Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078286
Status:
COMPLETED
Last Update Posted:
2013-02-27
First Post:
2004-02-20
Brief Title:
Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Safety and Efficacy of Sertraline for Depression CHF
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SADHART-CHF
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DATR A4-GPX | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH063211 |
| R01MH063211 | NIH | None | None |