JPRN-jRCT1080220706未知4 期
A postmarketing clinical study of milnacipran hydrochloride (MIL001) for the treatment of depression. -a double-blind parallel-group design, using a comparator of paroxetine hydrochloride hydrate
ASAHI KASEI PHARMA CORPORATIO0 个研究点目标入组 705 人开始时间: 2009年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 705
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 64age old（—）
- 性别
- All
入选标准
- •Aged between 20 and 64 years at the time of giving consent.
- •A HAM-D17 total score of 18 and a score of 2 on the HAM-D item 1 Depressed mood at the time of giving consent and at the time of completing the run-in period.
- •A <25% decrease in the HAM-D17 total score during the run-in period.
- •Have had symptoms of depression for at least one month (30 days) and less than 12 months prior to giving written informed consent.
排除标准
- •Patients who meet the following criteria during the relevant episode of depression:
- •1) Having received therapy with milnacipran hydrochloride or paroxetine hydrochloride hydrate for the relevant episode.
- •2) Not responded to therapies with two or more antidepressant drugs for the relevant episode.
- •3) Marked suicidal tendency (with 4 points according to HAM-D Score Item 3 Suicide)
研究者
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