Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)
This study has been completed.
Sponsor:
Columbia University
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
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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:
Drug Information available for:
Bupropion hydrochloride
Bupropion
Citalopram hydrobromide
Citalopram
Sertraline hydrochloride
Sertraline
Escitalopram oxalate
U.S. FDA Resources
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
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 School of Medicine |
| Principal Investigator: | Kenneth Freedland, PhD | Washington University School of Medicine |
More Information
Additional Information:
No publications provided
| 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 Antidepressive Agents, Second-Generation Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013