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

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ClinicalTrials.gov Identifier: NCT00004334
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Recruiting
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
University of Michigan
Information provided by:
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.

Condition or disease
Cushing's Syndrome

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 Type : Observational
Estimated Enrollment : 8 participants
Primary Purpose: Screening
Study Start Date : July 1994

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004334

United States, Michigan
University of Michigan Health Systems Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Monica N. Starkman    313-764-6168      
Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Michigan
Study Chair: Monica N. Starkman University of Michigan

ClinicalTrials.gov Identifier: NCT00004334     History of Changes
Other Study ID Numbers: NCRR-M01RR00042-1781
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003

Keywords provided by National Center for Research Resources (NCRR):
Cushing's syndrome
endocrine disorders
rare disease

Additional relevant MeSH terms:
Cushing Syndrome
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases