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NCT01163266 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 462
- Enrollment target
NCT01163266: Completed Phase 3 study, sponsored by Takeda.
NCT01163266 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 462 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01163266, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 462 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.
Primary Outcome
The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Ba
Interventions
- DRUG Placebo
- DRUG Vortioxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 462 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
What the finished NCT01163266 record still lists
NCT01163266 is an interventional study that assigns participants to a tested intervention. The registered 462 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01163266 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01163266 about?
NCT01163266 is a clinical study titled "Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder". The purpose of this study is to evaluate the efficacy of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.
What is the current status of trial NCT01163266?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 462 participants. The study started on 2010-07. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01163266?
The interventions under investigation include: Placebo (DRUG), Vortioxetine (DRUG).
Who is sponsoring clinical trial NCT01163266?
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 NCT01163266's enrollment target sits among peer trials
462 821st of 2000 higher than 1,179 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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