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

NCT02097147 | Completed Phase 1

• 1 other identifier: VLZ-MD-24
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Healthy

Keywords

Viibryd

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of subjects meeting criteria for sexual dysfunction.

  5 Weeks

Study Arms (4)

Vilazodone 20 mg

EXPERIMENTAL

Vilazodone 10 mg once daily for 7 days, followed by vilazodone 20 mg once daily for 28 days.

Drug: Vilazodone 20 mg

Vilazodone 40 mg

EXPERIMENTAL

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

Paroxetine 20 mg

ACTIVE COMPARATOR

Paroxetine 10 mg once daily for 7 days, followed by paroxetine 20 mg for 28 days

Drug: Paroxetine 20 mg

Placebo

PLACEBO COMPARATOR

Placebo once daily for 35 days

Drug: Placebo

Interventions

Vilazodone 20 mg DRUG

Oral administration, once per day.

Also known as: Viibyrd

Vilazodone 20 mg

Vilazodone 40 mg DRUG

Oral administration, once per day.

Also known as: Viibryd

Vilazodone 40 mg

Paroxetine 20 mg DRUG

Oral administration, once per day.

Also known as: Paxil

Paroxetine 20 mg

Placebo DRUG

Oral administration, once per day.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (4)

Forest Investigative Site 001

Miami, Florida, 33014, United States

Location

Forest Investigative Site 002

Overland Park, Kansas, 66212, United States

Location

Forest Investigative Site 003

Saint Paul, Minnesota, 55114, United States

Location

Forest Investigative Site 004

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Interventions

Vilazodone Hydrochloride; Paroxetine

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Piperidines

Study Officials

• Maju Mathews, MD

  Forest Laboratories

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 26, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 12, 2015

Record last verified: 2015-02

Locations

US (4)