Depression Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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