Does Vilazodone Help With Antidepressant-associated Sexual Dysfunction?
Primary Purpose
Sexual Dysfunction, Major Depressive Disorder
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vilazodone
Sertraline
Sponsored by
About this trial
This is an interventional treatment trial for Sexual Dysfunction focused on measuring Sexual Dysfunction, Antidepressant, Major Depressant, SSRI, SNRI, Vilazodone, Sertraline
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- University of Pennsylvania
- Thomas Jefferson University
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vilazodone
Sertraline
Arm Description
Vilazodone
Sertraline
Outcomes
Primary Outcome Measures
Changes in Sexual Functioning Questionnaire (CSFQ (c))
Secondary Outcome Measures
Full Information
NCT ID
NCT01856127
First Posted
March 21, 2013
Last Updated
August 24, 2016
Sponsor
Thomas Jefferson University
Collaborators
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT01856127
Brief Title
Does Vilazodone Help With Antidepressant-associated Sexual Dysfunction?
Official Title
A Randomized, Double-Blind, Active Controlled Clinical Trial of Switching to Vilazodone for Antidepressant-Associated Sexual Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
PI left institution
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
Collaborators
Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Major Depressive Disorder
Keywords
Sexual Dysfunction, Antidepressant, Major Depressant, SSRI, SNRI, Vilazodone, Sertraline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vilazodone
Arm Type
Experimental
Arm Description
Vilazodone
Arm Title
Sertraline
Arm Type
Active Comparator
Arm Description
Sertraline
Intervention Type
Drug
Intervention Name(s)
Vilazodone
Other Intervention Name(s)
Viibryd
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
Zoloft
Intervention Description
Sertraline hydrochloride (trade names Zoloft, Lustral) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class.
Primary Outcome Measure Information:
Title
Changes in Sexual Functioning Questionnaire (CSFQ (c))
Time Frame
Baseline-11 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajnish Mago, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Thase, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anita Clayton, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Does Vilazodone Help With Antidepressant-associated Sexual Dysfunction?
We'll reach out to this number within 24 hrs