A Multi-Center, Randomized, Double-Blind, Parallel-Group Study Evaluating The Sexual Functioning of Healthy Adults After Receiving Multiple-Dose Regimens of Vilazodone, Paroxetine, or Placebo
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 4
- 主要终点
- Change in Changes in Sexual Functioning Questionnaire (CSFQ) total score
研究概览
简要总结
To compare the effects of vilazodone, paroxetine and placebo on sexual function in sexually active healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female, aged 18 through 45 years, inclusive
- •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.
排除标准
- •Have sexual dysfunction
- •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
研究组 & 干预措施
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
干预措施: Vilazodone 40 mg (Drug)
Vilazodone 20 mg
Vilazodone 10 mg once daily for 7 days, followed by vilazodone 20 mg once daily for 28 days.
干预措施: Vilazodone 20 mg (Drug)
Paroxetine 20 mg
Paroxetine 10 mg once daily for 7 days, followed by paroxetine 20 mg for 28 days
干预措施: Paroxetine 20 mg (Drug)
Placebo
Placebo once daily for 35 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Changes in Sexual Functioning Questionnaire (CSFQ) total score
时间窗: From Baseline to Day 35
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.
次要结局
- Proportion of subjects meeting criteria for sexual dysfunction.(5 Weeks)