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CompletedNCT00001415Updated Mar 4, 2008

Glucocorticoid Effects on Cellular Cytokine Release

An observational study in Depressive Disorder, Fatigue Syndrome, Chronic and Fibromyalgia, sponsored by National Institute of Mental Health (NIMH). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2008-03-04.

Sponsored by National Institute of Mental Health (NIMH) · Observational

Study type
Observational
Enrollment
130
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Depressive Disorder
  • Fatigue Syndrome, Chronic
  • Fibromyalgia
  • Healthy
  • Inflammation

Keywords

  • IL-1
  • IL-6
  • Immune Response
  • Inflammation
  • Steroids
  • Chronic Fatigue Syndrome
  • Depression
  • Fibromyalgia
  • Normal Volunteer
03

In context

Depressive Disorder

4,847 studies on the registry are indexed under Depressive Disorder; 509 are open to participants now.

This study's enrollment of 130 is below the median of 150 across 656 observational studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

National Institute of Mental Health (NIMH) is the lead sponsor of 367 studies on the registry; 45 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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).

05

Study design

Enrollment
130 participants
06

Study locations

1 site
  • National Institute of Mental Health (NIMH)
    Bethesda, Maryland 20892, United States
07

References and documents

Publications

  • 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. PubMed 8550757 ↗
  • 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. PubMed 1416562 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00001415
First posted
Dec 10, 2002
Start date
May 1994
Completion
Jul 2000
Last update
Mar 4, 2008
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 1999. You cannot join it, but the record below documents what was studied.

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