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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

607 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

capsules, daily, orally

Vortioxetine: 15 mg

Group Type EXPERIMENTAL

Vortioxetine (Lu AA21004)

Intervention Type DRUG

encapsulated tablets, daily, orally

Vortioxetine: 20 mg

Group Type EXPERIMENTAL

Vortioxetine (Lu AA21004)

Intervention Type DRUG

encapsulated tablets, daily, orally

Duloxetine: 60 mg

Active Reference

Group Type OTHER

Duloxetine

Intervention Type DRUG

encapsulated capsules, daily, orally

Interventions

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Placebo

capsules, daily, orally

Intervention Type DRUG

Vortioxetine (Lu AA21004)

encapsulated tablets, daily, orally

Intervention Type DRUG

Duloxetine

encapsulated capsules, daily, orally

Intervention Type DRUG

Other Intervention Names

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Brintellix Cymbalta®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No