NCT00078286

Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure

Safety and Efficacy of Sertraline for Depression CHF

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 469 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Heart Failure, Congestive
• Chronic Heart Failure
• Depression

Interventions

Type	Name	Description
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

Timeline

• Start date: 2003-11-01
• Primary completion: 2008-03-01
• Completion: 2008-09-01
• First posted: 2004-02-24
• Last updated: 2013-02-27
• Results posted: 2013-02-27

Locations

1 site across 1 country: United States