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Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure (SADHART-CHF)
This study has been completed.
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00078286
  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 II
Phase III

MedlinePlus related topics: Antidepressants Depression Heart Failure
Drug Information available for: Sertraline hydrochloride Sertraline
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Safety and Efficacy of Sertraline for Depression CHF

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Secondary Outcome Measures:
  • Reduction in 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 ]

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
1: Experimental
Participants will take sertraline for 12 weeks
Drug: Sertraline
Dosage ranging from 50 mg to 200 mg once a day
2: Placebo Comparator
Participants will take placebo for 12 weeks
Drug: Placebo
Dosage ranging from 50 mg to 200 mg once a day

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
  • 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
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
Investigators
Principal Investigator: Ranga Krishnan, PhD Duke University
  More Information

Publications indexed to this study:
Responsible Party: Duke Univeristy Medical Center ( Ranga Krishnan )
Study ID Numbers: R01 MH63211, DATR A4-GPX
Study First Received: February 20, 2004
Last Updated: October 17, 2008
ClinicalTrials.gov Identifier: NCT00078286  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Antidepressive Agents

Study placed in the following topic categories:
Heart Failure
Heart Diseases
Depression
Mental Disorders
Mood Disorders
Sertraline
Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Cardiovascular Diseases
Serotonin Uptake Inhibitors
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009