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

December 11, 2009
February 20, 2013
January 2010
January 2012   (final data collection date for primary outcome measure)
Patient satisfaction with depressive symptom care [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01032018 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison of Depression Interventions After Acute Coronary Syndrome
Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
  • Acute Coronary Syndrome
  • Depression
  • 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
  • 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.
    Intervention: Other: Standard care
  • 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.
    Interventions:
    • Behavioral: Problem Solving Therapy
    • Drug: Sertraline, citalopram, or bupropion
Davidson KW, Bigger JT, Burg MM, Carney RM, Chaplin WF, Czajkowski S, Dornelas E, Duer-Hefele J, Frasure-Smith N, Freedland KE, Haas DC, Jaffe AS, Ladapo JA, Lespérance F, Medina V, Newman JD, Osorio GA, Parsons F, Schwartz JE, Shaffer JA, Shapiro PA, Sheps DS, Vaccarino V, Whang W, Ye S. Centralized, stepped, patient preference-based treatment for patients with post-acute coronary syndrome depression: CODIACS vanguard randomized controlled trial. JAMA Intern Med. 2013 Jun 10;173(11):997-1004. doi: 10.1001/jamainternmed.2013.915.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
July 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01032018
AAAE1932, RC2HL101663
Yes
Karina Davidson, Columbia University
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
Principal Investigator: Karina W Davidson, PhD Columbia University
Principal Investigator: J Thomas Bigger, MD Columbia University
Principal Investigator: Robert Carney, PhD Washington University
Principal Investigator: Kenneth Freedland, PhD Washington University
Columbia University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP