Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

469 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2008-09-30

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.

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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.

Conditions

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Heart Failure, Congestive Chronic Heart Failure Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sertraline

Participants will take sertraline for 12 weeks

Group Type EXPERIMENTAL

Sertraline

Intervention Type DRUG

Dosage ranging from 50 mg to 200 mg once a day

Placebo

Participants will take placebo for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dosage ranging from 50 mg to 200 mg once a day

Interventions

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Sertraline

Dosage ranging from 50 mg to 200 mg once a day

Intervention Type DRUG

Placebo

Dosage ranging from 50 mg to 200 mg once a day

Intervention Type DRUG

Other Intervention Names

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Zoloft Inactive pill

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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No