NCT05932407Completed
A Database Survey of Comparison The Risk of Haemorrhage Between Vortioxetine Tablet Treatment and Selective Serotonin Reuptake Inhibitor (SSRI) Treatment in Participants With Depression
Post-marketing Database Survey: A Cohort Study of Comparison the Risk of Haemorrhage (Serious Intracranial Haemorrhage Such as Cerebral Haemorrhage and Subarachnoid Haemorrhage) Between Vortioxetine Tablets and SSRIs In Patients With Depression Using JMDC Claims Database
Source: ClinicalTrials.gov · Last updated 3 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 147777 (actual)
- First submitted
- 28 Jun 2023
- Start date
- 1 Jun 2024
- Primary completion date
- 9 Sept 2024
- Lead sponsor
- Takeda
- Diseases
- Depression
- NCT number
- NCT05932407
What you commit to
- Study type: Observational
- Participants enrolled: 147777
- From 1 Jun 2024 to the primary completion date, 9 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Has diagnosis of intracranial hemorrhage during the look back period.
Other
- Has been taken Vortioxetine tablet in combination with SSRI on the index date.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.