Does Vilazodone Help With Antidepressant-associated Sexual Dysfunction?

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Thomas Jefferson University
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01856127
First received: March 21, 2013
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Sexual Dysfunction
Major Depressive Disorder
Drug: Vilazodone
Drug: Sertraline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Changes in Sexual Functioning Questionnaire (CSFQ (c)) [ Time Frame: Baseline-11 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vilazodone
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
Sertraline
Drug: Sertraline
Sertraline hydrochloride (trade names Zoloft, Lustral) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class.
Other Name: Zoloft

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01856127

Contacts
Contact: Rajnish Mago, MD 215-955-9474 rajnish.mago@jefferson.edu
Contact: Kelly Huhn, BS 215-503-1662 kelly.huhn@jefferson.edu

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Kelly Huhn, BS    215-503-1662    kelly.huhn@jefferson.edu   
Contact: Tania Ruggiero    215-955-9474    tania.ruggiero@jefferson.edu   
Principal Investigator: Rajnish Mago, MD         
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lalita Luthra    215-746-6419    luthra@mail.med.upenn.edu <luthra@mail.med.upenn.edu>;   
Principal Investigator: Michael Thase, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Dea Papajorgji    434-243-4646    DP3FC@hscmail.mcc.virginia.edu   
Principal Investigator: Anita Clayton, MD         
Sponsors and Collaborators
Thomas Jefferson University
Forest Laboratories
Investigators
Principal Investigator: Rajnish Mago, MD Thomas Jefferson University
Principal Investigator: Michael Thase, MD University of Pennsylvania
Principal Investigator: Anita Clayton, MD University of Virginia
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01856127     History of Changes
Other Study ID Numbers: VII-IT-09, VII-IT-09
Study First Received: March 21, 2013
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:
Sexual Dysfunction
Antidepressant
Major Depressant
SSRI
SNRI
Vilazodone
Sertraline

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Sertraline
Serotonin Uptake Inhibitors
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014