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Randomised Placebo-controlled Duloxetine-referenced Efficacy and Safety Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder

NCT00635219 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 766

Last updated 2014-02-11

Study results available
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Summary

The purpose of the study is to evaluate the efficacy and the tolerability of three fixed doses of Vortioxetine in order to establish the appropriate clinical effective dose range in the treatment of Major Depressive Disorder (MDD).

Conditions

Interventions

DRUG

Placebo

capsules; daily; orally

DRUG

Vortioxetine (Lu AA21004)

2.5 mg/day; encapsulated tablets; orally

DRUG

Vortioxetine (Lu AA21004)

5 mg/day; encapsulated tablets; orally

DRUG

Vortioxetine (Lu AA21004)

10 mg/day; encapsulated tablets; orally

DRUG

Duloxetine

60 mg/day; encapsulated capsules; orally

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-04-30
Completion
2009-04-30

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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 NCT00635219 on ClinicalTrials.gov