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

This study has been terminated.
(PI left Massachusetts General Hospital Inpatient service)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01310140
First Posted: March 8, 2011
Last Update Posted: February 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
John D. Matthews, Massachusetts General Hospital
  Purpose

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.


Condition
Major Depressive Disorder Major Depressive Disorder w/ Psychotic Features Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by John D. Matthews, Massachusetts General Hospital:

Primary Outcome Measures:
  • The primary measure is any change in fasting insulin from admission to discharge while subjects are inpatient. [ Time Frame: 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.


Secondary Outcome Measures:
  • 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled 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

  • Urine microalbumin; we want to measure a change in data from admission to discharge [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge ]
    Cortisol levels will be measured before and after a dexamethasone suppression test is administered at admission and discharge


Enrollment: 14
Actual Study Start Date: January 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Major Depressive Disorder
Major Depressive Disorder with Psychotic Features

Detailed 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible subjects are people who are inpatient in the medical-psychiatric unit at Massachusetts General Hospital. Included subjects have working diagnosis of major depressive disorder (MDD) or major depressive disorder with psychotic features (MDpsy).
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310140


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Alliance for Research on Schizophrenia and Depression
  More Information

Responsible Party: John D. Matthews, Principal Investigator, Assistant Professor of Psychiatry, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01310140     History of Changes
Other Study ID Numbers: 2009-P-002723
First Submitted: February 15, 2011
First Posted: March 8, 2011
Last Update Posted: February 13, 2017
Last Verified: February 2017

Keywords provided by John D. Matthews, Massachusetts General Hospital:
Metabolic Syndrome
Insulin Resistance
Massachusetts General Hospital
Major Depressive Disorder
Major Depressive Disorder with Psychotic Features
Cortisol
Dexamethasone Suppression Test

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Syndrome
Metabolic Syndrome X
Insulin Resistance
Mental Disorders
Psychotic Disorders
Pathologic Processes
Mood Disorders
Behavioral Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Schizophrenia Spectrum and Other Psychotic Disorders
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs