Comparison of Depression Interventions After Acute Coronary Syndrome
Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
Summary
Patients will be consented and screened within 2 to 6 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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Columbia University
Collaborators:
Emory University National Heart, Lung, and Blood Institute (NHLBI) University of North Carolina, Chapel Hill University of Pennsylvania Washington University Early Recognition Center Washington University School of Medicine Yale University