Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00078286

Purpose

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

Condition	Intervention	Phase
Heart Failure, Congestive Chronic Heart Failure Depression	Drug: Sertraline Drug: Placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Safety and Efficacy of Sertraline for Depression CHF

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression Heart Failure

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	469
Study Start Date:	November 2003
Study Completion Date:	September 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Participants will take sertraline for 12 weeks	Drug: Sertraline Dosage ranging from 50 mg to 200 mg once a day Other Name: Zoloft
Placebo Comparator: 2 Participants will take placebo for 12 weeks	Drug: Placebo Dosage ranging from 50 mg to 200 mg once a day Other Name: Inactive pill

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

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078286

Locations

United States, North Carolina
Duke Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Ranga Krishnan, PhD

Duke University

More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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. Epub 2010 Jan 25.

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. Epub 2008 Jul 7.

Responsible Party:	Ranga Krishnan, Duke Univeristy Medical Center
ClinicalTrials.gov Identifier:	NCT00078286 History of Changes
Other Study ID Numbers:	R01 MH63211, DATR A4-GPX
Study First Received:	February 20, 2004
Last Updated:	October 17, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Antidepressive Agents

Additional relevant MeSH terms:

Depression
Depressive Disorder
Heart Failure
Behavioral Symptoms
Mood Disorders
Mental Disorders
Heart Diseases
Cardiovascular Diseases
Antidepressive Agents
Sertraline

Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012