跳至主要内容
临床试验/NCT00825799
NCT00825799已完成不适用

Validation of Serum Markers as a Bioassay for Unipolar Depression

Steward St. Elizabeth's Medical Center of Boston, Inc.1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2007年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
Protein biomarker MDDScore.

研究概览

简要总结

The goal of the study is to validate a biomarker assay for unipolar depression based on serum proteins involved in inflammation, metabolism, and stress response. The study will compare patients with a current major depressive episode to individuals with no history of depression. The hypothesis is that the assay can serve as a diagnostic tool that would be more objective than standard diagnostic questionnaires.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Meets DSM-IV criteria for Bipolar Disorder, Schizophrenia, Schizoaffective disorder or other major Axis I Psychiatric disorders (except for depression and phobia per above).
  • Addison's Disease, Cushing's Disease, or other known dysfunction of the HPA-cortisol axis.
  • Rheumatoid arthritis, lupus, or other condition associated with increased inflammation.
  • Regular use of non-steroidal anti-inflammatory medications, steroids, or other medications know to interact with the inflammatory process of the HPA axis.
  • A medical condition or regular use of a mediation, which I the opinion of the investigator is likely to influence the inflammatory or HPA responses.
  • Pregnancy.
  • Meets DSM-IV criteria for substance abuse or dependence in the last month.
  • Regular cigarette smoking.
  • History of fainting or other significant adverse event during blood drawing in the past.

结局指标

主要结局

Protein biomarker MDDScore.

时间窗: 0 weeks

次要结局

  • Score on Hamilton Depression Rating Scale (HDRS).(0 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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