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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT01031134
Eligibility Criteria:
Inclusion Criteria:
* Age: 65 years and older;
* Medical outpatient presenting to Lincoln Hospital, Bronx NY, the New York City Health and Hospitals Corporation (HHC);
* Screen positive (PHQ-9 score\>9 for depression, in addition to primary care physician recommendation for depression treatment.
Exclusion Criteria:
* Presence of significant alcohol or substance abuse, psychotic disorder, or bipolar disorder;
* High suicide risk, i.e. intent or plan to attempt suicide in near future;
* Current treatment with antidepressant medication or psychotherapy prior to index physician visit (with the exception of low doses of antidepressant medication for pain disorders);
* Cognitive impairment: MMSE score \<20 or clinical diagnosis of dementia;
* Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver, or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs often causing depression, e.g., steroids, reserpine, alpha-methyl-dopa, tamoxifen, vincristine;
* Aphasia interfering with communication.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
95 Years
Study:
NCT01031134
Study Brief:
Protocol Section:
NCT01031134