Does Vilazodone Help With Antidepressant-associated Sexual Dysfunction?



Status:Recruiting
Conditions:Depression, Major Depression Disorder (MDD), Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:January 2013
End Date:June 2018
Contact:Rajnish Mago, MD
Email:rajnish.mago@jefferson.edu
Phone:215-955-9474

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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.

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
We found this trial at
3
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Michael Thase, MD
Phone: 215-746-6419
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Anita Clayton, MD
Phone: 434-243-4646
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Rajnish Mago, MD
Phone: 215-503-1662
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Philadelphia, PA
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