Trial · NCT00078286
Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure
NCT00078286, Phase 2, Phase 3, Completed, Duke University; results first posted 2013-02-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure. Trials, record NCT00078286. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00078286
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure
- NCT number
- NCT00078286
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 469 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Heart Failure, Congestive, Chronic Heart Failure, Depression
- Interventions
- Sertraline, Placebo
- First posted
- 2004-02-24
- Last updated
- 2013-02-27
- Results first posted
- 2013-02-27
- 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.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo | Measured at Week 12 | 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. |
| Secondary | 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 | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo | Measured at Week 12 | Analysis was based on intent to treat (ITT), using random coefficient modeling. | HDRS Change Score | MEAN |
| SECONDARY | 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 | Analysis was based on intent to treat (ITT). | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo | Sertraline | -7.1 | Standard Deviation 0.5 | HDRS Change Score | |
| Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo | Placebo | -6.8 | Standard Deviation 0.5 | HDRS Change Score | |
| Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo. | Sertraline | Cardiovascular Status Worsened | 29.9 | percentage of participants | |
| Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo. | Placebo | Cardiovascular Status Worsened | 31.1 | percentage of participants | |
| Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo. | Sertraline | Cardiovascular Status Improved | 40.6 | percentage of participants | |
| Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo. | Placebo | Cardiovascular Status Improved | 43.8 | percentage of participants | |
| Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo. | Sertraline | Cardiovascular Status Unchanged | 29.5 | percentage of participants | |
| Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo. | Placebo | Cardiovascular Status Unchanged | 25.1 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sertraline | 234 | |
| Overall Study | STARTED | Placebo | 235 | |
| Overall Study | COMPLETED | Sertraline | 138 | |
| Overall Study | COMPLETED | Placebo | 152 | |
| Overall Study | NOT COMPLETED | Sertraline | 96 | |
| Overall Study | NOT COMPLETED | Placebo | 83 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Congestive Heart Failure | Cardiac disorders | Sertraline | 11 | 234 | 19 |
| other | Congestive Heart Failure | Cardiac disorders | Placebo | 10 | 235 | 20 |
| other | Unstable Angina | Cardiac disorders | Sertraline | 2 | 234 | 5 |
| other | Unstable Angina | Cardiac disorders | Placebo | 2 | 235 | 5 |
| other | Other Cardiovascular | Cardiac disorders | Sertraline | 9 | 234 | 12 |
| other | Other Cardiovascular | Cardiac disorders | Placebo | 11 | 235 | 16 |
| serious | Cardiovascular | Cardiac disorders | Sertraline | 40 | 234 | 69 |
| serious | Cardiovascular | Cardiac disorders | Placebo | 44 | 235 | 72 |
| serious | Psychiatric | Psychiatric disorders | Sertraline | 0 | 234 | 0 |
| serious | Psychiatric | Psychiatric disorders | Placebo | 2 | 235 | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sertraline | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Sertraline | 22 | 234 |
| Total, other adverse events | Placebo | 23 | 235 |
| Total, serious adverse events | Sertraline | 57 | 234 |
| Total, serious adverse events | Placebo | 63 | 235 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01MH063211 | Safety and Efficacy of Sertraline for Depression Congestive Heart Failure | KRISHNAN, RANGA R | DUKE UNIVERSITY | NATIONAL INSTITUTE OF MENTAL HEALTH | 2003 to 2007 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sertraline vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00078286
GET https://conductscience.org/api/trials/v1/NCT00078286/registered