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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00078286 |
This study will examine the effect of antidepressant medication on rates of death and disease in depressed people with chronic heart failure.
Condition | Intervention | Phase |
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Heart Failure, Congestive Chronic Heart Failure Depression |
Drug: Sertraline Drug: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Safety and Efficacy of Sertraline for Depression CHF |
Enrollment: | 469 |
Study Start Date: | November 2003 |
Study Completion Date: | September 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will take sertraline for 12 weeks
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Drug: Sertraline
Dosage ranging from 50 mg to 200 mg once a day
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2: Placebo Comparator
Participants will take placebo for 12 weeks
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Drug: Placebo
Dosage ranging from 50 mg to 200 mg once a day
|
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.
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Duke Univeristy Medical Center ( Ranga Krishnan ) |
Study ID Numbers: | R01 MH63211, DATR A4-GPX |
Study First Received: | February 20, 2004 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00078286 |
Health Authority: | United States: Federal Government |
Antidepressive Agents |
Heart Failure Heart Diseases Depression Mental Disorders Mood Disorders |
Sertraline Depressive Disorder Serotonin Behavioral Symptoms |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Cardiovascular Diseases Serotonin Uptake Inhibitors Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |