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

NCT01310140 | Terminated

• 1 other identifier: 2009-P-002723
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Metabolic Syndrome; Insulin Resistance; Massachusetts General Hospital; Major Depressive Disorder; Major Depressive Disorder with Psychotic Features; Cortisol; Dexamethasone Suppression Test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  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

Study Arms (2)

Major Depressive Disorder

Major Depressive Disorder with Psychotic Features

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Metabolic Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor of Psychiatry, Harvard Medical School

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: March 8, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 13, 2017

Record last verified: 2017-02

Locations

US (1)