Does Vilazodone Help With Antidepressant-associated Sexual Dysfunction?

NCT ID: NCT01856127

Last Updated: 2016-08-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-06-30

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.

Conditions

Sexual Dysfunction; Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vilazodone

Vilazodone

Group Type: EXPERIMENTAL

Vilazodone

Intervention Type: 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

Sertraline

Sertraline

Group Type: ACTIVE_COMPARATOR

Sertraline

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Sertraline

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

Intervention Type: DRUG

Other Intervention Names

Viibryd; Zoloft

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rajnish Mago, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Michael Thase, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Anita Clayton, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

VII-IT-09

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

VII-IT-09

Identifier Type: -

Identifier Source: org_study_id