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Measurement of Pituitary Volume and Hormonal Changes in Patients With Post-Traumatic Stress Disorder
This study is currently recruiting participants.
Verified by Cedars-Sinai Medical Center, December 2008
Sponsored by: Cedars-Sinai Medical Center
Information provided by: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00815204
  Purpose

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 Intervention
Posttraumatic Stress Disorder
Procedure: MRI of the pituitary
Procedure: DEX/CRH test

MedlinePlus related topics: Post-Traumatic Stress Disorder
Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC BaseLine
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Measurement of Pituitary Volume and Hormonal Changes in Patients With Post-Traumatic Stress Disorder

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Pituitary volume [ Time Frame: On second day of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cortisol and ACTH levels on DEX/CRH test [ Time Frame: On day 1 and day 2 of study test ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

Will be collecting blood to check for hormone levels


Estimated Enrollment: 30
Study Start Date: May 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
posttraumatic stress disorder Procedure: MRI of the pituitary
Patients will undergo a T1 weighted MRI of the pituitary to measure pituitary volume
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.
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
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.
healthy controls Procedure: MRI of the pituitary
Patients will undergo a T1 weighted MRI of the pituitary to measure pituitary volume
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited from psychiatric clinics at Cedars-Sinai and at the West Los Angeles VA Center

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815204

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Stephanie DeLeon     310-423-2411     stephanie.deleon@cshs.org    
Principal Investigator: Shlomo Melmed            
Sub-Investigator: Odelia Cooper            
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Shlomo Melmed Cedars-Sinai Medical Center
  More Information

Responsible Party: Cedars-Sinai Medical Center ( Shlomo Melmed/Senior Vice President of Academic Affairs )
Study ID Numbers: 13353
Study First Received: December 24, 2008
Last Updated: December 24, 2008
ClinicalTrials.gov Identifier: NCT00815204  
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
PTSD
HPA axis
Pituitary volume

Study placed in the following topic categories:
Hydrocortisone
Cortisol succinate
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Hydrocortisone acetate
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 15, 2009