Clinical trial NCT00078286: Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure
Official title: Safety and Efficacy of Sertraline for Depression CHF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Heart Failure, Congestive
Chronic Heart Failure
Depression
Keywords: Antidepressive Agents
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2004-02-24
Enrollment: 469
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the effect of antidepressant medication on rates of death and disease in depressed people with chronic heart failure.

Detailed description: 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.

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

Primary outcomes:
measure: Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo
timeFrame: Measured at Week 12
Secondary outcomes:
measure: Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo.
timeFrame: Measured at Week 12
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Ranga Krishnan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Xiong 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.
citation: Steffens 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.
citation: 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. doi: 10.1016/j.ahj.2008.05.003. Epub 2008 Jul 7.