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| Descriptive Information Fields | |||||
| Brief Title † | Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure | ||||
| Official Title † | Safety and Efficacy of Sertraline for Depression 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. |
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| 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. |
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| Study Phase | Phase II, Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | 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 Measure † | 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 ] | ||||
| Condition † | Heart Failure, Congestive Chronic Heart Failure Depression |
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| Intervention † | Drug: Sertraline Drug: Placebo |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 500 | ||||
| Start Date † | November 2003 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 45 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00078286 | ||||
| Organization ID | R01 MH63211 | ||||
| Secondary IDs †† | DATR A4-GPX | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | February 2008 | ||||
| First Received Date † | February 20, 2004 | ||||
| Last Updated Date | February 27, 2008 | ||||
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