Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01032018
Recruitment Status : Completed
First Posted : December 15, 2009
Results First Posted : August 12, 2014
Last Update Posted : September 13, 2017
National Heart, Lung, and Blood Institute (NHLBI)
University of North Carolina, Chapel Hill
Emory University
Yale University
Washington University School of Medicine
University of Pennsylvania
Information provided by (Responsible Party):
Karina Davidson, Columbia University

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Depression Behavioral: Problem Solving Therapy Drug: Sertraline, citalopram, or bupropion Other: Standard care Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)
Study Start Date : January 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Referred Care
Immediately after the initial post-ACS screening, the participant's physician will be notified in writing if the participant is depressed according to the BDI. Depending upon the physician's own evaluation of the participant, he or she may elect to defer depression treatment, initiate it, or to refer the patient to a mental health specialist.
Other: Standard care
Participants will receive standard of care from the current physicians

Experimental: Stepped Care
Stepped Care participants will be given a description of the choices available in this arm, including choosing antidepressant medication and/or telephone-based, Problem-Solving Therapy (PST). If the patient is randomized to Stepped Care, their physician will be informed that depression treatment is being provided by the trial. Patients will select their preferred treatment approach. Depression symptoms will be monitored to determine whether the patient is improving relative to his/her baseline score. Relapse monitoring and maintenance therapy will continue for the duration of the study.
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

Primary Outcome Measures :
  1. Depressive Symptom Reduction [ Time Frame: Change from depression at baseline to depression at 6-months ]
    Symptoms of depression were assessed using the Beck Depression Inventory (BDI). This 21-question, multiple choice self-report instrument includes items pertaining to symptoms of depression, including hopelessness and irritability, physical symptoms such as fatigue, and thoughts such as guilt. Each item has at a set of four possible responses, ranging in intensity for least intense to most intense. The total score is calculated by adding the responses to each item. Higher scores indicate more severe depressive symptoms. The total score on the scale ranges from 0 to 63. Total scores on the scale of less 10 indicate minimal depression; total scores between 10 and 15 indicate mild depression; and total scores greater than 16 indicate a probable clinical diagnosis of depression.

  2. Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services) [ Time Frame: 6 months after randomization ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01032018

Layout table for location information
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63130
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
Trustees of the University of Pennsylvania, Penn Cardiac Center at Mercer Bucks
Yardley, Pennsylvania, United States, 19067
Sponsors and Collaborators
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
University of North Carolina, Chapel Hill
Emory University
Yale University
Washington University School of Medicine
University of Pennsylvania
Layout table for investigator information
Principal Investigator: Karina W Davidson, PhD Columbia University
Principal Investigator: J Thomas Bigger, MD Columbia University
Principal Investigator: Robert Carney, PhD Washington University School of Medicine
Principal Investigator: Kenneth Freedland, PhD Washington University School of Medicine
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Karina Davidson, Professor of Behavioral Medicine, Columbia University Identifier: NCT01032018    
Other Study ID Numbers: AAAE1932
RC2HL101663 ( U.S. NIH Grant/Contract )
First Posted: December 15, 2009    Key Record Dates
Results First Posted: August 12, 2014
Last Update Posted: September 13, 2017
Last Verified: August 2017
Keywords provided by Karina Davidson, Columbia University:
Acute coronary syndrome
Satisfaction with care
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Coronary Syndrome
Depressive Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin Uptake Inhibitors