Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)

• Current MDE duration of at least 3 months and less than 12 months

• The patient has a MADRS total score >=30

Exclusion Criteria:

• Any current psychiatric disorder other than 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

Other protocol-defined inclusion and exclusion criteria may apply.