Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure (SADHART-CHF)

Duke University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Heart Failure; Heart Failure, Congestive; Depression

Treatments: Drug: Placebo; Drug: Sertraline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00078286

DATR A4-GPX

Pro00010340

R01MH063211 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 469 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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469 participants in 2 patient groups, including a placebo group

Sertraline

Experimental group

Description:

Participants will take sertraline for 12 weeks

Treatment:

Drug: Sertraline

Placebo

Placebo Comparator group

Description:

Participants will take placebo for 12 weeks

Treatment:

Drug: Placebo