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

This study is currently recruiting participants.

Verified by National Center for Research Resources (NCRR), December 2003

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	University of Michigan
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00004334

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.

Condition
Cushing's Syndrome

Study Type:	Observational
Study Design:	Screening

Resource links provided by NLM:

MedlinePlus related topics: Cushing's Syndrome

U.S. FDA Resources

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment:	8
Study Start Date:	July 1994

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.

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004334

Locations

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

Investigators

Study Chair:

Monica N. Starkman

University of Michigan

More Information

No publications provided

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

Keywords provided by National Center for Research Resources (NCRR):

Cushing's syndrome
endocrine disorders
rare disease

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Cushing Syndrome

Endocrine System Diseases
Adrenal Gland Diseases
Adrenocortical Hyperfunction

ClinicalTrials.gov processed this record on February 08, 2010