Sexual Dysfunction | Does Vilazodone Help With Antidepressant-associated Sexual Dysfunction?
Sexual Dysfunction research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Major Depressive Disorder
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:VilazodoneVilazodone 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
Drug:SertralineSertraline hydrochloride (trade names Zoloft, Lustral) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: January 2013
Completed Date: June 2016
Phase: Phase 4
Primary Outcome: Changes in Sexual Functioning Questionnaire (CSFQ (c))
Study sponsors, principal investigator, and references
Principal Investigator: Rajnish Mago, MD
Lead Sponsor: Thomas Jefferson University
Collaborator: Forest Laboratories