A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Two Fixed Doses (200 Mg, Or 400 Mg) Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 375 人开始时间: 2003年12月8日最近更新: 2009年8月19日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 375

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

Primary Objective: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.

Secondary Objective: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general wellbeing, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D17] less than or equal to 7) versus those subjects receiving placebo.

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

入选标准

•Outpatients
•Sexually active women participating in the study must use a medically acceptable form of contraception
•Subjects must have a primary diagnosis of major depressive disorder of 4 on Clinical Global Impressions-Severity scale (CGI-S)

排除标准

•Treatment with DVS-233 SR at any time in the past
•Treatment with venlafaxine (immediate release [IR] or extended release [ER]) within 90 days of study day 1
•Known hypersensitivity to venlafaxine (IR or ER)

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

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