NCT00384436已完成4 期
Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients
Forest Laboratories2 个研究点 分布在 1 个国家目标入组 580 人开始时间: 2006年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 580
- 试验地点
- 2
- 主要终点
- Time to premature discontinuation
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of escitalopram to an active comparator in severely depressed patients
详细描述
Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to evaluate the safety and efficacy of escitalopram and an active comparator in severely depressed patients.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet DSM-IV criteria for Major Depressive Disorder.
- •Patients must have severe depression.
- •MADRS greater than or equal to 30
排除标准
- •Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
- •Patients who are considered a suicide risk.
- •Patients who currently meet DSM-IV criteria for: a principal diagnosis for Axis I disorder other than MDD (comorbid GAD is allowed), bipolar disorder, schizophrenia or any psychotic disorder, obsessive-compulsive disorder, dysthymia.
- •Patients with a family history of bipolar disorder, schizophrenia, or any psychotic disorder.
- •Patients with history of any psychotic disorder or any psychotic feature.
结局指标
主要结局
Time to premature discontinuation
次要结局
- Montgomery Asberg Depression Rating Scale (MADRS)
研究者
研究点 (2)
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