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

Lundbeck

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00596817

11985A

2007-001871-13 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 639 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

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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639 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Vortioxetine: 5 or 10 mg

Experimental group

Treatment:

Drug: Vortioxetine (Lu AA21004)