NCT01856127

Does Vilazodone Help With Antidepressant-associated Sexual Dysfunction?

A Randomized, Double-Blind, Active Controlled Clinical Trial of Switching to Vilazodone for Antidepressant-Associated Sexual Dysfunction

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a three-center, randomized, double-blind, fixed dose study designed to assess the efficacy, safety, and tolerability of a switch to vilazodone for sexual dysfunction associated with use of a selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI)compared to switching to sertraline in patients with Major Depressive Disorder (MDD). Vilazodone is a newly introduced, FDA approved antidepressant that is a combined serotonin specific reuptake inhibitor and serotonin 1A receptor partial agonist. In contrast to the SSRIs and SNRIs, appears to have low adverse effects on sexual functioning when compared to placebo.

Detailed description

The design will be a randomized, double blind study with patients being randomized to switching to either vilazodone or sertraline. This will consist of a 1-week Screening phase, a 2-week Cross Taper phase, an 8-week Treatment phase, and an optional 2-week Down taper phase. The total duration of each patient's participation will be 13 weeks. Seventy-two patients will be randomized at the Baseline visit to either vilazodone or sertraline, 24 at each of the 3 sites. Patients will be recruited over 12 months.

Conditions

• Sexual Dysfunction
• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Vilazodone	Vilazodone is a newly introduced antidepressant which, in contrast to the selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) appears to have a minimal adverse effect on sexual functioning
DRUG	Sertraline	Sertraline hydrochloride (trade names Zoloft, Lustral) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class.

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2013-05-17
• Last updated: 2016-08-25

Locations

3 sites across 1 country: United States