Efficacy Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder

NCT01355081 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2014-11-11

Study results available
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Summary

The purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Vortioxetine (Lu AA21004), once daily (QD), in Japanese participants with major depressive disorder.

The purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Lu AA21004, once daily (QD), in Japanese participants with major depressive disorder.

Conditions

Interventions

DRUG

Vortioxetine

Vortioxetine tablets

DRUG

Placebo

Vortioxetine placebo

Sponsors & Collaborators

Principal Investigators

  • Senior Manager · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Japan

Study Locations

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Entities

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 NCT01355081 on ClinicalTrials.gov