Efficacy and Safety of Lu AA34893 in Patients With Major Depressive Disorder

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the efficacy, safety and tolerability of three fixed dosages of Lu AA34893 compared to placebo in the treatment of patients with Major Depressive Disorder.

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

Details

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

Criteria

In- and out-patients with moderate to severe Major Depressive Disorder

Inclusion Criteria:

• Major Depressive Episode (MDE) as primary diagnosis according to DSM-IV (classification code 296.xx)

• Moderate to severe depression

• Current MDE duration of at least 3 months

Exclusion Criteria:

• Any current psychiatric disorder other than MDD as defined in the DSM-IV TR

• Any substance disorder within the previous 6 months

• Females of childbearing potential and not using adequate contraception

• Use of any psychoactive medication within 2 weeks before randomisation and during the study