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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00078286 |
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Date of registration:
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20/02/2004 |
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Primary sponsor: |
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Public title:
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Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure
SADHART-CHF |
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Scientific title:
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Safety and Efficacy of Sertraline for Depression CHF |
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Date of first enrolment:
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November 2003 |
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Target sample size:
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469 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00078286 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Ranga Krishnan, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Duke University |
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Key inclusion & exclusion criteria
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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
Age minimum:
45 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Heart Failure
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Depression
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Heart Failure, Congestive
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Intervention(s)
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Drug: Placebo
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Drug: Sertraline
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Primary Outcome(s)
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Symptoms of depression in congestive heart failure patients with clinical depression after treatment with sertraline or placebo
[Time Frame: Measured at Week 12]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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DATR A4-GPX
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R01 MH63211
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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