NCT00208117

A Trial of Inflammatory Markers, Depressive Symptoms, and Heart Disease

A Randomized Controlled Trial of Inflammatory Markers, Depressive Symptoms, and Heart Disease

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine the relationship between depressive symptoms and markers of inflammation, two predictors of heart disease.

Detailed description

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.

Conditions

• Depression
• Coronary Artery Disease (CAD)
• Acute Coronary Syndrome (ACS)

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2005-04-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2005-09-21
• Last updated: 2012-05-31

Locations

1 site across 1 country: United States