Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure

Depression Clinical Trial

— SADHART-CHF  

Official title:

Safety and Efficacy of Sertraline for Depression CHF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00078286
• Other study ID #: Pro00010340
• Secondary ID: R01MH063211DATR
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 20, 2004
• Last updated: January 23, 2013
• Start date: November 2003
• Est. completion date: September 2008

Study information

• Verified date: January 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 469
• Est. completion date: September 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Depression
• Depressive Disorder
• Heart Failure
• Heart Failure, Congestive

Intervention

Drug:
• Sertraline
Dosage ranging from 50 mg to 200 mg once a day
• Placebo
Dosage ranging from 50 mg to 200 mg once a day

Locations

Country	Name	City	State
United States	Duke Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 SADHAR — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo.	Composite cardiovascular scores are calculated for each participant using recorded cardiac events, morbidity/mortality, rehospitalization, and discontinuation due to cardiovascular events. Composite score is compared for sertraline and placebo treatment groups.	Measured at Week 12	No