Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-01-01 @ 4:42 PM
Study NCT ID:
NCT00815204
Status:
COMPLETED
Last Update Posted:
2015-02-04
First Post:
2008-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Pituitary Volume and Hormonal Changes in Patients With Post-traumatic Stress Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Will be collecting blood to check for hormone levels'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-02', 'studyFirstSubmitDate': '2008-12-24', 'studyFirstSubmitQcDate': '2008-12-24', 'lastUpdatePostDateStruct': {'date': '2015-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pituitary volume', 'timeFrame': 'On second day of study'}], 'secondaryOutcomes': [{'measure': 'Cortisol and ACTH levels on DEX/CRH test', 'timeFrame': 'On day 1 and day 2 of study test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PTSD', 'HPA axis', 'Pituitary volume'], 'conditions': ['Posttraumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nWe 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be recruited from psychiatric clinics at Cedars-Sinai and at the West Los Angeles VA Center', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80\n* history of PTSD\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT00815204', 'briefTitle': 'Measurement of Pituitary Volume and Hormonal Changes in Patients With Post-traumatic Stress Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Measurement of Pituitary Volume and Hormonal Changes in Patients With Post-traumatic Stress Disorder', 'orgStudyIdInfo': {'id': '13353'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'posttraumatic stress disorder', 'interventionNames': ['Procedure: MRI of the pituitary', 'Procedure: DEX/CRH test']}, {'label': 'history of trauma exposure but no PTSD', 'interventionNames': ['Procedure: MRI of the pituitary', 'Procedure: DEX/CRH test']}, {'label': 'healthy controls', 'interventionNames': ['Procedure: MRI of the pituitary', 'Procedure: DEX/CRH test']}], 'interventions': [{'name': 'MRI of the pituitary', 'type': 'PROCEDURE', 'otherNames': ['MRI', 'Pituitary'], 'description': 'Patients will undergo a T1 weighted MRI of the pituitary to measure pituitary volume', 'armGroupLabels': ['healthy controls', 'history of trauma exposure but no PTSD', 'posttraumatic stress disorder']}, {'name': 'DEX/CRH test', 'type': 'PROCEDURE', 'otherNames': ['Dexamethasone', 'CRH'], 'description': '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.', 'armGroupLabels': ['healthy controls', 'history of trauma exposure but no PTSD', 'posttraumatic stress disorder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Shlomo Melmed, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cedars-Sinai Medical Center'}, {'name': 'Odelia Cooper, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Odelia Cooper, MD', 'investigatorFullName': 'Odelia Cooper', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}