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

Major Depressive Disorder Clinical Trial

Official title: A Randomised, Double-blind, Parallel-group, Placebo-controlled, and Active-referenced Study Evaluating the Efficacy and Safety of Three Fixed Dose Regimens of Lu AA34893 in the Treatment of Major Depressive Disorder

Status Terminated

Clinical Trial 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.

Clinical Trial Description

Major Depressive Disorder (MDD) is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. MDD is characterised by the presence of one or more Major Depressive Episodes (MDEs) that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. MDD is a disabling, severe illness that tends to be chronic, and repeated episodes are common. Despite the availability of a range of effective treatments in MDD, a significant proportion of patients do not respond or achieve remission and many relapse despite continued treatment. Lu AA34893 has a novel mechanism of action and this could be of clinical relevance in addressing currently unmet needs in MDD. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

• NCT number: NCT00766870
• Study type: Interventional
• Source: H. Lundbeck A/S
• Status: Terminated
• Phase: Phase 2
• Start date: September 2008
• Completion date: February 2009