Clinical trial NCT01032018: Comparison of Depression Interventions After Acute Coronary Syndrome
Official title: Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Coronary Syndrome
Depression
Keywords: Acute coronary syndrome
Depression
Satisfaction with care
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of North Carolina, Chapel Hill
name: Emory University
name: Yale University
name: Washington University School of Medicine
name: University of Pennsylvania
First posted: 2009-12-15
Enrollment: 150
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Depressive Symptom Reduction
timeFrame: Change from depression at baseline to depression at 6-months
measure: Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services)
timeFrame: 6 months after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Yardley
country: United States
facility: Trustees of the University of Pennsylvania, Penn Cardiac Center at Mercer Bucks
state: Pennsylvania
Study officials:
affiliation: Columbia University
name: Karina W Davidson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: J Thomas Bigger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Robert Carney, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Kenneth Freedland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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, Lesperance 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.