Status:
TERMINATED
Does Vilazodone Help With Antidepressant-associated Sexual Dysfunction?
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Forest Laboratories
Conditions:
Sexual Dysfunction
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 s...
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 ...
Eligibility Criteria
Inclusion
- Patients must be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel about adverse events and concomitant medication use;
- Patients with major depressive disorder who are being treated with a selective serotonin reuptake inhibitor (citalopram, escitalopram, fluvoxamine, or paroxetine) or serotonin-norepinephrine reuptake inhibitor (desvenlafaxine, duloxetine, venlafaxine) for a minimum of 8 weeks.
- The current episode of MDD is in remission (MADRS score \< 10 and CGI score of 1 or 2)
- The duration of the current MDD episode is less than 2 years
- Presence of antidepressant-associated sexual dysfunction (i.e., absence of sexual dysfunction prior to becoming depressed and presence of significant dysfunction while on the SSRI or SNRI despite being in remission from the depression).
- Patient is at least 18 years old and not more than 65 years old
- Patients must have the opportunity for sexual activity during the study period (in the form of availability of a suitable partner for sexual activity and/or openness to masturbation)
- Patients must be willing to attempt some sexual activity (including masturbation) at least once every two weeks during the study
Exclusion
- Patients who have previously failed to respond to or to tolerate either vilazodone or sertraline.
- Patients with a history of severe discontinuation symptoms on tapering off the current antidepressant
- Patients with other known causes of sexual dysfunction
- Use of prohibited medications during the study period
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01856127
Start Date
January 1 2013
End Date
June 1 2016
Last Update
August 25 2016
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
2
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
3
University of Virginia
Charlottesville, Virginia, United States, 22908