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

Information source: H. Lundbeck A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Placebo (Drug); Vortioxetine (Lu AA21004) (Drug); Venlafaxine XL (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: H. Lundbeck A/S

Official(s) and/or principal investigator(s):
Email contact via H. Lundbeck A/S, Study Director, Affiliation: LundbeckClinicalTrials@lundbeck.com


The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD).

Clinical Details

Official title: Double-blind, Randomised, Placebo-controlled Study Comparing the Efficacy and Safety of Two Fixed Dosages of a Novel Antidepressant Compound to That of Placebo in Patients With Major Depressive Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in MADRS Total Score After 6 Weeks of Treatment

Secondary outcome:

Change From Baseline in MADRS Total Score After 1 Week of Treatment

Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment

Change From Baseline in HAM-A Total Score After 6 Weeks of Treatment

Change From Baseline in CGI-S Score After 6 Weeks of Treatment

Change in Clinical Status Using CGI-I Score at Week 6

Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)

Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10)


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296. xx)

- Current MDE duration of at least 3 months and less than 12 months

- The patient has a MADRS total score >=30

Exclusion Criteria:

- Any current psychiatric disorder other than MDD as defined in the DSM-IV TR

- Any substance disorder within the previous 6 months

- Female patients of childbearing potential who are not using effective contraception

- Use of any psychoactive medication 2 weeks prior to screening and during the study

Other protocol-defined inclusion and exclusion criteria may apply.

Locations and Contacts

Additional Information

Starting date: August 2006
Last updated: April 22, 2014

Page last updated: August 23, 2015

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