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临床试验/NCT00295347
NCT00295347已完成不适用

Mineralocorticoid Receptor in the Treatment of Severe Depression: A Randomized, Double Blind, and Placebo Controlled Trial

Universitätsklinikum Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2005年12月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
2

研究概览

简要总结

The proposed research aims to compare the onset of action and the efficacy of fludrocortisone, a mineralocorticoid receptor agonist vs. spironolactone, a mineralocorticoid antagonist, vs. placebo as augmentation to a selective serotonin reuptake inhibitor (SSRI) in 65 inpatients with severe depression. The study will also explore the utility of the hypothalamic-pituitary-adrenal (HPA) axis in predicting treatment response. The study will be a 5-week randomized and double-blind trial of fludrocortisone vs. spironolactone vs. placebo during three years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Depressed male and female inpatients according to DSM-IV
  • Age between 18 and 70 years
  • Minimum of 17-items Hamilton Depression Score of 18
  • Informed consent signed

排除标准

  • Relevant medical or neurological disorders
  • Pregnancy or unsure contraception
  • Relevant psychiatric comorbidity
  • Active alcohol or other substance abuse/dependance
  • Contraindications to SSRI, fludrocortisone, or spironolactone
  • Steroid medication

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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