A Phase 2/3 interventional study of Sertraline and Placebo in Heart Failure, Congestive, Chronic Heart Failure and Depression, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2013-02-27.
Sponsored by Duke University · Phase 2/3, Interventional, and Treatment
This study will examine the effect of antidepressant medication on rates of death and disease in depressed people with chronic heart failure.
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.
5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's enrollment of 469 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will take sertraline for 12 weeks
Drug: Sertraline
Participants will take placebo for 12 weeks
Drug: Placebo
Dosage ranging from 50 mg to 200 mg once a day
Also known as: Zoloft
Dosage ranging from 50 mg to 200 mg once a day
Also known as: Inactive pill
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.
Time frame: Measured at Week 12
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.
Time frame: Measured at Week 12
Recruitment began in November, 2003 and concluded in March, 2008. Subjects were recruited from cardiology inpatient units as well as outpatient cardiology clinics.
| Milestone | Sertraline | Placebo |
|---|---|---|
| Started | 234 | 235 |
| Completed | 138 | 152 |
| Not completed | 96 | 83 |
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.
| HDRS Change Score | Sertraline | Placebo |
|---|---|---|
| Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo | -7.1 ± 0.5 | -6.8 ± 0.5 |
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.
| percentage of participants | Sertraline | Placebo |
|---|---|---|
| Cardiovascular Status Worsened | 29.9 | 31.1 |
| Cardiovascular Status Improved | 40.6 | 43.8 |
| Cardiovascular Status Unchanged | 29.5 | 25.1 |
Collected over 12-weeks. Non-serious events are listed at a 0.80% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sertraline | — | 57/234 (24.4%) | 22/234 (9.4%) |
| Placebo | — | 63/235 (26.8%) | 23/235 (9.8%) |
| Event | Sertraline | Placebo |
|---|---|---|
| CardiovascularCardiac disorders | 40/234 | 44/235 |
| Noncardiovascular and nonpsychiatricGeneral disorders | 17/234 | 17/235 |
| PsychiatricPsychiatric disorders | 0/234 | 2/235 |
| Event | Sertraline | Placebo |
|---|---|---|
| Congestive Heart FailureCardiac disorders | 11/234 | 10/235 |
| Other CardiovascularCardiac disorders | 9/234 | 11/235 |
| Unstable AnginaCardiac disorders | 2/234 | 2/235 |
| Age, Categorical(Participants) | Sertraline | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0.0 |
| Between 18 and 65 years | 131 | 147 | 278.0 |
| >=65 years | 103 | 88 | 191.0 |
| Age Continuous(years) | Sertraline | Placebo | Total |
|---|---|---|---|
| Mean | 62.9 ± 10.5 | 61.4 ± 11.1 | 62.1 ± 10.8 |
| Sex: Female, Male(Participants) | Sertraline | Placebo | Total |
|---|---|---|---|
| Female | 101 | 89 | 190.0 |
| Male | 133 | 146 | 279.0 |
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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