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

NCT00815204 | Completed

• 1 other identifier: 13353
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; HPA axis; Pituitary volume

Outcome Measures

Primary Outcomes (1)

• Pituitary volume

  On second day of study

Secondary Outcomes (1)

• Cortisol and ACTH levels on DEX/CRH test

  On day 1 and day 2 of study test

Study Arms (3)

posttraumatic stress disorder

Procedure: MRI of the pituitary; Procedure: DEX/CRH test

history of trauma exposure but no PTSD

Procedure: MRI of the pituitary; Procedure: DEX/CRH test

healthy controls

Procedure: MRI of the pituitary; Procedure: DEX/CRH test

Interventions

MRI of the pituitary PROCEDURE

Patients will undergo a T1 weighted MRI of the pituitary to measure pituitary volume

Also known as: MRI, Pituitary

healthy controls; history of trauma exposure but no PTSD; posttraumatic stress disorder

DEX/CRH test PROCEDURE

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.

Also known as: Dexamethasone, CRH

healthy controls; history of trauma exposure but no PTSD; posttraumatic stress disorder

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age 18-80
• history of PTSD

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Will be collecting blood to check for hormone levels

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Shlomo Melmed, MD

  Cedars-Sinai Medical Center

  STUDY DIRECTOR

• Odelia Cooper, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Odelia Cooper, MD

Study Record Dates

• First Submitted: December 24, 2008
• First Posted: December 29, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

US (1)