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 |
| 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) |