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Glucocorticoid Effects on Cellular Cytokine Release

Primary Purpose

Depressive Disorder, Fatigue Syndrome, Chronic, Fibromyalgia

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Mental Health (NIMH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Depressive Disorder focused on measuring IL-1, IL-6, Immune Response, Inflammation, Steroids, Chronic Fatigue Syndrome, Depression, Fibromyalgia, Normal Volunteer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Healthy volunteers. Depressed patients. Fibromyalgia patients. Chronic fatigue patients. Subjects must not have been treated with steroids for more than two weeks during the previous year. Subjects must not be on chronic medications. Subjects must not have known medical problems or any condition which interferes with their immune system's ability to respond to infections (talk with your physician if you are not sure about a particular situation).

Sites / Locations

  • National Institute of Mental Health (NIMH)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00001415
Brief Title
Glucocorticoid Effects on Cellular Cytokine Release
Official Title
Glucocorticoid Effects on Cellular Cytokine Release
Study Type
Observational

2. Study Status

Record Verification Date
April 1999
Overall Recruitment Status
Completed
Study Start Date
May 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief Summary
A variety of hormones and immune system processes are responsible for how the body responds to illness. This study concentrates on how the hormone cortisol effects the release of immune system factors called cytokines. Cortisol is a hormone produced in the adrenal glands as a response to stimulation from the pituitary gland. Abnormal levels of cortisol have been seen in several diseases such as depression and multiple sclerosis. Cytokines are factors produced by certain white blood cells. They act by changing the cells that produce them (autocrine effect), altering other cells close to them (paracrine), and effecting cells throughout the body (endocrine effect). Cytokines are important in controlling inflammation processes. In this study researchers would like to determine if changes in levels of hormones in the blood are associated with changes in cytokine levels. In addition, researchers would like to learn more about how cytokines respond to hormones in certain diseases.
Detailed Description
Many of the biochemical alterations observed in people suffering from major depression are changes in the concentrations and activity of components of the generalized stress response. These include the principal hypothalamic stimulus of pituitary-adrenal activation (corticotropin releasing hormone) and the locus ceruleus/norepinephrine system. The current study attempts to provide a clearer picture of the stability of changes during the acute illness, the treatment phase and the recovery process. We particularly wish to determine whether abnormalities in HPA axis perturbability in the well-state can be demonstrated, and if so how these are related to the acutely-ill state, since this information could provide a quantifiable phenotypic marker for depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Fatigue Syndrome, Chronic, Fibromyalgia, Healthy, Inflammation
Keywords
IL-1, IL-6, Immune Response, Inflammation, Steroids, Chronic Fatigue Syndrome, Depression, Fibromyalgia, Normal Volunteer

7. Study Design

Enrollment
130 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Healthy volunteers. Depressed patients. Fibromyalgia patients. Chronic fatigue patients. Subjects must not have been treated with steroids for more than two weeks during the previous year. Subjects must not be on chronic medications. Subjects must not have known medical problems or any condition which interferes with their immune system's ability to respond to infections (talk with your physician if you are not sure about a particular situation).
Facility Information:
Facility Name
National Institute of Mental Health (NIMH)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8550757
Citation
DeRijk RH, Petrides J, Deuster P, Gold PW, Sternberg EM. Changes in corticosteroid sensitivity of peripheral blood lymphocytes after strenuous exercise in humans. J Clin Endocrinol Metab. 1996 Jan;81(1):228-35. doi: 10.1210/jcem.81.1.8550757.
Results Reference
background
PubMed Identifier
1416562
Citation
Sternberg EM, Chrousos GP, Wilder RL, Gold PW. The stress response and the regulation of inflammatory disease. Ann Intern Med. 1992 Nov 15;117(10):854-66. doi: 10.7326/0003-4819-117-10-854.
Results Reference
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Glucocorticoid Effects on Cellular Cytokine Release

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