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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00078286
First received: February 20, 2004
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Heart Failure, Congestive
Chronic Heart Failure
Depression
Drug: Sertraline
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Sertraline for Depression CHF

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 469
Study Start Date: November 2003
Study Completion Date: September 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sertraline
Participants will take sertraline for 12 weeks
Drug: Sertraline
Dosage ranging from 50 mg to 200 mg once a day
Other Name: 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 Name: Inactive pill

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078286

Locations
United States, North Carolina
Duke Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Ranga Krishnan, PhD Duke University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00078286     History of Changes
Other Study ID Numbers: Pro00010340, R01MH063211, DATR A4-GPX
Study First Received: February 20, 2004
Results First Received: May 11, 2009
Last Updated: January 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Duke University:
Antidepressive Agents

Additional relevant MeSH terms:
Depression
Depressive Disorder
Heart Failure
Behavioral Symptoms
Mood Disorders
Mental Disorders
Heart Diseases
Cardiovascular Diseases
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014