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临床试验/NCT00693680
NCT00693680已完成不适用

The Role of Zinc in Therapy of Unipolar Depression

Polish Academy of Sciences2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2005年1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
60
试验地点
2
主要终点
To compare the effect of zinc vs placebo in imipramine treated depressed patients (CGI, BDI, HADRS, MADRS)

研究概览

简要总结

Examination of the effect of zinc supplementation on imipramine therapy in major depression.

详细描述

A placebo-controlled, double blind study of zinc supplementation in imipramine therapy was conducted in sixty, depressed patients fulfilling the DSM-IV criteria for major depression without psychotic symptoms. After a one week washout period, patients were randomized into two groups treated with imipramine and receiving once daily either placebo (n=30) or zinc supplementation (n=30) for 12 weeks.

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 (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • patients with fulfilled DSM-IV criteria for moderate or severe depressive episode
  • one week washout period without any pharmacotherapy

排除标准

  • psychotic symptoms

结局指标

主要结局

To compare the effect of zinc vs placebo in imipramine treated depressed patients (CGI, BDI, HADRS, MADRS)

时间窗: 12 weeks

次要结局

  • To assess unwanted side effects in both groups(12 weeks)

研究者

申办方类型
Other

研究点 (2)

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