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

NCT ID: NCT00839423

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 426 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2007-09-30

Brief Summary

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).

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

capsules, daily, orally

Vortioxetine (Lu AA21004) 5 mg

Group Type: EXPERIMENTAL

Vortioxetine (Lu AA21004)

Intervention Type: DRUG

encapsulated tablets, daily, orally

Vortioxetine (Lu AA21004) 10 mg

Group Type: EXPERIMENTAL

Vortioxetine (Lu AA21004)

Intervention Type: DRUG

encapsulated tablets, daily, orally

Venlafaxine XL 225 mg

Active Reference

Group Type: OTHER

Venlafaxine XL

Intervention Type: DRUG

capsules, daily, orally

Interventions

Placebo

capsules, daily, orally

Intervention Type: DRUG

Vortioxetine (Lu AA21004)

encapsulated tablets, daily, orally

Intervention Type: DRUG

Venlafaxine XL

capsules, daily, orally

Intervention Type: DRUG

Other Intervention Names

Brintellix; Effexor®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

References

Alvarez E, Perez V, Dragheim M, Loft H, Artigas F. A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder. Int J Neuropsychopharmacol. 2012 Jun;15(5):589-600. doi: 10.1017/S1461145711001027. Epub 2011 Jul 18.

Reference Type: RESULT

PMID: 21767441 (View on PubMed)

Other Identifiers

2006-001515-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11492A

Identifier Type: -

Identifier Source: org_study_id