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

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: SSRI; Drug: Vortioxetine Tablet

• Registration Number: NCT05932407
• Lead Sponsor: Takeda

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-06-28
• Study First Posted: 2023-07-06
• Study Start: 2024-06-01
• Primary Completion: 2024-09-09
• Study Completion: 2024-09-09
• Results First Submitted: 2025-01-14
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Results First Posted: 2025-03-03
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147777

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SSRI Treatment	SSRI	Participants with depression who received SSRI treatment in accordance with package insert.
Vortioxetine Tablet Treatment	Vortioxetine Tablet	Participants with depression who received Vortioxetine tablet treatment in accordance with package insert.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period	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	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).

Secondary Outcome Measures

Name	Time	Method
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	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).
Incidence Rate of Intracranial Hemorrhage Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group	360 Days	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).
Incidence Rate of Serious Bleeding Requiring Hospitalization	360 Days	Incidence rate of serious bleeding requiring hospitalization in Vortioxetine Tablet Treatment group and 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). Serious bleeding was defined as bleeding (intracranial or gastrointestinal) requiring hospitalization.
Incidence Rate of Serious Bleeding Requiring Hospitalization Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group	360 Days	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). Serious bleeding was defined as bleeding (intracranial or gastrointestinal) requiring hospitalization.

Trial Locations

Locations (1)

Takeda Selected Site; 🇯🇵 Tokyo, Japan