: The effort needed to support contract start-up and management, including developing draft protocols, communication with NIH and other components of the FAST-PS effort, and preparation of Minutes, Quarterly, and Final Task Order Reports, and all other reports and deliverables listed in the Reporting Requirements/Deliverables attachment. Study 1 Description/abstract: This initiative seeks to expeditiously test and analyze a novel intervention (i.e., compound) and their molecular and/or clinical targets for treating clinical dimensions of psychopathology (e.g., anhedonia, cognitive function, social engagement) associated with traditional psychotic spectrum disorders. The overall goal of this project shall be to evaluate the ability of an agonist to reverse alterations in healthy humans. These modalities could provide information regarding the degree of target engagement association with the agent. If the agent significantly reverses effects on measurements, it would suggest availability of a predictive physiological marker to assess target engagement of novel compounds targeting the receptor and help facilitate future agent related clinical development. The study will be an initial 1st Phase Pilot Feasibility study/clinical trial to validate the feasibility, reliability, and comparability of the protocol and proposed biomarker measure tools to be used in a potential 2nd Phase POCM clinical trial