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To compare the effects of vilazodone, paroxetine and placebo on sexual function in sexually active healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vilazodone 20 mg | Experimental | Vilazodone 10 mg once daily for 7 days, followed by vilazodone 20 mg once daily for 28 days. |
|
| Vilazodone 40 mg | Experimental | Vilazodone 10 mg once daily for 7 days, followed by vilazodone 20 mg once daily for 7 days, followed by vilazodone 40 mg once daily for 21 days |
|
| Paroxetine 20 mg | Active Comparator | Paroxetine 10 mg once daily for 7 days, followed by paroxetine 20 mg for 28 days |
|
| Placebo | Placebo Comparator | Placebo once daily for 35 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilazodone 20 mg | Drug | Oral administration, once per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Changes in Sexual Functioning Questionnaire (CSFQ) total score | The CSFQ is a subject-rated scale designed to measure changes in sexual function and is a structured, self-report, 14-item questionnaire, that measures sexual functioning as a total score (all 14 items), and on the subscales of pleasure, desire/frequency, desire/interest, arousal, and orgasm, rated on a 5 point scale, with each item rated from 1 to 5, and a total score range of 14 to 70. Lower scores are associated with worsened sexual functioning. | From Baseline to Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects meeting criteria for sexual dysfunction. | Proportion of subjects meeting criteria for sexual dysfunction (ie, CSFQ <=47 for males and <=41 for females) at any 2 consecutive visits during the double-blind treatment period. | 5 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maju Mathews, MD | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 001 | Miami | Florida | 33014 | United States | ||
| Forest Investigative Site 002 |
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| Vilazodone 40 mg | Drug | Oral administration, once per day. |
|
|
| Paroxetine 20 mg | Drug | Oral administration, once per day. |
|
|
| Placebo | Drug | Oral administration, once per day. |
|
| Overland Park |
| Kansas |
| 66212 |
| United States |
| Forest Investigative Site 003 | Saint Paul | Minnesota | 55114 | United States |
| Forest Investigative Site 004 | Charlottesville | Virginia | 22903 | United States |
| ID | Term |
|---|---|
| D000069503 | Vilazodone Hydrochloride |
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007211 | Indoles |
| D010880 | Piperidines |
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