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 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT01032018
Eligibility Criteria:
Inclusion Criteria:
* Hospitalized for ACS defined as unstable angina or MI
* BDI greater or equal to 10 and \< 15 2-6 months post-ACS on each of 2 occasions, or BDI greater than 15 on one occasion
* Age at least 35 years
* Fluent in English or Spanish
* Able to complete baseline assessment within 2-6 months of index ACS event
* Able and willing to provide informed consent
Exclusion Criteria:
* Presence of non-cardiac condition likely to terminate fatally within 1 year
* Inaccessibility for intervention or follow-up (e.g., plans to move from the area)
* Cognitive impairment
* Need for immediate psychiatric intervention (i.e., requiring hospitalization or psychiatric intervention within 72 hours)
* Suicidal ideation
* Major psychiatric co-morbidity (current or by history) including active psychosis, bipolar disorder, or overt personality disorder
* Active substance abuse or dependency
* Chronic renal failure (receiving chronic dialysis treatment, or estimated glomerular filtration rate"…\[eGFR\] \< 30 ml/min/1.73 m2) or moderate/severe liver disease (e.g., esophageal varices, portal hypertension, encephalopathy, GI bleeding)
* Participation in another clinical trial for the treatment of depression.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT01032018
Study Brief:
Protocol Section:
NCT01032018