Trial Outcomes & Findings for A Database Survey of Comparison The Risk of Haemorrhage Between Vortioxetine Tablet Treatment and Selective Serotonin Reuptake Inhibitor (SSRI) Treatment in Participants With Depression (NCT NCT05932407)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

147777 participants

Primary outcome timeframe

360 Days

Results posted on

2025-03-03

Participant Flow

Collected data from the JMDC Claims Database in Japan were analyzed from 01 June 2024 to September 9 2024.

This study was a retrospective database study in Japan. Data of participants with depression who received Vortioxetine or Selective Serotonin Reuptake Inhibitor (SSRI) were collected from the medical database called as the JMDC Claims Database before data analysis.

Participant milestones

Participant milestones
Measure	Vortioxetine Treatment Data in the medical database for participants with depression who received Vortioxetine as part of a routine medical care.	SSRI Treatment Data in the medical database for participants with depression who received SSRI as part of a routine medical care.
Overall Study STARTED	22827	124950
Overall Study COMPLETED	22827	124950
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vortioxetine Treatment n=22827 Participants Data in the medical database for participants with depression who received Vortioxetine as part of a routine medical care.	SSRI Treatment n=124950 Participants Data in the medical database for participants with depression who received SSRI as part of a routine medical care.	Total n=147777 Participants Total of all reporting groups
Age, Continuous	37.7 years STANDARD_DEVIATION 12.5 • n=22827 Participants	36.4 years STANDARD_DEVIATION 13.3 • n=124950 Participants	36.6 years STANDARD_DEVIATION 13.2 • n=147777 Participants
Sex: Female, Male Female	9714 Participants n=22827 Participants	66886 Participants n=124950 Participants	76600 Participants n=147777 Participants
Sex: Female, Male Male	13113 Participants n=22827 Participants	58064 Participants n=124950 Participants	71177 Participants n=147777 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

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).

Outcome measures

Outcome measures
Measure	Vortioxetine Treatment n=22827 Participants Data in the medical database for participants with depression who received Vortioxetine as part of a routine medical care.	SSRI Treatment n=124950 Participants Data in the medical database for participants with depression who received SSRI as part of a routine medical care.
Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period	2 Participants	25 Participants

PRIMARY outcome

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).

Outcome measures

Outcome measures
Measure	Vortioxetine Treatment n=22827 Participants Data in the medical database for participants with depression who received Vortioxetine as part of a routine medical care.	SSRI Treatment n=124950 Participants Data in the medical database for participants with depression who received SSRI as part of a routine medical care.
Incidence Rate of Intracranial Hemorrhage	1.5 events per 10,000 participant-years	3.2 events per 10,000 participant-years

SECONDARY outcome

Timeframe: 60, 120, 180, 240, 300, and 360 Days

Population: Participants whose index date was the same as the end date of the observation period (patients whose follow-up period was 0 days) were not included.

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).

Outcome measures

Outcome measures
Measure	Vortioxetine Treatment n=22819 Participants Data in the medical database for participants with depression who received Vortioxetine as part of a routine medical care.	SSRI Treatment n=124912 Participants Data in the medical database for participants with depression who received SSRI as part of a routine medical care.
Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period 120 Days	2 Participants	15 Participants
Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period 180 Days	2 Participants	18 Participants
Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period 240 Days	2 Participants	22 Participants
Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period 300 Days	2 Participants	24 Participants
Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period 360 Days	2 Participants	25 Participants
Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period 60 Days	2 Participants	10 Participants

SECONDARY outcome

Timeframe: 360 Days

Population: 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 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).

Outcome measures

Outcome measures
Measure	Vortioxetine Treatment n=124950 Participants Data in the medical database for participants with depression who received Vortioxetine as part of a routine medical care.	SSRI Treatment Data in the medical database for participants with depression who received SSRI as part of a routine medical care.
Incidence Rate of Intracranial Hemorrhage Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group Escitalopram oxalate	2.3 events per 10,000 participant-years	—
Incidence Rate of Intracranial Hemorrhage Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group Paroxetine hydrochloride	5.9 events per 10,000 participant-years	—
Incidence Rate of Intracranial Hemorrhage Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group Fluvoxamine maleate	1.9 events per 10,000 participant-years	—
Incidence Rate of Intracranial Hemorrhage Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group 2 or more SSRI drugs	0.0 events per 10,000 participant-years	—
Incidence Rate of Intracranial Hemorrhage Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group Sertraline hydrochloride	3.5 events per 10,000 participant-years	—

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	Vortioxetine Treatment n=22827 Participants Data in the medical database for participants with depression who received Vortioxetine as part of a routine medical care.	SSRI Treatment n=124950 Participants Data in the medical database for participants with depression who received SSRI as part of a routine medical care.
Incidence Rate of Serious Bleeding Requiring Hospitalization	27.4 events per 10,000 participant-years	31.4 events per 10,000 participant-years

SECONDARY outcome

Timeframe: 360 Days

Population: 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 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.

Outcome measures

Outcome measures
Measure	Vortioxetine Treatment n=124950 Participants Data in the medical database for participants with depression who received Vortioxetine as part of a routine medical care.	SSRI Treatment Data in the medical database for participants with depression who received SSRI as part of a routine medical care.
Incidence Rate of Serious Bleeding Requiring Hospitalization Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group Paroxetine hydrochloride	43.7 events per 10,000 participant-years	—
Incidence Rate of Serious Bleeding Requiring Hospitalization Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group Fluvoxamine maleate	28.2 events per 10,000 participant-years	—
Incidence Rate of Serious Bleeding Requiring Hospitalization Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group 2 or more SSRI drugs	0.0 events per 10,000 participant-years	—
Incidence Rate of Serious Bleeding Requiring Hospitalization Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group Escitalopram oxalate	28.6 events per 10,000 participant-years	—
Incidence Rate of Serious Bleeding Requiring Hospitalization Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group Sertraline hydrochloride	31.1 events per 10,000 participant-years	—

Adverse Events

Vortioxetine Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SSRI Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place