Hypothalamic-Pituitary-Adrenal (HPA)/Dopamine Axis in Psychotic Depression
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Psychotic Symptoms Subscale (PSS) of the Brief Psychiatric Rating Scale (BPRS)
研究概览
简要总结
The purpose of this research study is to see how certain hormones cause changes in mood and thinking in some depressed patients and to determine the effectiveness of mifepristone in treating some forms of depression.
This study is conducted in conjunction with an observational study "Clinical and Biological Characteristics of Psychotic Depression".
详细描述
Eligibility Procedures: Before entering the study and prior to any other procedures, you will be asked to read and sign this consent form. To determine if you are eligible for our study, you will then have a general medical (including menstrual cycle history on female patients) and psychiatric history taken, a physical examination, your vital signs (blood pressure, pulse), height, weight and waist/hip ratio will be measured, as well as various psychiatric evaluations will be conducted.
You will be randomly (by chance) assigned to receive mifepristone or placebo (an inactive substance). Half of the participants in this research study will receive placebo, and half will receive mifepristone. Neither you nor your study doctor will know which of the two you are receiving. Treatment will begin in the morning of Treatment Day 1 and conclude on Treatment Day 8 for a total treatment period of 8 days. You will take the medication once a day in the morning. The dose was originally 600 mg but was changed to 1200 mg per day after the 4th patient. You will not be able to take any new medications (other than the study drug) or make changes to your current medications while participating in this part of the study unless ordered by the study physician.
On treatment Day 1, you will come to our office for an interview and we will evaluate your mood and other psychiatric symptoms. Additionally, we will take your vital signs and draw blood to administer clinical laboratory tests. You will meet with the study physician and will then be given 4-days of medication to take home with you and self-administer each morning.
On Treatment Day 4, you will come back to our office. We will evaluate your mood, take your vital signs and you will meet with the study physician. It is important that you discuss with your study physician or the research study staff all unpleasant or unusual symptoms that you may experience. Any positive effects that are experienced should be discussed as well. You will be given an additional 4-days of medication to take home with you to self-administer each morning.
On Treatment Day 8, we will re-evaluate your mood, take your vital signs and repeat the blood and urine lab tests. You will also meet with the study physician to discuss any side effects. If you are participating in the blood draw portion of this study, you will be admitted to the GCRC on this day for an overnight stay. At 2pm on Treatment Day 8, you will have an IV line inserted into one arm for hourly blood samples from 2pm, 4pm, then 6pm until 9am on Treatment Day 9. At 9am on treatment Day 9, 10 mls of blood will be taken for Mifepristone concentration. A total of 82mls (approximately 5.5 tablespoons) of blood will be drawn. You will be discharged from the GCRC following breakfast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for PMD (individuals with Psychotic Major Depression) are as follows:
- •DSM IV diagnosis of Major Depressive Disorder with psychotic features, Bipolar II Disorder with psychotic features in a major depressive episode.
- •21-item HAM-D score greater than or equal to
- •Thase Core Endogenomorphic Scale score greater than or equal to 6 on the items included in the 21-item HDRS.
- •Between 21 - 85 years of age.
- •Female patients of child bearing capacity with Psychotic Depression receiving treatment with mifepristone are required to use a double-barrier method of contraception or abstinence for the entire duration of the study as well as for thirty days after the last dose of Mifepristone is taken.
- •If currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least one-week prior to entering the study.
- •Pre-existing (current) primary treating psychiatrist for subjects with psychotic features.
- •Any secondary diagnoses from the anxiety disorder spectrum is acceptable. Any secondary diagnoses from the anxiety disorder spectrum is acceptable. Primary pre-existing chronic Obsessive-Compulsive Disorder(OCD) will be an exclusion criteria.
排除标准
- •Exclusion criteria for PMDs are as follows:
- •ECT in the 6 months prior to the study.
- •Abuse of drugs or alcohol in the 6 months prior to study.
- •Unstable or untreated hypertension, cardiovascular disease.
- •If participating in the blood draw portion of the protocol, endocrine disorders are exclusionary.
- •Use of additional prescription medications, street drugs, or alcohol during the week before the study.
- •Previous mifepristone failure or non-response.
- •Any Axis II diagnosis or traits which would make participation in the study difficult.
- •Current pregnancy or lactation.
研究组 & 干预措施
Mifepristone
Receive mifepristone for 8 days
干预措施: Mifepristone (RU-486) (Drug)
Placebo
Receive placebo rather than mifepristone
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Psychotic Symptoms Subscale (PSS) of the Brief Psychiatric Rating Scale (BPRS)
时间窗: baseline to day 9
The BRPS is a rating scale of various psychiatric symptoms. Each item is rated on a scale of 1 to 7, with 1 being not present. The PSS is the sum of 4 items from the BPRS, which indicates the level of positive psychotic symptoms.. Thus, the range for the PSS is 4 to 28, with higher scores indicating greater levels of positive psychotic symptoms. For ease of interpretation, the sum of the PSS then has 4 items subtracted so that a score of 0 (instead of 4) indicates that there are no psychotic symptoms. In doing this, the range for the PSS becomes 0 to 24), with larger values indicating more positive psychotic symptoms. The measure is the change score of PSS total day 1 less PSS total Day 9. 0 indicates no change, where as positive numbers indicate a decrease in psychotic symptoms.
Change in Mean Cortisol Level
时间窗: Day 1 to Day 9 difference
The reported value is the difference in mean evening cortisol from baseline to Day 9 The mean evening cortisol is calculated from the hourly cortisol value taken from 1800 hrs to 0100 hrs for both time points. The outcome measure is the difference of mean evening cortisol from Day 9 less the mean evening cortrisol from baseline. Negative values indicate a reduction in cortisol levels at Day 9, whereas positive values indicate an increase in cortisol at Day 9. Serum cortisol levels are reported in ug/dL
次要结局
- % Change in Mean Evening Pre- and Post- Florinef Cortisol After Treatment With Either Mifepristone or Placebo(Day 23)
研究者
Alan Schatzberg
Principle Investigator
Stanford University