Study to Evaluate the Sexual Functioning of Healthy Adults After Receiving Vilazodone, Paroxetine or Placebo

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Paroxetine 20 mg; Drug: Vilazodone 20 mg; Drug: Vilazodone 40 mg; Drug: Placebo

• Registration Number: NCT02097147
• Lead Sponsor: Forest Laboratories

Brief Summary

To compare the effects of vilazodone, paroxetine and placebo on sexual function in sexually active healthy adults.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-03-25
• Study First Posted: 2014-03-26
• Primary Completion: 2014-09
• Study Completion: 2014-11
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-11
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

• Healthy male or female, aged 18 through 45 years, inclusive
• Currently sexually active
• If female, non pregnant and agree to use acceptable for of contraception during
• If male, be sterile or have partner use contraception.

Exclusion Criteria

• Have sexual dysfunction
• Have history of diagnosis or treatment of any disorder related to sexual functioning.
• Clinically significant disease state, in the opinion of the examining physician, in any body system
• History of alcohol or other substance abuse or dependence within the previous 5 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paroxetine 20 mg	Paroxetine 20 mg	Paroxetine 10 mg once daily for 7 days, followed by paroxetine 20 mg for 28 days
Vilazodone 20 mg	Vilazodone 20 mg	Vilazodone 10 mg once daily for 7 days, followed by vilazodone 20 mg once daily for 28 days.
Vilazodone 40 mg	Vilazodone 40 mg	Vilazodone 10 mg once daily for 7 days, followed by vilazodone 20 mg once daily for 7 days, followed by vilazodone 40 mg once daily for 21 days
Placebo	Placebo	Placebo once daily for 35 days

Primary Outcome Measures

Name	Time	Method
Change in Changes in Sexual Functioning Questionnaire (CSFQ) total score	From Baseline to Day 35	The CSFQ is a subject-rated scale designed to measure changes in sexual function and is a structured, self-report, 14-item questionnaire, that measures sexual functioning as a total score (all 14 items), and on the subscales of pleasure, desire/frequency, desire/interest, arousal, and orgasm, rated on a 5 point scale, with each item rated from 1 to 5, and a total score range of 14 to 70. Lower scores are associated with worsened sexual functioning.

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects meeting criteria for sexual dysfunction.	5 Weeks	Proportion of subjects meeting criteria for sexual dysfunction (ie, CSFQ \<=47 for males and \<=41 for females) at any 2 consecutive visits during the double-blind treatment period.

Trial Locations

Locations (4)

Forest Investigative Site 001; 🇺🇸 Miami, Florida, United States

Forest Investigative Site 002; 🇺🇸 Overland Park, Kansas, United States

Forest Investigative Site 004; 🇺🇸 Charlottesville, Virginia, United States

Forest Investigative Site 003; 🇺🇸 St. Paul, Minnesota, United States