NCT00599911

Dose-finding Study With Lu AA24530 in Major Depressive Disorder

Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced, Dose-finding Study of Lu AA24530 in Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 652 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to assess the efficacy in treating patients with Major Depressive Disorder of one or more doses of Lu AA24530 relative to placebo

Detailed description

According to the World Health Organisation, Major Depressive Disorder is the leading cause of disability and the 4th leading contributor to the global burden of disease. There are unmet medical needs in the treatment of depressive disorders in terms of insufficient effectiveness and unpleasant side-effects of current therapies. The overall prognosis of the disorder is positive for the majority of patients, but as many as 30% of patients will develop a chronic and treatment-resistant depression. In the study, patients with depression are treated for 6 weeks. Assessments of efficacy and safety are taking place every week for the first 4 weeks and again after 6 weeks of treatment.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Lu AA24530	per oral, once daily for 6 weeks
DRUG	Duloxetine	per oral, once daily for 6 weeks
DRUG	Placebo	per oral, once daily for 6 weeks

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-03-01
• Completion: 2009-04-01
• First posted: 2008-01-24
• Last updated: 2016-11-08

Locations

72 sites across 17 countries: Australia, Austria, Belgium, Canada, Czechia, Finland, France, India, Lithuania, Malaysia, Norway, Philippines, Russia, Serbia, South Korea, Sweden, Ukraine