Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01032018
First received: December 11, 2009
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Patient satisfaction with depressive symptom care [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non-fatal myocardial infarction, urgent PCI, hospitalization for unstable angina, or all-cause mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Depressive symptom reduction [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: January 2010
Study Completion Date: July 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032018

Locations
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
St. 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
University of North Carolina, Chapel Hill
Emory University
Yale University
Washington University School of Medicine
University of Pennsylvania
Investigators
Principal Investigator: Karina W Davidson, PhD Columbia University
Principal Investigator: J Thomas Bigger, MD Columbia University
Principal Investigator: Robert Carney, PhD Washington University Early Recognition Center
Principal Investigator: Kenneth Freedland, PhD Washington University Early Recognition Center
  More Information

Additional Information:
No publications provided by Columbia University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karina Davidson, Professor of Behavioral Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01032018     History of Changes
Other Study ID Numbers: AAAE1932, RC2HL101663
Study First Received: December 11, 2009
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Acute coronary syndrome
Depression
Satisfaction with care

Additional relevant MeSH terms:
Depression
Depressive Disorder
Acute Coronary Syndrome
Behavioral Symptoms
Mood Disorders
Mental Disorders
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Antidepressive Agents
Citalopram
Sertraline
Bupropion
Dexetimide
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on August 01, 2014