Major Depression and Inflammatory Risk Markers for Coronary Heart Disease

June 23, 2005 updated by: National Center for Research Resources (NCRR)
The overall purpose of this research is to examine whether depression influences immune system function. Studies indicate that individuals who are depressed experience coronary heart disease at a higher rate than expected. This study's goal is to begin identifying mechanisms that might be responsible for this process. This research also examines whether behavioral processes (e.g. smoking) or hormonal processes (e.g. adrenaline release) are responsible for immune system differences between depressed and nondepressed people

Study Overview

Status

Completed

Conditions

Detailed Description

To qualify for participation, subjects are to be between the ages of 18-55, medically healthy and free of all medication three months prior to enrollment. Half of them will be clinically depressed; the remaining one half will be healthy controls without a history of psychiatric illness. All subjects who qualify for the study will attend two laboratory sessions. During the first visit, participants will undergo a structured psychological interview, complete questionnaires about their mood, personality, and behavior, and have blood drawn to assess their immune system function. During the second visit, participants will complete additional questionnaires about their mood, personality, and behavior. The subjects will also participate in a mock job interview to look at their body's response to stress. Before and after the interview, the subjects will have blood drawn and be asked to collect saliva samples to assess their immune system function. In addition to the two laboratory visits, participants will be asked to collect additional information while going about their normal activities. In order to accomplish this, they will be given a small hand held portable computer. Four times each day for four days, the computer will signal them to collect a saliva sample. This will be used later to measure hormone levels. This study will explore changes in the immune system and metabolic system that might predispose depressed individuals to develop heart disease

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63130
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For eligibility, potential subjects will be 18-55 years of age, free of all medication during the past three months, and have no history of chronic illness involving the cardiovascular, endocrine, immune systems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Defined Population
  • Time Perspectives: Other

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Collaborators

American Heart Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 17, 2002

First Submitted That Met QC Criteria

May 17, 2002

First Posted (Estimate)

May 20, 2002

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 2003

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCRR-M01RR00036-0849

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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