Generalized Anxiety Disorder Clinical Trial
Official title:
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of Single Dose of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder
The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in treating Generalized Anxiety Disorder.
The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested
to treat anxiety in adults who have general anxiety disorder (GAD). This study looked at GAD
relief in people who took vortioxetine.
The study enrolled 304 patients. Participants were randomly assigned (by chance, like
flipping a coin) to one of the two treatment groups—which remained undisclosed to the
patient and study doctor during the study (unless there was an urgent medical need):
- Vortioxetine 5 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-center trial was conducted in the United States. The overall time to participate
in this study was up to 13 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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