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NCT00004334 Clinical Trial

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

Cushing's Syndrome Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00004334
Other study ID # NCRR-M01RR00042-1781
Secondary ID UMMC-701
Status Recruiting
Phase N/A
First received October 18, 1999
Last updated June 23, 2005
Start date July 1994

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 8
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 60 Years
Eligibility 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

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Michigan Health Systems Ann Arbor Michigan

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) University of Michigan

Country where clinical trial is conducted

United States, 

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