The Efficacy of Venlafaxine XR (Efexor XR®) Versus SSRIs & Conventional Antidepressants in Depressed Patients Switched From Prior Antidepressants in Psychiatric Outpatient Care Settings in China
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,151
- 主要终点
- Number of Patients Achieving Remission
研究概览
简要总结
This study is an open-label, randomized, multi-center study conducted in a typical psychiatric outpatient practice in China. This study is intended to collect data on the efficacy and safety of venlafaxine XR (Efexor XR®) versus SSRIs and conventional antidepressants in depressed patients that previously failed antidepressant treatment. This data will be used to guide psychiatrists on recommendations for clinic use.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, 18 -65 years of age
- •Outpatients
- •Major depressive disorder based on DSM-IV criteria
- •The baseline score of 17-item HAM-D³17
- •Switchers from prior antidepressants, who have had no satisfactory improvement (normally after a minimum of 8weeks of treatment), with an approved antidepressant medication or have experienced intolerance due to side effects to their antidepressant medication based on clinical discretion
- •Provide written informed consent
- •If female is of childbearing potential, must be confirmed no pregnancy at baseline, and use a medically acceptable method of contraception throughout the study.
排除标准
- •Hypersensitivity to venlafaxine;
- •Clinically significant renal or hepatic disease or any other medical disease that, in the opinion of the investigator, might compromise the study, including seizure
- •Alcohol or drug abuse within the last year
- •A recent history of myocardial infarction or unstable heart disease (within 6 months of baseline)
- •Bipolar disorder
- •For female, known or suspected pregnancy or breast feeding
- •Use of a monoamine oxidase inhibitor (MAOI) within 14 days of baseline; use of any investigational drug within 30 days of baseline.
- •Patients have prior use of venlafaxine or use of venlafaxine for the current episode.
研究组 & 干预措施
1
1.Effexor XR Group
干预措施: Effexor (Drug)
2
2.SSRI or Conventional Antidepressant Group
干预措施: SSRI (Drug)
结局指标
主要结局
Number of Patients Achieving Remission
时间窗: 12 weeks
Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50.
次要结局
- Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)(12 weeks)