Trial · NCT05932407
A Database Survey of Comparison The Risk of Haemorrhage Between Vortioxetine Tablet Treatment and Selective Serotonin Reuptake Inhibitor (SSRI) Treatment in Participants With Depression
NCT05932407, Completed, Takeda; results first posted 2025-03-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Database Survey of Comparison The Risk of Haemorrhage Between Vortioxetine Tablet Treatment and Selective Serotonin Reuptake Inhibitor (SSRI) Treatment in Participants With Depression. Trials, record NCT05932407. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05932407
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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 number
- NCT05932407
- Status
- Completed
- Enrollment
- 147,777 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Major Depressive Disorder
- Interventions
- Vortioxetine Tablet, SSRI
- First posted
- 2023-07-06
- Last updated
- 2025-03-03
- Results first posted
- 2025-03-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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). |
| Primary | 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 | 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). |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period | 360 Days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Incidence Rate of Intracranial Hemorrhage | 360 Days | events per 10,000 participant-years | NUMBER | |
| SECONDARY | 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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. | events per 10,000 participant-years | NUMBER |
| SECONDARY | Incidence Rate of Serious Bleeding Requiring Hospitalization | 360 Days | events per 10,000 participant-years | NUMBER | |
| SECONDARY | 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. | events per 10,000 participant-years | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period | Vortioxetine Treatment | 2 | Participants | ||
| Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period | SSRI Treatment | 25 | Participants | ||
| Incidence Rate of Intracranial Hemorrhage | Vortioxetine Treatment | 1.5 | events per 10,000 participant-years | ||
| Incidence Rate of Intracranial Hemorrhage | SSRI Treatment | 3.2 | events per 10,000 participant-years | ||
| Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | Vortioxetine Treatment | 60 Days | 2 | Participants | |
| Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | SSRI Treatment | 60 Days | 10 | Participants | |
| Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | Vortioxetine Treatment | 120 Days | 2 | Participants | |
| Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | SSRI Treatment | 120 Days | 15 | Participants | |
| Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | Vortioxetine Treatment | 180 Days | 2 | Participants | |
| Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period | SSRI Treatment | 180 Days | 18 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vortioxetine Treatment | 22,827 | |
| Overall Study | STARTED | SSRI Treatment | 124,950 | |
| Overall Study | COMPLETED | Vortioxetine Treatment | 22,827 | |
| Overall Study | COMPLETED | SSRI Treatment | 124,950 | |
| Overall Study | NOT COMPLETED | Vortioxetine Treatment | 0 | |
| Overall Study | NOT COMPLETED | SSRI Treatment | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vortioxetine Treatment | 0 | 0 |
| Total, all-cause mortality | SSRI Treatment | 0 | 0 |
| Total, other adverse events | Vortioxetine Treatment | 0 | 0 |
| Total, other adverse events | SSRI Treatment | 0 | 0 |
| Total, serious adverse events | Vortioxetine Treatment | 0 | 0 |
| Total, serious adverse events | SSRI Treatment | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41449680 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Vortioxetine Treatment vs SSRI Treatment: Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05932407
GET https://conductscience.org/api/trials/v1/NCT05932407/results?page=2