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

NCT ID: NCT00004334

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

1994-07-31

Brief Summary

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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

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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.

Conditions

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Cushing's Syndrome

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Principal Investigators

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Monica N. Starkman

Role: STUDY_CHAIR

University of Michigan

Locations

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University of Michigan Health Systems

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Monica N. Starkman

Role: primary

313-764-6168

Other Identifiers

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UMMC-701

Identifier Type: -

Identifier Source: secondary_id

NCRR-M01RR00042-1781

Identifier Type: -

Identifier Source: org_study_id