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Trial record 13 of 72 for:    Taste Disorders | NIH

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01625845
Recruitment Status : Completed
First Posted : June 21, 2012
Results First Posted : December 3, 2015
Last Update Posted : December 3, 2015
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Indiana University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Major Depressive Disorder
Depression
Depressive Symptoms
Cardiovascular Disease (CVD)
Coronary Artery Disease (CAD)
Heart Disease
Interventions Drug: Pentoxifylline
Other: Placebo
Behavioral: Standard Treatment
Enrollment 36
Recruitment Details Recruitment was open from June 28, 2012 to February 28, 2014. Participants were recruited from Eskenazi Health and Indiana University Health primary care clinics in Indianapolis. 1369 patients were screened, of whom 36 (2.6%) were eligible and provided informed consent. 16 patients (44%) attended the pre-treatment visit and were randomized.
Pre-assignment Details  
Arm/Group Title Pentoxifylline + Standard Treatment Placebo + Standard Treatment
Hide Arm/Group Description

Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.

Standard Treatment: Beating the Blues (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.

Placebos: 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.

Standard Treatment: Beating the Blues (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.

Period Title: Overall Study
Started 10 6
Completed 5 3
Not Completed 5 3
Reason Not Completed
Adverse Event             1             2
Lost to Follow-up             2             1
Withdrawal by Subject             2             0
Arm/Group Title Pentoxifylline + Standard Treatment Placebo + Standard Treatment Total
Hide Arm/Group Description

Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.

Standard Treatment: Beating the Blues (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.

Placebos: 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.

Standard Treatment: Beating the Blues (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.

Total of all reporting groups
Overall Number of Baseline Participants 10 6 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 6 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  90.0%
6
 100.0%
15
  93.8%
>=65 years
1
  10.0%
0
   0.0%
1
   6.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 6 participants 16 participants
Female
5
  50.0%
4
  66.7%
9
  56.3%
Male
5
  50.0%
2
  33.3%
7
  43.8%
1.Primary Outcome
Title Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment
Hide Description 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
Time Frame 0 and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pentoxifylline + Standard Treatment Placebo + Standard Treatment
Hide Arm/Group Description:

Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.

Standard Treatment: Beating the Blues (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.

Placebos: 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.

Standard Treatment: Beating the Blues (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.

Overall Number of Participants Analyzed 5 3
Mean (Standard Error)
Unit of Measure: % change in brachial diameter
-1.18  (1.48) 0.79  (1.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pentoxifylline + Standard Treatment, Placebo + Standard Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .474
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Change in Depressive Symptoms Severity (Hopkins Symptom Checklist Depression Scale; SCL-20) From Pre- to Post- Treatment
Hide Description 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.
Time Frame 0 and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pentoxifylline + Standard Treatment Placebo + Standard Treatment
Hide Arm/Group Description:

Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.

Standard Treatment: Beating the Blues (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.

Placebos: 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.

Standard Treatment: Beating the Blues (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.

Overall Number of Participants Analyzed 5 3
Mean (Standard Error)
Unit of Measure: Change in Total Score
-0.35  (0.25) -1.41  (0.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pentoxifylline + Standard Treatment, Placebo + Standard Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .068
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Change in Circulating Tumor Necrosis Factor-Alpha (TNF-a) From Pre- to Post-Treatment
Hide Description A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
Time Frame 0 and12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with missing TNF-a data were excluded from this analysis.
Arm/Group Title Pentoxifylline + Standard Treatment Placebo + Standard Treatment
Hide Arm/Group Description:

Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.

Standard Treatment: Beating the Blues (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.

Placebos: 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.

Standard Treatment: Beating the Blues (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.

Overall Number of Participants Analyzed 3 2
Mean (Standard Error)
Unit of Measure: pg/mL
-0.65  (0.08) -0.47  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pentoxifylline + Standard Treatment, Placebo + Standard Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .296
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Change in Circulating Interleukin-6 (IL-6) From Pre- to Post-Treatment
Hide Description A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
Time Frame 0 and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pentoxifylline + Standard Treatment Placebo + Standard Treatment
Hide Arm/Group Description:

Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.

Standard Treatment: Beating the Blues (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.

Placebos: 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.

Standard Treatment: Beating the Blues (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.

Overall Number of Participants Analyzed 5 3
Mean (Standard Error)
Unit of Measure: pg/mL
-0.69  (1.02) 1.84  (1.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pentoxifylline + Standard Treatment, Placebo + Standard Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .203
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change in Circulating Interleukin-10 (IL-10) From Pre- to Post-Treatment
Hide Description An anti-inflammatory cytokine measured from blood samples collected at pre- and post-treatment.
Time Frame 0 and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant, with extreme outlier values at pre- and post-treatment, was excluded from analyses.
Arm/Group Title Pentoxifylline + Standard Treatment Placebo + Standard Treatment
Hide Arm/Group Description:

Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.

Standard Treatment: Beating the Blues (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.

Placebos: 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.

Standard Treatment: Beating the Blues (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.

