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

National Center for Research Resources (NCRR)

Status: Unknown

Conditions: Cushing's Syndrome

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00004334

NCRR-M01RR00042-1781

UMMC-701

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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