Measurement of Pituitary Volume and Hormonal Changes in Patients With Post-traumatic Stress Disorder
Recruitment status was Recruiting
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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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Measurement of Pituitary Volume and Hormonal Changes in Patients With Post-traumatic Stress Disorder |
- Pituitary volume [ Time Frame: On second day of study ] [ Designated as safety issue: No ]
- 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
Will be collecting blood to check for hormone levels
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | July 2011 (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
Other Names:
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:
|
| 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:
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:
|
| healthy controls |
Procedure: MRI of the pituitary
Patients will undergo a T1 weighted MRI of the pituitary to measure pituitary volume
Other Names:
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:
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Subjects will be recruited from psychiatric clinics at Cedars-Sinai and at the West Los Angeles VA Center
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| Contact: Odelia Cooper, MD | 3104232830 | coopero@cshs.org |
| United States, California | |
| Cedars-Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Contact: William Gellepis 310-423-3395 william.gellepis@cshs.org | |
| Principal Investigator: Odelia Cooper, MD | |
| Sub-Investigator: Shlomo Melmed, MD | |
| Study Director: | Shlomo Melmed, MD | Cedars-Sinai Medical Center |
| Principal Investigator: | Odelia Cooper, MD | Cedars-Sinai Medical Center |
More Information
No publications provided
| Responsible Party: | Shlomo Melmed/Senior Vice President of Academic Affairs, Cedars-Sinai Medical Center |
| ClinicalTrials.gov Identifier: | NCT00815204 History of Changes |
| Other Study ID Numbers: | 13353 |
| Study First Received: | December 24, 2008 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cedars-Sinai Medical Center:
|
PTSD HPA axis Pituitary volume |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders Dexamethasone Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 18, 2013