Overall Number of Participants Analyzed 5 2
Mean (Standard Error)
Unit of Measure: pg/mL
-0.58  (0.34) -0.66  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pentoxifylline + Standard Treatment, Placebo + Standard Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .906
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Change in Interleukin-1ra (IL-1ra) From Pre- to Post-Treatment
Hide Description A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
Time Frame 0 and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pentoxifylline + Standard Treatment Placebo + Standard Treatment
Hide Arm/Group Description:

Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.

Standard Treatment: Beating the Blues (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.

Placebos: 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.

Standard Treatment: Beating the Blues (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.

Overall Number of Participants Analyzed 5 3
Mean (Standard Error)
Unit of Measure: pg/mL
2.32  (75.03) 25.00  (99.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pentoxifylline + Standard Treatment, Placebo + Standard Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .869
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change in Circulating C-Reactive Protein (CRP) From Pre- to Post-Treatment
Hide Description A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
Time Frame 0 and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pentoxifylline + Standard Treatment Placebo + Standard Treatment
Hide Arm/Group Description:

Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.

Standard Treatment: Beating the Blues (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.

Placebos: 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.

Standard Treatment: Beating the Blues (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.

Overall Number of Participants Analyzed 5 3
Mean (Standard Error)
Unit of Measure: mg/L
-0.49  (1.34) 6.44  (1.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pentoxifylline + Standard Treatment, Placebo + Standard Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .026
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
Adverse Event Reporting Description A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant’s provider(s).
 
Arm/Group Title Pentoxifylline + Standard Treatment Placebo + Standard Treatment
Hide Arm/Group Description

Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.

Standard Treatment: Beating the Blues (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.

Placebos: 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.

Standard Treatment: Beating the Blues (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.

All-Cause Mortality
Pentoxifylline + Standard Treatment Placebo + Standard Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pentoxifylline + Standard Treatment Placebo + Standard Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/10 (30.00%)      0/6 (0.00%)    
General disorders     
Complications after removing nodules during endoscopy (Chest pain, esophagitis, dizziness, bleeding)   1/10 (10.00%)  1 0/6 (0.00%)  0
Injury, poisoning and procedural complications     
Hearing issues after explosion   1/10 (10.00%)  1 0/6 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Nasolabial abscess (Facial swelling)   1/10 (10.00%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pentoxifylline + Standard Treatment Placebo + Standard Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/10 (80.00%)      5/6 (83.33%)    
Blood and lymphatic system disorders     
Hemolyzed blood sample   0/10 (0.00%)  0 1/6 (16.67%)  1
Hypercalcemia   1/10 (10.00%)  1 0/6 (0.00%)  0
Abnormalities in the complete blood cell count   0/10 (0.00%)  0 1/6 (16.67%)  1
Impaired fasting glucose   1/10 (10.00%)  1 0/6 (0.00%)  0
Gastrointestinal disorders     
Nausea   2/10 (20.00%)  2 1/6 (16.67%)  1
General disorders     
Flushed   1/10 (10.00%)  1 2/6 (33.33%)  2
Hot flashes   0/10 (0.00%)  0 1/6 (16.67%)  1
Dizziness   3/10 (30.00%)  3 3/6 (50.00%)  3
Facial Pimple   0/10 (0.00%)  0 1/6 (16.67%)  1
Leg swelling   0/10 (0.00%)  0 1/6 (16.67%)  1
Headaches   3/10 (30.00%)  3 0/6 (0.00%)  0
Heartburn   1/10 (10.00%)  1 0/6 (0.00%)  0
Racing heart   1/10 (10.00%)  1 0/6 (0.00%)  0
Red eye   1/10 (10.00%)  1 0/6 (0.00%)  0
Diarrhea   3/10 (30.00%)  3 0/6 (0.00%)  0
Blurred vision   2/10 (20.00%)  2 1/6 (16.67%)  1
Low energy   1/10 (10.00%)  1 0/6 (0.00%)  0
Sleep disturbance   1/10 (10.00%)  1 0/6 (0.00%)  0
Stomach Pain   0/10 (0.00%)  0 1/6 (16.67%)  1
Nervousness / jittery hands   1/10 (10.00%)  1 0/6 (0.00%)  0
Leg pain   1/10 (10.00%)  1 0/6 (0.00%)  0
Back pain   1/10 (10.00%)  1 0/6 (0.00%)  0
Sweating   1/10 (10.00%)  1 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash   1/10 (10.00%)  1 1/6 (16.67%)  1
Indicates events were collected by systematic assessment

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.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jesse C. Stewart, Ph.D.
Organization: Indiana University-Purdue University Indianapolis (IUPUI)
Phone: (317) 274-6761
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01625845     History of Changes
Other Study ID Numbers: 1110007119
R24MH080827 ( U.S. NIH Grant/Contract )
1737 ( Other Identifier: Indiana Clinical Research Center )
First Submitted: June 19, 2012
First Posted: June 21, 2012
Results First Submitted: May 28, 2015
Results First Posted: December 3, 2015
Last Update Posted: December 3, 2015