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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01310140
• Other study ID #: 2009-P-002723
• Status: Terminated
• Phase: N/A
• First received: February 15, 2011
• Last updated: February 10, 2017
• Start date: January 2011
• Est. completion date: September 2012

Study information

• Verified date: February 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Insulin Resistance
• Major Depressive Disorder
• Major Depressive Disorder w/ Psychotic Features
• Mental Disorders
• Metabolic Syndrome
• Metabolic Syndrome X
• Psychotic Disorders
• Syndrome

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Blood pressure (supine & standing as available)		We will be measuring this continuously throughout inpatient hospitalization, beginning at time of admission
Secondary	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