Clinical Trial: Antidepressant Medication Treatment for Depression in Individuals with Congestive Heart Failure

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to examine the effect of antidepressant medication on rates of death and disease in depressed people with congestive heart failure.

Condition Treatment or Intervention Phase
Heart Failure, Congestive
Depression
 Drug: Sertraline
Phase II
Phase III

MedlinePlus related topics:  Depression;   Heart Failure

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Safety and Efficacy of Sertraline for Depression CHF

Further Study Details: 

Expected Total Enrollment:  500

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 congestive 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.

Eligibility

Ages Eligible for Study:  45 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Chronic systolic congestive heart failure
  • DSM-IV criteria for major depression

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

Location and Contact Information

Joseph English      919-681-3217 

North Carolina
      Duke Medical Center, Durham,  North Carolina,  27710,  United States; Recruiting

More Information

Study ID Numbers:  MH63211-01A2
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  February 20, 2004
ClinicalTrials.gov Identifier:  NCT00078286
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005