Acute Coronary Syndrome (ACS), Coronary Artery Disease (CAD), Depression
Conditions
Keywords
depression, inflammation, heart disease, randomized clinical trial, sertraline, simvastatin, placebo
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.
Interventions
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.
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.
Sponsors
National Alliance for Research on Schizophrenia and Depression
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score on Beck Depression Inventory and C-Reactive Protein Level at weeks 4, 8, and 12 | 3 months |
Countries
United States
Outcome results
None listed