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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

Studies

Study First Submitted Date 2023-06-28
Study First Posted Date 2023-07-06
Last Update Posted Date 2023-07-06
Start Month Year June 1, 2024
Primary Completion Month Year July 31, 2024
Verification Month Year June 2023
Verification Date 2023-06-30
Last Update Posted Date 2023-07-06

Browse Interventions

Sequence: 96005887 Sequence: 96005888 Sequence: 96005889 Sequence: 96005890 Sequence: 96005891 Sequence: 96005892 Sequence: 96005893 Sequence: 96005894 Sequence: 96005895 Sequence: 96005896 Sequence: 96005897 Sequence: 96005898 Sequence: 96005899 Sequence: 96005900 Sequence: 96005901 Sequence: 96005902 Sequence: 96005903
Mesh Term Vortioxetine Mesh Term Antidepressive Agents Mesh Term Psychotropic Drugs Mesh Term Anti-Anxiety Agents Mesh Term Tranquilizing Agents Mesh Term Central Nervous System Depressants Mesh Term Physiological Effects of Drugs Mesh Term Selective Serotonin Reuptake Inhibitors Mesh Term Neurotransmitter Uptake Inhibitors Mesh Term Membrane Transport Modulators Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Neurotransmitter Agents Mesh Term Serotonin Agents Mesh Term Serotonin 5-HT1 Receptor Agonists Mesh Term Serotonin Receptor Agonists Mesh Term Serotonin 5-HT3 Receptor Antagonists Mesh Term Serotonin Antagonists
Downcase Mesh Term vortioxetine Downcase Mesh Term antidepressive agents Downcase Mesh Term psychotropic drugs Downcase Mesh Term anti-anxiety agents Downcase Mesh Term tranquilizing agents Downcase Mesh Term central nervous system depressants Downcase Mesh Term physiological effects of drugs Downcase Mesh Term selective serotonin reuptake inhibitors Downcase Mesh Term neurotransmitter uptake inhibitors Downcase Mesh Term membrane transport modulators Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term neurotransmitter agents Downcase Mesh Term serotonin agents Downcase Mesh Term serotonin 5-ht1 receptor agonists Downcase Mesh Term serotonin receptor agonists Downcase Mesh Term serotonin 5-ht3 receptor antagonists Downcase Mesh Term serotonin antagonists
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52143743
Name Major Depressive Disorder
Downcase Name major depressive disorder

Id Information

Sequence: 40138594
Id Source org_study_id
Id Value Vortioxetine-4005

Design Groups

Sequence: 55564571 Sequence: 55564572
Title Vortioxetine Tablet Treatment Title SSRI Treatment
Description Participants with depression who received Vortioxetine tablet treatment in accordance with package insert. Description Participants with depression who received SSRI treatment in accordance with package insert.

Interventions

Sequence: 52459681 Sequence: 52459682
Intervention Type Drug Intervention Type Drug
Name Vortioxetine Tablet Name SSRI
Description Vortioxetine Tablet Description SSRI: Selective Serotonin Reuptake Inhibitor

Design Outcomes

Sequence: 177282870 Sequence: 177282871 Sequence: 177282872 Sequence: 177282873 Sequence: 177282874
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Hazard Ratio of Vortioxetine Tablets to SSRIs for Intracranial Hemorrhage Measure Time from Baseline to Onset of Intracranial Hemorrhage Measure Percentage of Participants with Intracranial Hemorrhage for Each SSRI Drug in SSRI Treatment Group Measure Hazard Ratio of Vortioxetine tablet to SSRIs for Serious Bleeding Requiring Hospitalization Measure Percentage of Participants with Serious Bleeding for Each SSRI Drug in SSRI Treatment Group
Time Frame 360 days Time Frame 360 days Time Frame 360 days Time Frame 360 days Time Frame 360 days
Description 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. Description 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. Description Serious bleeding will be defined as bleeding (intracranial or gastrointestinal) requiring hospitalization.

Browse Conditions

Sequence: 193384639 Sequence: 193384640 Sequence: 193384641 Sequence: 193384642 Sequence: 193384643 Sequence: 193384644
Mesh Term Hemorrhage Mesh Term Depressive Disorder Mesh Term Depressive Disorder, Major Mesh Term Mood Disorders Mesh Term Mental Disorders Mesh Term Pathologic Processes
Downcase Mesh Term hemorrhage Downcase Mesh Term depressive disorder Downcase Mesh Term depressive disorder, major Downcase Mesh Term mood disorders Downcase Mesh Term mental disorders Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48295024
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Takeda

Overall Officials

Sequence: 29270975
Role Study Director
Name Takeda Director
Affiliation Takeda

Central Contacts

Sequence: 12001779
Contact Type primary
Name Takeda Contact
Phone +1-877-825-3327
Email medinfoUS@takeda.com
Role Contact

Design Group Interventions

Sequence: 68114028 Sequence: 68114029
Design Group Id 55564571 Design Group Id 55564572
Intervention Id 52459681 Intervention Id 52459682

Eligibilities

Sequence: 30750390
Sampling Method Probability Sample
Gender All
Minimum Age N/A
Maximum Age N/A
Healthy Volunteers No
Population The population of this survey are all participants who meet the inclusion/exclusion criteria.
Criteria Inclusion Criteria: 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. Exclusion Criteria: Has diagnosis of intracranial hemorrhage during the look back period. Has been taken Vortioxetine tablet in combination with SSRI on the index date.
Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254151541
Registered In Calendar Year 2023
Were Results Reported False
Has Single Facility False
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 4

Designs

Sequence: 30496665
Observational Model Cohort
Time Perspective Retrospective

Intervention Other Names

Sequence: 26658287
Intervention Id 52459681
Name TRINTELLIX Tablets

Responsible Parties

Sequence: 28862936
Responsible Party Type Sponsor

Ipd Information Types

Sequence: 3331787 Sequence: 3331788 Sequence: 3331789 Sequence: 3331790
Name Study Protocol Name Statistical Analysis Plan (SAP) Name Informed Consent Form (ICF) Name Clinical Study Report (CSR)