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

Takeda

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Drug: SSRI; Drug: Vortioxetine Tablet

Study type: Observational

Funder types: Industry

Identifiers

NCT05932407

Vortioxetine-4005

jRCT2031230194 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 147,777 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

147,777 participants in 2 patient groups

Vortioxetine Tablet Treatment

Description:

Participants with depression who received Vortioxetine tablet treatment in accordance with package insert.

Treatment:

Drug: Vortioxetine Tablet

SSRI Treatment

Description:

Participants with depression who received SSRI treatment in accordance with package insert.

Treatment:

Drug: SSRI