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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

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 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.

Condition or disease Intervention/treatment Phase
Sexual Dysfunction Major Depressive Disorder Drug: Vilazodone Drug: Sertraline Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Active Controlled Clinical Trial of Switching to Vilazodone for Antidepressant-Associated Sexual Dysfunction
Study Start Date : January 2013
Primary Completion Date : June 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vilazodone
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
Active Comparator: Sertraline
Drug: Sertraline
Sertraline hydrochloride (trade names Zoloft, Lustral) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class.
Other Name: Zoloft

Primary Outcome Measures :
  1. Changes in Sexual Functioning Questionnaire (CSFQ (c)) [ Time Frame: Baseline-11 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01856127

United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
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

Responsible Party: Thomas Jefferson University Identifier: NCT01856127     History of Changes
Other Study ID Numbers: VII-IT-09
VII-IT-09 ( Other Grant/Funding Number: Forest Research Institute )
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Thomas Jefferson University:
Sexual Dysfunction
Major Depressant

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Vilazodone Hydrochloride
Serotonin Uptake Inhibitors
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists