Heart Failure Clinical Trial

Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure

Summary

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

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Chronic heart failure
Diagnostic and Statistical Manual- Fourth Edition (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

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

469

Study ID:

NCT00078286

Recruitment Status:

Completed

Sponsor:

Duke University

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There is 1 Location for this study

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Duke Medical Center
Durham North Carolina, 27710, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

469

Study ID:

NCT00078286

Recruitment Status:

Completed

Sponsor:


Duke University

How clear is this clinincal trial information?

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