- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00004334
Study of Depression, Peptides, and Steroids in Cushing's Syndrome
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding
Kontakter og lokationer
Studiesteder
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- Rekruttering
- University of Michigan Health Systems
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Kontakt:
- Monica N. Starkman
- Telefonnummer: 313-764-6168
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Monica N. Starkman, University of Michigan
Datoer for undersøgelser
Studer store datoer
Studiestart
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NCRR-M01RR00042-1781
- UMMC-701
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