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

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00815204
• Other study ID #: 13353
• Status: Completed
• Phase: N/A
• First received: December 24, 2008
• Last updated: February 2, 2015
• Start date: May 2008
• Est. completion date: July 2014

Study information

• Verified date: February 2015
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Procedure:
• MRI of the pituitary
Patients will undergo a T1 weighted MRI of the pituitary to measure pituitary volume
• 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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pituitary volume		On second day of study	No
Secondary	Cortisol and ACTH levels on DEX/CRH test		On day 1 and day 2 of study test	No