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

Lundbeck

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Vortioxetine (Lu AA21004); Drug: Venlafaxine extended release

Study type: Interventional

Funder types: Industry

Identifiers

NCT01571453

13926A

Details and patient eligibility

About

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).

Enrollment: 437 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Other inclusion criteria may apply.

Exclusion criteria

• The patient meets any of the exclusion criteria listed in the protocol or, in the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any reason.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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437 participants in 2 patient groups

Vortioxetine (Lu AA21004)

Experimental group

Treatment:

Drug: Vortioxetine (Lu AA21004)

Venlafaxine extended release

Active Comparator group

Treatment:

Drug: Venlafaxine extended release