Expired Study
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New York, New York 10032


Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

4976 (Davidson)


NCT ID:

NCT00208117


Secondary ID:


Study Acronym:

CHIME


Brief Title:

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


Official Title:

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


Overall Status:

Terminated


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

New York State Psychiatric Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Unable to enroll subjects


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

7


Enrollment Type:

Actual


Overall Contact Information

Official Name:Karina W Davidson, PhD
Principal Investigator
Columbia University: Behavioral Cardiovascular Health and Hypertension Program

Study Dates

Start Date:April 2005
Completion Date:January 2009
Completion Type:Actual
Primary Completion Date:January 2009
Primary Completion Type:Actual
Verification Date:May 2012
Last Changed Date:May 30, 2012
First Received Date:September 15, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Score on Beck Depression Inventory and C-Reactive Protein Level at weeks 4, 8, and 12
Time Frame:3 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Sertraline (Zoloft)
Description: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.
Arm Name:1
Intervention Type:Drug
Name:Simvastatin (Zocor)
Description: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.
Arm Name:2

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Description: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
Study Arm Type:Placebo Comparator
Arm Name:2
Description: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 blin

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:New York State Psychiatric Institute
Agency Class:Other
Agency Type:Collaborator
Agency Name:National Alliance for Research on Schizophrenia and Depression

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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