Comparative Risks for Insulin Resistance and Metabolic Syndrome (MS) Among Hospitalized Patients With Major Depressive Disorder With (MDpsy) or Without (MDD) Psychotic Features
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The primary measure is any change in fasting insulin from admission to discharge while subjects are inpatient.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
The primary measure is any change in fasting insulin from admission to discharge while subjects are inpatient.
时间窗: Measure fasting insulin at two timepoints; to determine change from baseline (admission) and discharge
To preserve statistical power, we will measure insulin as a continuous variable rather than dichotomizing participants into insulin sensitive vs insulin resistant.
次要结局
- 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(Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge)
- Urine microalbumin; we want to measure a change in data from admission to discharge(Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge)
- Blood pressure (supine & standing as available)(We will be measuring this continuously throughout inpatient hospitalization, beginning at time of admission)
- C-reactive Protein; we want to measure a change in data from admission to discharge(Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge)
- Fasting glucose will be a separate secondary outcome measure; we want to measure a change in data from admission to discharge(Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge)
- Waist Circumference; we want to measure a change in data from admission to discharge(Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge)
- Homocysteine; we want to measure a change in data from admission to discharge(Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge)
- Cortisol; we want to measure a change in data from admission to discharge(Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge)
研究者
John D. Matthews
Principal Investigator, Assistant Professor of Psychiatry, Harvard Medical School
Massachusetts General Hospital