NCT00109044已完成3 期
Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder
Forest Laboratories35 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2005年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 540
- 试验地点
- 35
- 主要终点
- Montgomery Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
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 efficacy and safety of a fixed-dose escitalopram combination relative to its component monotherapies and to placebo in patients with major depressive disorder.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
- •The patient's current depressive episode must be at least 12 weeks in duration.
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 currently meet DSM-IV criteria for: a. bipolar disorder; b. schizophrenia or any psychotic disorder; c. obsessive-compulsive disorder; d. mental retardation or any pervasive developmental disorder or cognitive disorder.
- •Patients who are considered a suicide risk.
- •Patients with a history of seizure disorder, or any history of seizure, stroke, significant head injury, or any other condition that predisposes toward risk of seizure.
结局指标
主要结局
Montgomery Asberg Depression Rating Scale (MADRS)
次要结局
- Hamilton Depression Rating Scale (HAMD)
研究者
研究点 (35)
Loading locations...
相似试验
已完成
3 期
Study of Escitalopram in Adult Patients With Major Depressive DisorderMajor Depressive DisorderNCT00108979Forest Laboratories240
Unknown
3 期
Escitalopram Combination Comparison Study for Adult Patients With Major Depressive DisorderMajor Depressive DisorderNCT00239954Pharmacology Research Institute
已完成
4 期
Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed PatientsMajor Depressive DisorderNCT00384436Forest Laboratories580
已完成
1 期
Bioequivalence Study of Escitalopram Tablets 10 mgAnxiety DisordersNCT01745601GlaxoSmithKline26
已完成
4 期
Brain Effects of Escitalopram and Citalopram Using fMRIAntidepressant Activity in Healthy VolunteersNCT00825825Michael Henry, MD27