Study of Depression, Peptides, and Steroids in Cushing's Syndrome

Descriptive Information
Brief Title † Study of Depression, Peptides, and Steroids in Cushing's Syndrome
Official Title †
Brief Summary 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.
Detailed Description 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.
Study Phase N/A
Study Type † Observational
Study Design † Primary Purpose: Screening
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Cushing's Syndrome
Intervention †
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status †
Estimated Enrollment † 8
Start Date † July 1994
Completion Date
Primary Completion Date
Eligibility Criteria † PROTOCOL ENTRY CRITERIA: - Patients aged 20 to 60 with spontaneous active Cushing's syndrome - At least 2 weeks since medication with psychoactive effects or influence on cortisol metabolism by hepatic hydroxylating enzyme induction - Antihypertensives allowed for severe hypertension - No barbiturates - No phenytoin
Gender Both
Ages 20 Years - 60 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT00004334
Organization ID NCRR-M01RR00042-1781
Secondary IDs †† UMMC-701
Responsible Party
Study Sponsor † National Center for Research Resources (NCRR)
Collaborators †† University of Michigan
Investigators † Study Chair: Monica N. Starkman, University of Michigan
Information Provided By
Verification Date December 2003
First Received Date † October 18, 1999
Last Updated Date June 23, 2005
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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