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

Lundbeck

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00839423

2006-001515-29 (EudraCT Number)

11492A

Details and patient eligibility

About

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).

Enrollment: 426 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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426 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Vortioxetine (Lu AA21004) 5 mg

Experimental group

Treatment:

Drug: Vortioxetine (Lu AA21004)

Vortioxetine (Lu AA21004) 10 mg

Experimental group

Treatment:

Drug: Vortioxetine (Lu AA21004)

Venlafaxine XL 225 mg

Other group

Description:

Active Reference

Treatment:

Drug: Venlafaxine XL