Does Vilazodone Help With Antidepressant-associated Sexual Dysfunction?

NCT01856127 | Terminated Phase 4

• 1 other identifier: VII-IT-09
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

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.

Conditions

Sexual Dysfunction; Major Depressive Disorder

Keywords

Sexual Dysfunction; Antidepressant; Major Depressant; SSRI; SNRI; Vilazodone; Sertraline

Outcome Measures

Primary Outcomes (1)

• Changes in Sexual Functioning Questionnaire (CSFQ (c))

  Baseline-11 weeks

Study Arms (2)

Vilazodone

EXPERIMENTAL

Vilazodone

Drug: Vilazodone

Sertraline

ACTIVE COMPARATOR

Sertraline

Drug: Sertraline

Interventions

Vilazodone DRUG

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

Also known as: Viibryd

Vilazodone

Sertraline DRUG

Sertraline hydrochloride (trade names Zoloft, Lustral) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class.

Also known as: Zoloft

Sertraline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Forest Laboratories: collaborator

Study Sites (3)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Depressive Disorder, Major

Interventions

Vilazodone Hydrochloride; Sertraline

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; 1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Rajnish Mago, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Michael Thase, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Anita Clayton, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: May 17, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 25, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)