Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

639 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-10-31

Brief Summary

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This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major depressive episodes in patients who responded to open-label treatment with Vortioxetine.

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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: 5 or 10 mg

Group Type EXPERIMENTAL

Vortioxetine (Lu AA21004)

Intervention Type DRUG

encapsulated tablets, daily, orally

Interventions

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Placebo

capsules, daily, orally

Intervention Type DRUG

Vortioxetine (Lu AA21004)

encapsulated tablets, daily, orally

Intervention Type DRUG

Other Intervention Names

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Brintellix

Eligibility Criteria

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Inclusion Criteria

* Major Depressive Episode (MDE) as the primary diagnosis according to DSM-IV TR criteria
* At least one other MDE before the current one
* Moderate to severe depression

Exclusion Criteria

* Any current psychiatric disorder other than Major Depressive Disorder (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

Randomisation Criteria: Patients in remission (MADRS total score \<=10) at both Week 10 and Week 12

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No