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: Complete
• Health condition(s) or Problem(s) studied: Depression
• Date of first enrollment: 01/06/2024
• Target sample size: 147777
• Study type: Observational

Outcome(s)

Primary Outcome

1.Number of Participants who Experienced of Intracranial Hemorrhage in Total Follow-up Period
Timeframe: 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).

2.Incidence Rate of Intracranial Hemorrhage
Timeframe: 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

1.Number of Participants who Experienced of Intracranial Hemorrhage from Baseline at Each Timepoint in Total Follow-up Period
Timeframe: 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).

2.Incidence Rate of Intracranial Hemorrhage Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group
Timeframe: 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).

3.Incidence Rate of Serious Bleeding Requiring Hospitalization
Timeframe: 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.

4.Incidence Rate of Serious Bleeding Requiring Hospitalization Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group
Timeframe: 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.

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
• Secondary ID(s): NCT05932407