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

这一举措旨在迅速测试和分析新的干预措施(即化合物)及其分子和/或临床目标，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层面(例如，快感缺乏、认知功能、社交参与)。特别令人感兴趣的是情绪和焦虑谱性障碍的特征，如目前的DSM-IV-TR诊断实体中所描述的，但通常不被确定为当前临床治疗的主要目标。如上所述，人们有兴趣研究跨越传统障碍类别的机制，其中相关机制和临床目标是直接评估的，而不是通过分配特定诊断来推断的。 NIMH对评估临床机制和展示靶点参与的研究和临床试验非常感兴趣。这一倡议的结果预计将通过这种新的干预措施加强对特定目标参与的理解，从而为与传统情绪和焦虑谱系障碍相关的精神病理学的临床层面开发创新的治疗方法。在这方面，新的干预措施(即化合物)可以是指新的化学实体(NCEs)，也可以是指正在考虑从其他适应症重新利用的化合物。如果最近的基础研究发现表明化合物(S)有可能影响导致精神障碍的生物机制，并且以前没有在临床研究中进行测试，那么对已被FDA批准用于其他适应症(重新用途)的化合物的测试是有意义的。作用于分子靶点的化合物复制了目前市场上销售的精神药物的分子靶点，对本合同不感兴趣。

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.