Official Title: “Safety and Efficacy of Sertraline for Depression CHF”

This study will examine the effect of antidepressant medication on rates of death and disease in depressed people with chronic heart failure.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2008

Comorbid depression in people with chronic medical illness is a serious public health concern. Depressive disorders lead to increased morbidity, mortality, and poorer outcomes in ischemic heart disease, a leading cause of chronic heart failure (CHF). Evidence suggests that a relationship exists between depression and CHF; studies that examine the way CHF is affected by depression treatments are needed.

Participants in this study will be randomly assigned to receive either sertraline or placebo for 12 weeks. Assessments will be made at Weeks 2, 4, 6, 8, 10, and 12. Participants who do not respond to their treatment will have their medication dose adjusted following assessment.

Interviews and rating scales will be used to assess depressive symptoms, cognitive status, psychiatric comorbidity, daily and chronic stress, and social support. A follow-up visit will take place 6 months, 1 year, 2 years, and 3 years after study completion.

Intervention(s) in this Clinical Trial

• Drug: Sertraline
  • Dosage ranging from 50 mg to 200 mg once a day
• Drug: Placebo
  • Dosage ranging from 50 mg to 200 mg once a day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Participants will take sertraline for 12 weeks
• Placebo Comparator: 2
  • Participants will take placebo for 12 weeks

Primary Measures

• Symptoms of depression in congestive heart failure patients with clinical depression after treatment with sertraline or placebo
  • Time Frame: Measured at Week 12
    Safety Issue?: No

Secondary Measures

• Reduction in cardiac events and morbidity / mortality, including rehospitalization, in congestive heart failure patients with depression after treatment with sertraline or placebo
  • Time Frame: Measured at Week 12
    Safety Issue?: No

Inclusion Criteria:

• Chronic heart failure
• DSM-IV criteria for major depression
• Current use of any antipsychotic medication at study entry

Exclusion Criteria:

• Life-threatening comorbidity with a 50% or higher likelihood of death within 1 year
• History of psychoses, bipolar disorder, or severe personality disorder
• History of alcohol or drug dependence in the last year
• Severe physical disability that may interfere with the study
• Neurological impairment
• Active suicidal ideations
• Current use of antidepressant medication(s) at the start of study medication

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Ranga Krishnan, PhD Principal Investigator Duke University  

Overall Contact: Tamara Foxworth 919-668-3647 tamara.foxworth@duke.edu

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00078286

Study ID Number: R01 MH63211

ClinicalTrials.gov Identifier: NCT00078286

Health Authority: United States: Federal Government