NCT05932407

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 147,777 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Vortioxetine Tablet	Vortioxetine Tablet
DRUG	SSRI	SSRI: Selective Serotonin Reuptake Inhibitor

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-09-09
• Completion: 2024-09-09
• First posted: 2023-07-06
• Last updated: 2025-03-03
• Results posted: 2025-03-03

Locations

1 site across 1 country: Japan