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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

February 20, 2004
January 23, 2013
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 ]

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.

Not Provided
Complete list of historical versions of study NCT00078286 on ClinicalTrials.gov Archive Site
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.
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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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Heart Failure, Congestive
  • Chronic Heart Failure
  • Depression
  • Drug: Sertraline
    Dosage ranging from 50 mg to 200 mg once a day
    Other Name: Zoloft
  • Drug: Placebo
    Dosage ranging from 50 mg to 200 mg once a day
    Other Name: Inactive pill
  • Experimental: Sertraline
    Participants will take sertraline for 12 weeks
    Intervention: Drug: Sertraline
  • Placebo Comparator: Placebo
    Participants will take placebo for 12 weeks
    Intervention: Drug: Placebo

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

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
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00078286
Pro00010340, R01MH063211, DATR A4-GPX
Yes
Duke University
Duke University
National Institute of Mental Health (NIMH)
Principal Investigator: Ranga Krishnan, PhD Duke University
Duke University
January 2013

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