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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT01913366
Eligibility Criteria:
Inclusion Criteria:
* Residence in rural Tuolumne, Calaveras, San Joaquin or Stanislaus Counties;
* Diagnosis: Major depression, unipolar (by SCID ascertained DSM-IV criteria);
* Severity of depression: A PHQ-9\>10 or a 24-Item HDRS\>19;
* Need for social services: CANE score\> 2, i.e. at least one unmet need;
Exclusion Criteria:
* Psychotic depression by SCID-IV, i.e., presence of delusions;
* High suicide risk, i.e. intent or plan to attempt suicide in near future;
* Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major depression;
* Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV);
* History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (including bipolar disorder, hypomania, and dysthymia);
* Dementia: MMSE below 24 or clinical diagnosis of dementia by DSM-IV;
* Acute/severe medical illness (delirium, metastatic cancer, de-compensated cardiac, liver or kidney failure, stroke or myocardial infarction) 3 months prior to entry; or use of drugs causing depression, (steroids, reserpine, alphamethyl-dopa, tamoxiphen, vincristine);
* Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance (walking with a cane is not an exclusion criterion)
* Inability to speak English;
* Aphasia interfering with communication;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01913366
Study Brief:
Protocol Section:
NCT01913366