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

Sponsor
Takeda (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05932407
Collaborator
(none)
115,000
Enrollment
2
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
115000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Anticipated Study Start Date :
Jun 1, 2024
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Vortioxetine Tablet Treatment

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

Drug: Vortioxetine Tablet
Vortioxetine Tablet
Other Names:
  • TRINTELLIX Tablets

    		•
    SSRI Treatment

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

    Drug: SSRI
    SSRI: Selective Serotonin Reuptake Inhibitor

    Outcome Measures

    Primary Outcome Measures

    1. Hazard Ratio of Vortioxetine Tablets to SSRIs for Intracranial Hemorrhage [360 days]

      Hazard ratio of Vortioxetine Tablets to SSRIs for intracranial hemorrhage will be reported. The rate of intracranial hemorrhage in Vortioxetine Tablet Treatment group and SSRI Treatment group will be estimated (per 10,000 person-years), and the hazard ratio of Vortioxetine Tablet Treatment group relative to the control group will be calculated by the rate of Vortioxetine Tablet Treatment group divided by the rate of SSRI Treatment group.

    Secondary Outcome Measures

    1. Time from Baseline to Onset of Intracranial Hemorrhage [360 days]

    2. Percentage of Participants with Intracranial Hemorrhage for Each SSRI Drug in SSRI Treatment Group [360 days]

    3. Hazard Ratio of Vortioxetine tablet to SSRIs for Serious Bleeding Requiring Hospitalization [360 days]

      Serious bleeding will be defined as bleeding (intracranial or gastrointestinal) requiring hospitalization. Hazard ratio of Vortioxetine Tablets to SSRIs for serious bleeding requiring hospitalization will be reported. The rate of serious bleeding requiring hospitalization in Vortioxetine Tablet Treatment group and SSRI Treatment group will be estimated (per 10,000 person-years), and the hazard ratio of Vortioxetine Tablet Treatment group relative to the control group will be calculated by the rate of Vortioxetine Tablet Treatment group divided by the rate of SSRI Treatment group.

    4. Percentage of Participants with Serious Bleeding for Each SSRI Drug in SSRI Treatment Group [360 days]

      Serious bleeding will be defined as bleeding (intracranial or gastrointestinal) requiring hospitalization.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Has diagnosis of depression and prescription of Vortioxetine tablet or SSRI within the enrollment period (Index Date: first prescription date within the enrollment period).

    2. Participants can be observed for the past 6 months (180 days) (Look back period) from the day before the Index Date.

    3. Had not prescription of Vortioxetine tablet or SSRI in the Look back period.

    Exclusion Criteria:

    1. Has diagnosis of intracranial hemorrhage during the look back period.

    2. Has been taken Vortioxetine tablet in combination with SSRI on the index date.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: Takeda Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT05932407
    Other Study ID Numbers:
    • Vortioxetine-4005
    First Posted:
    Jul 6, 2023
    Last Update Posted:
    Jul 6, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hemorrhage
    Depressive Disorder
    Depressive Disorder, Major
    Vortioxetine

    Study Results

    No Results Posted as of Jul 6, 2023