A Ten-Week, Randomized, Double-Blind Study Evaluating the Efficacy of Duloxetine 60mg Once Daily Versus Placebo in Outpatients With Major Depressive Disorder and Pain

Eli Lilly and Company38 个研究点分布在 6 个国家目标入组 310 人开始时间: 2005年5月最近更新: 2007年1月26日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Eli Lilly and Company
入组人数: 310
试验地点: 38
主要终点: Compare efficacy of Duloxetine versus placebo on somatic complaints of pain in patients meeting criteria for major depressive disorder.

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

To determine the efficacy of Duloxetine vs. placebo on pain as determined by change in the Brief Pain Inventory (BPI) from baseline over 8 weeks of treatment

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Major Depressive Disorder according to DSM-IV criteria with at least one previous depressive episode in the patient's medical history
•Painful physical symptoms as measured by the Brief Pain Inventory-Short Form

排除标准

•Any anxiety disorder as a primary diagnosis within the past 6 months (including panic disorder, OCD, PTSD, generalized anxiety disorder and social phobia)
•Any diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders

结局指标

主要结局

Compare efficacy of Duloxetine versus placebo on somatic complaints of pain in patients meeting criteria for major depressive disorder.

次要结局

Measure Efficacy by the following: MADRS total score, time to sustained clinical response for painful physical symptoms, time to sustained clinical response for overall depression symptoms, SCL-90R scale, PGI-I, CGI-S, CGI-I and BPI-SF.
Measure safety by the following: adverse events, withdrawals due to AE, vital signs, weight and laboratory values.

研究者

发起方

Eli Lilly and Company

申办方类型

Industry

研究点 (38)

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