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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

147777 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-09-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vortioxetine for the Treatment of Major Depression and Co-morbidities After Traumatic Brain Injury (TBI)

NCT02845349

TBI Major Depression

WITHDRAWN PHASE3

Efficacy and Safety Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder

NCT01255787

Depressive Disorder, Major

COMPLETED PHASE2/PHASE3

The Relationship Among Changes in Brain Network Activation in Adult Outpatients With Major Depressive Disorder

NCT02749721

Major Depressive Disorder

COMPLETED PHASE4

Efficacy Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder

NCT01355081

Major Depressive Disorder

COMPLETED PHASE3

Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine

NCT02969876

Depressive Disorder Major Depression Depression +1 more

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vortioxetine Tablet Treatment

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

Vortioxetine Tablet

Intervention Type DRUG

Vortioxetine Tablet

SSRI Treatment

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

SSRI

Intervention Type DRUG

SSRI: Selective Serotonin Reuptake Inhibitor

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vortioxetine Tablet

Intervention Type DRUG

SSRI

SSRI: Selective Serotonin Reuptake Inhibitor

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TRINTELLIX Tablets

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No