Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure, Congestive; Chronic Heart Failure; Depression
Intervention: Sertraline (Drug); Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: National Institute of Mental Health (NIMH) Official(s) and/or principal investigator(s):
Ranga Krishnan, PhD, Principal Investigator, Affiliation: Duke University
Overall contact:
Tamara Foxworth, Phone: 919-668-3647, Email: tamara.foxworth@duke.edu
Summary
This study will examine the effect of antidepressant medication on rates of death and disease
in depressed people with chronic heart failure.
Clinical Details
Official title: Safety and Efficacy of Sertraline for Depression CHF
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Symptoms of depression in congestive heart failure patients with clinical depression after treatment with sertraline or placebo
Secondary outcome: Reduction in cardiac events and morbidity / mortality, including rehospitalization, in congestive heart failure patients with depression after treatment with sertraline or placebo
Detailed description:
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.
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Tamara Foxworth, Phone: 919-668-3647, Email: tamara.foxworth@duke.edu
Duke Medical Center, Durham, North Carolina 27710, United States; Recruiting
Additional Information
Starting date: November 2003
Last updated: February 27, 2008
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