Comparison of Depression Interventions After Acute Coronary Syndrome

Completed · Phase 1/Phase 2

Conditions studied: Acute Coronary Syndrome, Depression

In brief

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.

Key facts

Study ID

NCT01032018

Run by

Columbia University

People needed

150

Starts

2010-01-01

Expected to finish

2012-07-01

Last updated by the study team

2017-09-13

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Yale University — New Haven, Connecticut, United States
• Emory University — Atlanta, Georgia, United States
• Washington University — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Trustees of the University of Pennsylvania, Penn Cardiac Center at Mercer Bucks — Yardley, Pennsylvania, United States

Full record on ClinicalTrials.gov

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