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

Forest Laboratories

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Vilazodone 20 mg; Drug: Paroxetine 20 mg; Drug: Vilazodone 40 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02097147

VLZ-MD-24

Details and patient eligibility

About

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

Enrollment: 202 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: 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

Trial design

202 participants in 4 patient groups, including a placebo group

Vilazodone 20 mg

Experimental group

Description:

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

Treatment:

Drug: Vilazodone 20 mg

Vilazodone 40 mg

Experimental group

Description:

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

Treatment:

Drug: Vilazodone 40 mg

Paroxetine 20 mg

Active Comparator group

Description:

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

Treatment:

Drug: Paroxetine 20 mg

Placebo

Placebo Comparator group

Description:

Placebo once daily for 35 days

Treatment:

Drug: Placebo