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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Vilazodone 20 mg; Drug: Vilazodone 40 mg; Drug: Paroxetine 20 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Forest Investigative Site 001
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Forest Investigative Site 002
  • Minnesota
    • St. Paul, Minnesota, United States, 55114
      • Forest Investigative Site 003
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Forest Investigative Site 004

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Forest Laboratories
• Investigators: Study Director: Maju Mathews, MD, Forest Laboratories

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: March 25, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Estimate): February 12, 2015
• Last Update Submitted That Met QC Criteria: February 11, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Viibryd
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine; Vilazodone Hydrochloride
• Other Study ID Numbers: VLZ-MD-24