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

January 23, 2013 updated by: Duke University

Safety and Efficacy of Sertraline for Depression CHF

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

469

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sertraline
Participants will take sertraline for 12 weeks
Drug: Sertraline
Dosage ranging from 50 mg to 200 mg once a day
Other Names:
  • Zoloft
Placebo Comparator: Placebo
Participants will take placebo for 12 weeks
Drug: Placebo
Dosage ranging from 50 mg to 200 mg once a day
Other Names:
  • Inactive pill

What is the study measuring?

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
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.
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.
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.
Measured at Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Ranga Krishnan, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

February 20, 2004

First Submitted That Met QC Criteria

February 23, 2004

First Posted (Estimate)

February 24, 2004

Study Record Updates

Last Update Posted (Estimate)

February 27, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00010340
  • DATR A4-GPX
  • R01MH063211 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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