- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00100490
Immune and Endocrine Function in Post-Traumatic Stress Disorder
January 20, 2009 updated by: US Department of Veterans Affairs
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.
Study Overview
Status
Completed
Conditions
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
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
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New York
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Bronx, New York, United States, 10468
- Bronx VAMC
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
- 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.
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Rachel Yehuda, Ph.D.
- Lloyd Mayer, M.D.
- Esther Sternberg, M.D.
- Bruce McEwen, Ph.D.
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 Major Dates
Study Start
October 1, 1999
Study Completion
September 1, 2002
Study Registration Dates
First Submitted
December 30, 2004
First Submitted That Met QC Criteria
December 30, 2004
First Posted (Estimate)
December 31, 2004
Study Record Updates
Last Update Posted (Estimate)
January 21, 2009
Last Update Submitted That Met QC Criteria
January 20, 2009
Last Verified
December 1, 2004
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CADE-RCD3
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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