NCT02972632

Goal Achievement After a Change to Vortioxetine in Adults With Major Depressive Disorder

An Open-Label, Single-Arm, Multicenter, Prospective, Phase 4, Interventional, Flexible Dose Study to Evaluate the Effectiveness of Vortioxetine on Goal Achievement After a Change in Antidepressant Medication for the Treatment of Subjects With Major Depressive Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effectiveness of treatment with vortioxetine on participant goal achievement after a change in antidepressant medication for the treatment of major depressive disorder (MDD).

Detailed description

The drug being tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in people who have major depressive disorder. This study will look at effectiveness of treatment with vortioxetine in participant's goal achievement for the treatment of major depressive disorder. The study enrolled 123 patients. Participants will receive: • Vortioxetine 10 to 20 mg All participants will be asked to take one tablet at the same time each day throughout the study. The participants will receive a starting dose of 10 mg. The dose may be up-titrated to 20 mg. The dose may then be decreased by 5 mg based on participant's response and tolerability to higher dose as judged by the Investigator. This multi-center trial will be conducted in Unites States. The overall time to participate in this study is 19 weeks. Participants will make multiple visits to the clinic and will be contacted by telephone for 4 weeks after last dose of study drug for a follow-up assessment.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Vortioxetine	Vortioxetine tablet

Timeline

• Start date: 2016-12-22
• Primary completion: 2018-02-06
• Completion: 2018-02-06
• First posted: 2016-11-23
• Last updated: 2019-07-11
• Results posted: 2019-07-11

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study