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

NCT01255787 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2013-12-18

Study results available
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Summary

The purpose of this study is to assess the efficacy and safety of multiple doses of vortioxetine, once daily (QD), in participants with major depressive disorder.

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Vortioxetine

Vortioxetine tablets

DRUG

Placebo

Vortioxetine placebo-matching tablets

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-03-31
Completion
2012-04-30

Countries

  • Croatia
  • Finland
  • Germany
  • Hong Kong
  • India
  • Japan
  • Latvia
  • Malaysia
  • Philippines
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Korea
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

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 NCT01255787 on ClinicalTrials.gov