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

NCT02097147 — Phase 1, Completed, 202 participants, Forest Laboratories

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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

Registry	NCT02097147
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: triple
Enrollment	202 (Actual)
Sponsor	Forest Laboratories (Industry)
Conditions	Healthy
Interventions	Vilazodone 20 mg, Vilazodone 40 mg, Paroxetine 20 mg, Placebo (Drug)
Dates	start 2014-03-01, primary completion 2014-09-01, completion 2014-11-01, first posted 2014-03-26, last updated 2015-02-12
Locations	4 sites in United States

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Vilazodone 20 mg	Experimental	Drug: Vilazodone 20 mg	Vilazodone 10 mg once daily for 7 days, followed by vilazodone 20 mg once daily for 28 days.
Vilazodone 40 mg	Experimental	Drug: 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
Paroxetine 20 mg	Active comparator	Drug: Paroxetine 20 mg	Paroxetine 10 mg once daily for 7 days, followed by paroxetine 20 mg for 28 days
Placebo	Placebo comparator	Drug: Placebo	Placebo once daily for 35 days

Vilazodone 20 mg (Drug), also known as Viibyrd: Oral administration, once per day.
Vilazodone 40 mg (Drug), also known as Viibryd: Oral administration, once per day.
Paroxetine 20 mg (Drug), also known as Paxil: Oral administration, once per day.
Placebo (Drug): Oral administration, once per day.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers

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

+Locations (4)

Facility	City	Country
Forest Investigative Site 001	Miami, Florida	United States
Forest Investigative Site 002	Overland Park, Kansas	United States
Forest Investigative Site 003	Saint Paul, Minnesota	United States
Forest Investigative Site 004	Charlottesville, Virginia	United States

+Investigators

Maju Mathews, MD, Study director, Forest Laboratories