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

JRCT ID: jRCT2031230194

Registered date:01/07/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Depression
• Date of first enrollment: 01/06/2024
• Target sample size: 115000
• Study type: Observational

Outcome(s)

Primary Outcome

1.Hazard Ratio of Vortioxetine Tablet to SSRIs for Intracranial Hemorrhage
Timeframe: 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

1.Time from Baseline to Onset of Intracranial Hemorrhage
Timeframe: 360 days

2.Percentage of Participants with Intracranial Hemorrhage for Each SSRI Drug in SSRI Treatment Group
Timeframe: 360 days

3.Hazard Ratio of Vortioxetine tablet to SSRIs for Serious Bleeding Requiring Hospitalization
Timeframe: 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.

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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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 Information

• Primary Sponsor: Contact for Clinical Trial Information