The purpose of this study is to understand why depressed people have a greater chance of developing heart disease than people who are not depressed. This study will examine insulin resistance in participants with major depression to determine how severe it is and why it occurs.

People with major depression have an increased risk for coronary artery disease. This increased risk may be a result of hormonal changes that occur with depression. Insulin resistance may be associated with these hormonal changes. This study will determine whether insulin resistance is an underlying mechanism that predisposes people with major depression to ischemic heart disease.

Participants will be screened with a medical and psychiatric history, a physical examination, blood and urine tests, and an electrocardiogram. A control group of healthy volunteers will also be recruited as a comparison group.

Condition
Adrenal Gland Hyperfunction Cardiovascular Disease Involutional Depression

Further Study Details: 

Expected Total Enrollment:  80

A series of studies in patients with major depression have consistently demonstrated a doubling of the mortality rate at any age, independent of suicide. In addition, the relative risk for clinically significant coronary artery disease in patients with major depression is also 2 or even higher in studies that are independently controlled for risk factors such as smoking, hypertension, etc. The principal long-term goals of the CNE include the determination of the mechanisms that underlie enhanced susceptibility to premature ischemic heart disease in patients with major depression, documenting the age at which demonstrable pathophysiologic or predictive changes begin to occur, and charting their rate of progression. Our long-term goal is to use our understanding of underlying mechanisms to enhance our capacity to predict who with major depression is most likely to develop premature ischemic heart disease, to determine the age of this susceptibility, and to develop improved means for treatment and prevention. While there are numerous risk factors for coronary artery disease and we plan to study them as well in our serial protocols, in this protocol, we propose to study insulin resistance as an underlying mechanism that predisposes patients with major depression to ischemic heart disease.

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

INCLUSION CRITERIA:
Men and women, from all ethnic backgrounds, between 18 and 65 years old who have had a history of any types of major depression or are currently depressed will be eligible for this study, provided they are free from the conditions described in the exclusion criteria. Candidates will be screened with a complete medical and psychiatric history and physical examination, as well as blood and urine tests, and electrocardiogram. Healthy volunteers will also be recruited to this study to serve as a control group. Volunteers will be matched to each patient in the study according to age, gender, body weight and height, and will undergo the same screening and study procedures.
Females must not be pregnant.
Subjects must not have diabetes mellitus.
Subjects must not have cardiovascular, renal, hepatic and other end organ diseases.
Subjects must not have peripheral vascular disease.
Subjects must not have any inflammatory diseases.
Subjects must not have HIV infection.
Subjects must not be on beta-blockers, thiazides, and/or glucocorticoids.
Subjects must have BMI of 29 or less.

Maryland
      National Institute of Mental Health (NIMH), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  000049; 00-M-0049
Record last reviewed:  November 4, 2003
Last Updated:  November 23, 2004
Record first received:  January 18, 2000
ClinicalTrials.gov Identifier:  NCT00001969
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08