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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Vortioxetine

Criteria

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.