NCT02932904

Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 361 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Vortioxetine	Vortioxetine Overencapsulated Tablet
DRUG	Paroxetine	Paroxetine Overencapsulated Tablets.
DRUG	Placebo	Vortioxetine Placebo-matching Capsules.

Timeline

• Start date: 2016-11-21
• Primary completion: 2017-05-31
• Completion: 2017-06-09
• First posted: 2016-10-13
• Last updated: 2018-09-14
• Results posted: 2018-09-14

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study