Phase 3
N=469
Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure
Heart Failure, Congestive · Chronic Heart Failure · Depression
Bottom Line
View on ClinicalTrials.gov: NCT00078286 ↗Enrolled (actual)
469
Serious AEs
25.6%
Results posted
Feb 2013
Primary outcome: Primary: Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo — -7.1; -6.8 HDRS Change Score — p=0.89
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sertraline (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo |
-7.1; -6.8 | 0.89 |
| SECONDARY Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo. |
29.9; 31.1; 40.6; 43.8; 29.5; 25.1 | .78 |
Summary
This study will examine the effect of antidepressant medication on rates of death and disease in depressed people with chronic heart failure.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00078286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.