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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 September 2016 |
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Main ID: |
NCT01856127 |
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Date of registration:
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21/03/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Does Vilazodone Help With Antidepressant-associated Sexual Dysfunction?
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Scientific title:
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A Randomized, Double-Blind, Active Controlled Clinical Trial of Switching to Vilazodone for Antidepressant-Associated Sexual Dysfunction |
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Date of first enrolment:
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January 2013 |
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Target sample size:
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4 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01856127 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Rajnish Mago, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Thomas Jefferson University |
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Name:
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Michael Thase, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pennsylvania |
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Name:
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Anita Clayton, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Virginia |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sexual Dysfunction
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Major Depressive Disorder
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Intervention(s)
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Drug: Vilazodone
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Drug: Sertraline
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Primary Outcome(s)
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Changes in Sexual Functioning Questionnaire (CSFQ (c))
[Time Frame: Baseline-11 weeks]
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Secondary ID(s)
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VII-IT-09
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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