NCT00766870

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Lu AA34893	Per oral doses, divided in twice daily administrations as capsules during 8 weeks, followed by a two-week tapering period
DRUG	Venlafaxine extended release	Per oral, once daily, during 8 weeks, followed by a two-week tapering period
DRUG	Placebo	Per oral doses, twice daily as capsules during 10 weeks

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-01-01
• Completion: 2009-02-01
• First posted: 2008-10-06
• Last updated: 2010-09-29

Locations

1 site across 1 country: Canada