Comparison of Depression Interventions After Acute Coronary Syndrome

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.

Conditions

• Acute Coronary Syndrome
• Depression

Interventions

BEHAVIORAL

Problem Solving Therapy

Problem Solving Therapy (PST) will be administered by a trained provider. The concepts of PST will be taught to the participant in the first session and reinforced across subsequent sessions. Sessions will last between 30 and 60 minutes each and continue weekly for the duration of the study (6 months).

DRUG

Sertraline, citalopram, or bupropion

Antidepressants should be started at the lowest dose, but should be adjusted upward to be within the therapeutic range within 1 week,with further adjustment higher in the therapeutic range possible at 3-4 weeks. Dosage of the first medication selected will be in the therapeutic range by 3 weeks of the initial step, as tolerated. If a patient cannot tolerate a particular treatment (i.e., intolerable side effects even with careful titration and clinical management), a switch to an alternative antidepressant or PST-PC after 2-4 weeks and 'restart' step 1. Sertraline: 25-150qam Citalopram: 10-40qam Bupropion: 100-450qam

OTHER

Standard care

Participants will receive standard of care from the current physicians

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Emory University

  collaborator OTHER

• Yale University

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Columbia University

  lead OTHER

Principal Investigators

• Karina W Davidson, PhD · Columbia University

• J Thomas Bigger, MD · Columbia University

• Robert Carney, PhD · Washington University School of Medicine

• Kenneth Freedland, PhD · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2012-01-31

Completion

2012-07-31

Countries

• United States

Study Locations