NCT01323478

Open-label Safety Extension Study of 15 and 20 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults

A Long-term, Open-label, Flexible-dose, Extension Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 (15 and 20 mg/Day) in Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Vortioxetine (Lu AA21004)	15 or 20 mg/day; tablets; orally

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-09-01
• Completion: 2012-10-01
• First posted: 2011-03-25
• Last updated: 2014-02-11
• Results posted: 2014-02-11