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

Depression Clinical Trial

— CHIME  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00208117
• Other study ID #: 4976 (Davidson)
• Status: Terminated
• Phase: Phase 1
• First received: September 15, 2005
• Last updated: May 30, 2012
• Start date: April 2005
• Est. completion date: January 2009

Study information

• Verified date: May 2012
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndrome (ACS)
• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Coronary Disease
• Depression
• Heart Diseases
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Columbia University Department of General Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on Beck Depression Inventory and C-Reactive Protein Level at weeks 4, 8, and 12		3 months	No