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

Takeda147,777 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

147,777

Conditions

Major Depressive Disorder

Interventions

Vortioxetine TabletDRUG

Vortioxetine Tablet

SSRIDRUG

SSRI: Selective Serotonin Reuptake Inhibitor

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. Has diagnosis of depression and prescription of Vortioxetine tablet or SSRI within the enrollment period (Index Date: first prescription date within the enrollment period). 2. Participants can be observed for the past 6 months (180 days) (Look back period) from the day before the Index Date. 3. Had not prescription of Vortioxetine tablet or SSRI in the Look back period. Exclusion Criteria: 1. Has diagnosis of intracranial hemorrhage during the look back period. 2. Has been taken Vortioxetine tablet in combination with SSRI on the index date.

Locations (1)

Takeda Selected Site

Tokyo, Japan

Outcomes

Primary Outcomes

Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period

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).

Time frame: 360 Days

Incidence Rate of Intracranial Hemorrhage

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).

Time frame: 360 Days

Secondary Outcomes

Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period

Time from baseline to the first onset 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).

Time frame: 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

Incidence rate of intracranial hemorrhage categorized by individual SSRI drug (Escitalopram oxalate, Sertraline hydrochloride, Paroxetine hydrochloride, and Fluvoxamine maleate) for intracranial hemorrhage treatment in SSRI treatment group was 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).

Data from ClinicalTrials.gov

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Incidence Rate of Serious Bleeding Requiring Hospitalization Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group

Time frame: 360 Days