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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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: 2024-07-30
• Study Completion: 2024-07-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02

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.

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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.

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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
Hazard Ratio of Vortioxetine Tablets to SSRIs for Intracranial Hemorrhage	360 days	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.

Secondary Outcome Measures

Name	Time	Method
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	360 days	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.
Percentage of Participants with Serious Bleeding for Each SSRI Drug in SSRI Treatment Group	360 days	Serious bleeding will be defined as bleeding (intracranial or gastrointestinal) requiring hospitalization.

Trial Locations

Locations (1)

Takeda selected site; 🇯🇵 Tokyo, Japan