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NCT02371980 · ClinicalTrials.gov registry record · Phase 4
Vortioxetine, 5, 10, and 20 mg, Relapse Prevention Study in Adults With Major Depressive Disorder (MDD)
A Phase 4 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,106
- Enrollment target
NCT02371980: Completed Phase 4 study, sponsored by Takeda.
NCT02371980 is a Phase 4 study that has completed, run by Takeda. The registered enrollment target is 1,106 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (114% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02371980, a Phase 4 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,106 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of vortioxetine (5, 10, and 20 mg) versus placebo during the first 28 weeks of the 32-week double-blind treatment period in the prevention of relapse in participants with MDD who responded to acute treatment with vortioxetine 10 mg.
Primary Outcome
Relapse was defined as either 1) MADRS Score ≥22, 2) lack of efficacy as determined by the investigator or 3) other unsatisfactory treatment response judged by the investigator. Time to relapse was defined as date of relapse - date of randomization + 1 (where date of relapse is the date of last dose, or date of last contact if date of last dose is missing, for participant with a relapse). Participants without relapse were censored at date of withdrawal or date of Week 28 visit, whichever was ear
Interventions
- DRUG Placebo
- DRUG Vortioxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,106 participants |
| Start Date | 2015-02-10 |
| Est. Completion | 2019-04-25 |
| Phase | Phase 4 |
What the finished NCT02371980 record still lists
NCT02371980 is an interventional study that assigns participants to a tested intervention. Its 1,106 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (114% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02371980 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02371980 about?
NCT02371980 is a clinical study titled "Vortioxetine, 5, 10, and 20 mg, Relapse Prevention Study in Adults With Major Depressive Disorder (MDD)". The purpose of this study is to evaluate the efficacy of vortioxetine (5, 10, and 20 mg) versus placebo during the first 28 weeks of the 32-week double-blind treatment period in the prevention of relapse in participants with MDD who responded to acute treatment with vortioxetine 10 mg.
What is the current status of trial NCT02371980?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,106 participants. The study started on 2015-02-10. Estimated completion is 2019-04-25.
What interventions are being tested in trial NCT02371980?
The interventions under investigation include: Placebo (DRUG), Vortioxetine (DRUG).
Who is sponsoring clinical trial NCT02371980?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02371980's enrollment target sits among peer trials
1,106 65th of 2000 higher than 1,936 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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