Anti-INFLammatory to Address Mood and Endothelial Dysfunction (INFLAMED)

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder, Depression, Depressive Symptoms, Cardiovascular Disease (CVD), Coronary Artery Disease (CAD), Heart Disease

In brief

The objective of this clinical trial is to evaluate whether an anti-inflammatory medication, pentoxifylline, reduces depressive symptoms and improves artery function. Participants in this trial will be older primary care patients (60 years and up) who are depressed but do not have a history of cardiovascular disease. Half of these patients will receive pentoxifylline, and half will receive placebo. In addition, participants in both arms will receive an evidence-based psychological treatment called Beating the Blues®, which is a computerized, cognitive behavioral treatment program for depression. The investigators will use questionnaires to assess change in depressive symptoms and an ultrasound test to measure change in artery function from pre- to post-treatment. It is hypothesized that patients who receive pentoxifylline will show greater improvements in both depression and artery function than patients who receive placebo.

Key facts

Study ID

NCT01625845

Run by

Indiana University

People needed

36

Starts

2012-06-01

Expected to finish

2014-05-01

Last updated by the study team

2015-12-03

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary care patients
• Age ≥ 40 years
• Clinically significant depressive symptoms, defined as a PHQ-9 score ≥15
• English speaking

You may not qualify if…

• History of clinical cardiovascular disease
• History of cardiac arrhythmias or cardiomyopathy
• History of carotid bruits
• History of certain chronic disorders (HIV/AIDS, kidney disease, liver disease, systemic inflammatory disease, or past-year cancer)
• History of bleeding disorder, gastrointestinal ulceration or bleeding, cerebrovascular aneurysm or bleeding, or retinal hemorrhage
• History of migraine headaches
• History of Raynaud's phenomenon
• History of bipolar disorder or psychosis
• Current use of anticoagulants or vasodilators (Lipid-lowering antihypertensive medications are allowed.)
• Current use of acetazolamide, anticonvulsants, or thyroid replacements
• Current use of glucocorticoids - including topical, nasal, or oral steroids - or anabolic steroids (Physiologic testosterone replacement therapy is allowed.)
• Current use of anti-inflammatory agents (including, but not limited to, plaquenil, infliximab, etanercept, mycophenolate mofetil, sirolimus, tacrolimus, cyclosporine, pentoxifylline, thalidomide)
• Known allergy or intolerance to pentoxifylline or other methylxanthines, such as , theophylline, caffeine, theobromine
• Known allergy or intolerance to nitroglycerin.
• Severe cognitive impairment (≥3 errors on 6-item cognitive screen105)
• Current alcohol use problem (≥2 on CAGE questionnaire106)
• Very severe depressive symptoms, defined as a PHQ-9 score ≥24
• Acute risk of suicide
• Vision or hearing problems
• Unable to lie flat for 30 minutes at a time
• Therapy for acute infection or other serious medical illnesses within 14 days prior to the pre-treatment visit (Therapy for acute infection or other serious medical illnesses that overlaps with a main study visit will result in postponement of that study visit until the course of therapy is completed; postponement outside of the allowed study visit timeframe will result in study discontinuation.)
• Creatinine clearance < 50mL/min using a serum creatinine level measured at the pre-treatment visit
• Hemoglobin < 9.0mg/dL at the pre-treatment visit
• Alanine aminotransferase (ALT) level or aspartate aminotransferase (AST) > 3 times ULN at the pre-treatment visit
• Total bilirubin > 2.5 times ULN at the pre-treatment visit

Where it is running

• Indiana University-Purdue University Indianapolis (IUPUI) — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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