A Trial of Inflammatory Markers, Depressive Symptoms, and Heart Disease (CHIME)

This study has been terminated.
(Unable to enroll subjects)
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00208117
First received: September 15, 2005
Last updated: May 30, 2012
Last verified: May 2012

September 15, 2005
May 30, 2012
April 2005
January 2009   (final data collection date for primary outcome measure)
Score on Beck Depression Inventory and C-Reactive Protein Level at weeks 4, 8, and 12 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Score on Beck Depression Inventory and C-Reactive Protein Level at weeks 4,8, and 12
Complete list of historical versions of study NCT00208117 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Trial of Inflammatory Markers, Depressive Symptoms, and Heart Disease
A Randomized Controlled Trial of Inflammatory Markers, Depressive Symptoms, and Heart Disease

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
  • Depression
  • Coronary Artery Disease (CAD)
  • Acute Coronary Syndrome (ACS)
  • 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.
  • Drug: 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.
  • Active Comparator: 1
    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.
    Intervention: Drug: Sertraline (Zoloft)
  • Placebo Comparator: 2
    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.
    Intervention: Drug: Simvastatin (Zocor)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00208117
4976 (Davidson)
No
New York State Psychiatric Institute
New York State Psychiatric Institute
National Alliance for Research on Schizophrenia and Depression
Principal Investigator: Karina W Davidson, PhD Columbia University: Behavioral Cardiovascular Health and Hypertension Program
New York State Psychiatric Institute
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP