Major Depressive Disorder Clinical Trial
Official title:
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.
The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested
to treat depression in adults who have major depressive disorder (MDD). This study looked at
MDD relief in people who took varying dosages of vortioxetine.
The study enrolled 611 patients. Participants were randomly assigned (by chance, like
flipping a coin) to one of the four treatment groups—which remained undisclosed to the
patient and study doctor during the study (unless there was an urgent medical need):
- Vortioxetine 2.5 mg
- Vortioxetine 5 mg
- Duloxetine 10 mg
- Placebo (dummy inactive capsule) - this was a capsule that looked like the study drug
but had no active ingredient.
All participants were asked to take one capsule at the same time each day throughout the
study.
This multi-center trial was conducted in the United States. The overall time to participate
in this study was up to 12 weeks. Participants made 8 visits to the clinic, and were
contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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