Comparison of Depression Interventions After Acute Coronary Syndrome

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Bupropion; Citalopram; Dexetimide; Sertraline

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.