A Database Survey of Comparison The Risk of Haemorrhage Between Vortioxetine Tablet Treatment and Selective Serotonin Reuptake Inhibitor (SSRI) Treatment in Participants With Depression

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Vortioxetine Tablet
* Drug: SSRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: Has diagnosis of intracranial hemorrhage during the look back period. Has been taken Vortioxetine tablet in combination with SSRI on the index date.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vortioxetine Tablet Treatment<br>Participants with depression who received Vortioxetine tablet treatment in accordance with package insert. | Drug: Vortioxetine Tablet<br>* Vortioxetine Tablet<br>* Other names: TRINTELLIX Tablets;|
| SSRI Treatment<br>Participants with depression who received SSRI treatment in accordance with package insert. | Drug: SSRI<br>* SSRI: Selective Serotonin Reuptake Inhibitor<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hazard Ratio of Vortioxetine Tablets to SSRIs for Intracranial Hemorrhage | Hazard ratio of Vortioxetine Tablets to SSRIs for intracranial hemorrhage will be reported. The rate of intracranial hemorrhage in Vortioxetine Tablet Treatment group and SSRI Treatment group will be estimated (per 10,000 person-years), and the hazard ratio of Vortioxetine Tablet Treatment group relative to the control group will be calculated by the rate of Vortioxetine Tablet Treatment group divided by the rate of SSRI Treatment group. | 360 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from Baseline to Onset of Intracranial Hemorrhage |  | 360 days | 
| Percentage of Participants with Intracranial Hemorrhage for Each SSRI Drug in SSRI Treatment Group |  | 360 days | 
| Hazard Ratio of Vortioxetine tablet to SSRIs for Serious Bleeding Requiring Hospitalization | Serious bleeding will be defined as bleeding (intracranial or gastrointestinal) requiring hospitalization. Hazard ratio of Vortioxetine Tablets to SSRIs for serious bleeding requiring hospitalization will be reported. The rate of serious bleeding requiring hospitalization in Vortioxetine Tablet Treatment group and SSRI Treatment group will be estimated (per 10,000 person-years), and the hazard ratio of Vortioxetine Tablet Treatment group relative to the control group will be calculated by the rate of Vortioxetine Tablet Treatment group divided by the rate of SSRI Treatment group. | 360 days | 
| Percentage of Participants with Serious Bleeding for Each SSRI Drug in SSRI Treatment Group | Serious bleeding will be defined as bleeding (intracranial or gastrointestinal) requiring hospitalization. | 360 days |