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
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
-
Vortioxetine placebo
Sponsors & Collaborators
- lead INDUSTRY
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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