NCT01152996

Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study

A Phase 3, Long-Term, Open-Label, Flexible-Dose, Extension Study Evaluating the Safety and Tolerability of Lu AA21004 (15 and 20 mg) in Subjects With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,075 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 77 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the long-term safety and tolerability of vortioxetine, once daily (QD), in participants with major depressive disorder.

Detailed description

Depression has been recognized as a chronic illness that imposes a significant burden on individuals, families and society. Major depressive disorder (MDD) is among the most important causes of disability worldwide, in both developing and developed countries. Major depressive disorder is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. Major depressive disorder is characterized by the presence of 1 or more major depressive episodes 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. This is a multicenter extension study designed to allow eligible patients who have completed short-term efficacy and safety studies LuAA21004\_315 (NCT01153009), LuAA21004\_316 (NCT01163266) and LuAA21004\_317 (NCT01179516) to receive the 52-week treatment with vortioxetine in this open-label extension study. Participants are expected to return to the site for approximately 13 visits. A safety follow-up call will be made 4 weeks after completion of the 52-week treatment period.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Vortioxetine	Vortioxetine tablets

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2010-06-29
• Last updated: 2014-05-28
• Results posted: 2014-05-28