NCT00051272已完成3 期
A Multicenter, Double-blind Randomized Placebo-controlled Comparison of the Effects on Sexual Functioning of Extended-release Bupropion Hydrochloride (300-450mg) and Escitalopram (10-20mg) in Outpatients With Moderate to Severe Major Depression Over an Eight-Week Treatment Period
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 425
- 试验地点
- 24
- 主要终点
- Percent of subjects with orgasm dysfunction. Change from baseline in HAMD-17 total score.
研究概览
简要总结
This study will evaluate the effects of two antidepression medications on sexual functioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of Major Depressive Disorder (MDD) with current duration lasting 12 weeks but no greater than 2 years.
- •Subjects must engage in sexual activity that leads to orgasm at least once every two weeks.
- •Subject must have normal orgasmic function and be willing to discuss with investigator.
排除标准
- •Subjects that have arousal or orgasm dysfunction.
- •Has previously failed to respond to two adequate trials of antidepressants in past 2 years.
- •Subject has other unstable medical disorders.
- •Subject has a positive urine test for illicit drug use at screening.
结局指标
主要结局
Percent of subjects with orgasm dysfunction. Change from baseline in HAMD-17 total score.
次要结局
- Percent of subjects in remission, HAMD-17. Changes in Sexual functioning Questionnaire. CGI-I and CGI-S. Percent of responders, HAMD-17.
研究者
研究点 (24)
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