NCT00191594已完成3 期
Open-Label Duloxetine Extension Phase in Patients Who Have Completed the HMDG Clinical Trial
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 6
- 主要终点
- Adverse events
研究概览
简要总结
A study in patients with depression
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female patients at least 18 years of age who have previously completed satisfactorily the Lilly sponsored previous clinical trial, and who are clinically controlled with Duloxetine, as judge by the investigator
- •All females must test negative for a urine pregnancy test at Visit
- •Females of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopausal) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study. Women who are pregnant or breast-feeding may not participate in the study.
- •Must sign the informed consent document (ICD).
排除标准
- •Have received treatment within the last 30 days with a drug ( not including study drug) that has not received regulatory approval for any indication at the time of study entry.
- •Patients who have entered the optional tapering period of the previous study.
- •In the opinion of the investigator, patients judged to be at serious suicidal risk.
- •Treatment with a MAOI within 14 days prior to Visit 1 or potential need to use MAOI during the study or within 5 days of discontinuation of the study drug.
- •Any patient who previously experienced a serious adverse event while taking duloxetine unless approved by the Lilly Physician
结局指标
主要结局
Adverse events
次要结局
- Vital signs
研究者
研究点 (6)
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