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Operations, Clinical Assessments and Adminstrative Core

Operations, Clinical Assessments and Adminstrative Core
运营、临床评估和管理核心
批准号:
8119602
负责人:
Helen S Mayberg
金额:
$91.91万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2010
资助国家:
美国
项目状态:
已结题
起止时间:
2010-07-01 至 2011-06-30

项目摘要

项目成果

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中文摘要
翻译
运营、临床评估和管理核心负责监督整个项目 负责进行临床试验并收集生物学和行为学数据 数据。根据对重度抑郁障碍(MDD)患者群体的研究,任何一个 当今临床实践中的心理治疗或药物治疗策略仅在 一小部分病人。因此,MDD患者最初接受的治疗很大程度上是 这是偶然的,而不是基于证据的选择。在5年的时间里,400人接受治疗 幼稚的MDD患者将被招募到随机分配的12周治疗试验中 使用SSRI、艾司匹兰、双重5-羟色胺/去甲肾上腺素再摄取抑制剂、度洛西汀或认知行为治疗 治疗(CBT)。受试者将使用最先进的临床评估方法进行评估 在急性治疗期结束前、期间和结束时。这一核心描述了将导致 患者的识别、招募以及治疗的评估和实施。一个 这项建议的独特部分是对未受 以前的治疗可能会混淆治疗反应的衡量标准。与之相称的 CIDAR目标,在此核心中生成的数据将为假设提供关键基础 在其他核心和项目中进行生成和测试。
英文摘要
The Operations, Clinical Assessment and Administrative Core oversees this entire project and is responsible for the conduct of the clinical trial and the collection of biological and behavioral data. Based on studies of groups of major depressive disorder (MDD) patients, any single psychotherapeutic or pharmacological strategy in clinical practice today achieves remission in only a minority of patients. Thus the initial treatment an individual with MDD receives is largely an accident of chance rather than an evidence based choice. Over a 5-year period, 400 treatment naive patients with MDD will be recruited into a 12 week treatment trial of randomly assigned treatment with an SSRI, escitalopram, a dual 5-HT/NE re-uptake inhibitor, duloxetine or cognitivebehavior therapy (CBT). Subjects will be evaluated using state-of-the-art clinical assessments prior to, during and at the end of acute treatment period. This core describes the efforts that will result in the identification, recruitment of the patients, and assessment and delivery of the treatments. A unique component of this proposal is the study of individuals with MDD not contaminated by previous treatments that may confound measures of treatment response. Commensurate with the CIDAR goals, the data generated in this core will provide the critical foundation for hypothesis generation and testing in the other cores and projects.
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