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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02097147
Enrollment
202
Registered
2014-03-26
Start date
2014-03-31
Completion date
2014-11-30
Last updated
2015-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Viibryd

Brief summary

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

Interventions

DRUGVilazodone 20 mg

Oral administration, once per day.

DRUGVilazodone 40 mg

Oral administration, once per day.

DRUGParoxetine 20 mg

Oral administration, once per day.

DRUGPlacebo

Oral administration, once per day.

Sponsors

Forest Laboratories
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Changes in Sexual Functioning Questionnaire (CSFQ) total scoreFrom Baseline to Day 35The 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

MeasureTime frameDescription
Proportion of subjects meeting criteria for sexual dysfunction.5 WeeksProportion 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026