Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure
SADHART-CHF
Safety and Efficacy of Sertraline for Depression CHF
3 other identifiers
interventional
469
1 country
1
Brief Summary
This study will examine the effect of antidepressant medication on rates of death and disease in depressed people with chronic heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2003
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 20, 2004
CompletedFirst Posted
Study publicly available on registry
February 24, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
February 27, 2013
CompletedFebruary 27, 2013
January 1, 2013
4.3 years
February 20, 2004
May 11, 2009
January 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo
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.
Measured at Week 12
Secondary Outcomes (1)
Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo.
Measured at Week 12
Study Arms (2)
Sertraline
EXPERIMENTALParticipants will take sertraline for 12 weeks
Placebo
PLACEBO COMPARATORParticipants will take placebo for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Chronic heart failure
- Diagnostic and Statistical Manual- Fourth Edition (DSM-IV) criteria for major depression
- Current use of any antipsychotic medication at study entry
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Duke Medical Center
Durham, North Carolina, 27710, United States
Related Publications (4)
O'Connor CM, Jiang W, Kuchibhatla M, Silva SG, Cuffe MS, Callwood DD, Zakhary B, Stough WG, Arias RM, Rivelli SK, Krishnan R; SADHART-CHF Investigators. Safety and efficacy of sertraline for depression in patients with heart failure: results of the SADHART-CHF (Sertraline Against Depression and Heart Disease in Chronic Heart Failure) trial. J Am Coll Cardiol. 2010 Aug 24;56(9):692-9. doi: 10.1016/j.jacc.2010.03.068.
PMID: 20723799RESULTXiong GL, Prybol K, Boyle SH, Hall R, Streilein RD, Steffens DC, Krishnan R, Rogers JG, O'Connor CM, Jiang W; SADHART-CHF Investigators. Inflammation Markers and Major Depressive Disorder in Patients With Chronic Heart Failure: Results From the Sertraline Against Depression and Heart Disease in Chronic Heart Failure Study. Psychosom Med. 2015 Sep;77(7):808-15. doi: 10.1097/PSY.0000000000000216.
PMID: 26186432DERIVEDSteffens DC, Wei Jiang, Krishnan KR, Karoly ED, Mitchell MW, O'Connor CM, Kaddurah-Daouk R. Metabolomic differences in heart failure patients with and without major depression. J Geriatr Psychiatry Neurol. 2010 Jun;23(2):138-46. doi: 10.1177/0891988709358592. Epub 2010 Jan 25.
PMID: 20101071DERIVEDJiang 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. doi: 10.1016/j.ahj.2008.05.003. Epub 2008 Jul 7.
PMID: 18760123DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
NFS may have limited our ability to detect effect of sertraline on depression scores. Dropout rate was higher than expected. A 12-week duration of therapy may have been insufficient to show potential effects of sertraline on clinical outcomes.
Results Point of Contact
- Title
- Dr. Ranga Krishnan
- Organization
- Duke University
Study Officials
- PRINCIPAL INVESTIGATOR
Ranga Krishnan, PhD
Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2004
First Posted
February 24, 2004
Study Start
November 1, 2003
Primary Completion
March 1, 2008
Study Completion
September 1, 2008
Last Updated
February 27, 2013
Results First Posted
February 27, 2013
Record last verified: 2013-01