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Completed

NCT Number: NCT00078286

Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure

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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Key information

Conditions

Heart Failure, Congestive Behavior Behavioral Symptoms Cardiovascular Diseases Chronic Heart Failure Depression Heart Diseases Heart Failure

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Duke Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sertraline

Drug

Dosage ranging from 50 mg to 200 mg once a day

Other names: Zoloft

Placebo

Drug

Dosage ranging from 50 mg to 200 mg once a day

Other names: Inactive pill

Primary outcomes

  1. Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo

    Time frame: 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 outcomes

  1. Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Safety and Efficacy of Sertraline for Depression CHF

Acronym: SADHART-CHF

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Feb 24, 2004
Registry last updated
Feb 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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