Risks for Insulin Resistance and Metabolic Syndrome Between Major Depressive Disorder (MDD) or MDD With Psychotic Features

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparative Risks for Insulin Resistance and Metabolic Syndrome (MS) Among Hospitalized Patients With Major Depressive Disorder With (MDpsy) or Without (MDD) Psychotic Features

Conditions
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Major Depressive Disorder, Major Depressive Disorder w/ Psychotic Features, Metabolic Syndrome

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Major Depressive Disorder<br> | |
| Major Depressive Disorder with Psychotic Features<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary measure is any change in fasting insulin from admission to discharge while subjects are inpatient. | To preserve statistical power, we will measure insulin as a continuous variable rather than dichotomizing participants into insulin sensitive vs insulin resistant. | Measure fasting insulin at two timepoints; to determine change from baseline (admission) and discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | Waist circumference will be measured once at admission and once at discharge to determine if any changes have occurred throughout time of inpatient hospitalization | 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 | 
| 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 | 
| 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 | 
| Blood pressure (supine & standing as available) |  | We will be measuring this continuously throughout inpatient hospitalization, beginning at time of admission | 
| Cortisol; we want to measure a change in data from admission to discharge | Cortisol levels will be measured before and after a dexamethasone suppression test is administered at admission and discharge | Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Syndrome, Insulin Resistance, Massachusetts General Hospital, Major Depressive Disorder, Major Depressive Disorder with Psychotic Features, Cortisol, Dexamethasone Suppression Test