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OpenTrials
Completed

NCT Number: NCT02097147

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

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Forest Investigative Site 001, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vilazodone 20 mg

Drug

Oral administration, once per day.

Other names: Viibyrd

Vilazodone 40 mg

Drug

Oral administration, once per day.

Other names: Viibryd

Paroxetine 20 mg

Drug

Oral administration, once per day.

Other names: Paxil

Placebo

Drug

Oral administration, once per day.

Primary outcomes

  1. Change in Changes in Sexual Functioning Questionnaire (CSFQ) total score

    Time frame: 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

  1. Proportion of subjects meeting criteria for sexual dysfunction.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 26, 2014
Registry last updated
Feb 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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