New Experimental Medicine Studies: Fast-Fail Trials in Mood and Anxiety

该计划旨在快速测试和分析新的干预措施（即化合物）及其分子和/或临床靶点，以治疗与传统情绪和焦虑谱系障碍相关的精神病理学的临床维度（如快感缺乏、认知功能、社会参与）。特别令人感兴趣的是当前DSM-IV-TR诊断实体中描述的情绪和焦虑谱系障碍的特征，但通常未被确定为当前临床治疗的主要目标。如上所述，人们对跨越传统障碍类别的机制研究很感兴趣，并且直接评估相关机制和临床靶点，而不是通过特定诊断的分配来推断。

This initiative seeks to expeditiously test and analyze novel interventions (i.e., compounds) and their molecular and/or clinical targets for treating clinical dimensions of psychopathology (e.g., anhedonia, cognitive function, social engagement) associated with traditional mood and anxiety spectrum disorders. Of particular interest are features of mood and anxiety spectrum disorders as described in the current DSM-IV-TR diagnostic entities, but not typically identified as the primary target of current clinical therapeutics. As described above, there is interest in the study of mechanisms that cut across traditional disorder categories and where relevant mechanisms and clinical targets are assessed directly rather than being inferred through assignment of a particular diagnosis. The NIMH has great interest in studies and clinical trials assessing clinical mechanism and demonstrating target engagement. The outcome of this initiative is expected to lead to enhanced understanding of specific target engagement by such novel interventions, leading to development of innovative treatment approaches for clinical dimensions of psychopathology associated with traditional mood and anxiety spectrum disorders. In this context, novel interventions (i.e., compounds) may refer either to new chemical entities (NCEs) or to compounds that are being considered for re-purposing from other indications. Testing of compounds that have been FDA-approved for other indications (re-purposing) is of interest if recent basic research discoveries suggest that the compound(s) have the potential to affect a biological mechanism contributing to mental disorders and that has previously been untested in clinical studies. Compounds acting on molecular targets that replicate those of currently marketed psychiatric pharmaceuticals are not of interest for this contract.