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:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT00562367
Eligibility Criteria:
Inclusion Criteria:
* DSM-IV diagnostic criteria for MDD (diagnosed with the use of SCID)
* Written informed consent
* Men or women aged 18-65
* A baseline Hamilton-D17 score of \> 16.
Exclusion Criteria:
* Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment.
* Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy)
* Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
* History of seizure disorder,
* History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months.
* History or current diagnosis of dementia, or a score of \< 26 on the Mini Mental Status Examination (Folstein, 1975) at the screening visit.
* History of multiple adverse drug reactions or allergy to the study drugs.
* Patients with mood congruent or mood incongruent psychotic features.
* Patients having shown minimal or no response to a standard course of antidepressant treatment with an SSRI. A standard course will be defined as the following medications taken for \> 4 weeks: fluoxetine \> 20 mg/day, sertraline \> 50 mg/day, paroxetine \> 20 mg/day, fluvoxamine \> 50 mg/day, citalopram \> 20 mg/day, venlafaxine \> 150 mg/day.
* Clinical or laboratory evidence of hypothyroidism.
* Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding baseline.
* History of intolerance to Cytomel
* History of cardiac pathology or diabetes
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00562367
Study Brief:
Protocol Section:
NCT00562367