Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT00001969
Eligibility Criteria:
* INCLUSION CRITERIA
Adults between the ages of 21 and 55, with or without major depression as diagnosed with The Structured Clinical Interview of Diagnosis (SCID) of the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition (DSM-IV), will be recruited. All depressed patients will be included, although we will characterize patients a priori as having a predominantly melancholic, atypical, or mixed symptom pattern. We plan to recruit at least 20 patients in each group.
Both currently depressed patients (greater than 14 on the Hamilton Depression Rating Scale) and those with a history of major depression who are clinically recovered will be included. Patients may be taking psychotropic medications for depression at the time of study. Sub-analyses will be done comparing steady-state glucose utilization rates as a function of mood state and medication status. Subjects should not have significant underlying illnesses known to affect insulin sensitivity, and should have a body mass index between 20 and 30 kg/m2.
EXCLUSION CRITERIA
1. Pregnancy
2. Existing diabetes mellitus
3. Body mass index less than 20 or greater than 30 kg/ m2
4. Existing cardiovascular diseases and other end organ diseases
5. Existing peripheral vascular disease
6. HIV infection
7. Patients who are on B-blockers, thiazides, and/or glucocorticoids and cannot discontinue these medications.
8. Subjects who are on oral contraceptives need to discontinue the medication for 1-2 days before the clamp study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
55 Years
Study:
NCT00001969
Study Brief:
Protocol Section:
NCT00001969