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

Condition(s) targeted: Depression; Coronary Artery Disease (CAD); Acute Coronary Syndrome (ACS)

Intervention: Sertraline (Zoloft) (Drug); Simvastatin (Zocor) (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Columbia University

Official(s) and/or principal investigator(s):
Karina W Davidson, PhD, Principal Investigator, Affiliation: Columbia University: Behavioral Cardiovascular Health and Hypertension Program

Overall contact:
Karina W Davidson, PhD, Phone: 212-342-4493, Email: kd2124@columbia.edu

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

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

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Score on Beck Depression Inventory and C-Reactive Protein Level at weeks 4, 8, and 12

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.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Karina W Davidson, PhD, Phone: 212-342-4493, Email: kd2124@columbia.edu

Columbia University Department of General Medicine, New York, New York 10032, United States; Recruiting
Karina W Davidson, PhD, Phone: 212-342-4493, Email: kd2124@columbia.edu
Karina W Davidson, PhD, Principal Investigator

Starting date: April 2005
Ending date: March 2009
Last updated: August 28, 2008