Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure

Phase 2

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will take placebo for 12 weeks
Sertraline	Sertraline	Participants will take sertraline for 12 weeks

Primary Outcome Measures

Name	Time	Method
Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo	Measured at Week 12	Symptoms of depression (as measured by the Hamilton Depression Rating Scale, HDRS) in congestive heart failure patients with clinical depression after treatment with sertraline or placebo. The 17-item Hamilton Depression Rating Scale (HDRS) is a rater-administered assessment of depression severity, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed). Change in depression was measured as the difference between the 12-week HDRS scores and the baseline HDRS scores. Thus, a negative value reflects an improvement in depressive symptoms over the 12-week period.

Secondary Outcome Measures

Name	Time	Method
Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo.	Measured at Week 12	Composite cardiovascular scores are calculated for each participant using recorded cardiac events, morbidity/mortality, rehospitalization, and discontinuation due to cardiovascular events. Composite score is compared for sertraline and placebo treatment groups.