A Database Survey of Comparison The Risk of Haemorrhage Between Vortioxetine Tablet Treatment and Selective Serotonin Reuptake Inhibitor (SSRI) Treatment in Participants With Depression

An observational study of Major Depressive Disorder, run by Takeda at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Major Depressive Disorder
What is being tested?: Vortioxetine Tablet and SSRI
Type of treatment: Pill or oral medicine
How many people: 147,777 participants
Where: 1 siteJapan
Study dates: 1 Jun 2024to 9 Sep 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The population of this survey are all participants who meet the inclusion/exclusion criteria.

Who may be able to join

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.

Who cannot join

Has diagnosis of intracranial hemorrhage during the look back period.
Has been taken Vortioxetine tablet in combination with SSRI on the index date.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Takeda Selected Site
Tokyo

Other trials in Japan

About this study

Official title: 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

Conditions: Major Depressive Disorder
Being tested: Vortioxetine Tablet, SSRI
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vortioxetine TabletDrug
Also called TRINTELLIX Tablets
Vortioxetine Tablet
SSRIDrug
SSRI: Selective Serotonin Reuptake Inhibitor

Study groups in NCT05932407
Study group	Role	What they receive
Vortioxetine Tablet Treatment		Participants with depression who received Vortioxetine tablet treatment in accordance with package insert. Receives: Drug: Vortioxetine Tablet
SSRI Treatment		Participants with depression who received SSRI treatment in accordance with package insert. Receives: Drug: SSRI

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 360 Days
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).
Measured: 360 Days

Secondary outcomes (4)

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).
Measured: 60, 120, 180, 240, 300, and 360 Days
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).
Measured: 360 Days
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.
Measured: 360 Days
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.
Measured: 360 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20249 Sep 2024

First posted6 Jul 2023
Study start1 Jun 2024
Primary completion9 Sep 2024
Study completion9 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 147,777 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05932407
Sponsor's protocol ID: Vortioxetine-4005
Other IDs: jRCT2031230194
Status last verified: Feb 2025
First submitted: 28 Jun 2023
Last updated: 3 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

Inoue T, Otake R, Hoshino T. Safety of Vortioxetine in Patients With Depression: A Post-Marketing Surveillance Study of Intracranial Hemorrhage in a Japanese Health Insurance Claims Database. Neuropsychopharmacol Rep. 2026 Mar;46(1):e70077. doi: 10.1002/npr2.70077.
PubMed 41449680

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05932407
Acronym / sponsor ID: Vortioxetine-4005
Conditions: Major Depressive Disorder
Study type: Observational
Recruitment status: Completed
Enrolment: 147,777 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 1 Jun 2024 (actual)
Primary completion: 9 Sep 2024 (actual)
Study completion: 9 Sep 2024 (actual)
First posted: 6 Jul 2023 (actual)
Results: Posted 3 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Vortioxetine Tablet Treatment	–	Drug: Vortioxetine TabletParticipants with depression who received Vortioxetine tablet treatment in accordance with package insert.
SSRI Treatment	–	Drug: SSRIParticipants with depression who received SSRI treatment in accordance with package insert.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The population of this survey are all participants who meet the inclusion/exclusion criteria.

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (2 listed)

Has diagnosis of intracranial hemorrhage during the look back period.
Has been taken Vortioxetine tablet in combination with SSRI on the index date.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vortioxetine TabletAlso: TRINTELLIX TabletsVortioxetine Tablet	Drug	Vortioxetine Tablet Treatment
SSRISSRI: Selective Serotonin Reuptake Inhibitor	Drug	SSRI Treatment

Primary outcome

Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period
Time frame: 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
Time frame: 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).

4 secondary outcomes

Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period
Time frame: 60, 120, 180, 240, 300, and 360 Days
Incidence Rate of Intracranial Hemorrhage Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group
Time frame: 360 Days
Incidence Rate of Serious Bleeding Requiring Hospitalization
Time frame: 360 Days
Incidence Rate of Serious Bleeding Requiring Hospitalization Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group
Time frame: 360 Days

Results and safety

Results posted to the registry on 3 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vortioxetine Treatment	22,827	22,827
SSRI Treatment	124,950	124,950

Primary outcome: Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period

Time frame: 360 Days. Count of participants. Unit: Participants

Measure	Vortioxetine Treatment n = 22827	SSRI Treatment n = 124950
Value	2	25

Vortioxetine Treatment vs SSRI Treatment: Hazard Ratio (HR): 0.5 (95% CI 0.1 to 2.0)
Vortioxetine Treatment vs SSRI Treatment: Hazard Ratio (HR): 0.5 (95% CI 0.1 to 1.9)

Primary outcome: Incidence Rate of Intracranial Hemorrhage

Time frame: 360 Days. Number. Unit: events per 10,000 participant-years

Measure	Vortioxetine Treatment n = 22827	SSRI Treatment n = 124950
Value	1.5	3.2

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events data were not collected/assessed in this study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vortioxetine Treatment	0 of 0	0 of 0	0
SSRI Treatment	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41449680Inoue T, Otake R, Hoshino T. Safety of Vortioxetine in Patients With Depression: A Post-Marketing Surveillance Study of Intracranial Hemorrhage in a Japanese Health Insurance Claims Database. Neuropsychopharmacol Rep. 2026 Mar;46(1):e70077. doi: 10.1002/npr2.70077.
To obtain more information on the study, click here/on this linkLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Related trials for Major Depressive Disorder

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Takeda Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Major Depressive Disorder, run by Takeda at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period (time frame: 360 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05932407, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.