Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 15 and 20 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults

Lundbeck

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01140906

13267A

2009-017523-26 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy, tolerability and the safety of two fixed doses of vortioxetine in the treatment of major depressive disorder.

Enrollment: 607 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient has recurrent MDD as the primary diagnosis according to DSM-IV-TR™ criteria (classification code 296.3x)
• The patient has a MADRS total score >=26
• The patient has a CGI-S score >=4
• The patient has had the current episode of MDE for >3 months

Exclusion criteria

• Any current anxiety psychiatric disorder as defined in the DSM-IV TR
• Current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV TR
• Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV TR
• Use of any psychoactive medication 2 weeks prior to screening and during the study
• The patient is at significant risk of suicide or has a score >=5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit

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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607 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Vortioxetine: 15 mg

Experimental group

Treatment:

Drug: Vortioxetine (Lu AA21004)

Vortioxetine: 20 mg

Experimental group

Treatment:

Drug: Vortioxetine (Lu AA21004)

Duloxetine: 60 mg

Other group

Description:

Active Reference

Treatment:

Drug: Duloxetine