Comparison of Depression Interventions After Acute Coronary Syndrome

NCT01032018 | Completed Phase 1 Results DMC

• 2 other identifiers: AAAE1932RC2HL101663
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

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.

Conditions

Acute Coronary Syndrome; Depression

Keywords

Acute coronary syndrome; Depression; Satisfaction with care

Outcome Measures

Primary Outcomes (2)

• 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

• Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services)

  6 months after randomization

Study Arms (2)

Referred Care

ACTIVE COMPARATOR

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

Stepped Care

EXPERIMENTAL

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; Drug: Sertraline, citalopram, or bupropion

Interventions

Problem Solving Therapy BEHAVIORAL

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).

Stepped Care

Sertraline, citalopram, or bupropion DRUG

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

Stepped Care

Standard care OTHER

Participants will receive standard of care from the current physicians

Referred Care

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of North Carolina, Chapel Hill: collaborator
• Emory University: collaborator
• Yale University: collaborator
• Washington University School of Medicine: collaborator
• University of Pennsylvania: collaborator

Study Sites (5)

Yale University

New Haven, Connecticut, 06520, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Washington University

St Louis, Missouri, 63130, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Trustees of the University of Pennsylvania, Penn Cardiac Center at Mercer Bucks

Yardley, Pennsylvania, 19067, United States

Location

Related 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, 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.

  PMID: 23471421 RESULT

Related Links

• Related Info
• Baseline design paper

MeSH Terms

Conditions

Acute Coronary Syndrome; Depression

Interventions

Sertraline; Citalopram; Bupropion; Standard of Care

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Propylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propiophenones; Ketones; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Karina W Davidson, PhD
• Organization: Columbia University Medical Center

kd2124@cumc.columbia.edu

212-342-4493

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Behavioral Medicine

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 15, 2009
• Study Start: January 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 13, 2017
• Results First Posted: August 12, 2014

Record last verified: 2017-08

Locations

US (5)