Measurement of Pituitary Volume and Hormonal Changes in Patients With Post-traumatic Stress Disorder

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00815204
Collaborator
(none)
39
1
74
0.5

Study Details

Study Description

Brief Summary

Approximately, post-traumatic stress disorder (PTSD) occurs in 8% of the adult population over time. Exposure to traumatic events increases the risk of poor physical health and often leads to disability. The biology of PTSD is continually being explored in order to help find better treatments for this debilitating disorder. In our study, we propose to further our understanding of PTSD. Prior research has found that patients with PTSD have changes in the stress hormone pathway. In this pathway, there is release of certain hormones from the pituitary gland in the brain that feed into the blood stream and tell the adrenal gland to produce stress hormones.

The pituitary is a gland located at the base of the brain which controls the hormones in the body, including the stress hormones. Research in other psychiatric disorders has found changes in the pituitary volume along with changes in the hormones. This has not been investigated yet in PTSD. Therefore, we propose in our study to measure pituitary volume in people with PTSD and look at the changes in the stress hormone pathway. Moreover, we will investigate whether other hormones are affected by PTSD. In this way, we can further our understanding of the the biology of PTSD and help develop new therapies which can intervene through the hormonal system.

Condition or Disease Intervention/Treatment Phase
  • Procedure: MRI of the pituitary
  • Procedure: DEX/CRH test

Detailed Description

Lifetime prevalence of post-traumatic stress disorder (PTSD) is estimated at 8%. Exposure to traumatic events increases the risk of poor physical health, and chronic PTSD often leads to disability. The pathophysiology of PTSD is continually being explored in order to help find better treatment modalities for this debilitating disorder. Proposed mechanisms for the altered stress axis in PTSD include changes at the level of the pituitary. Though the pituitary stress hormone axis has been explored, no work has been done to evaluate for changes in the pituitary volume in response to these changes in the stress axis in PTSD. We have designed a study which will assess for differences in pituitary volumes. We will compare volumes in patients with PTSD, non-PTSD subjects who have had a history of trauma, and healthy controls. We will test the HPA axis through the dexamethasone/CRH test, a standardized diagnostic test, and correlate the findings with changes in the pituitary volume. Moreover, we will assess for changes in other endocrine axes and proteins.

We propose to further our understanding of PTSD by establishing a direct link between structure and function. By establishing these links in structure and function, novel therapies which can intervene through the endocrine system may prove to be of benefit in treating PTSD

Study Design

Study Type:
Observational
Actual Enrollment :
39 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Measurement of Pituitary Volume and Hormonal Changes in Patients With Post-traumatic Stress Disorder
Study Start Date :
May 1, 2008
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
posttraumatic stress disorder

Procedure: MRI of the pituitary
Patients will undergo a T1 weighted MRI of the pituitary to measure pituitary volume
Other Names:
  • MRI
  • Pituitary
  • Procedure: DEX/CRH test
    Subjects will have blood drawn for baseline ACTH, cortisol, and other hormones and then undergo a DEX/CRH test. Will then measure ACTH and cortisol on test.
    Other Names:
  • Dexamethasone
  • CRH
  • history of trauma exposure but no PTSD

    Procedure: MRI of the pituitary
    Patients will undergo a T1 weighted MRI of the pituitary to measure pituitary volume
    Other Names:
  • MRI
  • Pituitary
  • Procedure: DEX/CRH test
    Subjects will have blood drawn for baseline ACTH, cortisol, and other hormones and then undergo a DEX/CRH test. Will then measure ACTH and cortisol on test.
    Other Names:
  • Dexamethasone
  • CRH
  • healthy controls

    Procedure: MRI of the pituitary
    Patients will undergo a T1 weighted MRI of the pituitary to measure pituitary volume
    Other Names:
  • MRI
  • Pituitary
  • Procedure: DEX/CRH test
    Subjects will have blood drawn for baseline ACTH, cortisol, and other hormones and then undergo a DEX/CRH test. Will then measure ACTH and cortisol on test.
    Other Names:
  • Dexamethasone
  • CRH
  • Outcome Measures

    Primary Outcome Measures

    1. Pituitary volume [On second day of study]

    Secondary Outcome Measures

    1. Cortisol and ACTH levels on DEX/CRH test [On day 1 and day 2 of study test]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age 18-80

    • history of PTSD

    Exclusion Criteria:
    • Uncontrolled medical or psychiatric conditions Liver or kidney disease Use of anti-depressants or ketoconazole Use of steroids within a year of the study Use of drugs of abuse Pregnancy or nursing Metal implants Low testosterone states A history of head bleeds or pituitary tumors

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cedars-Sinai Medical Center Los Angeles California United States 90048

    Sponsors and Collaborators

    • Cedars-Sinai Medical Center

    Investigators

    • Study Director: Shlomo Melmed, MD, Cedars-Sinai Medical Center
    • Principal Investigator: Odelia Cooper, MD, Cedars-Sinai Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Odelia Cooper, Odelia Cooper, MD, Cedars-Sinai Medical Center
    ClinicalTrials.gov Identifier:
    NCT00815204
    Other Study ID Numbers:
    • 13353
    First Posted:
    Dec 29, 2008
    Last Update Posted:
    Feb 4, 2015
    Last Verified:
    Feb 1, 2015
    Keywords provided by Odelia Cooper, Odelia Cooper, MD, Cedars-Sinai Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 4, 2015