DRUG USE INVESTIGATION OF EFFEXOR(REGISTERED) SR CAPSULES
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,408
- 主要终点
- Number of Participants With Adverse Drug Reactions
研究概览
简要总结
SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE
详细描述
This study will be conducted under the central registration system until the number of subjects who meet the conditions for registration reaches the target number of subjects. 12 weeks from the start date. The patients who completed the 12-week treatment with this product will be observed up until Week 52.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients with no experience of using this product who will be administered this product for the first time
排除标准
- •Exclusion criteria are not provided in this study
研究组 & 干预措施
venlafaxine
Patients with no experience of using time Effexor(venlafaxine) who will be administered time Effexor(venlafaxine)for the first
干预措施: venlafaxine (Drug)
结局指标
主要结局
Number of Participants With Adverse Drug Reactions
时间窗: 12 weeks from the start date (up until 52 weeks)
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Effexor in a participant who received Effexor. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Effexor was assessed by the physician.
次要结局
- Change From Baseline in the Montgomery - Asberg Depression Rating Scale (MADRS) Total Scores at Pre-specified Evaluation Points(12 weeks from the start date ( up until 52 weeks))
- Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Scores at Pre-specified Evaluation Points(12 weeks from the start date ( up until 52 weeks))
- Changes in the Clinical Global Impressions-Improvement(12 weeks from the start date (up until 52 weeks))
- Clinical Global Impressions-Severity(12 weeks from the start date (up until 52 weeks))