A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of Three Dose Levels of CORLUX™ (Mifepristone) Plus an Antidepressant vs. Placebo Plus an Antidepressant in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features (PMD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 443
- 试验地点
- 44
- 主要终点
- The change in a measure of psychosis
研究概览
简要总结
Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol. Under normal conditions, cortisol and other hormones are created by the body in response to physical and emotional stress, triggering a healthy stress response. People who suffer from psychotic major depression may have unusually high levels of cortisol circulating within them or abnormal patterns of cortisol levels, overloading the stress response mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If Corlux can keep the body's cortisol receptors from being overloaded, the stress response system may return to normal function, which may result in improvement of symptoms. The purpose of this 56 day study is to learn the safety and effectiveness of Corlux in patients who have been diagnosed with psychotic major depression (PMD).
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals eligible for enrollment into this study are male and female adult patients who:
- •Are 18 to 75 years of age
- •Have a diagnosis of major depressive disorder with psychotic features (DSM-IV 296.24 or 296.34)
- •Are able to provide written informed consent.
排除标准
- •Individuals not eligible to be enrolled into the study are those who:
- •Have a major medical problem
- •Have previously participated in a CORLUX (C-1073, mifepristone) clinical trial
- •Have a history of an allergic reaction to CORLUX (C-1073, mifepristone).
研究组 & 干预措施
mifepristone 300 mg
干预措施: mifepristone (Drug)
placebo
干预措施: mifepristone matched placebo (Drug)
mifepristone 600 mg
干预措施: mifepristone 600 mg (Drug)
mifepristone 1200 mg
干预措施: mifepristone 1200 mg (Drug)
结局指标
主要结局
The change in a measure of psychosis
时间窗: screen, Days 0, 7, 14, 28, 42, 56
次要结局
- The change in a measure of depression(screen, Days 0,7, 14, 28, 42, 56)
