Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-30 @ 8:23 AM
Study NCT ID:
NCT00004334
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Depression, Peptides, and Steroids in Cushing's Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003480', 'term': 'Cushing Syndrome'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D035583', 'term': 'Rare Diseases'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'count': 8}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '1994-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-12', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '1999-10-18', 'studyFirstSubmitQcDate': '1999-10-18', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '1999-10-19', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ["Cushing's syndrome", 'endocrine disorders', 'rare disease'], 'conditions': ["Cushing's Syndrome"]}, 'descriptionModule': {'briefSummary': "OBJECTIVES: I. Study the relationship between dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis and disorders of mood, vegetative function, and cognition in patients with Cushing's disease.\n\nII. Identify subgroups of patients with Cushing's disease who differ in the presence and severity of the depressive syndrome, and uncover HPA axis dysregulation differences among them using corticotropin-releasing hormone, metyrapone, and dexamethasone challenge testing.", 'detailedDescription': 'PROTOCOL OUTLINE: All patients receive a psychiatric evaluation at baseline, as well as assessments of plasma adrenocorticotropin, beta lipotropin, beta endorphin, and cortisol, and urinary cortisol. Peptide and steroid assays are performed, alone and in response to corticotropin-releasing hormone, metyrapone, and dexamethasone. Patients are given sleep electroencephalograms at baseline and 1 year following treatment.\n\nA weight maintenance diet is prescribed for all patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "PROTOCOL ENTRY CRITERIA:\n\n* Patients aged 20 to 60 with spontaneous active Cushing's syndrome\n* At least 2 weeks since medication with psychoactive effects or influence on cortisol metabolism by hepatic hydroxylating enzyme induction\n* Antihypertensives allowed for severe hypertension\n* No barbiturates\n* No phenytoin"}, 'identificationModule': {'nctId': 'NCT00004334', 'briefTitle': "Study of Depression, Peptides, and Steroids in Cushing's Syndrome", 'organization': {'class': 'NIH', 'fullName': 'National Center for Research Resources (NCRR)'}, 'orgStudyIdInfo': {'id': 'NCRR-M01RR00042-1781'}, 'secondaryIdInfos': [{'id': 'UMMC-701'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Monica N. Starkman', 'role': 'CONTACT', 'phone': '313-764-6168'}], 'facility': 'University of Michigan Health Systems', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Monica N. Starkman', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}, 'collaborators': [{'name': 'University of Michigan', 'class': 'OTHER'}]}}}