NCT00693680已完成不适用
The Role of Zinc in Therapy of Unipolar Depression
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
1
Active Comparator
zinc + imipramine
干预措施: Zincas Forte (Dietary Supplement)
2
Placebo Comparator
placebo + imipramine
干预措施: Placebo (Dietary Supplement)
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
研究点 (1)
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