Posttraumatic Stress DisorderNCT00815204
Measurement of Pituitary Volume and Hormonal Changes in Patients With Post-traumatic Stress Disorder
An observational study of Posttraumatic Stress Disorder, run by Cedars-Sinai Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- MRI of the pituitary and DEX/CRH test
- Type of treatment
- Surgery or procedure
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be recruited from psychiatric clinics at Cedars-Sinai and at the West Los Angeles VA Center
Who may be able to join
- Age 18-80
- history of PTSD
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
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.
Read the 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
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- MRI of the pituitary, DEX/CRH test
- Keywords
- PTSD, HPA axis, Pituitary volume
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI of the pituitaryProcedure or surgery
Also called MRI, Pituitary
Patients will undergo a T1 weighted MRI of the pituitary to measure pituitary volume
DEX/CRH testProcedure or surgery
Also called Dexamethasone, CRH
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.
| Study group | Role | What they receive |
|---|---|---|
| posttraumatic stress disorder | Not described Receives: Procedure: MRI of the pituitary; Procedure: DEX/CRH test | |
| history of trauma exposure but no PTSD | Not described Receives: Procedure: MRI of the pituitary; Procedure: DEX/CRH test | |
| healthy controls | Not described Receives: Procedure: MRI of the pituitary; Procedure: DEX/CRH test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pituitary volume
Measured: On second day of study
Secondary outcomes (1)
Cortisol and ACTH levels on DEX/CRH test
Measured: On day 1 and day 2 of study test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Odelia Cooper, Cedars-Sinai Medical Center
- Investigators
- Shlomo Melmed, MD, Study director, Cedars-Sinai Medical CenterOdelia Cooper, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815204
- Sponsor's protocol ID
- 13353
- Status last verified
- Feb 2015
- First submitted
- 24 Dec 2008
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Pituitary Volume and Hormonal Changes in Patients With Post-traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00815204
- Acronym / sponsor ID
- 13353
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, HPA axis, Pituitary volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 29 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from psychiatric clinics at Cedars-Sinai and at the West Los Angeles VA Center
Key inclusion criteria (2 listed)
- Age 18-80
- history of PTSD
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI of the pituitaryAlso: MRI, PituitaryPatients will undergo a T1 weighted MRI of the pituitary to measure pituitary volume | Procedure or surgery | healthy controls, history of trauma exposure but no PTSD, posttraumatic stress disorder |
| DEX/CRH testAlso: Dexamethasone, CRHSubjects 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. | Procedure or surgery | healthy controls, history of trauma exposure but no PTSD, posttraumatic stress disorder |
Primary outcome
Pituitary volume
Time frame: On second day of study
1 secondary outcome
Cortisol and ACTH levels on DEX/CRH test
Time frame: On day 1 and day 2 of study test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shlomo Melmed, MD study director
Cedars-Sinai Medical Center
Odelia Cooper, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posttraumatic Stress Disorder, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pituitary volume (time frame: On second day of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.