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

Lundbeck

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Duloxetine; Drug: Placebo; Drug: Vortioxetine (Lu AA21004)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00635219

11984A

EudraCT 2007-001870-95 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 766 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)
• Moderate to severe depression
• Current MDE duration of at least 3 months

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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766 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Vortioxetine: 2.5 mg

Experimental group

Treatment:

Drug: Vortioxetine (Lu AA21004)

Drug: Vortioxetine (Lu AA21004)

Drug: Vortioxetine (Lu AA21004)

Vortioxetine: 5 mg

Experimental group

Treatment:

Drug: Vortioxetine (Lu AA21004)

Drug: Vortioxetine (Lu AA21004)

Drug: Vortioxetine (Lu AA21004)

Vortioxetine: 10 mg

Experimental group

Treatment:

Drug: Vortioxetine (Lu AA21004)

Drug: Vortioxetine (Lu AA21004)

Drug: Vortioxetine (Lu AA21004)

Duloxetine: 60 mg

Other group

Description:

Active reference

Treatment:

Drug: Duloxetine