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Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure (SADHART-CHF)
This study has been completed.
Study NCT00078286   Information provided by National Institute of Mental Health (NIMH)
First Received: February 20, 2004   Last Updated: October 17, 2008   History of Changes

February 20, 2004
October 17, 2008
November 2003
March 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00078286 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure
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.

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.

Phase II, Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
  • Heart Failure, Congestive
  • Chronic Heart Failure
  • Depression
  • Drug: Sertraline
  • Drug: Placebo
  • Experimental: Participants will take sertraline for 12 weeks
  • Placebo Comparator: Participants will take placebo for 12 weeks
Jiang W, O'Connor C, Silva SG, Kuchibhatla M, Cuffe MS, Callwood DD, Zakhary B, Henke E, Arias RM, Krishnan R; SADHART-CHF Investigators. Safety and efficacy of sertraline for depression in patients with CHF (SADHART-CHF): a randomized, double-blind, placebo-controlled trial of sertraline for major depression with congestive heart failure. Am Heart J. 2008 Sep;156(3):437-44. Epub 2008 Jul 7.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
469
September 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00078286
Ranga Krishnan, Duke Univeristy Medical Center
R01 MH63211, DATR A4-GPX
National Institute of Mental Health (NIMH)
 
Principal Investigator: Ranga Krishnan, PhD Duke University
National Institute of Mental Health (NIMH)
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP