Depressive Disorder, Major Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Duloxetine-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (15 and 20 mg) of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
The purpose of this study is to evaluate the efficacy, safety and tolerability of vortioxetine, once daily (QD), compared with placebo 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 614 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 15 mg
- Vortioxetine 20 mg
- Duloxetine 60 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 13 weeks. Participants made 9 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, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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