Major Depressive Disorder
Conditions
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.
Interventions
DRUGVortioxetine Tablet
Vortioxetine Tablet
DRUGSSRI
SSRI: Selective Serotonin Reuptake Inhibitor
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period | 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). |
| Incidence Rate of Intracranial Hemorrhage | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | 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). |
| Incidence Rate of Intracranial Hemorrhage Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group | 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). |
| Incidence Rate of Serious Bleeding Requiring Hospitalization | 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. |
| Incidence Rate of Serious Bleeding Requiring Hospitalization Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group | 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. |
Countries
Japan
Participant flow
Recruitment details
Collected data from the JMDC Claims Database in Japan were analyzed from 01 June 2024 to September 9 2024.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Vortioxetine Treatment Data in the medical database for participants with depression who received Vortioxetine as part of a routine medical care. | 22,827 |
| SSRI Treatment Data in the medical database for participants with depression who received SSRI as part of a routine medical care. | 124,950 |
| Total | 147,777 |
Baseline characteristics
| Characteristic | Vortioxetine Treatment | SSRI Treatment | Total |
|---|---|---|---|
| Age, Continuous | 37.7 years STANDARD_DEVIATION 12.5 | 36.4 years STANDARD_DEVIATION 13.3 | 36.6 years STANDARD_DEVIATION 13.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 9714 Participants | 66886 Participants | 76600 Participants |
| Sex: Female, Male Male | 13113 Participants | 58064 Participants | 71177 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Incidence Rate of Intracranial Hemorrhage
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).
Time frame: 360 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vortioxetine Treatment | Incidence Rate of Intracranial Hemorrhage | 1.5 events per 10,000 participant-years |
| SSRI Treatment | Incidence Rate of Intracranial Hemorrhage | 3.2 events per 10,000 participant-years |
Primary
Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period
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).
Time frame: 360 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vortioxetine Treatment | Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period | 2 Participants |
| SSRI Treatment | Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period | 25 Participants |
Comparison: Crude hazard ratio of Vortioxetine Tablets to SSRIs for intracranial hemorrhage was reported. Crude hazard ratio of Vortioxetine Tablet Treatment group relative to the control group (SSRI Treatment group) was calculated by the rate of Vortioxetine Tablet Treatment group divided by the rate of SSRI Treatment group.95% CI: [0.1, 2]
Comparison: Adjusted hazard ratio of Vortioxetine Tablets to SSRIs for intracranial hemorrhage was reported. Adjusted hazard ratio of Vortioxetine Tablet Treatment group relative to the control group (SSRI Treatment group) was calculated by the rate of Vortioxetine Tablet Treatment group divided by the rate of SSRI Treatment group.95% CI: [0.1, 1.9]
Secondary
Incidence Rate of Intracranial Hemorrhage Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vortioxetine Treatment | 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 |
| Vortioxetine Treatment | 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 |
| Vortioxetine Treatment | 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 |
| Vortioxetine Treatment | 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 |
| Vortioxetine Treatment | 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 |
Secondary
Incidence Rate of Serious Bleeding Requiring Hospitalization
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.
Time frame: 360 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vortioxetine Treatment | Incidence Rate of Serious Bleeding Requiring Hospitalization | 27.4 events per 10,000 participant-years |
| SSRI Treatment | Incidence Rate of Serious Bleeding Requiring Hospitalization | 31.4 events per 10,000 participant-years |
Secondary
Incidence Rate of Serious Bleeding Requiring Hospitalization Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vortioxetine Treatment | 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 |
| Vortioxetine Treatment | 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 |
| Vortioxetine Treatment | 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 |
| Vortioxetine Treatment | 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 |
| Vortioxetine Treatment | 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 |
Secondary
Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period
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).
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vortioxetine Treatment | Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | 60 Days | 2 Participants |
| Vortioxetine Treatment | Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | 180 Days | 2 Participants |
| Vortioxetine Treatment | Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | 300 Days | 2 Participants |
| Vortioxetine Treatment | Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | 120 Days | 2 Participants |
| Vortioxetine Treatment | Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | 360 Days | 2 Participants |
| Vortioxetine Treatment | Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | 240 Days | 2 Participants |
| SSRI Treatment | Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | 360 Days | 25 Participants |
| SSRI Treatment | Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | 240 Days | 22 Participants |
| SSRI Treatment | Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | 60 Days | 10 Participants |
| SSRI Treatment | Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | 120 Days | 15 Participants |
| SSRI Treatment | Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | 180 Days | 18 Participants |
| SSRI Treatment | Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | 300 Days | 24 Participants |