NCT00316160已完成4 期
A Twelve-week, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group, Active Controlled, Escalating Dose Study to Compare the Effects on Sexual Functioning of Bupropion Hydrochloride Extended-release (WELLBUTRIN XL, 150-450 mg/Day) and Extended-release Venlafaxine (EFFEXOR XR, 75-225 mg/Day) in Subjects With Major Depressive Disorder
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 347
- 试验地点
- 45
- 主要终点
- To compare the effects of bupropion XL and venlafaxine XR on overall sexual functioning in outpatients with MDD as measured by mean changes in CSFQ-S total scores across Weeks 5, 6, 9 and 12.
研究概览
简要总结
Effects of two depression medication on sexual functioning
详细描述
A Twelve-week, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group, Active controlled, Escalating Dose Study to Compare the Effects on Sexual Functioning of Bupropion Hydrochloride Extended-release (WELLBUTRIN XL, 150-450 mg/day) and Extended-release Venlafaxine (EFFEXOR XR, 75-225 mg/day) in Subjects with Major Depressive Disorder
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
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)
- •must have met DSM-IV criteria for current major depressive episode for at least 8 weeks but no long than 2 years.
- •HAM-D17 total score of >17 at screening and baseline.
- •Severity of illness score of >4 at screening and baseline.
- •Willing to discuss sexual functioning with investigator or designee.
- •Sexual activity that leads to orgasm at least every 2 weeks.
排除标准
- •Past or current DSM-IV diagnosis of Bipolar Disorder I or II, schizophrenia or another psychotic disorder(s).
- •Primary DSM-IV diagnosis or received treatment for Panic Disorder, Obsessive Compulsive Disorder or Post Stress Disorder within previous 12 months.
- •Poses a homicidal or serious suicidal risk, have made an attempt within months prior to screening or who has ever been homicidal.
- •Myocardial infarction with 1 year of screening.
- •Taken ibupropion hydrochloride or venlafaxine in the last 6 months.
- •Positive urine test for illicit drug use or alcohol or substance abuse within the past 12 months.
- •Psychotherapy within 3 months.
- •Pregnant.
- •Electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior of screening.
- •ECG or clinical evidence of atrial or ventricular hypertrophy.
结局指标
主要结局
To compare the effects of bupropion XL and venlafaxine XR on overall sexual functioning in outpatients with MDD as measured by mean changes in CSFQ-S total scores across Weeks 5, 6, 9 and 12.
次要结局
- Efficacy, Safety, Tolerability, Health Outcome
研究者
研究点 (45)
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