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Comparison of Depression Interventions After Acute Coronary Syndrome

2014-08-27 03:17:17 | BioPortfolio

Summary

Patients will be consented and screened within 2 to 4 months of the index ACS. Patients who have elevated depression (BDI>=15 or BDI>=10 assessed twice over two week period) and who continue to meet all of the trial's eligibility criteria will be consented. Through informed consent, both arms of the trial will be described with equipoise as to these approaches to postACS depression care. Patients who consent to randomization will be enrolled in the treatment trial.

The intervention phase will be 6 months, and hence the final outcome assessments will be performed approximately 9 months after the index ACS. Interim measures of depression will be obtained at 2 and 4 months post-enrollment. Major adverse cardiac events and all-cause mortality will also be ascertained at 6 months post-enrollment. Quality assurance by an independent medical event adjudication committee using prospective guidelines will be employed.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Conditions

Acute Coronary Syndrome

Intervention

Problem Solving Therapy, Sertraline, citalopram, or bupropion, Standard care

Location

Yale University
New Haven
Connecticut
United States
06520

Status

Recruiting

Source

Columbia University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:17-0400

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