Clinical trial NCT00208117: A Trial of Inflammatory Markers, Depressive Symptoms, and Heart Disease
Official title: A Randomized Controlled Trial of Inflammatory Markers, Depressive Symptoms, and Heart Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Depression
Coronary Artery Disease (CAD)
Acute Coronary Syndrome (ACS)
Keywords: depression
inflammation
heart disease
randomized clinical trial
sertraline
simvastatin
placebo
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2005-09-21
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility 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

Primary outcomes:
measure: Score on Beck Depression Inventory and C-Reactive Protein Level at weeks 4, 8, and 12
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Department of General Medicine
state: New York
Study officials:
affiliation: Columbia University: Behavioral Cardiovascular Health and Hypertension Program
name: Karina W Davidson, PhD
role: PRINCIPAL_INVESTIGATOR
References: