N/A
Completed N=147,777
A Database Survey of Comparison The Risk of Haemorrhage Between Vortioxetine Tablet Treatment and Selective Serotonin Reuptake Inhibitor (SSRI) Treatment in Participants With Depression
Source: ClinicalTrials.gov NCT05932407 ↗Enrolled (actual)
147,777
Serious AEs
—
Results posted
Mar 2025
Primary outcomePrimary: Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period — 2; 25 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period |
2; 25 | — |
| PRIMARY Incidence Rate of Intracranial Hemorrhage |
1.5; 3.2 | — |
| SECONDARY Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period |
2; 10; 2; 15; 2; 18 | — |
| SECONDARY Incidence Rate of Intracranial Hemorrhage Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group |
2.3; 3.5; 5.9; 1.9; 0.0 | — |
| SECONDARY Incidence Rate of Serious Bleeding Requiring Hospitalization |
27.4; 31.4 | — |
| SECONDARY Incidence Rate of Serious Bleeding Requiring Hospitalization Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group |
28.6; 31.1; 43.7; 28.2; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Has diagnosis of depression and prescription of Vortioxetine tablet or SSRI within the enrollment period (Index Date: first prescription date within the enrollment period).
- Participants can be observed for the past 6 months (180 days) (Look back period) from the day before the Index Date.
- Had not prescription of Vortioxetine tablet or SSRI in the Look back period.
Exclusion Criteria
- Has diagnosis of intracranial hemorrhage during the look back period.
- Has been taken Vortioxetine tablet in combination with SSRI on the index date.
Data sourced from ClinicalTrials.gov (NCT05932407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.