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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of Michigan |
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Information provided by: | National Center for Research Resources (NCRR) |
ClinicalTrials.gov Identifier: | NCT00004334 |
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. II. 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.
Condition |
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Cushing's Syndrome |
Study Type: | Observational |
Study Design: | Screening |
Estimated Enrollment: | 8 |
Study Start Date: | July 1994 |
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.
A weight maintenance diet is prescribed for all patients.
Ages Eligible for Study: | 20 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
United States, Michigan | |
University of Michigan Health Systems | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Monica N. Starkman 313-764-6168 |
Study Chair: | Monica N. Starkman | University of Michigan |
Study ID Numbers: | NCRR-M01RR00042-1781, UMMC-701 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004334 History of Changes |
Health Authority: | United States: Federal Government |
Cushing's syndrome endocrine disorders rare disease |
Depression Rare Diseases Cushing Syndrome Adrenal Gland Diseases |
Endocrine System Diseases Endocrinopathy Depressive Disorder Adrenocortical Hyperfunction |
Pathologic Processes Disease Syndrome Cushing Syndrome |
Endocrine System Diseases Adrenal Gland Diseases Adrenocortical Hyperfunction |