NCT00100490

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.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 1999

Typical duration 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

October 1, 1999

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2004

Completed
Last Updated

January 21, 2009

Status Verified

December 1, 2004

First QC Date

December 30, 2004

Last Update Submit

January 20, 2009

Conditions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
* 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.

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

Sponsors & Collaborators

Study Sites (1)

Bronx VAMC

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Rachel Yehuda, Ph.D.

  • Lloyd Mayer, M.D.

  • Esther Sternberg, M.D.

  • Bruce McEwen, Ph.D.

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

December 30, 2004

First Posted

December 31, 2004

Study Start

October 1, 1999

Study Completion

September 1, 2002

Last Updated

January 21, 2009

Record last verified: 2004-12

Locations