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Completed Phase 3 Interventional Results available

Safety and Efficacy of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

ClinicalTrials.gov ID: NCT01153009

Public ClinicalTrials.gov record NCT01153009. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:43 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Duloxetine-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (15 and 20 mg) of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01153009
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Takeda
Industry
Enrollment
614 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2010 (Type not available)
Primary completion
Mar 2012 (Actual)
Completion
Mar 2012 (Actual)
Last update posted
Dec 18, 2013

2010 – 2012

United States locations

U.S. sites
56
U.S. states
24
U.S. cities
56
Facility City State ZIP Site status
Not listed Beverly Hills California — —
Not listed Chino California — —
Not listed Garden Grove California — —
Not listed Irvine California — —
Not listed Los Alamitos California — —
Not listed Oceanside California — —
Not listed Pasadena California — —
Not listed Pico Rivera California — —
Not listed San Diego California — —
Not listed Colorado Springs Colorado — —
Not listed Norwalk Connecticut — —
Not listed Boca Raton Florida — —
Not listed Fort Myers Florida — —
Not listed Gainesville Florida — —
Not listed Jacksonville Florida — —
Not listed Lauderhill Florida — —
Not listed Orlando Florida — —
Not listed Tampa Florida — —
Not listed West Palm Beach Florida — —
Not listed Atlanta Georgia — —
Not listed Marietta Georgia — —
Not listed Chicago Illinois — —
Not listed Libertyville Illinois — —
Not listed Oakbrook Ter Illinois — —
Not listed Valparaiso Indiana — —
Not listed Shreveport Louisiana — —
Not listed Boston Massachusetts — —
Not listed Weymouth Massachusetts — —
Not listed Rochester Hills Michigan — —
Not listed Flowood Mississippi — —
Not listed Toms River New Jersey — —
Not listed Cedarhurst New York — —
Not listed Fresh Meadows New York — —
Not listed New York New York — —
Not listed Rochester New York — —
Not listed Staten Island New York — —
Not listed Cincinnati Ohio — —
Not listed Toledo Ohio — —
Not listed Oklahoma City Oklahoma — —
Not listed Portland Oregon — —
Not listed Allentown Pennsylvania — —
Not listed Media Pennsylvania — —
Not listed Philadelphia Pennsylvania — —
Not listed North Charleston South Carolina — —
Not listed Memphis Tennessee — —
Not listed Nashville Tennessee — —
Not listed Austin Texas — —
Not listed Dallas Texas — —
Not listed Houston Texas — —
Not listed Irving Texas — —
Not listed San Antonio Texas — —
Not listed Orem Utah — —
Not listed Woodstock Vermont — —
Not listed Richmond Virginia — —
Not listed Middleton Wisconsin — —
Not listed Waukesha Wisconsin — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01153009, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 18, 2013 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01153009 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →