Phase 2 Completed N=16 Randomized Triple-blind Treatment

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

Major Depressive Disorder · Depression · Depressive Symptoms · Cardiovascular Disease (CVD)

Source: ClinicalTrials.gov NCT01625845 ↗

Enrolled (actual)

Serious AEs

18.8%

Results posted

Dec 2015

Primary outcomePrimary: Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment — -1.18; 0.79 % change in brachial diameter — p=.474

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment	-1.18; 0.79	.474
PRIMARY Change in Depressive Symptoms Severity (Hopkins Symptom Checklist Depression Scale; SCL-20) From Pre- to Post- Treatment	-0.35; -1.41	.068
SECONDARY Change in Circulating Tumor Necrosis Factor-Alpha (TNF-a) From Pre- to Post-Treatment	-0.65; -0.47	.296
SECONDARY Change in Circulating Interleukin-6 (IL-6) From Pre- to Post-Treatment	-0.69; 1.84	.203
SECONDARY Change in Circulating Interleukin-10 (IL-10) From Pre- to Post-Treatment	-0.58; -0.66	.906
SECONDARY Change in Interleukin-1ra (IL-1ra) From Pre- to Post-Treatment	2.32; 25.00	.869
SECONDARY Change in Circulating C-Reactive Protein (CRP) From Pre- to Post-Treatment	-0.49; 6.44	.026 sig

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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 3 times ULN at the pre-treatment visit
Total bilirubin > 2.5 times ULN at the pre-treatment visit
Current evidence of abuse of prescription medications
Current evidence of illicit drug use

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01625845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.