Healthy Volunteers Clinical Trial
Official title:
A Randomized, Double-Blind, Parallel Group, Placebo- and Active-Controlled, Phase 4 Study Evaluating the Effect of Vortioxetine 10 and 20 mg/Day vs Paroxetine 20 mg/Day on Sexual Functioning in Healthy Subjects
The purpose of this study is to evaluate the effect of vortioxetine (10 and 20 mg, once daily) versus paroxetine (20 mg, once daily) on sexual functioning in healthy participants after 5 weeks of double-blind treatment.
The drug being tested in this study is called vortioxetine. This study will look at the
effect of treatment on sexual functioning in healthy participants.
The study will enroll approximately 352 participants. Participants will be randomly assigned
(by chance, like flipping a coin) to one of the four treatment groups—which will remain
undisclosed to the patient and study doctor during the study (unless there is an urgent
medical need):
- Vortioxetine 10 mg
- Vortioxetine 20 mg
- Paroxetine 20 mg
- Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has
no active ingredient
All participants will be asked to take one tablet/capsule, daily, orally for up to 5 weeks.
This multicenter trial will be conducted in United States. The overall time to participate in
this study is approximately 7 weeks. Participants will be contacted by telephone 2 weeks
after last dose of study drug for a follow-up assessment.
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