NCT00001415

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 1994

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1994

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2000

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

April 1, 1999

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

IL-1IL-6Immune ResponseInflammationSteroidsChronic Fatigue SyndromeDepressionFibromyalgiaNormal Volunteer

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • 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.

    PMID: 8550757BACKGROUND
  • 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.

    PMID: 1416562BACKGROUND

MeSH Terms

Conditions

Depressive DisorderFatigue Syndrome, ChronicFibromyalgiaInflammationDepression

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersMuscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRheumatic DiseasesBehavioral SymptomsBehavior

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

May 1, 1994

Study Completion

July 1, 2000

Last Updated

March 4, 2008

Record last verified: 1999-04

Locations