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NCT03555136 · ClinicalTrials.gov registry record
Real-life Effectiveness of Vortioxetine in Depression
A clinical trial, sponsored by H. Lundbeck A/S.
- Completed
- Registry status
- 992
- Enrollment target
NCT03555136: Completed study, sponsored by H. Lundbeck A/S.
NCT03555136 is a clinical trial that has completed, run by H. Lundbeck A/S. The registered enrollment target is 992 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03555136 has completed, sponsored by H. Lundbeck A/S.
- COMPLETED
- Registry status
- 992 participants
- Enrollment target
Study Summary
Worldwide Major Depressive Disorder (MDD) has significant negative personal, societal and economic consequences. Vortioxetine (Brintellix®) is a new antidepressant authorized since 2013. Despite evidence generated from clinical trials which demonstrate that vortioxetine is an efficacious, well-tolerated antidepressant, there is a need to determine the effectiveness of vortioxetine in real life routine practice. The study aim is to examine the real-life effectiveness of vortioxetine on functioning, depressive symptom relief, cognition and quality of life. This is an observational, multi-national, study in patients with MDD initiating treatment with vortioxetine. Information will be collected by the physician, from the patient and their medical record at three time points - baseline, week 12 and week 24 (end of follow-up). This study will be conducted in six countries. In total 2,100 patients are planned for enrolment.
Primary Outcome
A series of patient self-rated, scales designed to measure the extent to which his or her 1) work or school, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms
Interventions
- DRUG Vortioxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 992 participants |
| Start Date | 2017-11-17 |
| Est. Completion | 2021-01-31 |
What the finished NCT03555136 record still lists
NCT03555136 is an observational study that tracks outcomes without assigning an intervention. The registered 992 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Vortioxetine is the first listed.
NCT03555136 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03555136 about?
NCT03555136 is a clinical study titled "Real-life Effectiveness of Vortioxetine in Depression". Worldwide Major Depressive Disorder (MDD) has significant negative personal, societal and economic consequences. Vortioxetine (Brintellix®) is a new antidepressant authorized since 2013. Despite evidence generated from clinical trials which demonstrate that vortioxetine is an efficacious, well-tole...
What is the current status of trial NCT03555136?
This trial is currently completed. The enrollment target is 992 participants. The study started on 2017-11-17. Estimated completion is 2021-01-31.
What interventions are being tested in trial NCT03555136?
The interventions under investigation include: Vortioxetine (DRUG).
Who is sponsoring clinical trial NCT03555136?
This trial is sponsored by H. Lundbeck A/S, which has 72 total clinical trials registered on ClinicalTrials.gov.
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