Major Depressive Disorder Clinical Trial
Official title:
A Randomized, Double-blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients 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 560 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 1 mg
- Vortioxetine 5 mg
- Vortioxetine 10 mg
- Placebo (dummy inactive pill) - 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-centre trial was conducted in Europe, Asia, Australia, and South Africa. The
overall time to participate in this study was up to 14 weeks. Participants made 7 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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