Comparison of Depression Interventions After Acute Coronary Syndrome

Depression Clinical Trial

— CODIACS  

Official title:

Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032018
• Other study ID #: AAAE1932
• Secondary ID: RC2HL101663
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 11, 2009
• Last updated: July 21, 2014
• Start date: January 2010
• Est. completion date: July 2012

Study information

• Verified date: July 2014
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Depression
• Depressive Disorder
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Yale University	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	Washington University	St. Louis	Missouri
United States	Trustees of the University of Pennsylvania, Penn Cardiac Center at Mercer Bucks	Yardley	Pennsylvania

Sponsors (7)

Lead Sponsor	Collaborator
Columbia University	Emory University, National Heart, Lung, and Blood Institute (NHLBI), University of North Carolina, Chapel Hill, University of Pennsylvania, Washington University Early Recognition Center, Yale University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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, She — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive Symptom Reduction	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.	Change from depression at baseline to depression at 6-months	No
Primary	Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services)		6 months after randomization	No

External Links

•   Link
•   Baseline design paper
•   CODIACS Study Website