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Heart Disease Risk Factors in Major Depression



Heart Disease Risk Factors in Major Depression

For Condition: Adrenal Gland Hyperfunction,Cardiovascular Disease,Involutional Depression
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 80

Location and Contact Information:

National Institute of Mental Health (NIMH) *Recruiting*
Bethesda,  Maryland,  20892
United States
Recruiting Patricia  Kasdan 3014967290


Additional Information:
Study ID Numbers:
  000049;  00-M-0049
Study Start Date: December 30, 1999
Record last reviewed: November 4, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001969

Other Involutional Depression Studies:
1. Heart Disease Risk Factors in Major Depression

2. Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients with Adrenal Insufficiency

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Heart Disease Risk Factors in Major Depression

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