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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05932407
• Other study ID #: Vortioxetine-4005
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: June 2023
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 115000
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Hemorrhage
• Major Depressive Disorder

Intervention

Drug:
• Vortioxetine Tablet
Vortioxetine Tablet
• SSRI
SSRI: Selective Serotonin Reuptake Inhibitor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hazard Ratio of Vortioxetine Tablets to SSRIs for Intracranial Hemorrhage	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.	360 days
Secondary	Time from Baseline to Onset of Intracranial Hemorrhage		360 days
Secondary	Percentage of Participants with Intracranial Hemorrhage for Each SSRI Drug in SSRI Treatment Group		360 days
Secondary	Hazard Ratio of Vortioxetine tablet to SSRIs for Serious Bleeding Requiring Hospitalization	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.	360 days
Secondary	Percentage of Participants with Serious Bleeding for Each SSRI Drug in SSRI Treatment Group	Serious bleeding will be defined as bleeding (intracranial or gastrointestinal) requiring hospitalization.	360 days