A Trial of Inflammatory Markers, Depressive Symptoms, and Heart Disease (CHIME)
Depression, Coronary Artery Disease (CAD), Acute Coronary Syndrome (ACS)
About this trial
This is an interventional prevention trial for Depression focused on measuring depression, inflammation, heart disease, randomized clinical trial, sertraline, simvastatin, placebo
Eligibility Criteria
Inclusion Criteria: Age 18 - 60 Mild depression Inflammatory markers: CRP > 2 Exclusion Criteria: Non-English or Non-Spanish speakers Active suicidal or homicidal ideation Current alcohol or other substance abuse Psychotic features Current personality disorder History of bipolar depressive disorder Any current psychotic disorder Current major depressive disorder Current depression treatment or treatment within preceding 6 weeks History of chronic liver and/or renal disease Current use or contraindication to any of the tested medications Absence of a response to a previous adequate trial of any of the tested medications Pregnant or lactating women History of coronary artery disease Current use of statins Current, regular aspirin use Antibiotic use within the previous four weeks History of diabetes Inflammatory diseases Meets NCEP guidelines for cholesterol lowering therapy
Sites / Locations
- Columbia University Department of General Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
1
2
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 AEs 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 psychiatry fellow will be responsible for drug administration and will see all patients weekly. All randomized patients will also be seen at the mid-treatment, post-treatment, and follow-up visits by the study psychiatrist to determine depression symptom severity (HAM-D), assess medical tolerance to the study medications, and ensure patient psychiatric safety. The study psychiatrist will be blinded to treatment allocation.
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. All randomized patients will also be seen at the mid-treatment, post-treatment, and follow-up visits by the study psychiatrist to determine depression symptom severity (HAM-D), assess the medical tolerance to the study medications (including placebo), and ensure patient psychiatric safety. The study psychiatrist will be blinded to treatment allocation.