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

NCT00208117 | Terminated Phase 1

• 1 other identifier: 4976 (Davidson)
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression; Coronary Artery Disease (CAD); Acute Coronary Syndrome (ACS)

Keywords

depression; inflammation; heart disease; randomized clinical trial; sertraline; simvastatin; placebo

Outcome Measures

Primary Outcomes (1)

• Score on Beck Depression Inventory and C-Reactive Protein Level at weeks 4, 8, and 12

  3 months

Study Arms (2)

1

ACTIVE COMPARATOR

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)

2

PLACEBO COMPARATOR

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)

Interventions

Sertraline (Zoloft) DRUG

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.

1

Simvastatin (Zocor) DRUG

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.

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 - 60
• Mild depression
• Inflammatory markers: CRP \> 2

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

Columbia University Department of General Medicine

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depression; Coronary Artery Disease; Acute Coronary Syndrome; Inflammation; Heart Diseases

Interventions

Sertraline; Simvastatin

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Lovastatin

Study Officials

• Karina W Davidson, PhD

  Columbia University: Behavioral Cardiovascular Health and Hypertension Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: May 31, 2012

Record last verified: 2012-05

Locations

US (1)