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
  Purpose

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


Condition Intervention Phase
Depression
Coronary Artery Disease (CAD)
Acute Coronary Syndrome (ACS)
Drug: Sertraline (Zoloft)
Drug: Simvastatin (Zocor)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Inflammatory Markers, Depressive Symptoms, and Heart Disease

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • 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 ]

Enrollment: 7
Study Start Date: April 2005
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208117

Locations
United States, New York
Columbia University Department of General Medicine
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Karina W Davidson, PhD Columbia University: Behavioral Cardiovascular Health and Hypertension Program
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00208117     History of Changes
Other Study ID Numbers: 4976 (Davidson)
Study First Received: September 15, 2005
Last Updated: May 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
depression
inflammation
heart disease
randomized clinical trial
sertraline
simvastatin
placebo

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Depression
Depressive Disorder
Heart Diseases
Acute Coronary Syndrome
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Sertraline
Simvastatin
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on April 14, 2014