Major Depressive Disorder Clinical Trial
Official title:
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
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).
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.
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