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临床试验/NCT00128505
NCT00128505已完成3 期

An International, Open-Label Extension Study of the Safety and Tolerability of CORLUX™ (Mifepristone) for Recurrent Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features

Corcept Therapeutics19 个研究点 分布在 4 个国家目标入组 104 人开始时间: 2005年8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
104
试验地点
19
主要终点
To evaluate the safety and tolerability of Corlux (mifepristone) for the treatment of recurrent psychotic symptoms with major depression with psychotic features (PMD) who previously participated in Corcept Therapeutics Protocol C-1073-09

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 study is to allow patients who have already participated in an earlier 8 week study of Corlux versus placebo (an inactive pill) to receive additional courses of treatment with Corlux periodically if a psychotic episode should reappear during a period of one year.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Completed participation through Day 56 in Corcept Therapeutics Protocol C-1073-09
  • 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

  • Have a major medical problem
  • Have a history of an allergic reaction to CORLUX (C-1073, mifepristone)

研究组 & 干预措施

mifepristone

Experimental

干预措施: Mifepristone (Drug)

结局指标

主要结局

To evaluate the safety and tolerability of Corlux (mifepristone) for the treatment of recurrent psychotic symptoms with major depression with psychotic features (PMD) who previously participated in Corcept Therapeutics Protocol C-1073-09

次要结局

  • To assess the frequency of retreatment with Corlux in patients with PMD and qualitatively describe the psychotic symptoms for which retreatment is clinically indicated

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (19)

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