NCT00479726已完成4 期
Lilly's Emotional and Physical Symptoms of Depression Study
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- Clinical Global Impression of Severity
研究概览
简要总结
To assess the effectiveness of duloxetine administered once daily in patients with Major Depressive Disorder in a practice based setting
详细描述
To assess physical and emotional symptoms of depressed patients
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
- •Meet criteria for major depressive disorder according to the DSM-IV diagnostic criteria
- •Outpatients at least 18 years of age
- •Sign the informed consent
- •All females must test negative for a urine pregnancy test at visit
- •Females of child bearing potential must agree to utilize medically acceptable and reliable means of birth control
- •Have a level of understanding sufficient to communicate with the investigator and are able to complete all patient self-rated scales in the study
排除标准
- •Are investigator site personnel directly affiliated with the study or immediate family
- •Are employed by Eli Lilly and Company
- •Have received treatment within the last 30 days or are currently enrolled in a study with a drug that has not received regulatory approval for any indication at time of study entry
- •Current substance dependence, excluding nicotine and caffeine
- •Treatment with a monoamine oxidase inhibitor within 14 days prior to visit 1 or potential need to use an MAOI within 5 days after discontinuation of study drug
- •Acute liver injury or severe (Child-Pugh Class C) cirrhosis
结局指标
主要结局
Clinical Global Impression of Severity
Somatic Symptom Inventory
Depressive Symptomatology-Self Report
次要结局
- Patient Global Impression of Improvement
- Mood and Physical Symptoms in Depression
- Quality of Life Enjoyment Satisfaction Questionnaire-Short form
研究者
研究点 (1)
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