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临床试验/NCT00725270
NCT00725270终止2 期

Treatment of Schizoaffective Disorder Using Mifepristone

Stanford University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 1998年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
12
试验地点
1
主要终点
Change in Mood Symptoms

研究概览

简要总结

This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.

详细描述

You are invited to participate in a research study which evaluates the effectiveness of mifepristone (RU 486) in rapidly reducing the symptoms associated with schizoaffective disorder. Our group believes that the cognitive deficits (a decline in the ability to think clearly) and psychosis (hallucinations or delusions) exhibited in some affective disorders are driven by an excess of stress hormone effects (hypercortisolemia). Often the origin of this hormonal imbalance is unknown. Current treatment for schizoaffective disorder (characterized by mood swings and hallucinations and/or delusions) involves using a combination of antidepressant medication (for mood elevation), mood stabilizing medications (to prevent extreme high and low moods) and antipsychotic medication (for the correction of altered thinking). While these therapies are often effective, they can take several weeks or longer to work. We hope to uncover a quick, effective, safe therapy for the treatment of individuals with your condition.

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
Triple (Participant, Investigator, Outcomes Assessor)

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

  • The subjects will be 30 inpatients or outpatients with schizoaffective disorder.

排除标准

  • Subjects must be between the ages of eighteen and seventy-five without major medical problems.

研究组 & 干预措施

Placebo

Placebo Comparator

Patients will be randomized to placebo

干预措施: Placebo Oral Tablet (Drug)

Mifepristone

Experimental

Patients will be randomized to mifepristone

干预措施: Mifepristone (Drug)

结局指标

主要结局

Change in Mood Symptoms

时间窗: Baseline and Day 9

Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63, with higher scores indicating greater levels of depression.

Change in Positive Psychotic Symptoms Over the Course of Treatment

时间窗: 8 days

Utilized the Positive Symptoms Subscale of the Brief Psychiatric Rating Scale is assess psychotic symptoms. Range for the subscale is 4-28, with 4 = no positive symptoms

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Keller

Principle Investigator

Stanford University

研究点 (1)

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