Post-marketing Database Survey: A Cohort Study of Comparison the Risk of Haemorrhage (Serious Intracranial Haemorrhage Such as Cerebral Haemorrhage and Subarachnoid Haemorrhage) Between Vortioxetine Tablets and SSRIs In Patients With Depression Using JMDC Claims Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 147,777
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period
研究概览
简要总结
This study is a retrospective database study in Japan to evaluate the relative risk of serious intracranial hemorrhage requiring hospitalization between Vortioxetine tablet treatment and selective serotonin reuptake inhibitor (SSRI) treatment for patients with depression. This survey will conduct in use of medical database called JMDC claims database.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has diagnosis of depression and prescription of Vortioxetine tablet or SSRI within the enrollment period (Index Date: first prescription date within the enrollment period).
- •Participants can be observed for the past 6 months (180 days) (Look back period) from the day before the Index Date.
- •Had not prescription of Vortioxetine tablet or SSRI in the Look back period.
排除标准
- •Has diagnosis of intracranial hemorrhage during the look back period.
- •Has been taken Vortioxetine tablet in combination with SSRI on the index date.
研究组 & 干预措施
Vortioxetine Tablet Treatment
Participants with depression who received Vortioxetine tablet treatment in accordance with package insert.
干预措施: Vortioxetine Tablet (Drug)
SSRI Treatment
Participants with depression who received SSRI treatment in accordance with package insert.
干预措施: SSRI (Drug)
结局指标
主要结局
Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period
时间窗: 360 Days
Number of participants who experienced of intracranial hemorrhage in Vortioxetine Tablet Treatment group and SSRI Treatment group were reported. Total follow-up period was defined as the period to follow up each participant to confirm the onset of intracranial hemorrhage (after the index date to the end of observation period, up to 360 days).
Incidence Rate of Intracranial Hemorrhage
时间窗: 360 Days
Incidence rate of intracranial hemorrhage in Vortioxetine Tablet Treatment group and SSRI Treatment group were reported. Incidence rate was based on per 10,000 participants-year considering the total follow-up period. Total follow-up period was defined as the period to follow up each participant to confirm the onset of intracranial hemorrhage (after the index date to the end of observation period, up to 360 days).
次要结局
- Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period(60, 120, 180, 240, 300, and 360 Days)
- Incidence Rate of Intracranial Hemorrhage Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group(360 Days)
- Incidence Rate of Serious Bleeding Requiring Hospitalization(360 Days)
- Incidence Rate of Serious Bleeding Requiring Hospitalization Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group(360 Days)