Immune and Endocrine Function in Post-Traumatic Stress Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00100490
Recruitment Status : Completed
First Posted : December 31, 2004
Last Update Posted : January 21, 2009
Information provided by:
VA Office of Research and Development

Brief Summary:
This is a study investigating immune function and relationships to the hypothalamic-pituitary-adrenal (HPA) axis in Post-traumatic stress disorder (PTSD) compared to controls without PTSD. The study involves 99 adult veterans and civilian subjects over a 3 year period. The study involves measuring immune and neuroendocrine parameters from blood samples obtained before and after a dexamethasone suppression test. The aim of the study is to determine whether immune alterations exist in PTSD and whether the immune-HPA axis interactions in this disorder are different from non-PTSD subjects with the future aim of studying whether immune dysregulation in PTSD may be linked to the increased risk for medical and psychiatric comorbidity in this population.

Condition or disease
Post-Traumatic Stress Disorders

Detailed Description:
The subjects undergo a thorough medical (physical and blood/urine tests) and psychiatric evaluation to determine eligibility after signed informed consent is obtained. If eligible, the subject will complete questionnaires and undergo structured clinical interviews with a study psychiatrist. The subject will then undergo a 2-day testing period during which time, blood is drawn each morning at 8 am, with the subject taking 0.5 mg of dexamethasone (a synthetic steroid) at 11 pm prior to the second day of blood testing. About 80 ml of blood will be drawn on each morning. The blood collected will then be assayed for cortisol dexamethasone, lymphocyte glucocorticoid receptor levels; cytokine levels in plasma and lipopolysaccharide stimulated and unstimulated whole blood (IL-2, sIL-2R, IL-6, sIL-6R, and IL-10); lymphocyte subsets (T helper and suppressor, B, and Natural Killer cell numbers), and antigen stimulation responses to tetanus and candida. In addition, blood from the first day of testing will undergo ex vivo challenge with dexamethasone at varying concentrations to determine differential cytokine sensitivities to steroid exposure in subjects.

Study Type : Observational
Time Perspective: Prospective
Official Title: Immune and Endocrine Function in Post-Traumatic Stress Disorder
Study Start Date : October 1999
Study Completion Date : September 2002

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
  • Subjects with DSM-IV criteria of PTSD and control subjects without any Axis I diagnosis, both groups of subjects are not on any psychotropic medications or medications that could interfere with the biological results, and do not have unstabilized medical conditions or neuroendocrine or immune disorders;
  • Do not have comorbid psychosis, bipolar disorder, or substance use disorders;
  • Have the capacity to give written informed consent;
  • Do not have abnormalities on medical evaluation/physical examination;
  • Are not a danger to self or others;
  • Women subjects are not pregnant or lactacting, and use a safe form of contraception with a negative pregnancy test.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00100490

United States, New York
Bronx VAMC
Bronx, New York, United States, 10468
Sponsors and Collaborators
VA Office of Research and Development
OverallOfficial: Rachel Yehuda, Ph.D.
OverallOfficial: Lloyd Mayer, M.D.
OverallOfficial: Esther Sternberg, M.D.
OverallOfficial: Bruce McEwen, Ph.D. Identifier: NCT00100490     History of Changes
Other Study ID Numbers: CADE-RCD3
First Posted: December 31, 2004    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: December 2004

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders