Risks for Insulin Resistance and Metabolic Syndrome Between Major Depressive Disorder (MDD) or MDD With Psychotic Features
Comparative Risks for Insulin Resistance and Metabolic Syndrome (MS) Among Hospitalized Patients With Major Depressive Disorder With (MDpsy) or Without (MDD) Psychotic Features
Studies have shown that people with certain disorders have an increased risk of developing a condition called Metabolic Syndrome (MS). In this study, the investigators want to learn more about MS among people staying in the hospital for treatment of Major Depressive Disorder (MDD) and also Major Depressive Disorder with Psychotic Features (MDpsy). The investigators also want to learn more about a stress hormone called cortisol that is made in the body. Those who take part in this study will answer some questionnaires, be given some psychiatric interviews, and have some blood taken along with a urine sample.
The investigators believe that patients in the hospital with MDpsy will have higher baseline rates of MS factors, cortisol levels, dexamethasone non-suppression, and insulin resistance, compared with MDD alone.
研究概览
详细说明
Metabolic syndrome (MS) is a combination of medical problems that can increase the risk of heart disease and diabetes in some people. People with MS can have some or all of the following:
- High blood glucose
- High blood pressure
- Abdominal obesity
- Low levels of high-density lipoprotein (HDL) cholesterol
- High levels of triglycerides
Some studies have shown that people with certain disorders have a greater risk for developing MS. This may be because of a combination of factors, including but not limited to the type of medications used, age, and whether or not someone smokes. This study will also aim to learn more about a naturally-occurring stress hormone called cortisol that is made in the body.
In order to measure these factors, the following things will occur:
- administer a number of questionnaires
- gather information from medical history
- gather information about current psychiatric mood
- draw blood and collect a urine sample
To study the amount of cortisol in the body, a dexamethasone suppression test (DST) will be given. This test involves taking a single 1mg pill of dexamethasone, a steroid, and numerous blood draws. Like any drug, it has some risks, however it is unlikely any side effects will occur because of the low dose administered.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Capable of giving informed consent
- DSM-IV TR diagnosis of Major Depressive Disorder with (MDpsy) or without (MDD) Psychotic Features
- Age between 18 and 85, inclusive
- Pre-existing Hyperlipidemia, Hypertension, and Diabetes must be stable with laboratory and clinical results within acceptable range; with or without medication for three months prior to admission
Exclusion Criteria:
- DSM-IV TR diagnosis of: schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder, organic mental disorder, substance use dependence including alcohol, that has been active within the past 6 months, acute bereavement, and psychotic disorder not elsewhere classified
- Subjects that meet criteria for substance or alcohol dependence more recently than three months prior to entering the study
- Subjects that meet criteria for substance or alcohol abuse more recently than four weeks prior to entering the study
- Pregnancy
- Unstable or inadequately treated pre-existing hyperlipidemia, hypertension, and diabetes
- Subjects who are involuntarily committed.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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严重抑郁症
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Major Depressive Disorder with Psychotic Features
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The primary measure is any change in fasting insulin from admission to discharge while subjects are inpatient.
大体时间：Measure fasting insulin at two timepoints; to determine change from baseline (admission) and discharge
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To preserve statistical power, we will measure insulin as a continuous variable rather than dichotomizing participants into insulin sensitive vs insulin resistant.
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Measure fasting insulin at two timepoints; to determine change from baseline (admission) and discharge
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The first secondary measure is a fasting lipid panel, including fasting total cholesterol, fasting LDL, fasting HDL, and fasting triglycerides; we want to measure a change in data from admission to discharge
大体时间：Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Fasting glucose will be a separate secondary outcome measure; we want to measure a change in data from admission to discharge
大体时间：Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Waist Circumference; we want to measure a change in data from admission to discharge
大体时间：Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Waist circumference will be measured once at admission and once at discharge to determine if any changes have occurred throughout time of inpatient hospitalization
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Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Urine microalbumin; we want to measure a change in data from admission to discharge
大体时间：Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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C-reactive Protein; we want to measure a change in data from admission to discharge
大体时间：Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Homocysteine; we want to measure a change in data from admission to discharge
大体时间：Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Blood pressure (supine & standing as available)
大体时间：We will be measuring this continuously throughout inpatient hospitalization, beginning at time of admission
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We will be measuring this continuously throughout inpatient hospitalization, beginning at time of admission
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Cortisol; we want to measure a change in data from admission to discharge
大体时间：Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Cortisol levels will be measured before and after a dexamethasone suppression test is administered at admission and discharge
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Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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