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NCT00001969 · ClinicalTrials.gov registry record

Heart Disease Risk Factors in Major Depression

A clinical trial of Cardiovascular Disease and Adrenal Gland Hyperfunction, sponsored by National Institute of Mental Health (NIMH).

Completed
Registry status
160
Enrollment target
1
Study location

NCT00001969 is a study of Cardiovascular Disease and Adrenal Gland Hyperfunction that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 160 participants, below the 2,712-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00001969, a study of Cardiovascular Disease and Adrenal Gland Hyperfunction, has completed, sponsored by National Institute of Mental Health (NIMH).

COMPLETED
Registry status
160 participants
Enrollment target
1
Study location

Study Summary

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 more in studies that 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 what the mechanisms underlying this susceptibility are, and to develop improved means for treatment and prevention. Depressed patients are known to manifest a variety of neuroendocrine changes that predispose to coronary artery disease including hypercortisolism, decreased secretion of growth hormone and a deficiency of sex steroids. A final common denominator of these neuroendocrine abnormalities is insulin resistance. Insulin resistance promotes several changes that would favor hypertension and increased coronary artery disease including increased sodium retention, increased activity of the sympathetic nervous system, proliferation of vascular smooth muscle and deposition of highly metabolically active visceral fat. The latter induces additional risk factors for coronary disease, including dyslipidemia, hypercoagulation, and enhanced inflammation. It is a matter of public health importance to document the frequency and severity of insulin resistance in patients with major depression compared to a closely matched group of healthy controls. To accurately quantify

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 1999-12-30
Est. Completion 2007-01-19

What the Registry Record Tells You About NCT00001969

The ClinicalTrials.gov registry entry for NCT00001969 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,712-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (94% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Cardiovascular Disease appearing as the primary indexed condition, and to 0 interventions.

NCT00001969 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00001969 about?

NCT00001969 is a clinical study titled "Heart Disease Risk Factors in Major Depression". 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 more in studies t...

What is the current status of trial NCT00001969?

This trial is currently completed. The enrollment target is 160 participants. The study started on 1999-12-30. Estimated completion is 2007-01-19.

What conditions does trial NCT00001969 study?

This clinical trial studies the following conditions: Cardiovascular Disease, Adrenal Gland Hyperfunction, Involutional Depression.

Who is sponsoring clinical trial NCT00001969?

This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00001969 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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