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

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

Official Title
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A Multi-Center, Randomized, Double-Blind, Parallel-Group Study Evaluating The Sexual Functioning of Healthy Adults After Receiving Multiple-Dose Regimens of Vilazodone, Paroxetine, or Placebo

Conditions
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Healthy

Intervention / Treatment
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* Drug: Vilazodone 20 mg
* Drug: Vilazodone 40 mg
* Drug: Paroxetine 20 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vilazodone 20 mg<br>Vilazodone 10 mg once daily for 7 days, followed by vilazodone 20 mg once daily for 28 days. | Drug: Vilazodone 20 mg<br>* Oral administration, once per day.<br>* Other names: Viibyrd;|
| Experimental: Vilazodone 40 mg<br>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 | Drug: Vilazodone 40 mg<br>* Oral administration, once per day.<br>* Other names: Viibryd;|
| Active Comparator: Paroxetine 20 mg<br>Paroxetine 10 mg once daily for 7 days, followed by paroxetine 20 mg for 28 days | Drug: Paroxetine 20 mg<br>* Oral administration, once per day.<br>* Other names: Paxil;|
| Placebo Comparator: Placebo<br>Placebo once daily for 35 days | Drug: Placebo<br>* Oral administration, once per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Changes in Sexual Functioning Questionnaire (CSFQ) total score | 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. | From Baseline to Day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects meeting criteria for sexual dysfunction. | 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. | 5 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Viibryd