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

NCT00811252 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 453

Last updated 2014-01-29

Study results available
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Summary

To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of depression by means of the change from baseline in the 24-item Hamilton Depression Scale (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients.

Conditions

Interventions

DRUG

Placebo

capsules; daily; orally

DRUG

Vortioxetine (Lu AA21004)

encapsulated tablets; daily; orally

DRUG

Duloxetine

encapsulated tablets; daily; orally

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-02-28
Completion
2010-03-31

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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 NCT00811252 on ClinicalTrials.gov