A Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Mifepristone vs. Placebo in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 292
- 试验地点
- 42
- 主要终点
- Proportion of Mifepristone vs. Placebo Treated Patients With at Least a 50% Reduction From Baseline in Brief Psychiatric Rating Scale-Positive Symptom Subscale (BPRS-PSS) at Days 7 and 56
研究概览
简要总结
Approximately 450 patients will be randomized to receive mifepristone or placebo for 7 days followed by antidepressant. The purpose is to compare the efficacy of mifepristone followed by antidepressant versus placebo followed by antidepressant in reducing psychotic symptoms in patients with a diagnosis of psychotic depression.
详细描述
Up to 450 patients with psychotic depression will be randomly assigned to receive either mifepristone or matching placebo. Patients will be assessed by the investigator or site staff during screening and on study days. A single antidepressant selected from a list of approved drugs will be administered after the administration of investigational drug. Adverse events, laboratory assessments, electrocardiograms, and physical examinations will be used to assess safety.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have provided written consent to participate in the study prior to any study procedures and understand that they are free to withdraw from the study at any time. Patients must be able to read and understand the consent form, complete study-related procedures, and communicate with the study staff
- •Have a DSM-IV TR diagnosis of Major Depressive Disorder with Psychotic Features (DSM-IV 296.24 or 296.34), and are clinically symptomatic with their illness
- •Have pre-specified minimum scores on standardized psychiatric rating scales at baseline
- •Have not been taking excluded medication for at least 7 days prior to randomization
- •Have a negative pregnancy test
- •If not postmenopausal for ≥ 2 years or surgically sterile (6 months post-surgery), must consent (patient or partner) to utilize two medically acceptable methods of contraception, one of which is a barrier method, throughout the entire study period and for 3 months after the study is completed
排除标准
- •Have any primary psychiatric diagnosis other than psychotic depression.
- •Have a major medical problem, which in the opinion of the investigator would place the patient at undue risk.
- •Have undergone electroconvulsive therapy within 3 months prior to randomization
- •Have had a hospitalization due to a suicide attempt within 45 days prior to randomization
- •Are female and of childbearing age, and are unable or unwilling to use two medically acceptable methods of contraception during the study and for three months after study completion, one of which must be a barrier method
- •Are female and are pregnant or lactating
- •Are currently taking excluded medications
- •Have used drugs of abuse within 30 days prior to screen, as per patient report and urine drug screen
- •Have a history of active drug or alcohol abuse within 3 months or dependence within 6 months prior to screening
- •Are in the opinion of the investigator at immediate risk of suicide, or at risk of harming others
- •Have received investigational therapy (drug, vaccine, biological agent or device) within 6 months prior to randomization
- •Have previously participated in a clinical trial of mifepristone
- •Have a history of an allergic reaction to mifepristone
- •Are in the investigator's opinion not appropriate for participation in the study or may not be capable of following the study schedule for any reason
- •Are patients who are employees of the study unit or their family members, students who are working in the study unit, or family members of the investigator or Corcept Therapeutics
研究组 & 干预措施
1
Mifepristone followed by an antidepressant
干预措施: mifepristone (Drug)
2
Placebo followed by an antidepressant
干预措施: placebo (Drug)
结局指标
主要结局
Proportion of Mifepristone vs. Placebo Treated Patients With at Least a 50% Reduction From Baseline in Brief Psychiatric Rating Scale-Positive Symptom Subscale (BPRS-PSS) at Days 7 and 56
时间窗: 56 days
Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group administered mifepristone
次要结局
- Proportion of Mifepristone Treated Patients With Plasma Drug Concentrations Equal to or Above 1637 ng/mL vs. Placebo Treated Patients Who Achieve a ≤ 50% Reduction in BPRS-PSS at Days 7 and 56(56 days)