Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100490
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2004-12-30
Brief Title:
Immune and Endocrine Function in Post-Traumatic Stress Disorder
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Immune and Endocrine Function in Post-Traumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2004-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The subjects undergo a thorough medical physical and bloodurine 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 05 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None