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

Depressive Disorder, Major Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

• NCT number: NCT01152996
• Study type: Interventional
• Source: Takeda
• Status: Completed
• Phase: Phase 3
• Start date: September 2010
• Completion date: May 2013