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

基本信息

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
项目类别：
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

项目摘要

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.

该计划旨在迅速测试和分析新的干预措施（即化合物）及其分子和/或临床靶标，用于治疗与传统情绪和焦虑症障碍相关的精神病理学临床维度（例如，ANHEDONIA，认知功能，社会参与）。特别感兴趣的是当前DSM-IV-TR诊断实体中所述的情绪和焦虑谱障碍的特征，但通常不能被鉴定为当前临床疗法的主要靶标。如上所述，人们对跨传统疾病类别的机制以及相关机制和临床靶标的进行了直接评估，而不是通过分配特定诊断来推断。 NIMH对评估临床机制并证明目标参与的研究和临床试验非常感兴趣。预计该倡议的结果将通过这种新颖的干预措施增强对特定目标参与的了解，从而开发与传统情绪和焦虑症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，新颖的干预措施（即化合物）可能是指新化学实体（NCE）或正在考虑从其他指示重新使用的化合物。如果最近的基础研究发现表明该化合物有可能影响导致精神疾病的生物学机制，并且以前在临床研究中未经测试的化合物，则对已FDA批准的化合物进行了其他指征（重新修复）的测试（重新进行了）的测试是有趣的。该合同对复制当前销售精神病药物的分子靶标的作用的化合物对本合同不感兴趣。