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

• Conditions: Cushing's Syndrome

• Registration Number: NCT00004334
• Lead Sponsor: National Center for Research Resources (NCRR)

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 Timeline

• Study Start: 1994-07
• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Status Verified: 2003-12
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of Michigan Health Systems; 🇺🇸 Ann Arbor, Michigan, United States