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| ID | Type | Description | Link |
|---|---|---|---|
| VII-IT-09 | Other Grant/Funding Number | Forest Research Institute |
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PI left institution
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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vilazodone | Experimental | Vilazodone |
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| Sertraline | Active Comparator | Sertraline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Sexual Functioning Questionnaire (CSFQ (c)) | Baseline-11 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajnish Mago, MD | Thomas Jefferson University | Principal Investigator |
| Michael Thase, MD | University of Pennsylvania | Principal Investigator |
| Anita Clayton, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States | ||
| Thomas Jefferson University |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D000069503 | Vilazodone Hydrochloride |
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001572 | Benzofurans |
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| Sertraline | Drug | Sertraline hydrochloride (trade names Zoloft, Lustral) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. |
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| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| D001523 |
| Mental Disorders |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007211 | Indoles |
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |