Study to Evaluate the Sexual Functioning of Healthy Adults After Receiving Vilazodone, Paroxetine or Placebo
NCT ID: NCT02097147
Last Updated: 2015-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
202 participants
INTERVENTIONAL
2014-03-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Vilazodone 20 mg
Vilazodone 10 mg once daily for 7 days, followed by vilazodone 20 mg once daily for 28 days.
Vilazodone 20 mg
Oral administration, once per day.
Vilazodone 40 mg
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
Vilazodone 40 mg
Oral administration, once per day.
Paroxetine 20 mg
Paroxetine 10 mg once daily for 7 days, followed by paroxetine 20 mg for 28 days
Paroxetine 20 mg
Oral administration, once per day.
Placebo
Placebo once daily for 35 days
Placebo
Oral administration, once per day.
Interventions
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Vilazodone 20 mg
Oral administration, once per day.
Vilazodone 40 mg
Oral administration, once per day.
Paroxetine 20 mg
Oral administration, once per day.
Placebo
Oral administration, once per day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently sexually active
* If female, non pregnant and agree to use acceptable for of contraception during
* If male, be sterile or have partner use contraception.
Exclusion Criteria
* Have history of diagnosis or treatment of any disorder related to sexual functioning.
* Clinically significant disease state, in the opinion of the examining physician, in any body system
* History of alcohol or other substance abuse or dependence within the previous 5 years
18 Years
45 Years
ALL
Yes
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Maju Mathews, MD
Role: STUDY_DIRECTOR
Forest Laboratories
Locations
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Forest Investigative Site 001
Miami, Florida, United States
Forest Investigative Site 002
Overland Park, Kansas, United States
Forest Investigative Site 003
Saint Paul, Minnesota, United States
Forest Investigative Site 004
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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VLZ-MD-24
Identifier Type: -
Identifier Source: org_study_id
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