Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

437 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Brief Summary

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This study will be conducted with the aim of investigating the efficacy, safety and tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active comparator (venlafaxine extended release 150 mg/day).

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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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Vortioxetine (Lu AA21004)

Group Type EXPERIMENTAL

Vortioxetine (Lu AA21004)

Intervention Type DRUG

10 mg/day

Venlafaxine extended release

Group Type ACTIVE_COMPARATOR

Venlafaxine extended release

Intervention Type DRUG

150 mg/day

Interventions

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Vortioxetine (Lu AA21004)

10 mg/day

Intervention Type DRUG

Venlafaxine extended release

150 mg/day

Intervention Type DRUG

Other Intervention Names

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Brintellix Efexor® XL

Eligibility Criteria

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Inclusion Criteria

* The patient suffers from recurrent MDD as the primary diagnosis according to DSM-IVTR™ criteria. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI)
* The patient has a MADRS total score ≥26
* The patient has a CGI-S score ≥4
* The reported duration of the current MDE is ≥3 months.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No