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 Results

• 2 other identifiers: Vortioxetine-4005jRCT2031230194
• Study Type: observational
• Target: 147,777
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  360 Days

Secondary Outcomes (4)

• 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

• Incidence Rate of Intracranial Hemorrhage Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group

  360 Days

• Incidence Rate of Serious Bleeding Requiring Hospitalization

  360 Days

• Incidence Rate of Serious Bleeding Requiring Hospitalization Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group

  360 Days

Study Arms (2)

Vortioxetine Tablet Treatment

Participants with depression who received Vortioxetine tablet treatment in accordance with package insert.

Drug: Vortioxetine Tablet

SSRI Treatment

Participants with depression who received SSRI treatment in accordance with package insert.

Drug: SSRI

Interventions

Vortioxetine Tablet DRUG

Vortioxetine Tablet

Also known as: TRINTELLIX Tablets

Vortioxetine Tablet Treatment

SSRI DRUG

SSRI: Selective Serotonin Reuptake Inhibitor

SSRI Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Takeda Selected Site

Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 41449680 DERIVED

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Takeda Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 6, 2023
• Study Start: June 1, 2024
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2024
• Last Updated: March 3, 2025
• Results First Posted: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (1)