Expired Study
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Ann Arbor, Michigan 48109


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00004334


Primary Contact:

Study Chair
Monica N. Starkman
University of Michigan


Backup Contact:

N/A


Location Contact:

Ann Arbor, Michigan 48109
United States

Monica N. Starkman
Phone: 313-764-6168

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 25, 2017

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