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NCT01179516 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
A Phase 3 study of Depressive Disorder, Major, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 469
- Enrollment target
- 20
- Study locations
NCT01179516: Completed Phase 3 study of Depressive Disorder, Major, sponsored by Takeda.
NCT01179516 is a Phase 3 study of Depressive Disorder, Major that has completed, run by Takeda. The registered enrollment target is 469 participants, above the 233-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (101% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01179516, a Phase 3 study of Depressive Disorder, Major, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 469 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability 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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Vortioxetine
Study Locations (20)
California
- - Carson
- - Cerritos
- - El Centro
- - Fresno
- - Glendale
- - Los Angeles
- - Oakland
- - Oceanside
- - San Diego
- - Santa Ana
- - Sherman Oaks
- - Stanford
- - Upland
Florida
- - Fort Walton Beach
- - Kissimmee
- - Miami
Arkansas
- - Little Rock
Colorado
- - Denver
Connecticut
- - Hartford
Delaware
- - Hockessin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 469 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
What the finished NCT01179516 record still lists
NCT01179516 is an interventional study that assigns participants to a tested intervention. The registered 469 participants enrollment target is mid-sized for trials with a published cap, above the 233-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (101% higher).
The record links to 1 condition, with Depressive Disorder, Major appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01179516 names 20 study sites across 6 states, led by California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT01179516 about?
NCT01179516 is a clinical study titled "Safety and Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder". The purpose of this study is to evaluate the efficacy, safety and tolerability of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.
What is the current status of trial NCT01179516?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 469 participants. The study started on 2010-08. Estimated completion is 2012-06.
What conditions does trial NCT01179516 study?
This clinical trial studies the following conditions: Depressive Disorder, Major.
What interventions are being tested in trial NCT01179516?
The interventions under investigation include: Placebo (DRUG), Vortioxetine (DRUG).
Who is sponsoring clinical trial NCT01179516?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01179516 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depressive Disorder, Major
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01179516's enrollment target sits among peer trials
469 11th of 52 higher than 42 of 52 other Depressive Disorder, Major trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depressive Disorder, Major 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.
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