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Sponsors and Collaborators: |
Columbia University National Alliance for Research on Schizophrenia and Depression |
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Information provided by: | Columbia University |
ClinicalTrials.gov Identifier: | NCT00208117 |
The purpose of this study is to examine the relationship between depressive symptoms and markers of inflammation, two predictors of heart disease.
Condition | Intervention | Phase |
---|---|---|
Depression Coronary Artery Disease (CAD) Acute Coronary Syndrome (ACS) |
Drug: Sertraline (Zoloft) Drug: Simvastatin (Zocor) |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Controlled Trial of Inflammatory Markers, Depressive Symptoms, and Heart Disease |
Estimated Enrollment: | 60 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Patients randomized to sertraline will receive 50 mg/d for the first 6 weeks. Based on clinical response and tolerability, the dosage will be increased to 2 tablets (100 mg/d) at the end of week 6 until the end of the study (8 weeks). If AEs occur, the dosage will be reduced by 50 mg (1 tablet) at a time, as long as a minimum daily dose of 50 mg is maintained. The psychiatry fellow will be responsible for drug administration and will see all patients weekly. All randomized patients will also be seen at the mid-treatment, post-treatment, and follow-up visits by the study psychiatrist to determine depression symptom severity (HAM-D), assess medical tolerance to the study medications, and ensure patient psychiatric safety. The study psychiatrist will be blinded to treatment allocation.
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Drug: Sertraline (Zoloft)
Patients randomized to sertraline will receive 50 mg/d for the first 6 weeks. Based on clinical response and tolerability, the dosage will be increased to 2 tablets (100 mg/d) at the end of week 6 until the end of the study (8 weeks). If adverse events occur, the dosage will be reduced by 50 mg (1 tablet) at a time, as long as a minimum daily dose of 50 mg is maintained.
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2: Placebo Comparator
To ensure blinding of research assessments and the patient, all medications, including the placebo, will be reformulated into a matching number of identical-appearing pills. All randomized patients will also be seen at the mid-treatment, post-treatment, and follow-up visits by the study psychiatrist to determine depression symptom severity (HAM-D), assess the medical tolerance to the study medications (including placebo), and ensure patient psychiatric safety. The study psychiatrist will be blinded to treatment allocation.
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Drug: Simvastatin (Zocor)
The placebo drug will be administered for 8 weeks. To ensure blinding of research assessments and the patient, all medications, including the placebo, will be reformulated into a matching number of identical-appearing pills.
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Depressive symptoms and inflammatory markers have both been proposed as measures that indicate/precede coronary artery disease (CAD). However, no controlled research study has tested the impact of these two candidate CAD risk factors within the same design to see the directionality of their influence. This study will explore if simvastatin reduces depressive symptoms and if sertraline reduces C-Reactive protein (CRP). Additionally, the recruitment process will help determine the feasibility of a larger trial, powered for significance testing. Three hundred and seventy-five participants will be consented and screened for this study. We expect forty-two otherwise healthy outpatients to have both elevated symptoms and high CRP levels, and be willing to be randomly assigned to sertraline, an antidepressant, simvastatin, a drug with anti-inflammatory properties, or a placebo for 8 weeks. Depressive symptoms and inflammatory indicators will be assessed before treatment (screening and baseline), mid-treatment (after 4 weeks), post-treatment (after 8 weeks), and a follow-up visit (after 12 weeks), using blood tests and depression interviews. We expect that both inflammation and depressive symptoms may be reduced by both medications, but the number of subjects needed to test this hypothesis is not yet known. Hence, this pilot study will be conducted. Knowledge about the inter-dependency of these two CAD risk factors allows the most promising future observational/intervention studies to be designed and conducted.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Karina W Davidson, PhD | 212-342-4493 | kd2124@columbia.edu |
Contact: Gabrielle Albanese, BA | 212-342-4497 | ga2150@columbia.edu |
United States, New York | |
Columbia University Department of General Medicine | Recruiting |
New York, New York, United States, 10032 | |
Contact: Karina W Davidson, PhD 212-342-4493 kd2124@columbia.edu | |
Principal Investigator: Karina W Davidson, PhD |
Principal Investigator: | Karina W Davidson, PhD | Columbia University: Behavioral Cardiovascular Health and Hypertension Program |
Responsible Party: | Columbia University ( Karina W. Davidson/Associate Professor of Behavioral Medicine ) |
Study ID Numbers: | 4976 - Davidson |
Study First Received: | September 15, 2005 |
Last Updated: | August 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00208117 |
Health Authority: | United States: Institutional Review Board |
depression inflammation heart disease randomized clinical trial |
sertraline simvastatin placebo |
Arterial Occlusive Diseases Heart Diseases Depression Simvastatin Myocardial Ischemia Vascular Diseases Ischemia Arteriosclerosis Depressive Disorder |
Serotonin Inflammation Behavioral Symptoms Coronary Disease Mental Disorders Acute Coronary Syndrome Mood Disorders Sertraline Coronary Artery Disease |
Antimetabolites Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antilipemic Agents Physiological Effects of Drugs Psychotropic Drugs Enzyme Inhibitors Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Therapeutic Uses Cardiovascular Diseases Central Nervous System Agents Antidepressive Agents |