A Phase 1 interventional study of Vilazodone 20 mg and Vilazodone 40 mg in Healthy, sponsored by Forest Laboratories. Completed at 4 sites in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-12.
Sponsored by Forest Laboratories · Phase 1 and Interventional
To compare the effects of vilazodone, paroxetine and placebo on sexual function in sexually active healthy adults.
Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vilazodone 10 mg once daily for 7 days, followed by vilazodone 20 mg once daily for 28 days.
Drug: Vilazodone 20 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
Drug: Vilazodone 40 mg
Paroxetine 10 mg once daily for 7 days, followed by paroxetine 20 mg for 28 days
Drug: Paroxetine 20 mg
Placebo once daily for 35 days
Drug: Placebo
Oral administration, once per day.
Also known as: Viibyrd
Oral administration, once per day.
Also known as: Viibryd
Oral administration, once per day.
Also known as: Paxil
Oral administration, once per day.
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.
Time frame: From Baseline to Day 35
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.
Time frame: 5 Weeks
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Forest Laboratories