Overview

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

Status:
Terminated
Trial end date:
2009-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to examine the relationship between depressive symptoms and markers of inflammation, two predictors of heart disease.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
New York State Psychiatric Institute
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Treatments:
Sertraline
Simvastatin
Criteria
Inclusion Criteria:

1. Age 18 - 60

2. Mild depression

3. Inflammatory markers: CRP > 2

Exclusion Criteria:

1. Non-English or Non-Spanish speakers

2. Active suicidal or homicidal ideation

3. Current alcohol or other substance abuse

4. Psychotic features

5. Current personality disorder

6. History of bipolar depressive disorder

7. Any current psychotic disorder

8. Current major depressive disorder

9. Current depression treatment or treatment within preceding 6 weeks

10. History of chronic liver and/or renal disease

11. Current use or contraindication to any of the tested medications

12. Absence of a response to a previous adequate trial of any of the tested medications

13. Pregnant or lactating women

14. History of coronary artery disease

15. Current use of statins

16. Current, regular aspirin use

17. Antibiotic use within the previous four weeks

18. History of diabetes

19. Inflammatory diseases

20. Meets NCEP guidelines for cholesterol lowering therapy