Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure

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

Detailed Description
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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.

Official Title
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Safety and Efficacy of Sertraline for Depression CHF

Conditions
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Heart Failure, Congestive, Chronic Heart Failure, Depression

Intervention / Treatment
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* Drug: Sertraline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sertraline<br>Participants will take sertraline for 12 weeks | Drug: Sertraline<br>* Dosage ranging from 50 mg to 200 mg once a day<br>* Other names: Zoloft;|
| Placebo Comparator: Placebo<br>Participants will take placebo for 12 weeks | Drug: Placebo<br>* Dosage ranging from 50 mg to 200 mg once a day<br>* Other names: Inactive pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo | 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. | Measured at Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo. | 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. | Measured at Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antidepressive Agents