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临床试验/NCT00128479
NCT00128479已完成3 期

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)

Corcept Therapeutics44 个研究点 分布在 1 个国家目标入组 443 人开始时间: 2004年9月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

干预措施: mifepristone (Drug)

placebo

Placebo Comparator

干预措施: mifepristone matched placebo (Drug)

mifepristone 600 mg

Experimental

干预措施: mifepristone 600 mg (Drug)

mifepristone 1200 mg

Experimental

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (44)

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