Back to resultsStudy of Depression, Peptides, and Steroids in Cushing's Syndrome
Primary Purpose
Cushing's Syndrome
Status
Unknown status
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cushing's Syndrome focused on measuring Cushing's syndrome, endocrine disorders, rare disease
Eligibility 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
Sites / Locations
- University of Michigan Health SystemsRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004334
First Posted
October 18, 1999
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT00004334
Brief Title
Study of Depression, Peptides, and Steroids in Cushing's Syndrome
Study Type
Observational
2. Study Status
Record Verification Date
December 2003
Overall Recruitment Status
Unknown status
Study Start Date
July 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Michigan
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cushing's Syndrome
Keywords
Cushing's syndrome, endocrine disorders, rare disease
7. Study Design
Enrollment
8 (false)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica N. Starkman
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
Facility Information:
Facility Name
University of Michigan Health Systems
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica N. Starkman
Phone
313-764-6168
12. IPD Sharing Statement
Learn more about this trial
Study of Depression, Peptides, and Steroids in Cushing's Syndrome
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