Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

Pharmacology Research Institute5 个研究点分布在 1 个国家开始时间: 2005年3月1日最近更新: 2012年5月9日

适应症

试验速览

阶段: 3 期
发起方
试验地点: 5
主要终点: Montgomery Asberg Depression Rating Scale (MADRS)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness, safety and tolerability of an escitalopram combination treatment compared to single treatments, and to placebo in patients with major depressive disorder.

详细描述

Both active drugs being tested, alone and in combination, in this study are currently available antidepressants. However, the doses used in this study are lower than the standard approved doses.

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

发起方

Pharmacology Research Institute

申办方类型

Other

研究点 (5)

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