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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:
7645107
负责人:
Helen S Mayberg
金额:
$97.87万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2008
资助国家:
美国
项目状态:
已结题
起止时间:
2008-07-01 至 2011-06-30

项目摘要

项目成果

Helen S Mayberg的其他基金

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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, 负责临床试验的开展,收集生物学和行为学数据, 数据基于对重度抑郁症(MDD)患者群体的研究,任何单一的 目前临床实践中的心理治疗或药理学策略仅在 少数患者。因此,患有MDD的个体接受的初始治疗主要是 这是一个偶然的机会,而不是一个基于证据的选择。在5年的时间里, MDD初治患者将被招募到一个12周的治疗试验中, 使用SSRI、艾司西酞普兰、双重5-HT/NE再摄取抑制剂、度洛沙汀或认知行为治疗 治疗(CBT)。将使用最先进的临床评估对受试者进行评价, 至急性治疗期、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 这项建议的一个独特组成部分是对没有受到污染的MDD患者的研究。 可能混淆治疗反应测量的既往治疗。适应 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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