Trial · NCT01625845

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

NCT01625845, Phase 2, Completed, Indiana University; results first posted 2015-12-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Anti-INFLammatory to Address Mood and Endothelial Dysfunction (INFLAMED). Trials, record NCT01625845. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01625845

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Anti-INFLammatory to Address Mood and Endothelial Dysfunction (INFLAMED)
NCT number: NCT01625845
Status: Completed
Phases: Phase 2
Enrollment: 36 participants, actual
Lead sponsor: Indiana University
Conditions: Major Depressive Disorder, Depression, Depressive Symptoms, Cardiovascular Disease (CVD), Coronary Artery Disease (CAD), Heart Disease
Interventions: Pentoxifylline, Placebo, Standard Treatment
First posted: 2012-06-21
Last updated: 2015-12-03
Results first posted: 2015-12-03
Limitations and caveats: Missing data precluded analysis of two secondary outcome variables: IL-1α and IL-1β.~Due to the very small sample of randomized patients, conclusions should not be drawn from the results of this pilot trial.

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment	0 and 12 weeks	Patients underwent ultrasound assessment of brachial FMD in accordance with established guidelines at pre- (0 weeks) and post- (12 weeks) treatment. After a 10-minute supine rest, high-resolution baseline images of the brachial artery were obtained from 3 consecutive cardiac cycles. Next, the forearm cuff was inflated to 250 mmHg for 5 minutes and then was rapidly deflated. At 60 and 90 seconds post-deflation, images from 3 consecutive cardiac cycles were acquired. FMD values were computed as the % change in brachial diameter at either 60 or 90 seconds after cuff deflation
Primary	Change in Depressive Symptoms Severity (Hopkins Symptom Checklist Depression Scale; SCL-20) From Pre- to Post- Treatment	0 and 12 weeks	Self-reported depressive symptom severity was measured at pre- (0 weeks) and post- (12 weeks) treatment visits by the 20 depression items from the Symptom Checklist 90 (Hopkins Symptom Checklist depression scale; SCL-20). Each item on the scale ranges from 0 (not at all) to 4 (extremely). Total scores are the average across all response items and range from 0 to 4 with higher scores indicating greater levels of depressive symptoms.
Secondary	Change in Circulating Tumor Necrosis Factor-Alpha (TNF-a) From Pre- to Post-Treatment	0 and12 weeks	A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
Secondary	Change in Circulating Interleukin-6 (IL-6) From Pre- to Post-Treatment	0 and 12 weeks	A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
Secondary	Change in Circulating Interleukin-10 (IL-10) From Pre- to Post-Treatment	0 and 12 weeks	An anti-inflammatory cytokine measured from blood samples collected at pre- and post-treatment.
Secondary	Change in Interleukin-1ra (IL-1ra) From Pre- to Post-Treatment	0 and 12 weeks	A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
Secondary	Change in Circulating C-Reactive Protein (CRP) From Pre- to Post-Treatment	0 and 12 weeks	A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment	0 and 12 weeks		% change in brachial diameter	MEAN
PRIMARY	Change in Depressive Symptoms Severity (Hopkins Symptom Checklist Depression Scale; SCL-20) From Pre- to Post- Treatment	0 and 12 weeks		Change in Total Score	MEAN
SECONDARY	Change in Circulating Tumor Necrosis Factor-Alpha (TNF-a) From Pre- to Post-Treatment	0 and12 weeks	Participants with missing TNF-a data were excluded from this analysis.	pg/mL	MEAN
SECONDARY	Change in Circulating Interleukin-6 (IL-6) From Pre- to Post-Treatment	0 and 12 weeks		pg/mL	MEAN
SECONDARY	Change in Circulating Interleukin-10 (IL-10) From Pre- to Post-Treatment	0 and 12 weeks	One participant, with extreme outlier values at pre- and post-treatment, was excluded from analyses.	pg/mL	MEAN
SECONDARY	Change in Interleukin-1ra (IL-1ra) From Pre- to Post-Treatment	0 and 12 weeks		pg/mL	MEAN
SECONDARY	Change in Circulating C-Reactive Protein (CRP) From Pre- to Post-Treatment	0 and 12 weeks		mg/L	MEAN

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment	Pentoxifylline + Standard Treatment	-1.18	Standard Error 1.48	% change in brachial diameter
Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment	Placebo + Standard Treatment	0.79	Standard Error 1.95	% change in brachial diameter
Change in Depressive Symptoms Severity (Hopkins Symptom Checklist Depression Scale; SCL-20) From Pre- to Post- Treatment	Pentoxifylline + Standard Treatment	-0.35	Standard Error 0.25	Change in Total Score
Change in Depressive Symptoms Severity (Hopkins Symptom Checklist Depression Scale; SCL-20) From Pre- to Post- Treatment	Placebo + Standard Treatment	-1.41	Standard Error 0.34	Change in Total Score
Change in Circulating Tumor Necrosis Factor-Alpha (TNF-a) From Pre- to Post-Treatment	Pentoxifylline + Standard Treatment	-0.65	Standard Error 0.08	pg/mL
Change in Circulating Tumor Necrosis Factor-Alpha (TNF-a) From Pre- to Post-Treatment	Placebo + Standard Treatment	-0.47	Standard Error 0.10	pg/mL
Change in Circulating Interleukin-6 (IL-6) From Pre- to Post-Treatment	Pentoxifylline + Standard Treatment	-0.69	Standard Error 1.02	pg/mL
Change in Circulating Interleukin-6 (IL-6) From Pre- to Post-Treatment	Placebo + Standard Treatment	1.84	Standard Error 1.34	pg/mL
Change in Circulating Interleukin-10 (IL-10) From Pre- to Post-Treatment	Pentoxifylline + Standard Treatment	-0.58	Standard Error 0.34	pg/mL
Change in Circulating Interleukin-10 (IL-10) From Pre- to Post-Treatment	Placebo + Standard Treatment	-0.66	Standard Error 0.54	pg/mL

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pentoxifylline + Standard Treatment	10
Overall Study	STARTED	Placebo + Standard Treatment	6
Overall Study	COMPLETED	Pentoxifylline + Standard Treatment	5
Overall Study	COMPLETED	Placebo + Standard Treatment	3
Overall Study	NOT COMPLETED	Pentoxifylline + Standard Treatment	5
Overall Study	NOT COMPLETED	Placebo + Standard Treatment	3

Source ClinicalTrials.gov

Adverse events54

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hemolyzed blood sample	Blood and lymphatic system disorders	Pentoxifylline + Standard Treatment	0	10	0
other	Hemolyzed blood sample	Blood and lymphatic system disorders	Placebo + Standard Treatment	1	6	1
other	Flushed	General disorders	Pentoxifylline + Standard Treatment	1	10	1
other	Flushed	General disorders	Placebo + Standard Treatment	2	6	2
other	Hot flashes	General disorders	Pentoxifylline + Standard Treatment	0	10	0
other	Hot flashes	General disorders	Placebo + Standard Treatment	1	6	1
other	Dizziness	General disorders	Pentoxifylline + Standard Treatment	3	10	3
other	Dizziness	General disorders	Placebo + Standard Treatment	3	6	3
other	Facial Pimple	General disorders	Pentoxifylline + Standard Treatment	0	10	0
other	Facial Pimple	General disorders	Placebo + Standard Treatment	1	6	1

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pentoxifylline + Standard Treatment
Total, all-cause mortality	Placebo + Standard Treatment
Total, other adverse events	Pentoxifylline + Standard Treatment	8	10
Total, other adverse events	Placebo + Standard Treatment	5	6
Total, serious adverse events	Pentoxifylline + Standard Treatment	3	10
Total, serious adverse events	Placebo + Standard Treatment	0	6

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R24MH080827	Indianapolis Interventions and Practice Research Infrastructure Program	CALLAHAN, CHRISTOPHER M	INDIANA UNIVERSITY INDIANAPOLIS	NATIONAL INSTITUTE OF MENTAL HEALTH	2008 to 2012

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Pentoxifylline + Standard Treatment vs Placebo + Standard Treatment: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01625845

GET https://conductscience.org/api/trials/v1/NCT01625845/events?page=2

API reference For AI assistants