Does Vilazodone Help With Antidepressant-associated Sexual Dysfunction?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01856127
Recruitment Status : Terminated (PI left institution)
First Posted : May 17, 2013
Last Update Posted : August 25, 2016
Forest Laboratories
Information provided by (Responsible Party):
Thomas Jefferson University

March 21, 2013
May 17, 2013
August 25, 2016
January 2013
June 2016   (Final data collection date for primary outcome measure)
Changes in Sexual Functioning Questionnaire (CSFQ (c)) [ Time Frame: Baseline-11 weeks ]
Same as current
Complete list of historical versions of study NCT01856127 on Archive Site
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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

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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Sexual Dysfunction
  • Major Depressive Disorder
  • 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
    Other Name: Viibryd
  • Drug: Sertraline
    Sertraline hydrochloride (trade names Zoloft, Lustral) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class.
    Other Name: Zoloft
  • Experimental: Vilazodone
    Intervention: Drug: Vilazodone
  • Active Comparator: Sertraline
    Intervention: Drug: Sertraline
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2016
June 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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;
  2. 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.
  3. The current episode of MDD is in remission (MADRS score < 10 and CGI score of 1 or 2)
  4. The duration of the current MDD episode is less than 2 years
  5. 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).
  6. Patient is at least 18 years old and not more than 65 years old
  7. 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)
  8. Patients must be willing to attempt some sexual activity (including masturbation) at least once every two weeks during the study

Exclusion Criteria:

  1. Patients who have previously failed to respond to or to tolerate either vilazodone or sertraline.
  2. Patients with a history of severe discontinuation symptoms on tapering off the current antidepressant
  3. Patients with other known causes of sexual dysfunction
  4. Use of prohibited medications during the study period
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
VII-IT-09 ( Other Grant/Funding Number: Forest Research Institute )
Not Provided
Plan to Share IPD: No
Thomas Jefferson University
Thomas Jefferson University
Forest Laboratories
Principal Investigator: Rajnish Mago, MD Thomas Jefferson University
Principal Investigator: Michael Thase, MD University of Pennsylvania
Principal Investigator: Anita Clayton, MD University of Virginia
Thomas Jefferson University
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP