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

新的实验医学研究：情绪和焦虑的快速失败试验

• 批准号: 9004318
• 负责人: ANDREW KRYSTAL
• 金额: $ 1.5万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-29 至 2015-06-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9004318
• 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; Medicine; 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 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; anxiety spectrum disorders; cognitive function; cohort; design; drug development; drug metabolism; healthy volunteer; innovation; interest; novel; phase 1 study; phase 2 study; phase I trial; 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）和它们用于治疗精神病理学临床方面的分子和/或临床靶点（例如，快感缺乏、认知功能、社会参与）与传统的情绪和焦虑谱系障碍相关。特别令人感兴趣的是如在当前DSM-IV-TR诊断实体中描述的情绪和焦虑谱系障碍的特征，但通常未被鉴定为当前临床治疗的主要靶标。如上所述，人们对研究跨越传统疾病类别的机制感兴趣，并且直接评估相关机制和临床靶点，而不是通过指定特定诊断来推断。 NIMH对评估临床机制和证明靶点参与的研究和临床试验非常感兴趣。这一举措的结果，预计将导致这种新的干预措施的具体目标的参与，导致创新的治疗方法的发展与传统的情绪和焦虑谱系障碍相关的精神病理学的临床层面的认识。在这种情况下，新的干预措施（即，化合物）可以指新的化学实体（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学机制，并且以前未在临床研究中进行过测试，则对FDA批准用于其他适应症（重新用途）的化合物进行测试是有意义的。本合同对作用于分子靶点的化合物不感兴趣，这些分子靶点与目前市售的精神科药物的分子靶点相似。