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临床试验/NCT00130676
NCT00130676已完成3 期

A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of CORLUX™ (Mifepristone) in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features

Corcept Therapeutics22 个研究点 分布在 1 个国家目标入组 257 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
257
试验地点
22
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 600 mg

Experimental

干预措施: Mifepristone (Drug)

matching placebo

Placebo Comparator

干预措施: matching placebo (Drug)

结局指标

主要结局

The change in a measure of psychosis

时间窗: screening and on Days 0, 7, 14, 28, 42, and 56

次要结局

  • The change in a measure of depression(screening and on Days 0, 7, 14, 28, 42, and 56)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (22)

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