A Study Of The Utility Of Effexor® (Venlafaxine) In Achieving Response And Maintaining Remission Among Taiwanese Patients With Depression

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 350 人开始时间: 2004年2月1日最近更新: 2007年10月19日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 350
主要终点: Primary efficacy variable will be the proportion of patients with remission defined as a HAM-D score of less than or equal to 7 at 8 weeks of treatment.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This is a study to determine the utility of Effexor® (venlafaxine) in achieving response, including time to response, maintaining remission, and time to remission as measured by the 17-item Hamilton Rating Scale for Depression (HAM-D) and to determine the utility of Effexor® (venlafxine) on the various cluster of symptom scales in the 17-item HAM-D.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Patients meeting criteria for a diagnosis of major depression, single or recurrent episode as described by the DSM-IV manual (appendix 1).
•A HAM-D 17 total score of at least 16 at baseline (DSM-IV manual, appendix 2).
•Patients above 18 years of age who meet the eligibility requirements.

排除标准

•Patients taking MAOI's within 2 weeks prior to the survey.
•Patients known to be suffering from bipolar disorder or schizophrenia.
•Patients who are treatment-resistant, i.e., in the past 3 years have failed (a) three previous adequate trials of greater than or equal to 2 classes of antidepressant medication, or (b) electroconvulsive therapy.
•Drug or alcohol dependence or abuse in the past 6 months per DSM IV criteria.

结局指标

主要结局

Primary efficacy variable will be the proportion of patients with remission defined as a HAM-D score of less than or equal to 7 at 8 weeks of treatment.

次要结局

Safety and tolerability will be assessed based on adverse events that occurred during the survey for all patients who received at least one dose of Effexor®.

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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