FAST-MAS HHSN271201200006I (Duke University)- 2nd Admin Task

FAST-MAS HHSN271201200006I（杜克大学）- 第二个管理任务

• 批准号: 8759374
• 负责人: ROSE HOOD
• 金额: $ 8.98万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-24 至 2014-09-23
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8759374
• 关键词: Address; Adverse effects; Affect; Anhedonia; Anxiety; Basic Science; Benefits and Risks; Biological; Biological Markers; Biological Phenomena; Brain; Categories; Chemicals; Clinical; Clinical Research; Clinical Trials; Consensus; Contracts; DSM-IV; Data; Development; Diagnosis; Diagnostic; Dimensions; Disease; Dose; Drug Kinetics; Drug usage; Effectiveness; Electrophysiology (science); Emotional; Evaluation; FDA approved; Functional Magnetic Resonance Imaging; Geographic state; Government; Human; Intervention; Investigational Drugs; Judgment; Lead; Marketing; Mental disorders; Metabolic; Metabolism; Molecular; Molecular Analysis; Molecular Target; Monitor; Moods; National Institute of Mental Health; Neurocognitive; Outcome; Participant; Patients; Performance; Pharmaceutical Preparations; Pharmacologic Actions; Pharmacologic Substance; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Phase IV Clinical Trials; Positron-Emission Tomography; Process; Psychopathology; Research; Research Design; Risk; Safety; Site; Structure-Activity Relationship; System; Testing; Therapeutic; United States Food and Drug Administration; Universities; cognitive function; cohort; design; drug development; drug metabolism; healthy volunteer; innovation; interest; novel; phase 1 study; phase 2 study; pre-clinical; receptor; response; social; tool

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.

该倡议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临床维度（例如快感缺乏、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，但通常不被确定为当前临床治疗的主要目标。如上所述，人们对跨越传统疾病类别的机制的研究很感兴趣，并且直接评估相关机制和临床目标，而不是通过特定诊断的分配来推断。 NIMH 对评估临床机制和证明目标参与的研究和临床试验非常感兴趣。该举措的结果预计将通过此类新颖的干预措施增强对特定目标参与的理解，从而开发出与传统情绪和焦虑谱系障碍相关的精神病理学临床维度的创新治疗方法。在这种情况下，新的干预措施（即化合物）可能指新的化学实体（NCE）或正在考虑从其他适应症中重新利用的化合物。如果最近的基础研究发现表明化合物有可能影响导致精神障碍的生物机制并且之前未经临床研究测试，那么对已获得 FDA 批准用于其他适应症（重新利用）的化合物进行测试是有意义的。作用于复制当前市售精神科药物的分子靶点的化合物不在本合同范围内。