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

NCT01153009 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 614

Last updated 2013-12-18

Study results available
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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.

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Vortioxetine

Encapsulated vortioxetine immediate release tablets

DRUG

Duloxetine

Overencapsulated duloxetine delayed-release capsules

DRUG

Placebo

Placebo-matching capsules

Sponsors & Collaborators

Principal Investigators

  • Medical Director, Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01153009 on ClinicalTrials.gov