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

PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

May 31, 2014

Study Completion Date

May 31, 2014

Conditions
Major Depressive DisorderDepressionDepressive SymptomsCardiovascular 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.

Trial Locations (1)

46202

Indiana University-Purdue University Indianapolis (IUPUI), Indianapolis

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Indiana University

OTHER

NCT01625845 - Anti-INFLammatory to Address Mood and Endothelial Dysfunction (INFLAMED) | Biotech Hunter | Biotech Hunter