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

Summary

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.

Conditions

• Major Depressive Disorder
• Depression
• Depressive Symptoms
• Cardiovascular Disease (CVD)
• Coronary Artery Disease (CAD)
• Heart Disease

Interventions

DRUG

Pentoxifylline

Pentoxifylline 400 mg p.o. t.i.d. for 12 weeks

OTHER

Placebo

Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.

BEHAVIORAL

Standard Treatment

BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Indiana University

  lead OTHER

Principal Investigators

• Jesse C Stewart, PhD · Indiana University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-06-30

Primary Completion

2014-05-31

Completion

2014-05-31

Countries

• United States

Study Locations