A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of a Flexible Dose 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 247 人开始时间: 2003年6月25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: 247

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

Secondary: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general well-being, pain, and remission (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D<sub>17</sub>] < 7) versus those subjects receiving placebo.

研究设计

研究类型: Interventional
主要目的: Treatment

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

•* Subjects must have a primary diagnosis of major depressive disorder (MDD)
•* Depressive symptoms for at least 30 days prior to the screening visit
•* Minimum screening and study day -1 (baseline) scores of 20 on the Hamilton Psychiatric Rating Scale for Depression (HAM D\17\)

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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